Bacternil may be available in the countries listed below.
Sulfadiazine silver (a derivative of Sulfadiazine) is reported as an ingredient of Bacternil in the following countries:
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Deltacortenesol may be available in the countries listed below.
Prednisolone 21-(sodium succinate) (a derivative of Prednisolone) is reported as an ingredient of Deltacortenesol in the following countries:
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CO Amlodipine may be available in the countries listed below.
Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of CO Amlodipine in the following countries:
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In the US, Oncaspar (pegaspargase systemic) is a member of the drug class miscellaneous antineoplastics and is used to treat Acute Lymphoblastic Leukemia.
US matches:
Gadodiamide is reported as an ingredient of Oncaspar in the following countries:
Pegaspargase is reported as an ingredient of Oncaspar in the following countries:
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Tazepam may be available in the countries listed below.
Oxazepam is reported as an ingredient of Tazepam in the following countries:
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Spiramycine Métronidazole Winthrop may be available in the countries listed below.
Metronidazole is reported as an ingredient of Spiramycine Métronidazole Winthrop in the following countries:
Spiramycin is reported as an ingredient of Spiramycine Métronidazole Winthrop in the following countries:
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Torasemide Sandoz may be available in the countries listed below.
Torasemide is reported as an ingredient of Torasemide Sandoz in the following countries:
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Bocouture may be available in the countries listed below.
Botulinum A Toxin is reported as an ingredient of Bocouture in the following countries:
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Ther may be available in the countries listed below.
Tegaserod maleate (a derivative of Tegaserod) is reported as an ingredient of Ther in the following countries:
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Diabetol may be available in the countries listed below.
Tolbutamide is reported as an ingredient of Diabetol in the following countries:
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Nufatrac may be available in the countries listed below.
Itraconazole is reported as an ingredient of Nufatrac in the following countries:
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NF
B05AA06
0009000-70-8
Pharmaceutic aid
Plasmaexpander
Hemostatic agent, local
International Drug Name Search
Glossary
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| NF | The National Formulary (USA) |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
Terbinafin Nordic Drugs may be available in the countries listed below.
Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terbinafin Nordic Drugs in the following countries:
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Neutraflux may be available in the countries listed below.
Domperidone is reported as an ingredient of Neutraflux in the following countries:
Esomeprazole magnesium, trihydrate (a derivative of Esomeprazole) is reported as an ingredient of Neutraflux in the following countries:
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Zetia is a brand name of ezetimibe, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Zetia available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zetia. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Vincristin-Teva may be available in the countries listed below.
Vincristine sulfate (a derivative of Vincristine) is reported as an ingredient of Vincristin-Teva in the following countries:
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Dany may be available in the countries listed below.
Domperidone is reported as an ingredient of Dany in the following countries:
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Clozapina Chiesi may be available in the countries listed below.
Clozapine is reported as an ingredient of Clozapina Chiesi in the following countries:
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Femenil A may be available in the countries listed below.
Tibolone is reported as an ingredient of Femenil A in the following countries:
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Zarin may be available in the countries listed below.
Miconazole nitrate (a derivative of Miconazole) is reported as an ingredient of Zarin in the following countries:
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Pantosil may be available in the countries listed below.
Pantoprazole is reported as an ingredient of Pantosil in the following countries:
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Vibral may be available in the countries listed below.
Dropropizine is reported as an ingredient of Vibral in the following countries:
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Haemato-tron may be available in the countries listed below.
Mitoxantrone dihydrochloride (a derivative of Mitoxantrone) is reported as an ingredient of Haemato-tron in the following countries:
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Tussycalm may be available in the countries listed below.
Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Tussycalm in the following countries:
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Tostop may be available in the countries listed below.
Bromhexine is reported as an ingredient of Tostop in the following countries:
Bromhexine hydrochloride (a derivative of Bromhexine) is reported as an ingredient of Tostop in the following countries:
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Cec Hexal may be available in the countries listed below.
Cefaclor monohydrate (a derivative of Cefaclor) is reported as an ingredient of Cec Hexal in the following countries:
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Scalphen may be available in the countries listed below.
Mesulfen is reported as an ingredient of Scalphen in the following countries:
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Steramina may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Benzalkonium chloride (a derivative of Benzalkonium) is reported as an ingredient of Steramina in the following countries:
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Ezosina may be available in the countries listed below.
Terazosin is reported as an ingredient of Ezosina in the following countries:
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In some countries, this medicine may only be approved for veterinary use.
In the US, Tolazoline is a member of the drug class miscellaneous cardiovascular agents.
Rec.INN
C04AB02,M02AX02
0000059-98-3
C10-H12-N2
160
Vasodilator, peripheric
α-Adrenergic blocking agent
1H-Imidazole, 4,5-dihydro-2-(phenylmethyl)-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Heparin-Natrium-ratiopharm may be available in the countries listed below.
Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Heparin-Natrium-ratiopharm in the following countries:
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Generic Name: isometheptene, dichloralphenazone, and acetaminophen (Oral route)
eye-soe-meth-EP-teen MUE-kate, dye-klor-al-FEN-a-zone, a-seet-a-MIN-oh-fen
In the U.S.
Available Dosage Forms:
Therapeutic Class: Acetaminophen Combination
Pharmacologic Class: Isometheptene
Isometheptene, dichloralphenazone, and acetaminophen combination is used to treat certain kinds of headaches, such as “tension” headaches and migraine headaches. This combination is not used regularly (for example, every day) to prevent headaches. It should be taken only after headache pain begins, or after a warning sign that a migraine is coming appears. Isometheptene helps to relieve throbbing headaches, but it is not an ordinary pain reliever. Dichloralphenazone helps you to relax, and acetaminophen relieves pain.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Studies with this medicine have been done only in adult patients, and there is no specific information about its use in children.
Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of this combination medicine in the elderly with use in other age groups.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain isometheptene, dichloralphenazone, and acetaminophen. It may not be specific to Duradrin. Please read with care.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often than directed, and do not take it every day for several days in a row. If the amount you are to take does not relieve your headache, check with your doctor. If a headache medicine is used too often, it may lose its effectiveness or even cause a type of physical dependence. If this occurs, your headaches may actually get worse. Also, taking too much acetaminophen can cause liver damage.
This medicine works best if you:
People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor's directions, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve, than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Check with your doctor:
Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. Taking other medicines that contain acetaminophen together with this medicine may lead to an overdose. If you have any questions about this, check with your health care professional.
This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. These effects may be especially severe if you also take CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness) together with this medicine. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; antiemetics (medicines that prevent or relieve nausea or vomiting), and anesthetics. If you are not able to lie down for a while, make sure you know how you react to this medicine or combination of medicines before you drive, use machines, or do anything else that could be dangerous if you are drowsy or dizzy or are not alert.
Do not drink alcoholic beverages while taking this medicine. To do so may increase the chance of liver damage caused by acetaminophen, especially if you drink large amounts of alcoholic beverages regularly. Also, because drinking alcoholic beverages may make your headaches worse or cause new headaches to occur, people who often get headaches should probably avoid alcohol.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Duradrin side effects (in more detail)
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Elstatin may be available in the countries listed below.
Lovastatin is reported as an ingredient of Elstatin in the following countries:
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Generic Name: repaglinide (oral) (re PAG li nide)
Brand Names: Prandin
Repaglinide is an oral diabetes medicine that helps control blood sugar levels. This medication lowers blood sugar by causing the pancreas to produce insulin.
Repaglinide is used together with diet and exercise to treat type 2 diabetes. Other diabetes medicines are sometimes used in combination with repaglinide if needed.
Repaglinide may also be used for purposes not listed in this medication guide.
Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.
Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss. Your blood sugar will need to be checked often, and you may need to adjust your repaglinide dose.
Repaglinide is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.
To make sure you can safely take repaglinide, tell your doctor if you have liver disease.
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Repaglinide is usually taken 2 to 4 times daily, within 30 minutes before eating a meal. Follow your doctor's instructions. If you skip a meal, do not take your dose of repaglinide. Wait until your next meal.
Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.
Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.
Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.
Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.
Your doctor may want you to stop taking repaglinide for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.
Repaglinide is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.
Use repaglinide regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
See also: Repaglinide dosage (in more detail)
Take the missed dose as soon as you remember, but only if you are getting ready to eat a meal. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).
seizure (convulsions);
severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
pale or yellowed skin, dark colored urine, fever, confusion or weakness; or
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.
Less serious side effects may include:
runny or stuffy nose, sneezing, cough, cold or flu symptoms;
diarrhea, nausea;
back pain, headache;
dizziness;
blurred vision;
joint pain; or
temporary hair loss.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Diabetes Mellitus Type II:
Patients who have not previously taken an oral hypoglycemic or patients who have an HbA1c less than 8%: 0.5 mg orally with meals.
Patients previously treated with an oral hypoglycemic or patients who have an HbA1c greater than or equal to 8%: 1 to 2 mg orally with meals.
All doses should be taken within 15 minutes of the meal or as much as 30 minutes before the meal. If a meal is skipped, the repaglinide dose should also be skipped. Likewise, if a meal is added during the day, so should a dose of repaglinide.
cyclosporine (Gengraf, Neoral, Sandimmune);
St. John's wort;
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);
an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral);
a barbiturate such as phenobarbital (Solfoton);
heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nicardipine (Cardene), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;
HIV/AIDS medicine such as delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), fosamprenavir (Lexiva), indinavir (Crixivan), ritonavir (Norvir), and others;
rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin); or
seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), primidone (Mysoline), and others.
You may be more likely to have hyperglycemia (high blood sugar) if you are taking repaglinide with other drugs that raise blood sugar, such as:
isoniazid;
diuretics (water pills);
steroids (prednisone and others);
phenothiazines (Compazine and others);
thyroid medicine (Synthroid and others);
birth control pills and other hormones;
seizure medicines (Dilantin and others); and
diet pills or medicines to treat asthma, colds or allergies.
You may be more likely to have hypoglycemia (low blood sugar) if you are taking other drugs that lower blood sugar, such as:
probenecid (Benemid);
some nonsteroidal anti-inflammatory drugs (NSAIDs);
aspirin or other salicylates (including Pepto-Bismol);
a blood thinner (warfarin, Coumadin, Jantoven, and others);
sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others);
a monoamine oxidase inhibitor (MAOI); or
other oral diabetes medications, especially acarbose (Precose), metformin (Glucophage), miglitol (Glyset), pioglitazone (Actos, Duetact, Actoplus Met), or rosiglitazone (Avandia, Avandaryl, Avandamet).
These lists are not complete and there are many other medicines that can increase or decrease the effects of repaglinide on lowering your blood sugar. Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: repaglinide side effects (in more detail)
Tranxène may be available in the countries listed below.
Dipotassium Clorazepate is reported as an ingredient of Tranxène in the following countries:
International Drug Name Search
Cromiton may be available in the countries listed below.
Crotamiton is reported as an ingredient of Cromiton in the following countries:
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Triamcinolonacetonide A may be available in the countries listed below.
Triamcinolone 16α,17α-acetonide (a derivative of Triamcinolone) is reported as an ingredient of Triamcinolonacetonide A in the following countries:
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Prednisona Iqfarma may be available in the countries listed below.
Prednisone is reported as an ingredient of Prednisona Iqfarma in the following countries:
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Tetracycline HCl PCH may be available in the countries listed below.
Tetracycline hydrochloride (a derivative of Tetracycline) is reported as an ingredient of Tetracycline HCl PCH in the following countries:
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Diemil may be available in the countries listed below.
Dihydroergocristine mesilate (a derivative of Dihydroergocristine) is reported as an ingredient of Diemil in the following countries:
Piracetam is reported as an ingredient of Diemil in the following countries:
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In some countries, this medicine may only be approved for veterinary use.
Poloxalene is reported as an ingredient of Therabloat in the following countries:
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Butomidor may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Butorphanol tartrate (a derivative of Butorphanol) is reported as an ingredient of Butomidor in the following countries:
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Diamalin may be available in the countries listed below.
Tretinoin is reported as an ingredient of Diamalin in the following countries:
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Ceruxim may be available in the countries listed below.
Cefuroxime sodium salt (a derivative of Cefuroxime) is reported as an ingredient of Ceruxim in the following countries:
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Bicalutamida Winthrop may be available in the countries listed below.
Bicalutamide is reported as an ingredient of Bicalutamida Winthrop in the following countries:
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Potasio may be available in the countries listed below.
Potassium Chloride is reported as an ingredient of Potasio in the following countries:
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Butacaina may be available in the countries listed below.
Butacaina (DCIT) is also known as Butacaine (Rec.INN)
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Glossary
| DCIT | Denominazione Comune Italiana |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Theophylline sodium acetate may be available in the countries listed below.
Theophylline sodium acetate (JAN) is known as Theophylline in the US.
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
Sandoz Glimepiride may be available in the countries listed below.
Glimepiride is reported as an ingredient of Sandoz Glimepiride in the following countries:
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Krenosin may be available in the countries listed below.
Adenosine is reported as an ingredient of Krenosin in the following countries:
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Natriumnitrit may be available in the countries listed below.
Natriumnitrit (IUPAC) is known as Sodium Nitrite in the US.
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Glossary
| IUPAC | International Union of Pure and Applied Chemistry |
Tokovit may be available in the countries listed below.
Tocopherol, α- is reported as an ingredient of Tokovit in the following countries:
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Syntostigmin may be available in the countries listed below.
Neostigmine bromide (a derivative of Neostigmine) is reported as an ingredient of Syntostigmin in the following countries:
Neostigmine metilsulfate (a derivative of Neostigmine) is reported as an ingredient of Syntostigmin in the following countries:
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Mebendazol Best may be available in the countries listed below.
Mebendazole is reported as an ingredient of Mebendazol Best in the following countries:
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Tetradar may be available in the countries listed below.
Tetracycline complex with sodium metaphosphate (a derivative of Tetracycline) is reported as an ingredient of Tetradar in the following countries:
Tetracycline hydrochloride (a derivative of Tetracycline) is reported as an ingredient of Tetradar in the following countries:
International Drug Name Search
Cipromed may be available in the countries listed below.
Ciprofloxacin is reported as an ingredient of Cipromed in the following countries:
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Cipromed in the following countries:
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Losartan Uxa may be available in the countries listed below.
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Losartan Uxa in the following countries:
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Ambroxol Ratiopharm Conseil may be available in the countries listed below.
Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Ambroxol Ratiopharm Conseil in the following countries:
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Norflox may be available in the countries listed below.
Norfloxacin is reported as an ingredient of Norflox in the following countries:
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Teva-Paclitaxel may be available in the countries listed below.
Paclitaxel is reported as an ingredient of Teva-Paclitaxel in the following countries:
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Unguento Callicida Naion may be available in the countries listed below.
Lactic Acid is reported as an ingredient of Unguento Callicida Naion in the following countries:
Salicylic Acid is reported as an ingredient of Unguento Callicida Naion in the following countries:
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Daiyavitan may be available in the countries listed below.
Fursultiamine is reported as an ingredient of Daiyavitan in the following countries:
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Maxidauno may be available in the countries listed below.
Daunorubicin hydrochloride (a derivative of Daunorubicin) is reported as an ingredient of Maxidauno in the following countries:
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Troken may be available in the countries listed below.
Clopidogrel hydrogen sulfate (a derivative of Clopidogrel) is reported as an ingredient of Troken in the following countries:
International Drug Name Search
Ergolan may be available in the countries listed below.
Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of Ergolan in the following countries:
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Neosynephrine may be available in the countries listed below.
Phenylephrine hydrochloride (a derivative of Phenylephrine) is reported as an ingredient of Neosynephrine in the following countries:
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Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: Immunoglobulin G 1 (human-mouse monoclonal rhuMAb-VEGF γ-chain anti-human vascular endothelial growth factor), disulfide with human-mouse monoclonal rhuMAb-VEGF light chain, dimer
Molecular Formula: C6638H10160N1720O2108S44
CAS Number: 216974-75-3
Brands: Avastin
GI perforation reported in 0.3–2.4% of patients receiving bevacizumab; may be fatal.a If GI perforation occurs, discontinue bevacizumab permanently.a (See GI Perforations under Cautions.)
Increased incidence of surgical and wound healing complications; may be serious and fatal.a Discontinue bevacizumab if wound dehiscence occurs.a (See Wound Healing Complications under Cautions.)
Appropriate interval between discontinuance of bevacizumab and subsequent elective surgery required to decrease risk of wound dehiscence not established.a However, manufacturer recommends discontinuing therapy ≥28 days prior to elective surgery and resuming therapy only after surgical incision has fully healed.a
Do not initiate therapy until ≥28 days following major surgery and after surgical incision has fully healed.a
Severe, sometimes fatal hemorrhagic events (e.g., hemoptysis, epistaxis, GI hemorrhage, CNS hemorrhage, vaginal hemorrhage) reported.a Do not administer to patients with serious hemorrhage or recent hemoptysis.a (See Hemorrhage under Cautions.)
Antineoplastic agent; a recombinant humanized monoclonal antibody.1 2 3 4 5
Used in combination with IV fluorouracil-based chemotherapy for the first-line treatment of metastatic cancer of the colon or rectum.1 2 3 4 9 Analysis of pooled data suggests that use of bevacizumab in combination with fluorouracil and leucovorin is associated with prolonged survival.20
Has also been used in combination with oxaliplatin-containing regimens as first-line therapy for metastatic colorectal cancer†.38
Used in combination with IV fluorouracil-based chemotherapy for the second-line treatment of previously treated metastatic cancer of the colon or rectum.1 Interim analysis of data from one study indicated bevacizumab monotherapy† was associated with decreased survival compared with combination regimen consisting of fluorouracil, leucovorin, and oxaliplatin.1
Under investigation for use as adjuvant therapy following surgery for early-stage (i.e., stage I or II) colon cancer†.28
Used in combination with carboplatin and paclitaxel for first-line treatment of unresectable, locally advanced, recurrent or metastatic nonsquamous NSCLC.1 10 11 33 d e
Some clinicians consider combination of bevacizumab, carboplatin, and paclitaxel as a regimen of choice in the initial treatment of advanced NSCLC for eligible patients (i.e., performance status of 0–2, nonsquamous histology, no history of hemoptysis, absence of CNS metastases, and no concomitant anticoagulant therapy).27
Used in combination with paclitaxel for initial treatment of metastatic HER2-negative breast cancer.1 Efficacy is based on prolonged progression-free survival; currently, no data available that demonstrate prolonged overall survival or amelioration of disease-related symptoms.1 In December 2010, after reviewing data from 4 clinical studies, FDA recommended to remove this indication from bevacizumab’s approved labeling because of lack of benefit on overall survival and unfavorable risk-benefit ratio.58 59 60 A public hearing was held on June 28–29, 2011.61 FDA’s final decision regarding approval status for this indication was pending at the time this drug monograph was finalized for publication.
Bevacizumab is not indicated for use in the treatment of breast cancer that has progressed following the use of an anthracycline and taxane regimen for metastatic disease.1
Used as a single agent for treatment of glioblastoma in patients whose disease has progressed following previous therapy.a Efficacy is based on increased objective response rate; currently, no data available that demonstrate prolonged overall survival or amelioration of disease-related symptoms.a
Used in combination with interferon alfa for treatment of metastatic renal cell carcinoma.a
Under investigation for use in treatment of ovarian cancer†.26
Under investigation for use in treatment of prostate cancer†.23 24
Has been used by intravitreal injection† in treatment of neovascular age-related macular degeneration†.34
Use in combination with other chemotherapeutic agents.1 (See Dosage under Dosage and Administration.)
Do not initiate therapy until ≥28 days following major surgery and after surgical incision has fully healed.1 (See Wound Healing Complications under Cautions.)
Discontinue therapy ≥28 days prior to elective surgery; do not resume until surgical incision is fully healed.1 (See Wound Healing Complications under Cautions.)
For solution and drug compatibility information, see Compatibility under Stability.
Administer by IV infusion.1 Do not administer by rapid IV injection (e.g., IV push or bolus.1
Do not shake vial prior to dilution.1
Withdraw appropriate dose of bevacizumab and dilute in 100 mL of 0.9% sodium chloride.1 Do not administer or mix with dextrose solutions.1
Administer initial dose over 90 minutes.1 (See Infusion Reactions under Cautions.)
If well tolerated, administer second dose over 60 minutes.1
If second dose is well tolerated, administer subsequent doses over 30 minutes.1
Has been administered safely over shorter infusion times (0.5 mg/kg per minute).43
Consult respective manufacturers or published protocols for dosage, method of administration, and administration sequence of drugs in combination regimens.3
5 mg/kg every 14 days; continue until disease progression or unacceptable toxicity occurs.1
Use in combination with IV fluorouracil-based chemotherapy.1 In clinical studies, bevacizumab was used in combination with the IFL regimen (irinotecan 125 mg/m2, fluorouracil 500 mg/m2, and leucovorin 20 mg/m2, administered by IV injection once weekly for 4 out of every 6 weeks)1 4 or the 5-FU/LV regimen (leucovorin 500 mg/m2 by IV infusion over 2 hours, then fluorouracil 500 mg/m2 by slow IV injection [1 hour after initiation of leucovorin] given once weekly for the first 6 weeks out of every 8-week cycle).1 2 3
10 mg/kg every 14 days; continue until disease progression or unacceptable toxicity occurs.1
Use in combination with IV fluorouracil-based chemotherapy.1 In clinical studies, bevacizumab was administered on day 1 of the treatment cycle prior to the FOLFOX4 regimen (oxaliplatin 85 mg/m2 and leucovorin 200 mg/m2 concurrently IV, then fluorouracil 400 mg/m2 by direct IV injection, followed by fluorouracil 600 mg/m2 by continuous IV infusion on day 1; and leucovorin 200 mg/m2 IV, then fluorouracil 400 mg/m2 by direct IV injection, followed by fluorouracil 600 mg/m2 by continuous IV infusion on day 2; treatment cycles repeated every 2 weeks).1
15 mg/kg every 3 weeks; continue until disease progression or unacceptable toxicity occurs.1 e f
Use in combination with IV paclitaxel and carboplatin (PC regimen).1 f In clinical studies, bevacizumab was administered 1 hour after the PC regimen (paclitaxel 200 mg/m2 by IV infusion over 3 hours, then carboplatin [at dose required to obtain AUC of 6 mg/mL per minute] by IV infusion over 15–30 minutes beginning 60 minutes after completion of paclitaxel; treatment cycles repeated every 3 weeks).1 11 d e f In these studies, patients received up to 6 cycles of bevacizumab in combination with the PC regimen, after which bevacizumab monotherapy (15 mg/kg every 3 weeks) was continued until disease progression or unacceptable toxicity occurred.1 11 d e f A median of 7 treatment cycles (including cycles of bevacizumab monotherapy) was administered.11
10 mg/kg every 14 days; continue until disease progression or unacceptable toxicity occurs.1
Use in combination with IV paclitaxel (90 mg/m2 IV once weekly for 3 out of 4 weeks).1
10 mg/kg every 14 days; continue until disease progression or unacceptable toxicity occurs.1
10 mg/kg every 14 days; continue until disease progression or unacceptable toxicity occurs.1
Use in combination with interferon alfa (9 million units sub-Q 3 times weekly).a
Dosage reductions not recommended in any patient;1 instead, temporarily or permanently discontinue therapy based on causality.1
Discontinue therapy permanently if GI perforation (i.e., GI perforation, fistula formation in GI tract, intra-abdominal abscess), fistula formation involving an internal organ, wound dehiscence (requiring medical intervention), severe bleeding (requiring medical intervention), severe arterial thromboembolic event, nephrotic syndrome, hypertensive crisis, or hypertensive encephalopathy occurs.1 7
Discontinue therapy if reversible posterior leukoencephalopathy syndrome (RPLS) occurs.1 31 32 a (See Reversible Posterior Leukoencephalopathy Syndrome [RPLS] under Cautions.) Risk of reinitiating therapy in patients previously experiencing RPLS not known.1 32
Discontinue therapy temporarily in patients with evidence of moderate to severe proteinuria pending further evaluation, in patients with severe hypertension not controlled by medical management, or in patients with severe infusion reactions.1 (See Cautions.)
No dosage adjustment required in geriatric patients.1
None.1 3
Consider the usual cautions, precautions, and contraindications of any other antineoplastic agents included in the therapeutic regimen.3
Potentially fatal GI perforation reported; generally manifested as abdominal pain, nausea, vomiting, constipation, and/or fever; usually occurs within the first 50 days following initiation of bevacizumab.1 3 a
GI perforation sometimes associated with or complicated by fistula formation (see Fistula Formation under Cautions) and/or intra-abdominal abscess.1 4 a
If GI perforation occurs, discontinue bevacizumab permanently.1
Impaired wound healing, bleeding complications, and/or wound dehiscence, sometimes fatal, reported.1 Discontinue bevacizumab in patients with wound healing complications requiring medical intervention.a (See Boxed Warning.)
Do not initiate therapy until ≥28 days following major surgery and after surgical incision has fully healed.1
Discontinue bevacizumab ≥28 days prior to elective surgery.1 a Appropriate interval between discontinuance of bevacizumab and subsequent elective surgery not established, but consider long half-life of bevacizumab.1 (See Half-life under Pharmacokinetics.) Manufacturer recommends resuming therapy only after surgical incision has fully healed.1
Severe, sometimes fatal, hemorrhagic events (e.g., pulmonary hemorrhage, hemoptysis, hematemesis, epistaxis, severe GI hemorrhage, CNS hemorrhage, intracranial hemorrhage) reported.1 (See Boxed Warning.)
Risk of severe pulmonary hemorrhage in patients with non-small cell lung cancer.a Serious or fatal pulmonary hemorrhage reported in 31% of patients with squamous cell histology and in 4% of patients with non-squamous cell histology.a
Risk of CNS hemorrhage in patients with CNS metastases.a Intracranial hemorrhage reported in patients with glioblastoma.a
Mild hemorrhagic events, most commonly grade 1 epistaxis, also reported.1
Do not administer to patients with recent hemoptysis (≥½ teaspoon of red blood).1 If severe hemorrhage (i.e., requiring medical intervention) occurs, discontinue therapy and manage aggressively.1
Serious, sometimes fatal, arterial thromboembolic events (e.g., cerebral infarction, TIA, MI, angina) reported.1 7 8 16 17 Increased risk in patients with a history of arterial thromboembolic events or patients ≥65 years of age.1 7 Weigh risks against benefits of therapy.17 Discontinue therapy permanently if severe arterial thromboembolic event occurs;1 7 safety of resuming therapy after resolution of an arterial thromboembolic event not studied.1
Grade 3 or 4 venous thromboembolic events (e.g., DVT, intra-abdominal venous thrombosis) reported.1 Increased risk of developing second thromboembolic event reported in patients with metastatic colorectal cancer receiving bevacizumab with chemotherapy despite use of full-dose warfarin therapy following an initial venous thromboembolic event.1
Severe hypertension (grade 3 or 4) reported.1 Complications include potentially fatal hypertensive encephalopathy and CNS hemorrhage.1
Monitor BP every 2–3 weeks or more frequently if hypertension develops.1 Hypertension may respond to antihypertensive therapy.1 6 Temporarily discontinue therapy in patients with severe hypertension not controlled with medical management.1 If therapy is discontinued because of hypertension, monitor BP at regular intervals thereafter.1 Discontinue therapy permanently if hypertensive crisis or hypertensive encephalopathy occurs.1
RPLS (a brain-capillary leak syndrome) reported.1 29 30 32 May manifest with headache, seizure, lethargy, confusion, blindness, and other visual and neurologic disturbances; mild to severe hypertension also may occur.1 32 Manifestations occurred from 16 hours to 1 year after initiation of bevacizumab.1 32 Magnetic resonance imaging (MRI) is necessary to confirm diagnosis of RPLS.1 32
Closely monitor and maintain strict control of BP during and following bevacizumab infusion.30 If RPLS develops, discontinue bevacizumab and initiate treatment of hypertension as clinically indicated.1 31 32 Symptoms usually lessen or resolve within days of drug discontinuance, but some patients have experienced ongoing neurologic sequelae.1 32 Risk of reinitiating bevacizumab in patients previously experiencing RPLS not known.1 32
Severe neutropenia, febrile neutropenia, and serious infection (including pneumonia, catheter infections, and wound infections), sometimes fatal, reported at higher incidence in patients receiving bevacizumab in combination with chemotherapy compared with those receiving chemotherapy alone.1
Increased incidence and severity of proteinuria reported.1 Severity ranges from clinically silent to nephrotic syndrome.6 Proteinuria with findings of thrombotic microangiopathy on renal biopsy reported in patients receiving bevacizumab alone or in combination with other antineoplastic agents for various cancers.37
Monitor patients for development or worsening of proteinuria with serial urinalysis.1 Further assessment (e.g., 24-hour urine collection) recommended if ≥2+ urine dipstick reading occurs.a Interrupt bevacizumab therapy for moderate proteinuria (≥2 g per 24 hours); resume therapy when proteinuria is <2 g per 24 hours.a Safety of continuing or temporarily discontinuing therapy in patients with moderate to severe proteinuria not known.1
Discontinue therapy in patients with nephrotic syndrome.1 In clinical studies, proteinuria associated with nephrotic syndrome decreased in severity several months following discontinuance of bevacizumab in some patients but did not completely resolve.1
GI tract fistula formation reported in patients with colorectal and other types of cancer (e.g., NSCLC) receiving bevacizumab.1 g (See GI Perforations under Cautions.)
Non-GI fistula formation, sometimes fatal and usually occurring within first 6 months of treatment, reported.1 Non-GI fistula sites include tracheo-esophageal, bronchopleural, biliary, vaginal, and bladder.1 If fistula formation involving an internal organ occurs, discontinue bevacizumab permanently.1
Infusion reactions (e.g., hypertension, hypertensive crisis associated with neurologic manifestations, wheezing, oxygen desaturation, grade 3 hypersensitivity, chest pain, headache, rigor, diaphoresis) reported.1
Infuse initial doses slowly, increasing rate of infusion as tolerated.1 (See Rate of Administration under Dosage and Administration.)
If severe infusion reactions occur, interrupt infusion and administer appropriate medical therapy.1 Adequate information on rechallenge not available.1
Microangiopathic hemolytic anemia reported in patients with solid tumors receiving bevacizumab and sunitinib†;35 36 cases were reversible within 3 weeks following discontinuance of both drugs without other interventions.35 36 Use of bevacizumab in combination with sunitinib is not recommended.35 36
Report cases of microangiopathic hemolytic anemia associated with bevacizumab therapy to the manufacturer or FDA.35 36
Severe neutropenia, febrile neutropenia, and serious infection (including pneumonia, catheter infections, and wound infections), sometimes fatal, reported.1
Potential for immunogenicity.1 Incidence of antibody formation not established.1
CHF reported; higher risk in patients also receiving or who had previously received anthracyclines.1
Safety of continuation or resumption of bevacizumab in patients who develop cardiac dysfunction not studied.1
Category C.1
Not known whether distributed into milk.1 Discontinue nursing during treatment, taking into account the long half-life.1 (See Half-life under Pharmacokinetics.)
Safety and efficacy not established in children <18 years of age.1 3
No difference in overall survival relative to younger adults observed in patients receiving bevacizumab and chemotherapy for metastatic colorectal cancer.1 a However, possible increased risk of asthenia, sepsis, deep thrombophlebitis, hypertension, hypotension, MI, CHF, diarrhea, constipation, anorexia, leukopenia, anemia, dehydration, hypokalemia, hyponatremia, nausea, vomiting, ileus, and fatigue.1
Increased risk of proteinuria in patients ≥65 years of age receiving bevacizumab in combination with paclitaxel and carboplatin, compared with younger adults.1 (See Proteinuria under Cautions.)
Insufficient experience in patients ≥65 years of age receiving bevacizumab in combination with paclitaxel for metastatic breast cancer to determine whether adverse effects differ from those in younger adults.1
Possible increased incidence of arterial thromboembolic events, dyspepsia, GI hemorrhage, edema, epistaxis, increased cough, and voice alteration compared with younger adults.1
Epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, exfoliative dermatitis.a
Drug | Interaction | Comments |
|---|---|---|
Carboplatin | No effect on carboplatin exposure1 |
|
Interferon alfa | No effect on interferon alfa exposure.1 a | |
Irinotecan | No effect on pharmacokinetics of irinotecan or the active metabolite of irinotecan1 5 a |
|
Paclitaxel | Possible decreased paclitaxel exposure after 4 treatment cycles of bevacizumab in combination with paclitaxel and carboplatin1 |
|
Sunitinib | Possible microangiopathic hemolytic anemia35 36 (see Microangiopathic Hemolytic Anemia under Cautions) | Use of bevacizumab in combination with sunitinib not recommended35 36 |
Relationship between bevacizumab exposure and clinical outcome not studied.1
Metabolized by reticuloendothelial system.3
Eliminated via reticuloendothelial system.3
Approximately 20 days (range: 11–50 days).1
Clearance varies by body weight, gender, and tumor burden.1 Increased clearance observed in men and in patients with higher tumor burden; however, no evidence of reduced efficacy.1
2–8°C.1 Do not freeze; protect from light.1
Store diluted solution at 2–8°C for up to 8 hours.1
For information on systemic interactions resulting from concomitant use, see Interactions.
No incompatibilities with PVC or polyolefin bags.1
Compatible |
|---|
Sodium chloride 0.9% |
Incompatible |
Dextrose solutions |
Antineoplastic agent;1 3 5 a recombinant humanized monoclonal IgG1 antibody containing human framework regions and murine complementarity-determining regions.1 6
Binds to human vascular endothelial growth factor (VEGF) and prevents interaction of VEGF with its receptors (Flt-1, KDR) on the surface of endothelial cells.1 This may result in inhibition of angiogenesis, thus reducing microvascular growth of tumors and inhibiting metastatic disease progression.1 2 3 5
Importance of understanding potential risks associated with therapy, including severe hypertension, wound healing complications, and arterial thromboembolic events.1 a
Importance of routine monitoring of BP; advise patients to inform clinician if BP is elevated.a
Importance of immediately informing clinician if unusual bleeding, high fever, rigors, sudden worsening of neurological function, persistent or severe abdominal pain, severe constipation, or vomiting occurs.a
Importance of women informing clinicians immediately if they are or plan to become pregnant or plan to breast-feed;1 necessity for clinicians to advise women to avoid pregnancy during therapy and to use an effective method of contraception for ≥6 months after last dose of bevacizumab.3 Advise pregnant women of risk to the fetus and/or the potential risk for loss of the pregnancy.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular disease).1
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | For injection, concentrate, for IV infusion | 25 mg/mL (100 and 400 mg) | Avastin | Genentech |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 01/2012. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Avastin 100MG/4ML Solution (GENENTECH): 4/$645.96 or 12/$1,850.05
Avastin 400MG/16ML Solution (GENENTECH): 16/$2,525.85 or 48/$7,374.16
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2012, Selected Revisions December 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
1. Genentech. Avastin (bevacizumab) prescribing information. South San Francisco, CA; 2008 Mar.
2. Kabbinavar F, Hurwitz HI, Fehrenbacher L et al. Phase II, randomized trial comparing bevacizumab plus fluorouracil (FU)/leucovorin (LV) with FU/LV alone in patients with metastatic colorectal cancer. J Clin Oncol. 2003; 21:60-5. [IDIS 495428] [PubMed 12506171]
3. Genentech, South San Francisco, CA: Personal communication.
4. Hurwitz H, Fehrenbacher L, Novotny W et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004; 350:2335-42. [IDIS 516117] [PubMed 15175435]
5. Presta LG, Chen H, O’Connor SJ et al. Humanization of an anti-vascular endothelial growth factor monoclonal antibody for the therapy of solid tumors and other disorders. Cancer Res. 1997; 57:4593-9. [PubMed 9377574]
6. Zondor SD, Medina PJ. Bevacizumab: An angiogenesis Inhibitor with efficacy in colorectal and other malignancies. Ann Pharmacother. 2004; 38:1258-64. [IDIS 528874] [PubMed 15187215]
7. Barron H. Dear healthcare provider regarding adverse arterial thromboembolic events associated with Avastin. South San Francisco, CA: Genentech; 2004 Jul.
8. Food and Drug Administration. Avastin (bevacizumab) injection [August 13, 2004: Genentech]. MedWatch drug labeling changes. Rockville, MD; August 2004. From FDA website.
9. Colon cancer. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2007 Aug 9.
10. Non-small cell lung cancer. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2007 May 1.
11. Sandler A, Gray R, Perry MC et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small lung cancer. N Engl J Med 2006; 355:2542-50. [PubMed 17167137]
12. Yang JC, Haworth L, Sherry RM et al. A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N Engl J Med. 2003; 349:427-34. [IDIS 502305] [PubMed 12890841]
13. Rini BI, Halabi S, Rosenberg JE et al. CALGB 90206: A phase III trial of bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in metastatic renal cell carcinoma. Proc ASCO 2008 Genitourinary Cancers Symposium. 2008; Abstract 350.
14. Miller KD, Chap LI, Holmes FA et al. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol. 2005; 23:792-9. [IDIS 532659] [PubMed 15681523]
15. Miller K, Wang M, Gralow J et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007; 357:2666-76.
16. Food and Drug Administration. MedWatch—Safety-related drug labeling changes: Avastin (bevacizumab) [January 2005]. From FDA website.
17. Barron H. Dear healthcare provider letter regarding increased risk of arterial thromboembolic events associated with the use of Avastin in combination with chemotherapy. South San Francisco, CA: Genentech; 2005 Jan 5.
18. Hurwitz HI, Fehrenbacher L, Hainsworth JD et al. Bevacizumab in combination with fluorouracil and leucovorin: an active regimen for first-line metastatic colorectal cancer. J Clin Oncol. 2005; 23:3502-8. [IDIS 536385] [PubMed 15908660]
19. Kabbinavar FF, Schulz J, McCleod M et al. Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: results of a randomized phase II trial. J Clin Oncol. 2005; 23:3697-705. [IDIS 540182] [PubMed 15738537]
20. Kabbinavar FF, Hambleton J, Mass RD et al. Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J Clin Oncol. 2005; 23:3706-12. [IDIS 540183] [PubMed 15867200]
21. Giantonio BJ, Catalano PJ, Meropol NJ et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol. 2007; 25:1539-44. [PubMed 17442997]
22. Chen HX, Mooney M, Boron M et al. Phase II multicenter trial of bevacizumab plus fluorouracil and leucovorin in patients with advanced refractory colorectal cancer: an NCI treatment referral center trial TRC-0301. J Clin Oncol. 2006; 24:3354-60. [PubMed 16849749]
23. Picus J, Halabi S, Rini B et al. The use of bevacizumab (B) with docetaxel (D) and estramustine (E) in hormone refractory prostate cancer (HRPC): initial results of CALGB 90006. Proc ASCO. 2003; Abstract No. 1578.
24. Kelly W, protocol chair. Phase III randomized study of docetaxel and prednisone with versus without bevacizumab in patients with hormone-refractory metastatic adenocarcinoma of the prostate. Protocol ID: CALGB-90401. Last modified: 7/22/2006. National Cancer Institute: Clinical Trials (database).
25. Kindler H, protocol chair. Phase III randomized study of gemcitabine with versus without bevacizumab in patients with locally advanced or metastatic adenocarcinoma of the pancreas. Protocol ID: CALGB-80303. Last modified: 4/19/2006. National Cancer Institute: Clinical Trials (database).
26. Burger R, Fleming G, protocol chairs. Phase III randomized study of carboplatin and paclitaxel versus carboplatin, paclitaxel, and concurrent bevacizumab with versus without extended bevacizumab in patients with stage III or IV ovarian epithelial or primary peritoneal cancer. Protocol ID: GOG-0218. Last modified: 10/10/2008. National Cancer Institute: Clinical Trials (database).
27. National Comprehensive Cancer Network (NCCN). Clinical practice guidelines in oncology: non-small cell lung cancer. Version 2.2006.
28. Allegra C, protocol chair. Phase III randomized study of adjuvant chemotherapy comprising fluorouracil, leucovorin calcium, and oxaliplatin with versus without bevacizumab in patients with resected stage II or III adenocarcinoma of the colon. Protocol ID: NSABP-C-08. Last modified: 6/20/2008. National Cancer Institute: Clinical Trials (database).
29. Glusker P, Recht L, Lane B. Reversible posterior leukoencephalopathy syndrome and bevacizumab. N Engl J Med. 2006; 354:980-1. [PubMed 16510760]
30. Ozcan C, Wong SJ, Hari P. Reversible posterior leukoencephalopathy syndrome and bevacizumab. N Engl J Med. 2006; 354:981-2.
31. Barron H. Reversible posterior leukoencephalopathy syndrome and bevacizumab. Manufacturer reply. N Engl J Med. 2006; 354:982.
32. Barron H. Dear healthcare provider letter regarding reversible posterior leukoencephalopathy syndrome in patients receiving bevacizumab (Avastin). South San Francisco, CA: Genentech; 2006 Sep.
33. Cruzan S (US Food and Drug Administration). FDA approves new combination therapy for lung cancer. Rockville, MD; 2006 Oct 12. Press release P06-166.
34. Steinbrook R. The price of sight—ranibizumab, bevacizumab, and the treatment of macular degeneration. N Engl J Med. 2006; 355:1409-12. [PubMed 17021315]
35. Food and Drug Administration. Safety Alert: Avastin (bevacizumab) [July 14 2008]. From FDA web site .
36. Barron H. Dear healthcare provider letter: Important drug warning: microangiopathic hemolytic anemia (MAHA) in patients treated with Avastin (bevacizumab) and sunitinib malate. South San Francisco, CA: Genentech; 2008 Jul.
37. Eremina V, Jefferson JA, Kowalewska J et al. VEGF inhibition and renal thrombotic microangiopathy. N Engl J Med. 2008; 358:1129-36. [PubMed 18337603]
38. Saltz LB, Clarke S, Diaz-Rubio E et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008; 26:2013-9. [PubMed 18421054]
39. Miles D, Chan A, Romieu G et al. Randomized, double-blind, placebo-controlled, phase III study of bevacizumab with docetaxel or docetaxel with placebo as first-line therapy for patients with locally recurrent or metastatic breast cancer (mBC): AVADO. Proc ASCO. 2008; Abstract LBA1011.
40. Escudier B, Pluzanska A, Koralewski P et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007; 370:2103-11.
41. Martin DF, Fine SL, protocol chairs. Comparison of age-related macular degeneration treatments trials: Lucentis-Avastin Trial (CATT). Last updated: 3/4/2008. National Eye Institute: Clinical Studies (database).
42. Scappaticci FA, Skillings JR, Holden SN et al. Arterial thromboembolic events in patients with metastatic carcinoma treated with chemotherapy and bevacizumab. J Natl Cancer Inst. 2007; 99:1232-9. [PubMed 17686822]
43. Reidy DL, Chung KY, Timoney JP et al. Bevacizumab 5 mg/kg can be infused safely over 10 minutes. J Clin Oncol. 2007; 25:2691-5. [PubMed 17602073]
44. Genentech. Avastin (bevacizumab) prescribing information. South San Francisco, CA; 2008 Mar.
58. Food and Drug Administration. FDA drug safety communication: Avastin (bevacizumab): Process for removal of breast cancer indication begun. Rockville, MD; 2010 Dec 16. From FDA website.
59. Food and Drug Administration. Memorandum to the file BLA 125085 Avastin (bevacizumab): Regulatory decision to withdraw Avastin (bevacizumab) first-line metastatic breast cancer indication. Rockville, MD; 2010 Dec 15. From FDA website.
60. Woodcock J. Dear breast cancer community letter. Silver Spring, MD: Food and Drug Administration; 2010 Dec 16. From FDA website.
61. Food and Drug Administration. Avastin (bevacizumab) information. Rockville, MD; 2011 Jun 29. From FDA website.
64. Genentech. Avastin (bevacizumab) prescribing information. South San Francisco, CA; 2011 Feb.
a. Genentech. Avastin (bevacizumab) prescribing information. South San Francisco, CA; 2009 Jul.
d. Johnson DH, Fehrenbacher L, Novotny WF et al. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non–small-cell lung cancer. J Clin Oncol. 2004; 22:2184-91. [PubMed 15169807]
e. Genentech. Avastin dosing and administration in the first-line treatment of NSCLC. From Genentech website. Accessed 2007 Feb 7.
f. Genentech. Pivotal NSCLC trial overview. From Genentech website. Accessed 2007 Feb 7.
g. Barron H. Dear healthcare provider letter: important drug warning regarding Avastin (bevacizumab). South San Francisco, CA: Genentech, Inc; 2007 Apr. From FDA website.
h. Food and Drug Administration. Avastin (bevacizumab) [April 21, 2007: Genentech]. Medwatch alert. Rockville, MD; April 2007. From FDA website.
