Avastin

DRUG DESCRIPTION

Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) in in vitro and in vivo assay systems. Bevacizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to VEGF. Avastin has an approximate molecular weight of 149 kD. Bevacizumab is produced in a mammalian cell (Chinese Hamster Ovary) expression system in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product.

Avastin is a clear to slightly opalescent, colorless to pale brown, sterile, pH 6.2 solution for intravenous infusion. Avastin is supplied in 100 mg and 400 mg preservative-free, single-use vials to deliver 4 mL or 16 mL of Avastin (25 mg/mL). The 100 mg product is formulated in 240 mg ?,?-trehalose dihydrate, 23.2 mg sodium phosphate (monobasic, monohydrate), 4.8 mg sodium phosphate (dibasic, anhydrous), 1.6 mg polysorbate 20, and Water for Injection, USP. The 400 mg product is formulated in 960 mg ?,?-trehalose dihydrate, 92.8 mg sodium phosphate (monobasic, monohydrate), 19.2 mg sodium phosphate (dibasic, anhydrous), 6.4 mg polysorbate 20, and Water for Injection, USP.

What are the possible side effects of bevacizumab (Avastin)?

Bevacizumab can cause a rare but serious neurologic disorder affecting the brain. Symptoms include headache, confusion, vision problems, feeling light-headed, fainting, and seizure (blackout or convulsions). These rare symptoms may occur within hours of your first dose of bevacizumab, or they may not appear for up to a year after your treatment started. Call your doctor at once if you have any of these side effects.

Some people receiving a bevacizumab injection have had a reaction to the infusion (when the medicine is injected into the vein)....

Read All Potential Side Effects and See Pictures of Avastin

What are the precautions when taking bevacizumab (Avastin)?

Before using bevacizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: stomach/intestinal ulcers, recent bloody vomiting or coughing up blood, recent major surgery, a fistula (an abnormal tunnel connecting two body cavities such as the bladder and the vagina).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart disease or blood clots (arterial vessels), kidney...

Read All Potential Precautions of Avastin


Avastin Consumer (continued)

SIDE EFFECTS: Dry mouth, cough, voice changes, loss of appetite, diarrhea, vomiting, constipation, mouth sores, nausea, headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist immediately.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: trouble breathing, swelling of ankles/feet, sudden weight gain, unusual tiredness, fast heartbeat, fainting, signs of infection (e.g., fever, persistent sore throat), difficulty urinating, calf pain/swelling, muscle cramps, severe stomach/abdominal pain, frothy/dark urine, yellowing eyes/skin, muscle loss, decreased amount of urine.

Symptoms of a severe infusion reaction that may occur during bevacizumab treatment include difficulty breathing, flushing, severe dizziness, nausea/vomiting, shaking, or chest pain. Tell your healthcare professional if you have any of these symptoms during your treatment. Your doctor will monitor you closely and will temporarily stop your treatment if a reaction occurs.

Bevacizumab infrequently may cause blood clots to form, leading to serious medical conditions (heart attack/angina, stroke/TIA). Seek immediate medical attention if you develop chest pain/tightness, sudden vision changes, weakness on one side of the body, confusion, or slurred speech. If any of these conditions occur, you should not be given this medication again.

This medication can cause bleeding. Some episodes may be minor including nosebleeds, minor gum bleeding, and vaginal bleeding. If these persist or worsen, notify your doctor or pharmacist promptly. Other episodes may be more serious including stomach bleeding or bleeding in the lungs (see also Warning section).

This medication may cause high blood pressure. This reaction can be severe enough to require blood pressure treatment. Learn to check your blood pressure regularly and share the results with your doctor.

Rarely, bevacizumab may cause a condition called RPLS (reversible posterior leukoencephalopathy syndrome). Get medical help right away if you develop persistent headache, seizures, sudden vision changes, mental/mood changes (e.g., confusion).

A serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, severe trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using bevacizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: stomach/intestinal ulcers, recent bloody vomiting or coughing up blood, recent major surgery, a fistula (an abnormal tunnel connecting two body cavities such as the bladder and the vagina).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart disease or blood clots (arterial vessels), kidney disease.

Before having any surgery (including dental), tell your doctor that you are using this medication. Bevacizumab has been shown to slow wound healing. Do not begin using this medication until at least 28 days after any major surgery, unless directed otherwise by your doctor.

Do not have immunizations/vaccinations without your doctor's consent and avoid contact with people who have recently received oral polio vaccine.

Use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised, or injured.

Caution is advised when using this drug in the elderly because they may be at greater risk for side effects (e.g., blood clots, kidney effects such as protein in the urine). See also Side Effects section.

This medication should be used only when clearly needed during pregnancy. Bevacizumab may cause harm to an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Women of child-bearing age should use an effective form of birth control while using this medication and for an extended period after stopping this drug. Discuss the risks, benefits and any other concerns with your doctor.

Based on information from related drugs, this medication may pass into breast milk. Therefore, breast-feeding while using this medication is not recommended. Also, do not breast-feed for extended period after stopping this drug. Consult your doctor or pharmacist before breast-feeding and if more details are needed.


Avastin Patient Information Including Side Effects

Brand Names: Avastin

Generic Name: bevacizumab (Pronunciation: bev a CIZ oo mab)

  • What is bevacizumab (Avastin)?
  • What are the possible side effects of bevacizumab (Avastin)?
  • What is the most important information I should know about bevacizumab (Avastin)?
  • What should I discuss with my healthcare provider before using bevacizumab (Avastin)?
  • How is bevacizumab used (Avastin)?
  • What happens if I miss a dose (Avastin)?
  • What happens if I overdose (Avastin)?
  • What should I avoid while using bevacizumab (Avastin)?
  • What other drugs will affect bevacizumab (Avastin)?
  • Where can I get more information?

What is bevacizumab (Avastin)?

Bevacizumab is a cancer medicine that interferes with the growth of cancer cells and slows their growth and spread in the body.

Bevacizumab is used to treat a certain type of brain tumor as well as cancers of the kidney, colon, rectum, lung, or breast. It is usually given as part of a combination of cancer medicines.

Bevacizumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of bevacizumab (Avastin)?

Bevacizumab can cause a rare but serious neurologic disorder affecting the brain. Symptoms include headache, confusion, vision problems, feeling light-headed, fainting, and seizure (blackout or convulsions). These rare symptoms may occur within hours of your first dose of bevacizumab, or they may not appear for up to a year after your treatment started. Call your doctor at once if you have any of these side effects.

Some people receiving a bevacizumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, chills, wheezing, or chest pain during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • stomach pain with vomiting or constipation;
  • black, bloody, or tarry stools;
  • vomit that looks like blood or coffee grounds;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • feeling short of breath, even with mild exertion;
  • swelling or rapid weight gain;
  • feeling like you might pass out;
  • urinating less than usual or not at all;
  • fever, chills, body aches, flu symptoms;
  • unusual bleeding such as nosebleeds, bleeding gums, or any bleeding that will not stop; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include::

  • diarrhea, stomach pain, loss of appetite;
  • dry mouth, increased thirst;
  • dizziness; or
  • 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.

What is the most important information I should know about bevacizumab (Avastin)?

Avoid having surgery while you are being treated with bevacizumab. You may have problems with wound healing, which could result in bleeding or infection.

If you need to have any type of surgery, you will need to stop receiving bevacizumab for at least 4 weeks while your surgical incision heals.

Before being treated with bevacizumab, tell your doctor if you have liver disease, kidney disease, heart disease, high blood pressure, a history of stroke or blood clots, or an open wound.

Some people receiving a bevacizumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, chills, wheezing, or chest pain during the injection.

Call your doctor at once if you have serious side effects such as blood in your stools or vomit, sudden numbness or weakness (especially on one side of the body), sudden headache or confusion, problems with vision or speech, chest pain spreading to the arm or shoulder, shortness of breath, swelling, rapid weight gain, or flu symptoms.

Bevacizumab can cause a rare but serious neurologic disorder affecting the brain. Symptoms include headache, confusion, vision problems, feeling light-headed, fainting, and seizure (blackout or convulsions). These rare symptoms may occur within hours of your first dose of bevacizumab, or they may not appear for up to a year after your treatment started. Call your doctor at once if you have any of these side effects.

To be sure this medication is not causing harmful effects, your blood pressure will need to be tested on a regular basis. Your urine may also need to be tested. Do not miss any scheduled visits to your doctor.

This medication can affect a woman's fertility (ability to have children). Talk to your doctor about your specific risks.

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