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Bevacizumab (Hamster) Solution for injection

It targets a protein found in many cancer cell types, and halts cancer growth

Generic Name: bevacizumab  |  Brand Name: Avastin

Brand Names: Avastin

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 12/16/2010] ISSUE: FDA notified healthcare professionals and patients that it is recommending removing the breast cancer indication for bevacizumab (Avastin) because the drug has not been shown to be safe and effective for that use. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers.

BACKGROUND: FDA is making this recommendation after reviewing the results of four clinical studies of bevacizumab in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. None of the studies demonstrated that patients receiving bevacizumab lived longer and patients receiving bevacizumab experienced a significant increase in serious side effects. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

RECOMMENDATION: Oncologists currently treating patients with bevacizumab for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.

Patients currently receiving bevacizumab for breast cancer should speak with their oncologists about whether to continue their treatment or explore other treatment options. For more information visit the FDA website at: [Web] and [Web].

[Posted 07/14/2008] Genentech, Inc. informed healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving bevacizumab (Avastin) in combination with sunitinib malate (Sutent). Bevacizumab is not approved for use in combination with sunitinib malate and this combination is not recommended. Twenty-five patients were enrolled in a Phase I dose-escalation study combining bevacizumab and sunitinib malate. The study consisted of 3 cohorts using a fixed dose of bevacizumab at 10mg/kg/IV every 2 weeks and escalating doses of sunitinib that included 25, 37.5, and 50 mg orally daily given in a 4 weeks on/ 2 weeks off schedule. Five of 12 patients at the highest sunitinib dose level exhibited laboratory findings consistent with MAHA. Two of these cases were considered severe with evidence of thrombocytopenia, anemia, reticulocytosis, reductions in serum haptoglobin, schistocytes on peripheral smear, modest increases in serum creatinine levels, and severe hypertension, reversible posterior leukoencephalopathy syndrome, and proteinuria. The findings in these two cases were reversible within three weeks upon discontinuation of both drugs without additional interventions. Healthcare professionals should report cases of MAHA or any serious adverse events suspected to be associated with the use of bevacizumab. For more information visit the FDA website at: [Web] and [Web].

What is this medicine?

BEVACIZUMAB (be va SIZ yoo mab) is a chemotherapy drug. It targets a protein found in many cancer cell types, and halts cancer growth. This drug treats many cancers including non-small cell lung cancer, and colon or rectal cancer. It is usually given with other chemotherapy drugs.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • blood clots
  • heart disease, including heart failure, heart attack, or chest pain (angina)
  • high blood pressure
  • infection (especially a virus infection such as chickenpox, cold sores, or herpes)
  • kidney disease
  • lung disease
  • prior chemotherapy with doxorubicin, daunorubicin, epirubicin, or other anthracycline type chemotherapy agents
  • recent or ongoing radiation therapy
  • recent surgery
  • stroke
  • an unusual or allergic reaction to bevacizumab, hamster proteins, mouse proteins, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Interactions are not expected.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. You will need important blood work and urine testing done while you are taking this medicine.

During your treatment, let your health care professional know if you have any unusual symptoms, such as difficulty breathing.

This medicine may rarely cause 'gastrointestinal perforation' (holes in the stomach, intestines or colon), a serious side effect requiring surgery to repair.

This medicine should be started at least 28 days following major surgery and the site of the surgery should be totally healed. Check with your doctor before scheduling dental work or surgery while you are receiving this treatment. Talk to your doctor if you have recently had surgery or if you have a wound that has not healed.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

This medicine has caused ovarian failure in some women. This medicine may interfere with the ability to have a child. You should talk to your doctor or health care professional if you are concerned about your fertility.


Last Updated: November 18, 2011
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