Avastin (Bevacizumab)

Class of Drugs: Anti-VEGF antibody; Vascular endothelial growth factor (VEGF) inhibitor; Antineoplastic monoclonal antibody

Manufacturer: Genentech

Information on Patient Assistance program:
The Partnership for Prescription Assistance -1-888-4PPA-NOW (1-888-477-2669) or
Genentech Access to Care Foundation
1 DNA Way MS #13A
South San Francisco, CA 94080
(800) 530-3083
FAX: (650) 225-1366

Description: Avastin is designed to inhibit Vascular Endothelial Growth Factor (VEGF), a protein that plays an important role in tumor angiogenesis and maintenance of existing tumor vessels. By inhibiting VEGF, Avastin is designed to interfere with the blood supply to tumors, a process that is critical to tumor growth and metastasis.

Ingredient: Bevacizumab

Use: The FDA approved Avastin in February 2004. Avastin is approved for use in combination with intravenous 5-Fluorouracil-based chemotherapy as a treatment for patients with first-line — or previously untreated — metastatic cancer of the colon or rectum. (See Clinical Trials)

Warnings:
Gastrointestinal Perforations/Wound Healing Complications - AVASTIN administration can result in the development of gastrointestinal perforation and wound dehiscence, in some instances resulting in fatality. Gastrointestinal perforation, sometimes associated with intra-abdominal abscess, occurred throughout treatment with AVASTIN (i.e., was not correlated to duration of exposure). The incidence of gastrointestinal perforation in patients receiving bolus-IFL with AVASTIN was 2%. The typical presentation was reported as abdominal pain associated with symptoms such as constipation and vomiting. Gastrointestinal perforation should be included in the differential diagnosis of patients presenting with abdominal pain on AVASTIN. AVASTIN therapy should be permanently discontinued in patients with gastrointestinal perforation or wound dehiscence requiring medical intervention. The appropriate interval between termination of AVASTIN and subsequent elective surgery required to avoid the risks of impaired wound healing/wound dehiscence has not been determined.

Hemorrhage - Serious, and in some cases fatal, hemoptysis has occurred in patients with non—small cell lung cancer treated with chemotherapy and AVASTIN. In a small study, the incidence of serious or fatal hemoptysis was 31% in patients with squamous histology and 4% in patients with adenocarcinoma receiving AVASTIN as compared to no cases in patients treated with chemotherapy alone. Patients with recent hemoptysis should not receive AVASTIN.

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to bevacizumab. Also tell your health care professional if you are allergic to any other substances such as foods, preservatives, or dyes.

Pregnancy—Bevacizumab has not been studied in pregnant women. However, studies in animals have shown that bevacizumab causes problems in both the mother and the child. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether bevacizumab passes into breast milk. However, bevacizumab is not recommended during breast feeding , because it may cause unwanted effects in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no information comparing use of bevacizumab in children with use in other age groups. However, studies of this medicine in animals have shown an increase in side effects.

Older adults—Specific side effects may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of bevacizumab.

Other medical problems—The presence of other medical problems may affect the use of bevacizumab. Be sure you tell your doctor if you have any other medical problems, especially:
Angina, previous heart attack or heart failure, high risk group for heart attack, high blood pressure, previous stroke or high risk group for stroke, hypersensitivity to bevacizumab, kidney or liver problems, protein in the urine, stomach or intestinal problems, bleeding problems.

Side Effects: Check with your doctor immediately if any of the following side effects occur -

More common
Black, tarry stools ; bleeding gums ; body aches or pain; chest pain ; chills; cloudy urine ; cough; cracks in the skin; convulsions; decreased urine output; dilated neck veins; ear congestion ; extreme fatigue; fever; high blood pressure; irregular breathing; irregular heartbeat; loss of appetite; loss of heat from the body; lack or loss of strength; loss of voice; mood changes; nasal congestion; pain; painful or difficult urination ; pinpoint red spots on skin; redness; runny nose; shortness of breath; sore throat; sores, ulcers, or white spots on lips or in mouth; swollen glands; swelling of face, fingers, feet, or lower legs; troubled breathing; tightness in chest; unusual bleeding or bruising; unusual tiredness or weakness; vomiting of blood or material that looks like coffee grounds; watery or bloody diarrhea; weight gain; wheezing; yellow skin

Less common
Difficulty having a bowel movement (stool); fainting; stomach tenderness
Rare

Blisters; coma; confusion; convulsions; decreased urine output; increased thirst; muscle pain or cramps; open sores; pale skin; white spots on lips or in mouth.

Other side effects that do not require immediate medical attention:

Belching; bloody nose; change in walking and balance; clumsiness or unsteadiness; excess flow of tears; hair loss; heartburn; indigestion; low blood pressure; weight loss; thinning of hair or hair loss.

Clinical Trials: Based on preclinical and clinical studies showing that VEGF plays a broad role in a range of cancers, Genentech is pursuing a late-stage clinical development program with Avastin evaluating its potential use in metastatic colorectal, renal cell (kidney), breast and non-small cell lung cancers. Avastin is also being evaluated in earlier stage trials as a potential therapy in prostate, ovarian, melanoma and several types of solid tumor cancers and hematologic malignancies.

References: Avastin (Bevacizumab)

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This information is intended as reference and not as medical advice. All treatment decisions should be made with your team of medical professionals and prescriptions must be given by your doctor. See TERMS AND CONDITIONS.