Bevacizumab

(be va siz' yoo mab)

Molecule Info

 | See TERMINOLOGY & ABBREVIATIONS |
WARNING GASTROINTESTINAL PERFORATIONS, SURGERY AND WOUND HEALING COMPLICATIONS and HEMORRHAGE

 

Gastrointestinal Perforations

The incidence of gastrointestinal perforation, some fatal, in Bevacizumab-treated patients ranges from 0.3 to 2.4%. Discontinue Bevacizumab in patients with gastrointestinal perforation.

Surgery and Wound Healing Complications

The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in Bevacizumab-treated patients. Discontinue Bevacizumab in patients with wound dehiscence. The appropriate interval between termination of Bevacizumab and subsequent elective surgery required to reduce the risks of impaired wound healing/wound dehiscence has not been determined. Discontinue at least 28 days prior to elective surgery. Do not initiate Bevacizumab for at least 28 days after surgery and until the surgical wound is fully healed.

Hemorrhage
Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, central nervous systems (CNS) hemorrhage, epistaxis, and vaginal bleeding occurred up to five-fold more frequently in patients receiving Bevacizumab. Do not administer Bevacizumab to patients with serious hemorrhage or recent hemoptysis.
Recent Major Changes

Recent major changes with U.S. FDA:

Indications and Usage   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...       1/2013

Dosage and Administration  ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...       1/2013

Indications and Usage, Limitation of Use  ...   ...   ...   ...   ...   ...   ...   ...   ...  ...10/2012

Warnings and Precautions, Surgery and Wound Healing Complications ...  ... ... 3/2013

Indication(s) & Dosage

Bevacizumab is a vascular endothelial growth factor-specific angiogenesis inhibitor indicated for the treatment of:

  • Metastatic colorectal cancer, with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment.
  • Metastatic colorectal cancer, with fluoropyrimidine- irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Bevacizumab-containing regimen.
  • Non-squamous non-small cell lung cancer, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease.
  • Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy.
  • Effectiveness based on improvement in objective response rate. No data available demonstrating improvement in disease-related symptoms or survival with Bevacizumab.
  • Metastatic renal cell carcinoma with interferon alfa

Limitation of Use: Bevacizumab is not indicated for adjuvant treatment of colon cancer.

 

Dosage:

  • Do not administer as an IV push or bolus.
  • Do not initiate Bevacizumab for 28 days following major surgery and until surgical wound is fully healed.

Metastatic colorectal cancer

  • 5 mg/kg IV every 2 weeks with bolus-IFL
  • 10 mg/kg IV every 2 weeks with FOLFOX4
  • 5 mg/kg IV every 2 weeks or 7.5 mg/kg IV every 3 weeks with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy after progression on a first-line Bevacizumab containing regimen

Non-squamous non-small cell lung cancer

  • 15 mg/kg IV every 3 weeks with carboplatin/paclitaxel

Glioblastoma

  • 10 mg/kg IV every 2 weeks

Metastatic renal cell carcinoma (mRCC)

  • 10 mg/kg IV every 2 weeks with interferon alfa.
Warning & Precautions
  • Non-Gastrointestinal Fistula Formation: Discontinue Bevacizumab if fistula formation occurs.
  • Arterial Thromboembolic Events (e.g., myocardial infarction, cerebral infarction): Discontinue Bevacizumab for severe ATE.
  • Hypertension: Monitor blood pressure and treat hypertension. Temporarily suspend Bevacizumab if not medically controlled. Discontinue Bevacizumab for hypertensive crisis or hypertensive encephalopathy.
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue Bevacizumab.
  • Proteinuria: Monitor urine protein. Discontinue for nephrotic syndrome. Temporarily suspend Bevacizumab for moderate proteinuria.
  • Infusion Reactions: Stop for severe infusion reactions.
  • Ovarian Failure: Inform females of reproductive potential of the risk of ovarian failure with Bevacizumab.
Adverse Drug Reaction(s)

Most common adverse reactions incidence ( > 10% and at least twice the control arm rate) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis.

Drug Interactions May affect the PK of irinotecan.
Potentially Fatal: May affect the PK of irinotecan. Please consult detailed drug interactions before prescribing.
Pregnancy Category (FDA) Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Storage Intravenous: Store at 2-8°C. Diluted solutions may be stored at 2-8°C for up to 8 hr.
Pharmacology A recombinant humanised monoclonal antibody that binds to vascular endothelial growth factor (VEGF), prevents interaction of VEGF with its receptors (Flt-1, KDR) on the surface of endothelial cells & thereby inhibits the angiogenesis that occurs during tumour growth.
Excretion: Likely to be cleared via the reticuloendothelial system.Terminal half-life: About 20 days.
ATC Classification L01XC07 - bevacizumab; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.

Brand/Product Info


Total Products : 0
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price

Gen. MedInfo

IMPORTANT WARNING:

Bevacizumab may cause you to develop a hole in the wall of your stomach or intestine. This is a serious and possibly life-threatening condition. If you experience any of the following symptoms, call your doctor immediately: stomach pain, constipation, nausea, vomiting, or fever.

Bevacizumab may slow the healing of wounds, such as cuts made by a doctor during surgery. In some cases, bevacizumab may cause a wound that has closed to split open. This is a serious and possibly life-threatening condition. If you experience this problem, call your doctor immediately. inform your doctor if you have recently had surgery or if you plan to have surgery. If you have recently had surgery, you should not use bevacizumab until at least 28 days have passed and until the area has completed healed. If you are scheduled to have surgery, your doctor will stop your treatment with bevacizumab at least 28 days before the surgery.

Bevacizumab may cause severe bleeding that can be life-threatening. inform your doctor if you have recently coughed up blood. If you experience any of the following symptoms at any time during your treatment, call your doctor immediately: nosebleeds or bleeding from your gums, coughing up or vomiting blood or material that looks like coffee grounds, unusual bleeding or bruising, increased menstrual flow or vaginal bleeding, pink, red, or dark brown urine, red or tarry black bowel movements, headache, dizziness, or weakness.

Talk to your doctor about the risks of using bevacizumab.

 

Why is Bevacizumab prescribed?

Bevacizumab is used with chemotherapy to treat cancer of the colon (large intestine) or rectum that has spread to other parts of the body. Bevacizumab is also used with chemotherapy to treat certain types of lung cancer. Bevacizumab is also used to treat glioblastoma (a certain type of cancerous brain tumor) that has been already treated with other medications. Bevacizumab is also used in combination with another medication to treat renal cell cancer (RCC, a type of cancer that begins in the kidney) that has spread to other parts of the body. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumors. This may slow the growth and spread of tumors.

How should Bevacizumab be used?

Bevacizumab comes as a solution to administer slowly into a vein. Bevacizumab is administered by a doctor or nurse in a medical office, infusion center, or hospital. Bevacizumab is usually given once every 14 days to treat cancer of the colon or rectum, glioblastoma, or renal cell cancer and once every 3 weeks to treat lung cancer.

It should take 90 minutes for you to receive your first dose of bevacizumab. A doctor or nurse will watch you closely to see how your body reacts to bevacizumab. If you do not have any serious problems when you receive your first dose of bevacizumab, it will usually take 30 to 60 minutes for you to receive each of your remaining doses of the medication.

Other uses for Bevacizumab

Bevacizumab has previously been used to treat breast cancer, however, further investigation by the FDA has found that the risks associated with treatment do not justify use for the benefit found in most cases. Bevacizumab is also sometimes used to treat wet age-related macular degeneration (AMD; an ongoing disease of the eye that causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities) and other types of cancer. Talk to your doctor about the risks of using bevacizumab to treat your condition.

Bevacizumab may be prescribed for other uses; ask your doctor for more information.

What special precautions to follow?

Before receiving bevacizumab,

  • inform your doctor if you are allergic to bevacizumab or any other medications.
  • inform your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention anticoagulants (blood thinners) such as warfarin; irinotecan and sunitinib. Also inform your doctor if you are taking or if you have ever taken an anthracycline (a type of chemotherapy used for breast cancer and some types of leukemia) such as daunorubicin, doxorubicin, epirubicin, or idarubicin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • inform your doctor if you have ever been treated with radiation therapy to the left side of your chest; and if you have or have ever had cancer that spread to your brain or spine, high blood pressure, or any condition that affects your heart or blood vessels (tubes that move blood between the heart and other parts of the body).
  • you should know that bevacizumab may cause infertility in women (difficulty becoming pregnant); however, you should not assume that you cannot get pregnant. inform your doctor if you are pregnant or plan to become pregnant. You should use birth control to prevent pregnancy during your treatment with bevacizumab and for at least 6 months after you stop using the medication. If you become pregnant while using bevacizumab, call your doctor. Bevacizumab may harm the fetus and increase the risk of a pregnancy loss.
  • inform your doctor if you are breast-feeding. You should not breast-feed during your treatment with bevacizumab and for some time after you stop using the medication.

What special dietary instructions to follow?

Unless your doctor informs you otherwise, continue your normal diet.

What to do if I forget a dose?

If you miss an appointment to receive a dose of bevacizumab, call your doctor as soon as possible.

What side effects can Bevacizumab cause?

Bevacizumab may cause side effects. inform your doctor if any of these symptoms are severe or do not go away:

  • fainting

  • loss of appetite

  • heartburn

  • change in ability to taste food

  • diarrhea

  • weight loss

  • dry mouth

  • sores on the skin or in the mouth

  • voice changes

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • coughing, gagging, or choking after eating or drinking

  • neck pain

  • slow or difficult speech

  • dizziness or faintness

  • weakness or numbness of an arm or leg

  • chest pain

  • pain in the arms, neck, or upper back

  • shortness of breath

  • seizures

  • extreme tiredness

  • confusion

  • change in vision or loss of vision

  • sore throat, fever, chills, and other signs of infection

  • swelling of the face, eyes, stomach, hands, feet, ankles, or lower legs

  • unexplained weight gain

  • foamy urine

  • dry, hacking cough

  • pain, tenderness, warmth, redness, or swelling in one leg only

  • redness, itching, or scaling of the skin

Bevacizumab may cause other side effects. Call your doctor if you have any unusual problems while receiving Bevacizumab.

In case of emergency/overdose

In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.

Symptoms of overdose may include the following:

  • headache

What other information to know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Bevacizumab.

Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Ref: MedlinePlus, U.S. National Library of Medicine.


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

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