What Is Avastin?(Bevacizumab)

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Avastin (bevacizumab) is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Avastin is used to treat a certain type of brain tumor, and certain types of cancers of the kidney, lung, colon, rectum, cervix, ovary, or fallopian tube. Avastin is also used to treat cancer of the membrane lining the internal organs in your abdomen. It is usually given as part of a combination of cancer medicines.

Bevacizumab, sold under the trade name Avastin, is medication used to treat a number of types of cancers and a specific eye disease. For cancer it is given by slow injection into a vein and used for colon cancerlung cancer, glioblastoma, and renal-cell carcinoma. For age-related macular degeneration it is given by injection into the eye.

Common side effects when use for cancer include nose bleeds, headache, high blood pressure, and rash. Other severe side effects include gastrointestinal perforation, bleeding, allergic reactions, blood clots, and an increased risk of infection. When used for eye disease side effects can include vision loss and retinal detachment. Bevacizumab is in the angiogenesis inhibitor and monoclonal antibody families of medication. It works by slowing the growth of new blood vessels.

Important information

Avastin can make it easier for you to bleed. Contact your doctor or seek emergency medical attention if you have any bleeding that will not stop. You may also have bleeding on the inside of your body, such as in your stomach or intestines, or in your brain.

Call your doctor at once if you have: signs of bleeding in your digestive tract – feeling very weak or dizzy, severe stomach pain, black or bloody stools, or if you cough up blood or vomit that looks like coffee grounds; or signs of bleeding in the brain – sudden numbness or weakness (especially on one side of the body), sudden severe headache, or problems with vision or balance.

Avastin can also cause problems with wound healing, which could result in bleeding or infection. Do not use this medicine within 28 days before or after a planned surgery.

Avastin can cause a rare but serious neurologic disorder affecting the brain. Symptoms include headache, confusion, vision problems, feeling very weak or tired, fainting, and seizure (blackout or convulsions). These rare symptoms may occur within hours of your first dose of Avastin, 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 Avastin 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.

Avastin may cause a woman’s ovaries to stop working correctly. Symptoms of ovarian failure include 3 or more missed menstrual periods in a row. This may affect your fertility (ability to have children). Talk to your doctor about your specific risks.

Use in Cancer

Bevacizumab is approved to be used alone or with other drugs to treat:

  • Cervical cancer that has not gotten better with other treatment, has metastasized (spread to other parts of the body), or has recurred (come back).
  • Colorectal cancer that has metastasized.
  • Glioblastoma (a type of brain cancer) in patients whose disease has not gotten better with other treatment.
  • Non-small cell lung cancer that is locally advanced, cannot be removed by surgery, has metastasized, or has recurred.
  • Ovarian epithelial, fallopian tube, or primary peritoneal cancer that has recurred. It is used in patients whose disease does not respond to platinumchemotherapy.
  • Renal cell cancer that has metastasized.

Side Effects

Possible serious side effects

Everyone reacts differently to Avastin therapy. So it’s important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. Be sure to contact your health care team if there are any signs of these side effects.

Most serious side effects (not common, but sometimes fatal):

  • GI perforation. A hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever
  • Wounds that don’t heal. A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed
  • Serious bleeding. This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, be sure to tell your doctor

Other possible serious side effects

  • Abnormal passage in the body. This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal
  • Severe high blood pressure. Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment
  • Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
  • Infusion reactions. These were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion reactions
  • Severe stroke or heart problems. These may include blood clots, mini-stroke, heart attack, and chest pain. These can sometimes be fatal
  • Nervous system and vision problems. Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness

Side effects seen most often

In clinical studies across different types of cancer, some patients experienced the following side effects:

  • High blood pressure
  • Too much protein in the urine
  • Nosebleeds
  • Rectal bleeding
  • Back pain
  • Headache
  • Taste change
  • Dry skin
  • Inflammation of the skin
  • Inflammation of the nose
  • Watery eyes

Indications 

Metastatic Colorectal Cancer (mCRC)

Avastin is indicated for the first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil–based chemotherapy.

Avastin, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastin-containing regimen.

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

Non-Squamous Non–Small Cell Lung Cancer (NSCLC)

Avastin is indicated for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer in combination with carboplatin and paclitaxel.

Glioblastoma

Avastin is indicated for the treatment of glioblastoma with progressive disease in adult patients following prior therapy as a single agent.

The effectiveness of Avastin in glioblastoma is based on an improvement in objective response rate. There are no data demonstrating an improvement in disease-related symptoms or increased survival with Avastin.

Metastatic Renal Cell Carcinoma (mRCC)

Avastin is indicated for the treatment of metastatic renal cell carcinoma in combination with interferon alfa.

Persistent, Recurrent, or Metastatic Carcinoma of the Cervix

Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix.

Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Avastin in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.

​Avastin, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Dosage and Administration

Administration

Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion.

  • Do not initiate Avastin until at least 28 days following major surgery. Administer Avastin after the surgical incision has fully healed.
  • First infusion: Administer infusion over 90 minutes.
  • Subsequent infusions: Administer second infusion over 60 minutes if first infusion is tolerated; administer all subsequent infusions over 30 minutes if infusion over 60 minutes is tolerated.

Recommended Doses and Schedules

Patients should continue treatment until disease progression or unacceptable toxicity.

Metastatic Colorectal Cancer (mCRC)

The recommended doses are 5 mg/kg or 10 mg/kg every 2 weeks when used in combination with intravenous 5-FU-based chemotherapy.

  • Administer 5 mg/kg when used in combination with bolus-IFL.
  • Administer 10 mg/kg when used in combination with FOLFOX4.
  • Administer 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks when used in combination with a fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy regimen in patients who have progressed on a first-line Avastin-containing regimen.

Bevacizumab Pregnancy Warnings

Animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy. -Bevacizumab could impair female fertility. Fertility preservation methods should be discussed with women of child bearing potential before initiation of treatment. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage.

These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

UK: Contraindicated AU, US: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: D US FDA pregnancy category: C Comments: -Women of childbearing potential should use contraception during therapy and for 6 months following the last dose.

Bevacizumab Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Unknown Comments: -Women should discontinue breast-feeding during therapy and not breast-feed for at least six months following the last dose. -Human IgG1 is secreted into human milk. The potential for absorption and harm to the infant after ingestion is unknown.

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