Zirabev

Zirabev is a prescription medication used to treat colorectal cancer, lung cancer, renal cell cancer (a type of cancer that begins in the kidney), glioblastoma, and cervical cancer.

Zirabev is a biosimilar to bevacizumab (brand name Avastin), which belongs to a group of drugs called antiangiogenic agents. It inhibits the development of new blood vessels by recognizing and binding to a particular protein. This inhibits the growth and spread of tumors.

This medication comes in a liquid form and is injected intravenously (into a vein) by your healthcare provider. You will most likely receive an injection every 2 or 3 weeks.

Common side effects include nosebleeds, headache, and high blood pressure.

Metastatic (spread to other parts of the body) Colorectal Cancer

Zirabev is approved to treat metastatic colorectal cancer (mCRC) for:

• First- or second-line treatment in combination with intravenous fluorouracil-based chemotherapy
• Second-line treatment when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy after cancer progresses following a first-line treatment that includes a bevacizumab product

Zirabev is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body.

Non–Small Cell Lung Cancer

Zirabev, in combination with carboplatin and paclitaxel, is approved to treat advanced non–squamous non–small cell lung cancer (NSCLC) in people who have not received chemotherapy for their advanced disease.

Recurrent Glioblastoma

Zirabev is approved to treat glioblastoma (GBM) in adult patients whose cancer has progressed after prior treatment (recurrent or rGBM).

Metastatic Renal Cell Carcinoma

Zirabev, used with interferon alfa, is approved to treat metastatic kidney cancer (mRCC).

Persistent, Recurrent, or Metastatic Cervical Cancer

Zirabev, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is approved to treat persistent, recurrent, or metastatic cancer of the cervix.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects maya occur with Zirabev use. See the “Zirabev Precautions” section.

In clinical studies across different types of cancer, some patients treated with bevacizumab (Avastin), a biosimilar, 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

This is not a complete list of Zirabev side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No drug interactions have been identified, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Zirabev may cause serious side effects.

Everyone reacts differently to Zirabev therapy, so it's important to know what the side effects are. Zirabev may cause serious side effects that can be life-threatening. Your doctor will stop treatment if any serious side effects occur. Be sure to contact your healthcare 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. Zirabev 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 Zirabev and after stopping treatment
• Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
• Infusion-related reactions. These were uncommon with the first dose of bevacizumab (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, chest pain, and your heart may become too weak to pump blood to other parts of your body (congestive heart failure). These can sometimes be fatal
• Nervous system and vision problems. Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness

Do not receive Zirabev if you are allergic to any ingredient in it. Tell your doctor if you are allergic to any medication.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Zirabev, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are allergic to any ingredient in Zirabev.

Tell your doctor about all of your medical conditions, including if you:

• have high blood pressure (hypertension)
• have heart disease (history of heart attack, stroke, blood clot, congestive heart failure)
• have kidney disease
• have any infection or fever

Talk to your doctor if you are:

• Undergoing surgery. Zirabev should not be used for 28 days before or after surgery and until surgical wounds are fully healed
• Pregnant, think you are pregnant, planning to become pregnant, or breastfeeding. Data have shown that bevacizumab products may harm your unborn baby. Use birth control while on Zirabev. If you stop Zirabev, you should keep using birth control for 6 months before trying to become pregnant. Taking bevacizumab products could cause a woman's ovaries to stop working and may impair her ability to have children. Breastfeeding while on bevacizumab products may harm your baby therefore women should not breastfeed during and for 6 months after taking Zirabev.

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you are pregnant or planning to become pregnant. Data have shown that bevacizumab products may harm your unborn baby. Use birth control while on Zirabev. If you stop Zirabev, you should keep using birth control for 6 months before trying to become pregnant. Taking bevacizumab products could cause a woman's ovaries to stop working and may impair her ability to have children.

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. Breastfeeding while on bevacizumab products may harm your baby therefore women should not breastfeed during and for 6 months after taking Zirabev.

Zirabev comes as a liquid to be injected intravenously (into a vein) by your doctor or healthcare provider in a medical setting (hospital or clinic). You will likely receive an injection every 2 or 3 weeks, depending upon the condition being treated.

• The first infusion will last 90 minutes.
• If the first infusion is received with no serious side effects, the second infusion will be given over 60 minutes. 
• If the infusion over 60 minutes was tolerated, the next doses will be given over 30 minutes.

Depending on how your body responds, your doctor may delay or stop your Zirabev treatments.

Your doctor will determine how much Zirabev you will receive and how often you will receive it based on your weight and the condition being treated.

Metastatic Colorectal Cancer

The recommended dosage when Zirabev is administered in combination with intravenous fluorouracil-based chemotherapy is:

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

First-Line Non-Squamous Non-Small Cell Lung Cancer

The recommended dosage is 15 mg/kg intravenously every 3 weeks in combination with carboplatin and paclitaxel.

Recurrent Glioblastoma

The recommended dosage is 10 mg/kg intravenously every 2 weeks.

Metastatic Renal Cell Carcinoma

The recommended dosage is 10 mg/kg intravenously every 2 weeks in combination with interferon alfa.

Persistent, Recurrent, or Metastatic Cervical Cancer

The recommended dosage is 15 mg/kg intravenously every 3 weeks in combination with paclitaxel and cisplatin or in combination with paclitaxel and topotecan.

Zirabev is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep all medical and laboratory appointments. To get the most benefit, you should receive Zirabev doses as scheduled. If you miss an appointment, reschedule as soon as possible.