IMPORTANT SAFETY INFORMATION
Possible 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 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. Do not undergo surgery without first discussing this potential risk with your doctor
- 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); 0.4% 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
Side effects seen most often
In clinical studies across different types of cancer, some patients treated with bevacizumab experienced the following side effects:
- High blood pressure
- Too much protein in the urine
- Nosebleeds
- Bleeding
- Back pain
- Headache
- Taste change
- Dry skin
- Inflammation of the skin
- Inflammation of the nose
- Watery eyes
ZIRABEV is not for everyone.
Talk to your doctor if you are:
- Undergoing surgery. ZIRABEV should not be used for at least 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
INDICATIONS
Metastatic 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.
Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
ZIRABEV is approved to treat epithelial ovarian, fallopian tube, or primary peritoneal cancer:
- In combination with carboplatin and paclitaxel, followed by ZIRABEV alone, for the treatment of patients with advanced (stage III or IV) disease following initial surgery
- In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, for platinum-resistant recurrent disease in women who received no more than 2 prior chemotherapy treatments
- Either in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by ZIRABEV alone, for patients with platinum-sensitive recurrent disease
If you have any questions about your condition or treatment, talk to your doctor.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch. You may also report side effects to Pfizer at 1-800-438-1985.
Please see Full Prescribing Information for additional Important Safety Information.
ZIRABEV is a registered trademark of Pfizer Inc.
Avastin is a registered trademark of Genentech, Inc.
