Indications

Metastatic Colorectal Cancer (mCRC) MVASI® is approved to treat metastatic colorectal cancer (mCRC) for:

  • First- or second-line treatment in combination with intravenous fluorouracil-based chemotherapy... Read More
  • Second-line treatment when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy after cancer progresses following a first-line treatment that includes MVASI®
MVASI® is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body. Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) MVASI®, 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 (rGBM) MVASI® is approved to treat recurrent glioblastoma in adults. Metastatic Renal Cell Carcinoma (mRCC) MVASI®, used with interferon alfa, is approved to treat metastatic kidney cancer (mRCC). Advanced Cervical Cancer (CC)
MVASI®, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is approved to treat persistent, recurrent, or metastatic cancer of the cervix.
Ovarian Cancer (OC) MVASI®, in combination with carboplatin and paclitaxel, followed by Avastin alone, is used for the treatment of patients with advanced (Stage III or IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgery. MVASI®, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in women who received no more than two prior chemotherapy treatments. MVASI®, either in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by Avastin alone, is approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Indications Dosing Storage and Handling Prescribing Information

FOR PATIENTS

GETTING TO KNOW MVASI®

 
WHAT IS MVASI® WHY AMGEN BIOSIMILARS SUPPORT ABOUT YOUR DIAGNOSIS

For Patients / Why Amgen Biosimilars

WHAT IS A BIOSIMILAR?

MVASI® IS A BIOLOGIC MEDICINE CALLED A BIOSIMILAR

MVASI® (bevacizumab-awwb) is a biosimilar to Avastin®. It was shown to have similar efficacy and side effects to Avastin®.1,2

MVASI® is carefully made and tested. This is to make sure it is similar in efficacy and side effects to the existing biologic (also called the reference product).1,3

A BIOSIMILAR IS DIFFERENT THAN A GENERIC

Biosimilars are made to be almost identical to the original biologic drug. But it is not possible to make exact copies of biologics because they are made from living cells. Biosimilars are also made from living cells.3

Biosimilars go through rigorous testing to demonstrate that they provide results similar to those of the reference product.3

AMGEN HAS A WEALTH OF EXPERIENCE IN BRINGING BIOLOGICS TO PATIENTS

MVASI® is made by Amgen, which has a 40-year track record of developing biologics and bringing treatments to millions of people with cancer.

#1 Prescribed BEVACIZUMAB
Over 40 years experience making 18 biologic medicines
Over 40 years experience making 18 biologic medicines

Amgen is deeply committed to supporting patients through their treatment journey. You can expect Amgen to deliver quality products on time and to provide support every step of the way.

*Current as of April 2021.

Important Safety Information

Possible serious side effects

Everyone reacts differently to MVASI® 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.

  • GI perforation. A hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever
  • 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
  • Wounds that don't heal. A cut made during surgery can be slow to heal or may not fully heal. MVASI® 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
  • 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 MVASI® 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 (less than 3% of patients). 0.4% of patients had severe reactions. Infusion-related 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-related 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 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

MVASI® is not for everyone

Talk to your doctor if you are:

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

For more information about your treatment or condition, talk to your doctor.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Amgen at 1-800-772-6436.

Please see full Product Information for additional Important Safety Information.

Indications

Metastatic Colorectal Cancer (mCRC)

MVASI® 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 MVASI®

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

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

MVASI®, 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 (rGBM)

MVASI® is approved to treat recurrent glioblastoma in adults.

Metastatic Renal Cell Carcinoma (mRCC)

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

Advanced Cervical Cancer (CC)

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

Ovarian Cancer (OC)

MVASI®, in combination with carboplatin and paclitaxel, followed by Avastin alone, is used for the treatment of patients with advanced (Stage III or IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgery.

MVASI®, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in women who received no more than two prior chemotherapy treatments.

MVASI®, either in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by Avastin alone, is approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

MVASI® is a trademark of Amgen, Inc.

Important Safety Information

Possible serious side effects

Everyone reacts differently to MVASI® 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.

References: 1. MVASI® (bevacizumab-awwb) Prescribing Information, Amgen. 2. Thatcher N, Goldschmidt JH, Thomas M, et al. Efficacy and safety of the biosimilar ABP 215 compared with bevacizumab in patients with advanced nonsquamous non-small cell lung cancer (MAPLE): a randomized, double-blind, phase III study. Clin Cancer Res. 2019;25:2088-2095. 3. US Food and Drug Administration. Biosimilars: more treatment choices and innovation. www.fda.gov/forconsumers/consumerupdates/ucm436399.htm. Accessed March 2, 2020. 4. Data on file, Amgen [#1 Prescribed Bevacizumab]; 2021.