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...
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  • 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. Show Less

FOR PATIENTS

GETTING TO KNOW MVASI™

 
WHAT IS MVASI™ WHY AMGEN BIOSIMILARS SUPPORT ABOUT YOUR DIAGNOSIS

THERE IS A TREATMENT FOR YOUR CANCER AND IT IS CALLED MVASI™

MVASI™ (EM-VA-SEE):

  • APPROVED by the FDA (Food and Drug Administration) and known by its chemical name, bevacizumab-awwb (bev-uh-SIZZ-oo-mab)1
  • STUDIED in a clinical trial in patients with cancer2
  • PROVEN in a clinical trial to be safe and effective2
  • A BIOLOGIC, which is a unique drug made from a living cell1,3
    • Biologic medicines are used to treat many conditions4

MVASI™ is indicated for the treatment of: metastatic colorectal cancer (mCRC), advanced non-squamous non-small cell lung cancer (NSCLC), recurrent glioblastoma (rGBM), metastatic renal cell carcinoma (mRCC), and advanced cervical cancer (CC)1

MVASI™ WORKS WITH YOUR BODY TO STARVE THE TUMOR1,5

SOME TYPES OF CANCER DEVELOP INTO TUMORS.
AS THE TUMOR GROWS, IT CAUSES THE BODY TO CREATE BLOOD VESSELS TO FEED IT.
MVASI™ BLOCKS THE FORMATION OF NEW BLOOD VESSELS. THIS COULD STARVE THE TUMOR.*
How does MVASI(TM) work?
 
How does MVASI(TM) work?
 
How does MVASI(TM) work?
MVASI Logo

*However, in a study of mCRC patients who continued on Avastin® for second-line treatment after a first-line treatment that included Avastin®, tumors did not shrink.


IS MVASI™ RIGHT FOR ME?

PROVEN EFFECTIVE FOR PATIENTS2

  • MVASI™ (bevacizumab-awwb) is biosimilar to another drug called Avastin® (bevacizumab). MVASI™ has been tested with patients worldwide.
  • It has been shown to be as effective as Avastin®and have similar side effects.
 
MVASI(TM) – Proven similar to Avastin(R)
Tested with patients worldwide

A few things to keep in mind as you start MVASI™

Now that you know more about MVASI™, you may have some questions about starting on this course of therapy.

How is MVASI(TM) prescribed?
MVASI™ MAY BE PRESCRIBED WITH CHEMOTHERAPY1

You and your doctor will discuss your MVASI™ dose and type of chemotherapy. Your doctor or nurse will explain which combination of treatments is right for you.

You and your doctor will discuss your MVASI™ dose and type of chemotherapy. Your doctor or nurse will explain which combination of treatments is right for you.

MVASI™ infusion
MVASI™ IS GIVEN THROUGH AN IV INFUSION1
  • You will receive MVASI™ every 2 or 3 weeks for as long as you need it.1
  • MVASI™ is given in the same amount and for the same length of time as Avastin®, another bevacizumab.1,6
  • You will receive MVASI™ every 2 or 3 weeks for as long as you need it.1
  • MVASI™ is given in the same amount and for the same length of time as Avastin®, another bevacizumab.1,6

The points above offer only an outline of what you might expect when starting MVASI™.

Your doctor will ultimately make these treatment decisions with you. If your treatment plan is not clear, please talk with your treatment team.


REGULAR BLOOD PRESSURE MONITORING IS IMPORTANT

Per standard bevacizumab treatment, you will receive regular blood pressure checkups. These checkups will occur throughout the course of your treatment.1

ALT TEXT

YOUR BLOOD PRESSURE WILL BE MONITORED EVERY 2 TO 3 WEEKS

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.

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. 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

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 MVASI™ 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, 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
  • Rectal 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, think you are pregnant, planning to become pregnant, or breastfeeding. 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. Taking MVASI™ could cause a woman’s ovaries to stop working and may impair her ability to have children. Breastfeeding while on MVASI™ may harm your baby and is therefore not recommended during and for 6 months after taking MVASI™

If you have any questions about your condition or treatment, 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.

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.

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

 

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 June 8, 2019. 4. US Food and Drug Administration. What are "biologics" questions and answers. www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cber/ucm133077.htm. Accessed June 8, 2019. 5. Apte RS, Chen DS, Ferrara N. VEGF in signaling and disease: beyond discovery and development. Cell. 2019;176:1248-1264. 6. Avastin® (bevacizumab) Prescribing Information, Genentech Inc.