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 / About Your Diagnosis

MVASI® IS APPROVED FOR THE TREATMENT OF 6 DIFFERENT CANCER TYPES 1

For information about your specific diagnosis, please make a selection below:

METASTATIC COLORECTAL CANCER (mCRC)
ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC)
RECURRENT GLIOBLASTOMA (rGBM)
METASTATIC RENAL CELL CARCINOMA (mRCC)
Advanced cervical cancer (CC)
OVARIAN CANCER (OC)

WHAT IS RECURRENT GLIOBLASTOMA (rGBM)?

YOUR DOCTOR HAS SAID THAT YOU HAVE A TYPE OF CANCER CALLED RECURRENT GLIOBLASTOMA (rGBM)

Glioblastoma is a cancer of the brain and spinal cord.2

Unlike cancers that start in other parts of the body, tumors that start in the brain or spinal cord rarely spread to other organs, but they can still grow and spread into nearby areas of the brain.2

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Cancer spread to brain

ACCORDING TO THE WORLD HEALTH ORGANIZATION (WHO), THERE ARE 4 GRADES OF BRAIN AND SPINAL CORD TUMORS:2

GRADE I

Tumors that typically grow slowly and do not infiltrate other nearby tissues. Can often be cured with surgery.

GRADE II

Tumors that tend to grow slowly but can grow into nearby brain tissue. May eventually start growing faster and are likely to return after surgery.

GRADE III

Tumors have a more abnormal appearance when viewed under a microscope. Can grow into nearby brain tissue and may need treatment in addition to surgery.

GRADE IV

The fastest growing tumors that usually require the most aggressive treatment.

YOUR TREATMENT TEAM IS THERE TO HELP

Because glioblastoma can impact you and your loved ones' lives, it is important to work closely with your treatment team. If you have questions, reach out to your doctor’s office directly for more information.

Links to the following organizations are provided for additional information and support, but should not be considered as an endorsement of MVASI® by these organizations.

VISIT THESE WEBSITES FOR MORE INFORMATION ABOUT GLIOBLASTOMA

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. American Cancer Society. Types of brain and spinal cord tumors in adults. www.cancer.org/cancer/brain-spinal-cord-tumors-adults/about/types-of-brain-tumors.html. Accessed March 2, 2020.