Mvasi

Mvasi is a prescription medication used to treat glioblastoma (GBM), a fast-growing brain tumor. It is also used to treat colorectal cancer, lung cancer, renal cell cancer (a type of cancer that begins in the kidney), and cervical cancer. Mvasi belongs to a group of drugs called antiangiogenic agents, which stops blood vessels that feed tumors from forming. Mvasi is a biosimilar (closely related) product to bevacizumab (Avastin).

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional. You will most likely receive an injection every 2 or 3 weeks.

Common side effects of Mvasi include nose bleeding, headache, and high blood pressure.

Mvasi is a prescription medication used alone or with other medicines to treat:

• glioblastoma, a fast-growing brain tumor, that has not gotten better with other types of treatment
• colorectal cancer that has spread to other parts of the body 
• non-squamous non-small cell lung cancer 
• kidney cancer that has spread to other parts of the body 
• cervical cancer that has spread to other parts of the body 

When treating some of the listed types of cancer, Mvasi will be given in combination with other medications. In some cases, will be given with specific chemotherapy treatment. 

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

Serious side effects have been reported with Mvasi. See the “Mvasi Precautions” section.

Common side effects of Mvasi include the following:

• nose bleeding
• headache
• high blood pressure
• stuffy or runny nose
• too much protein in the urine
• taste changes
• dry skin
• bleeding in the rectum
• excessive tear production
• back pain
• skin inflammation

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

Tell your doctor if you have any side effects that bother you or that do 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 Mvasi 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.

Serious side effects have been reported with Mvasi including the following:

• a hole develops in the stomach or intestine (gastrointestinal perforation). Call your doctor right away if you have stomach pain, constipation, nausea (upset stomach), vomiting, or fever. This is a serious, possibly life-threatening condition.
• a surgical wound (cut) that won't heal. Call your doctor right away if you experience this problem. Don't receive Mvasi for at least 28 days after surgery and until surgical wounds are fully healed. Also, this medication is not to be given at least 4 weeks before surgery. 
• serious bleeding (coughing or vomiting blood). This condition can be life-threatening. Call your doctor right away if you have nosebleeds, find blood in your stool, have vaginal bleeding, or vomit blood.  
• high blood pressure. Monitor your blood pressure and notify your health care provider if your blood pressure is elevated. 
• problems in brain function or structure (posterior reversible encephalopathy syndrome). Tell your health care provider if you experience headaches, seizures, feeling very tired, confusion, blindness and other visual and disturbances.
• strokes, heart attacks, chest pain, and transient ischemic attacks (TIAs, or "mini-strokes"). Tell your doctor if you have heart disease or if you have ever had any of these conditions.
• an increased risk for ovarian failure. This medication may make it more difficult to become pregnant. Speak with your health care provider if you are planning on becoming pregnant. 
• harm to your unborn baby. Speak with health care provider if you are planning on becoming pregnant. It is recommended women use effective contraception during treatment with Mvasi and for 6 months after the last dose of Mvasi.

These most serious side effects are rare, but can be fatal.

Do not take Mvasi if you are allergic to Mvasi or to any of its ingredients

Medications 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 Mvasi, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Mvasi, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Mvasi or to any of its ingredients
• have stomach and intestinal problems
• have had protein in the urine before
• have kidney disease
• have heart disease (history of heart attack, stroke, blood clot, congestive heart failure)
• have high blood pressure
• have any infection or fever
• are planning to have surgery
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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

Tell your doctor if you are pregnant or plan to become pregnant.

Based on the way this medication works, Mvasi may cause harm to your unborn baby. It is recommended to use effective contraception during treatment with Mvasi and for 6 months after the last dose of Mvasi.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. 

Furthermore, this medication may impair one's ability to get pregnant. This is because it may increase the risk of ovarian failure. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Mvasi crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, it is not recommended to breastfeeding during treatment with Mvasi.

Mvasi comes as a liquid to be injected intravenously (into a vein) by your doctor or healthcare provider in a medical setting (hospital or clinic).

The first injection will last 90 minutes. You will likely receive an injection every 2 or 3 weeks, depending upon the condition being treated.

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

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

For the treatment of glioblastoma, a brain cancer, Mvasi is usually given every 2 weeks.

For the treatment of colorectal cancer, Mvasi is usually given every 2 or 3 weeks in combination with other cancer medicines.

For the treatment of kidney cancers, Mvasi is usually given every 2 weeks in combination with other medicines.

For the treatment of non-small cell lung and cervical cancer, Mvasi is usually given every 3 weeks in combination with other cancer medicines.

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

Keep all appointments with your doctor and the laboratory.

To get the most benefit, be sure to receive Mvasi doses as scheduled. If you miss an appointment, reschedule as soon as possible. 

GASTROINTESTINAL PERFORATIONS

Gastrointestinal Perforation: Occurs in up to 3.2% of bevacizumab product-treated patients. Discontinue Mvasi for gastrointestinal perforation.

SURGERY AND WOUND HEALING COMPLICATIONS

Surgery and Wound Healing Complications: Discontinue in patients with wound dehiscence. Discontinue at least 28 days prior to elective surgery. Do not initiate Mvasi for at least 28 days after surgery and until the surgical wound is fully healed.

HEMORRHAGE

Severe or fatal hemorrhage, hemoptysis, gastrointestinal bleeding, CNS hemorrhage, and vaginal bleeding are increased in bevacizumab product-treated patients. Do not administer Mvasi to patients with serious hemorrhage or recent hemoptysis.