Mvasi

What is Mvasi?

Mvasi is a prescription medicine that is used to treat cancer. Mvasi may be given to you for other reasons.

Children:

• This medicine is not approved for use in children. However, the doctor may decide the benefits of taking Mvasi outweigh the risks. If your child has been given Mvasi, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving Mvasi to your child.

Description

Bevacizumab-awwb is a vascular endothelial growth factor inhibitor. Bevacizumab-awwb is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-awwb has an approximate molecular weight of 149 kDa. Bevacizumab-awwb is produced in a mammalian cell (Chinese Hamster Ovary) expression system.

MVASI (bevacizumab-awwb) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution in a single-dose vial for intravenous use. MVASI contains bevacizumab-awwb at a concentration of 25 mg/mL in either 100 mg/4 mL or 400 mg/16 mL, single-dose vials.

Each mL of solution contains 25 mg bevacizumab-awwb, α,α-trehalose dihydrate (60 mg), polysorbate 20 (0.4 mg), sodium phosphate dibasic, anhydrous (1.2 mg), sodium phosphate monobasic, monohydrate (5.8 mg), and Water for Injection, USP. The pH is 6.2.

Mechanism of Action

Bevacizumab products bind VEGF and prevent the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in vitro models of angiogenesis. Administration of bevacizumab to xenotransplant models of colon cancer in nude (athymic) mice caused reduction of microvascular growth and inhibition of metastatic disease progression.

Before taking Mvasi, tell your doctor:

• If you are allergic to Mvasi; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have high blood pressure.
• If you have had recent bleeding or coughing up blood.
• If you have had daunorubicin, doxorubicin, epirubicin, idarubicin, or mitoxantrone before, talk with your doctor.
• If you are pregnant or may be pregnant. Women must use birth control while taking Mvasi and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
• If you are breast-feeding. Do not breast-feed while you take Mvasi or within 6 months after your last dose.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Mvasi with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Mvasi?

• Tell all of your health care providers that you take Mvasi. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may affect how wounds heal, including problems with healing after surgery. Problems healing after surgery can be deadly. If you need to have surgery, you may need to stop Mvasi before surgery. Start taking it again after surgery as you have been told by your doctor. Talk with your doctor.
• Very bad and sometimes deadly holes in the GI (gastrointestinal) tract or fistulas have happened with Mvasi. Talk with the doctor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Severe and sometimes deadly bleeding problems have happened with Mvasi.
• Call your doctor right away if you have any signs of bleeding problems, like bruising; black, tarry, or bloody stools; bleeding gums; blood in the urine; coughing up blood; cuts that take a long time to stop bleeding; feel dizzy; feeling very tired or weak; nosebleeds; pain or swelling; throwing up blood or throw up that looks like coffee grounds; or very bad headache.
• Blood clots have happened with Mvasi. Sometimes, blood clots like heart attack and stroke have been deadly. Talk with the doctor.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
• A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with Mvasi. Call your doctor right away if you have signs like feeling confused, lowered alertness, change in eyesight, loss of eyesight, seizures, or very bad headache.
• High blood pressure has happened with Mvasi. Have your blood pressure checked as you have been told by your doctor.
• Some patients have very bad side effects during the infusion. Tell your doctor if you have any bad effects during the infusion.
• If you are 65 or older, use Mvasi with care. You could have more side effects.
• This medicine may cause menstrual periods to stop in females who can get pregnant. This may affect being able to have children. It is not known if this will go back to normal. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.

How is Mvasi best taken?

Use Mvasi as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have your urine checked as you have been told by your doctor.
• If you have upset stomach, throwing up, diarrhea, or are not hungry, talk with your doctor. There may be ways to lower these side effects.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Mvasi that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Severe constipation or stomach pain. These may be signs of a severe bowel problem.
• Sweating a lot.
• A burning, numbness, or tingling feeling that is not normal.
• Anxiety.
• Redness or irritation of the palms of hands or soles of feet.
• Very bad and sometimes deadly kidney problems have happened with Mvasi. Call your doctor right away if you are unable to pass urine or if you have blood in the urine or a change in the amount of urine passed.
• A very bad skin problem (necrotizing fasciitis) has happened in people taking Mvasi. Sometimes, this has been deadly. Call your doctor right away if your skin is warm with red or purple areas of swelling that spread quickly. Call your doctor right away if you have ulcers, blisters, black spots on the skin, or any other skin changes that concern you.

What are some other side effects of Mvasi?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Feeling dizzy, tired, or weak.
• Back, muscle, or joint pain.
• Stomach pain or diarrhea.
• Neck pain.
• Upset stomach or throwing up.
• Not hungry.
• Dry skin.
• Change in nails.
• Change in taste.
• Weight loss.
• Change in voice.
• Runny or stuffy nose.
• Trouble sleeping.
• More tears.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Mvasi?

• If you need to store Mvasi at home, talk with your doctor, nurse, or pharmacist about how to store it.

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