Avzivi

Not indicated for the adjuvant treatment of colon cancer.

Avzivi can make it easier for you to bleed. Seek emergency medical attention if you have any bleeding that will not stop. You may also have bleeding on the inside of your body including your gastrointestinal tract or any organ in your body. Call your doctor if you have signs of bleeding in your digestive tract, such as feeling very weak or dizzy, severe stomach pain, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or signs of bleeding in the brain including sudden numbness or weakness, slurred speech, severe headache, or problems with vision or balance.

Avzivi can also cause problems with wound healing, which could result in bleeding or infection. Do not use within 28 days of or after a planned surgery.

Bevacizumab can cause a rare but serious neurologic disorder affecting the brain. Symptoms include headache, confusion, vision problems, feeling very weak or tired, fainting, and seizures (blackouts or convulsions). These rare symptoms may occur within hours of your first dose of Avzivi, or they may not appear for up to a year after your treatment starts. Call your doctor at once if you have any of these side effects.

Avzivi may also increase your blood pressure, cause damage to your kidneys, or cause Posterior Reversible Encephalopathy Syndrome (PRES) – an acute neurological disorder that may cause seizures or headaches. Your healthcare provider will monitor you for these.

Some people receiving Avzivi have reacted to the infusion (when the medicine is injected into the vein). Tell your medical caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, chills, wheezing, or chest pain during the injection.

May cause fetal harm and you will need to use adequate contraception if you are a woman of childbearing potential.

There is also a potential risk for ovarian failure and congestive heart disease.

You may not be able to use Avzivi if you are being treated with other cancer medicines such as doxorubicin, or daunorubicin, or if you have or ever had:

• ovarian cancer with symptoms such as severe stomach pain or pelvic pain
• slow healing of a skin wound or surgical incision
• surgery within the past 4 weeks (28 days) or you plan to have surgery within the next 4 weeks (28 days) or
• coughing up blood or vomit that looks like coffee grounds.

To make sure Avzivi is safe for you, tell your doctor if you:

• have diabetes
• have heart problems such as a heart attack, stroke, blood clot, or blood clotting disorder
• have high blood pressure
• have bleeding problems or a perforation (a hole or tear) in your esophagus, stomach, or intestines or
• have kidney disease.
• are undergoing surgery. Do not use Avzivi for 28 days before or after surgery and until surgical wounds are fully healed
• are pregnant or think you are pregnant? Data have shown that Avzivi may harm your unborn baby.
• are breastfeeding.

Pregnancy and breastfeeding

Avzivi may harm an unborn baby. Do not use it if you are pregnant. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using Avzivi and for at least 6 months after your last dose. Tell your doctor at once if you become pregnant.

Avzivi may cause a woman's ovaries to stop working correctly. Symptoms of ovarian failure include 3 or more missed menstrual periods in a row. It may be harder for you to get pregnant while you are using this medicine and after this treatment. Talk to your doctor about your risk.

Do not breastfeed while using this medicine and for at least 6 months after your last dose.

Get emergency medical help if you have signs of an allergic reaction to Avzivi, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregiver right away if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Bevacizumab can cause a serious but rare neurologic disorder that affects the brain. Symptoms may occur within hours of your first dose or may not appear for up to a year after your treatment started. Call your doctor at once if you have: extreme weakness or tiredness, headache, confusion, vision problems, fainting, or seizures (blackout or convulsions).

Bevacizumab can cause you to bleed more easily. Call your doctor or seek emergency medical attention if you have:

• easy bruising, unusual bleeding, or any bleeding that will not stop
• signs of bleeding in your digestive tract - severe stomach pain, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds or
• signs of bleeding in the brain - sudden numbness or weakness, slurred speech, severe headache, problems with vision or balance.

Some people taking bevacizumab have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) in the stomach, intestines, throat, lungs, gallbladder, kidney, bladder, or vagina. Call your doctor if you have severe stomach pain or if you feel like you are choking when you eat or drink.

Also, call your doctor if you have:

• slow wound healing
• skin infection or open sores
• missed menstrual periods
• kidney problems - swelling, urinating less, feeling tired or short of breath
• signs of a blood clot - chest pain, sudden cough or shortness of breath, dizziness, coughing up blood, pain, swelling, or warmth in one leg
• heart problems - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating, swelling, rapid weight gain, feeling short of breath or
• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Avzivi side effects affecting 10% or more people may include:

• nose bleeds or other bleeding
• increased blood pressure
• headache, back pain
• protein in the urine
• dry or watery eyes
• dry or flaky skin
• stuffy nose, runny nose, sneezing or
• altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Bio-Thera Solution, Ltd. at 400-999-8703.

Avzivi is given as an infusion into a vein. A healthcare provider will give you this injection.

• Tell your caregivers right away if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, shortness of breath, or chest pain during the injection.
• Avzivi is usually given once every 2 or 3 weeks.
• Doses are based on weight. Your dose may change if you gain or lose weight.

Call your doctor for instructions if you miss an appointment for your Avzivi injection.

In a medical setting, an overdose would be treated quickly.

Avoid activities that may increase your risk of bleeding or injury. Use extra care while shaving or brushing your teeth.

Tell your doctor about all other cancer treatments you are receiving. Other drugs may interact with bevacizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

No clinically meaningful interactions have been observed with irinotecan or its active metabolite SN38, interferon alfa, carboplatin, or paclitaxel.

See the prescribing information for a full list of interactions.

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton until the time of use to protect from light. Do not freeze or shake the vial or carton.

Bio-Thera Solutions, Ltd.

Available as 100 mg/4 mL (25 mg/mL) or 400 mg/16 mL (25 mg/mL) injections in a single-dose vial.

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Avzivi.

Avastin (bevacizumab) - Genentech, Inc.

View Avastin information in detail.

Lytenava (bevacizumab-vikg) - Outlook Therapeutics, Inc.

View Lytenava information in detail.

Avastin biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

Alymsys (bevacizumab-maly) - Amneal Pharmaceuticals LLC

View Alymsys information in detail.

Avzivi (bevacizumab-tnjn) - Bio-Thera Solutions, Ltd.

Jobevne (bevacizumab-nwgd) - Biocon Biologics Inc.

View Jobevne information in detail.

Mvasi (bevacizumab-awwb) - Amgen Inc.

View Mvasi information in detail.

Vegzelma (bevacizumab-adcd) - CELLTRION, Inc.

View Vegzelma information in detail.

Zirabev (bevacizumab-bvzr) - Pfizer Inc.

View Zirabev information in detail.