Bavencio Vial

GENERIC NAME(S): Avelumab

OTHER NAME(S): Bavencio Solution

Uses

Uses

Avelumab is used to treat a certain type of skin cancer (Merkel cell carcinoma). It is also used to treat cancer in the bladder or urinary tract. It works by changing the action of your own immune system, directing it to attack cancer cells. Avelumab belongs to a class of drugs known as monoclonal antibodies.

How to use Bavencio Vial

Read the Medication Guide provided by your pharmacist before you start receiving avelumab and each time you get a treatment. If you have any questions, ask your doctor or pharmacist.

This medication is given by a health care professional. It is injected slowly into a vein over 60 minutes. It is given as directed by your doctor, usually once every 2 weeks.

Infusion reactions may happen while you are receiving avelumab. Your doctor may prescribe other medications (such as diphenhydramine, acetaminophen) before treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as flushing, trouble breathing, fever, chills, hives, abdominal/back pain, or dizziness.

The dosage is based on your medical condition, weight, and response to treatment. Your doctor may stop your treatment for some time if you get serious side effects. Your doctor may also prescribe another medication (a corticosteroid such as prednisone) to help treat side effects of this medication.

To get the most benefit, do not miss any doses. To help you remember, mark the days on the calendar when you need to receive this medication.

Side Effects

Side Effects

See also How to Use section.

Fatigue or dizziness may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: signs of infection (such as fever, runny/stuffy nose, new/worsening cough), diarrhea with blood/mucus, mouth/throat sores, severe stomach/abdominal pain, symptoms of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, yellowing eyes/skin, dark urine), signs of kidney problems (such as change in the amount of urine, pink/bloody urine), easy bruising/bleeding, swelling hands/ankles/feet, unusual weakness, joint stiffness/pain, muscle weakness/pain, eye redness/pain, sensitivity to light, vision changes.

Avelumab may cause hormone gland problems (such as thyroid, pituitary, adrenal, pancreas). Your body could make too much or too little hormone. Tell your doctor right away if you have any symptoms such as: cold or heat intolerance, unexplained weight loss/gain, increased thirst/urination, mood or behavior changes (such as decreased sex drive, irritability, forgetfulness), slow/fast/pounding/irregular heartbeat, unusual tiredness, constipation.

Get medical help right away if you have any very serious side effects, including: chest pain, shortness of breath.

Avelumab can commonly cause itching or a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash or itching.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Precautions

Before using avelumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using avelumab. Avelumab may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 1 month after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 1 month after stopping treatment. Consult your doctor before breast-feeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as liver/kidney/thyroid function, blood sugar) should be done before and during treatment with this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.Information last revised May 2017. Copyright(c) 2017 First Databank, Inc.

Images
Bavencio 20 mg/mL intravenous solution
Bavencio 20 mg/mL intravenous solutioniconicon
Bavencio 20 mg/mL intravenous solution

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Bavencio 20 mg/mL intravenous solution
Bavencio 20 mg/mL intravenous solution

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This medicine is a colorless, clear, vial

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.