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ropeginterferon alfa-2b

Brand: BESREMi

What is the most important information I should know about ropeginterferon alfa-2b?

Ropeginterferon alfa-2b may cause serious or fatal side effects.

Tell your doctor right away about any new or worsening mood symptoms, such as feeling irritable, hostile, aggressive, depressed, or having thoughts about suicide or hurting yourself.

Call your doctor right away if you have symptoms such as tiredness, increased thirst or urination, chest pain, or fast heartbeats.

What is ropeginterferon alfa-2b?

Ropeginterferon alfa-2b is used in adults to treat polycythemia vera, which is a disorder that affects your body's ability to produce blood cells.

Ropeginterferon alfa-2b may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using ropeginterferon alfa-2b?

You should not use ropeginterferon alfa-2b if you are allergic to it, or if you:

  • have liver disease;
  • have or had severe mental health problems, especially severe depression, thoughts of suicide;
  • have or had a serious autoimmune disease; or
  • have received a transplant and take medications that weaken the immune system.

Tell your doctor if you:

  • are being treated for a mental illness or had treatment in the past for any mental illness;
  • have diabetes;
  • have or ever had any heart problems or high blood pressure;
  • have or ever had bleeding problems or a blood clot;
  • have or ever had low blood cells;
  • have a condition that suppresses your immune system;
  • have hepatitis B or HIV; or
  • kidney or liver problems.

You may need to have a negative pregnancy test before starting this treatment.

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using ropeginterferon alfa-2b and for at least 8 weeks after your last dose. This medicine may affect your menstrual cycle. Tell your doctor if you become pregnant.

Do not breastfeed while using this medicine, and for at least 8 weeks after your last dose.

How should I use ropeginterferon alfa-2b?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Ropeginterferon alfa-2b is usually given once every 2 weeks.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Ropeginterferon alfa-2b is injected into a muscle, under the skin. A healthcare provider will give you this injection and may teach you how to properly use the medication by yourself.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Pay special attention to your dental hygiene and have regular dental exams while using ropeginterferon alfa-2b.

You will need frequent blood tests before and during treatment with ropeginterferon alfa-2b.

Store in the refrigerator away from heat and light. Do not freeze.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using ropeginterferon alfa-2b?

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

What are the possible side effects of ropeginterferon alfa-2b?

Get emergency medical help if you have signs of an allergic reaction: hives, or a rash that spreads and causes blistering and peeling; chest pain, anxiety, difficult breathing, feeling light-headed; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have unusual changes in mood or behavior, such as: depression, irritability, feeling hostile or aggressive, hallucinations, or thoughts about hurting yourself.

Call your doctor at once if you have:

  • pain and burning when you urinate, increased urination;
  • new or worsening cough, cough with mucus, trouble breathing;
  • vision changes;
  • liver problems --diarrhea, loss of appetite, pain or swelling in your stomach, swelling in your legs, easy bleeding, drowsiness, confusion, or jaundice (yellowing of the skin or eyes);
  • kidney problems --swelling, urinating less, feeling tired or short of breath; or
  • low blood cell counts --fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

  • flu-like symptoms (tiredness, weakness, fever, chills, muscle aches, and joint pain);
  • itching; or
  • sore throat.

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 FDA at 1-800-FDA-1088.

What other drugs will affect ropeginterferon alfa-2b?

Some drugs should not be used at the same time with ropeginterferon alfa-2b. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about ropeginterferon alfa-2b.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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