ropeginterferon alfa-2b

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

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.

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?

• 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.

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.

What happens if I miss a dose?

What happens if I overdose?

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

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

• 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.