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Ropeginterferon alfa-2b

Generic name: ropeginterferon alfa-2b
Brand name: BESREMi
Dosage form: subcutaneous solution (500 mcg/mL)
Drug class: Antineoplastic interferons

Medically reviewed by Drugs.com on Jun 27, 2023. Written by Cerner Multum.

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.

Ropeginterferon alfa-2b side effects

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.

Ropeginterferon alfa-2b may cause serious side effects. Call your doctor at once if you have:

Common side effects of ropeginterferon alfa-2b may include:

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.

Warnings

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.

Before taking this medicine

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

Tell your doctor if you:

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. ropeginterferon alfa-2b 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 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.

Ropeginterferon alfa-2b dosing information

Usual Adult Dose for Polycythemia Vera:

For Patients NOT Receiving Hydroxyurea:
Initial dose: 100 mcg subcutaneously every 2 weeks
-Increase the dose in increments of 50 mcg every 2 weeks until the hematologic parameters stabilize
Maximum dose: 500 mcg subcutaneously every 2 weeks

For Patients TRANSITIONING from Hydroxyurea:
Initial dose: 50 mcg subcutaneously every 2 weeks in combination with hydroxyurea
-Gradually taper off hydroxyurea in weeks 3 through 12 by reducing total biweekly dose by 20% to 40% every 2 weeks while increasing this drug in increments of 50 mcg every 2 weeks until the hematologic parameters stabilize; discontinue hydroxyurea by week 13
Maximum dose: 500 mcg subcutaneously every 2 weeks

Stabilized Hematologic Parameters:
--Hematocrit less than 45%
--Platelets less than 400 x 10(9)/L
--Leukocytes less than 10 x 10(9)/L

Maintenance dose:
-Maintain 2-week dosing interval with hematological stability for at least 1 year
-After 1 year of hematological stability on a stable dose, the dosing interval may be expanded to every 4 weeks

Comments:
-Patients should be monitored closely; complete blood counts (CBC) should be obtained every 2 weeks during titration and every 3 to 6 months during maintenance phase, and as clinically indicated.
-Phlebotomy may be necessary as rescue treatment to normalize blood hyperviscosity,

Use: For the treatment of polycythemia vera.

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 ropeginterferon alfa-2b will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

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.

Further information

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.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.