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Ropeginterferon alfa-2b

Brand name: BESREMI
Dosage form: subcutaneous solution (500 mcg/mL)
Drug class: antineoplastic interferons

What is Rogeginterferon alfa-2b?

Ropeginterferon is used to treat polycythemia vera in adults. This is a disorder that affects the body's production of blood cells. This medication guide does not list all possible uses for Ropeginterferon Alfa-2b.

Side effects of Ropeginterferon alfa-2b

If you experience any of the following: symptoms of an allergic reaction; hives or a skin rash that spreads and blisters; chest pain; anxiety; difficulty breathing; feeling light-headed or dizzy; swelling on your face, lips, or tongue; or if it is accompanied by chest pain or anxiety, Inform your physician immediately if you experience unusual changes in behavior or mood, such as depressive symptoms, increased irritability or aggression, hallucinations or thoughts of harming oneself.

Ropeginterferon alfa-2b may cause serious side effects. If you experience:

  • Increased urination, pain, and burning while urinating
  • New or worsening Cough; cough with mucus;
  • Vision changes
  • Liver problems: diarrhea; loss of appetite; pain or swelling of your stomach or legs. Easy bleeding. Drowsiness.
  • If you have kidney problems, it could be that you feel tired, swollen, or are urinating less.
  • Low blood cell counts: fever; chills; skin and mouth sores. Easy bruising. Unusual bleeding. Pale skin. Cold hands and feet. Feeling light-headed.

Rogeginterferon Alfa-2b side effects may include:

  • Flu-like symptoms (tiredness and weakness, as well as fever, chills, and joint pain)
  • Itching
  • Sore throat.

There may be other side effects. Call your physician if experiencing symptoms. For reporting side effects to FDA call their toll-free number 1800FDA-1088.

Warnings

Ropeginterferon Alfa-2b can cause serious or even fatal side effects. Inform your doctor immediately if you notice any changes in mood, including feeling hostile, depressed, or aggressive. If you experience symptoms like fatigue, increased thirst, increased urination, chest pain, or rapid heartbeats, call your doctor immediately.

Before you take this drug

If you have an allergy to ropeginterferon or:

  • Have you had liver disease?
  • Have or have severe mental health issues, including severe depression and thoughts of suicide.
  • Have or have had a serious auto-immune disease;
  • You have received a kidney transplant and are taking medications that weaken your immune system.

Tell your doctor if you:

  • You are currently being treated for mental illness, or you have received treatment for mental illness in the past.
  • Have Diabetes?
  • Have you ever suffered from heart disease or high blood pressure?
  • Have you ever experienced bleeding or a blood clot?
  • Have you ever had a low blood cell count?
  • Are You Suffering From an Immune System Disorder? If this is the case for you, your immune system could become impaired and needs support in order to keep functioning optimally.
  • Have HIV or hepatitis B?
  • Kidney or liver disease

Before starting the treatment, you may need to take a pregnancy test. Can harm an unborn child.If you are pregnant, do not take this medication. Roliginterferon alfa-2b can affect your menstrual cycles. Inform your doctor immediately if you fall pregnant. Do not breastfeed for 8 weeks after the last dose of this medication.

How to take Ropeginterferon alfa-2b?

Read all instructions or guides that accompany your medication and comply with its directives. Follow the directions on the label. Ropeginterferon Alfa-2b is typically given every two weeks. Please read and follow all instructions for use that come with your medication. If you do not understand the instructions, ask your doctor or pharmacist. Ropeginterferon alfa-2b injections are given under the skin. This injection will be given by a healthcare provider. They may also teach you how to use it properly. Never reuse a syringe or needle. Put them in a "sharps container" that is puncture-proof, and dispose of the sharps according to local or state laws. Keep away from children and pets. While using ropeginterferon, you should pay special attention to your oral hygiene. You should also have regular dental examinations. Before and during the treatment with ropeginterferon a-2b, you will need to undergo frequent blood tests. Keep away from heat or light. Do not freeze.

Details on dosage

Adult dose for polycythemia vera:

For Patients Not Receiving Hydrooxyurea
Initial dose: 100 mg subcutaneously every two weeks
Increase the dose by 50 mcg increments every 2 weeks until the hematologic parameter stabilizes.
Maximum dose: 500 mg subcutaneously once every 2 weeks.
For Patients Transitioning from Hydroxyurea
Initial dose: 50 mg subcutaneously every two weeks in combination with the hydroxyurea
In weeks 3–12, taper off the hydroxyurea gradually by decreasing the total biweekly dosage by 20%–40% each 2 weeks and increasing this drug by increments of up to 50 mcg per 2 weeks.
Maximum dose: 500 mg subcutaneously once every 2 weeks.
Stabilized Hematologic Parameters:
Hematocrit below 45%
Platelets less than 400 x 10-(9)/L
Leukocytes below 10 x 10(9)/L
Maintenance dose:
Maintain a 2-week interval of dosing with hematological stability for at least one year.
After 1 year of stable hematological status on a stable dosage, the interval between doses may be extended to every 4 weeks.
Comments:
Patients should be closely monitored. Complete blood counts (CBCs) should be taken every two weeks during the titration phase and every three to six months during the maintenance phase.
Phlebotomy is sometimes required as a rescue treatment for normalizing blood hyperviscosity.
Use: To treat polycythemia vera.

What happens if I miss the dose?

If you miss an injection dose, contact your healthcare provider immediately for instructions.

What happens if I overdose?

Contact poison control immediately by dialling 1-800-222-1222, or seek emergency medical attention as soon as you suspect any form of poison exposure.

What should be avoided?

You should avoid driving or engaging in hazardous activities until you understand how interferon beta-2b affects you. Dizziness and drowsiness may cause accidents or serious injuries.

Interaction with other drug

Rogeginterferon Alfa-2b should not be taken in conjunction with certain medications. Please inform your physician of all medicines you take - both prescription and over-the-counter drugs, vitamins, and herbal products are included here; the following list does not represent every possible interaction.

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Prescription only

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