Ropeginterferon alfa-2b

What is Ropeginterferon alfa-2b?

• Ropeginterferon alfa-2b (Besremi) is an interferon alfa-2b used is a medication used to treat polycythemia vera.

What are the uses of this medicine?

• Ropeginterferon alfa-2b (Besremi) is a prescription medicine that is used to treat adults with polycythemia vera.

How does this medicine work?

• Ropeginterferon alfa-2b is a long-acting formulation of recombinant interferon alpha subtype 2b (IFN-a2b), in which IFN-a2b is coupled, via proline, to polyethylene glycol (PEG), with antiviral, immunomodulating and antineoplastic activities.
• Upon administration of ropeginterferon alfa-2b, IFN-a2b targets and binds to specific IFN cell-surface receptors.
• This activates IFN-mediated signal transduction pathways and induces the transcription and translation of genes with IFN-specific response elements (ISREs).
• Their protein products mediate antiviral, antiproliferative, anticancer, and immune-modulating effects.
• The PEG moiety inhibits proteolytic breakdown and clearance of IFN-a2b, which prolongs its half-life, extends the duration of its therapeutic effects and allows less frequent dosing.
• The proline linker facilitates the synthesis of a single positional isomer which further increases its stability and half-life.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have or had severe mental health problems, especially severe depression, thoughts of suicide, or attempted suicide
• have or had a serious or untreated autoimmune disease
• have had a serious allergic reaction to another interferon product or to any of the ingredients in Besremi. Symptoms of a serious allergic reaction to alpha-interferon may include itching, swelling of your face, tongue, throat, trouble breathing, feeling dizzy or faint, and chest pain.
• have certain types of liver problems
• have received a transplant and take immunosuppressive medicines

What drug interactions can this medicine cause?

• Patients on Besremi who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index should be monitored to inform the need for dosage modification for these concomitant drugs.
• Concomitant use of Besremi and myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
• Concomitant use of Besremi and narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

Is this medicine FDA approved?

• It was approved for medical use in the European Union in February 2019, and in the United States in November 2021.

How should this medicine be used?

• Pregnancy testing is recommended prior to Besremi treatment in females of reproductive potential.

Recommended dosage:

• The recommended Besremi starting dosage for patients not on hydroxyurea is 100 mcg by subcutaneous injection every two weeks.
• Increase the dose by 50 mcg every 2 weeks (up to a maximum of 500 mcg) until hematological parameters are stabilized.
• Interrupt or discontinue dosing if certain adverse reactions occur.

Administration:

• Use Besremi exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much Besremi to inject and when to inject it. Do not inject more than your prescribed dose.
• Besremi is given as an injection under your skin (subcutaneous injection). Your healthcare provider should show you how to prepare and measure your dose of Besremi, and how to inject yourself before you use Besremi for the first time.
• You should not inject Besremi until your healthcare provider has shown you how to use Besremi the right way. Your healthcare provider will prescribe the amount of Besremi that is right for you.
• Do not inject more than 1 dose of Besremi every 2 weeks without talking to your healthcare provider. Do not re-use the single-dose prefilled syringe.
• Your healthcare provider should do blood tests before you start Besremi, and regularly during treatment to monitor your polycythemia vera, and to check you for side effects.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 500 mcg/mL solution in a single-dose prefilled syringe

This medicine is available in fallowing brand namesː

• Besremi

What side effects can this medication cause?

The most common side effects of this medicine include:

• flu like symptoms including: tiredness, weakness, fever, chills, muscle aches, and joint pain
• itching
• sore throat

Besremi can cause serious side effects including:

• may cause death, or
• may worsen certain serious diseases that you may already have
• New or worsening autoimmune problems
• Heart problems
• Decreased blood cell counts
• Serious allergic reactions and skin reactions
• Eye problems
• Liver problems
• Kidney problems
• Tooth and gum (periodontal) problems
• Skin problems

What special precautions should I follow?

• Life-threatening or fatal neuropsychiatric reactions have occurred in patients receiving interferon alfa products, including Besremi. Closely monitor patients for any symptoms of psychiatric disorders and consider psychiatric consultation and treatment if such symptoms emerge. If psychiatric symptoms worsen, it is recommended to discontinue Besremi therapy.
• Endocrine toxicity has occurred in patients receiving interferon alfa products, including Besremi. These toxicities may include worsening hypothyroidism and hyperthyroidism. Autoimmune thyroiditis and hyperglycemia, including new onset type 1 diabetes, have been reported in patients receiving interferon alfa-2b products. Discontinue if endocrine disorders occur that cannot be medically managed.
• Cardiovascular toxicity has occurred in patients receiving interferon alfa products, including Besremi. Toxicities may include cardiomyopathy, myocardial infarction, atrial fibrillation and coronary artery ischemia. Avoid use in patients with severe, acute or unstable cardiovascular disease. Monitor patients with history of cardiovascular disorders more frequently.
• Decreased peripheral blood counts have occurred in patients receiving interferon alfa products, including Besremi. Perform blood counts at baseline, every 2 weeks during titration, and at least every 3-6 months during maintenance treatment.
• Hypersensitivity reactions have occurred in patients receiving interferon alfa products, including Besremi. Stop treatment and immediately manage reaction.
• Pancreatitis has occurred in patients receiving interferon alfa products, including Besremi. Consider discontinuation if confirmed pancreatitis.
• Fatal and serious ulcerative or hemorrhagic/ischemic colitis have occurred in patients receiving interferon alfa products, some cases occurring as early as 12 weeks after start of treatment. Discontinue if signs or symptoms of colitis.
• Pulmonary toxicity has occurred in patients receiving interferon alfa products, including Besremi. Discontinue if pulmonary infiltrates or pulmonary function impairment.
• Ophthalmologic toxicity has occurred in patients receiving interferon alfa products, including Besremi. Advise patients to have eye examinations before and during treatment. Evaluate eye symptoms promptly and discontinue if new or worsening eye disorders.
• Hyperlipidemia has occurred in patients treated with interferon alfa products, including Besremi. Monitor serum triglycerides before Besremi treatment and intermittently during therapy and manage when elevated.
• Hepatotoxicity has occurred in patients receiving interferon alfa products, including Besremi. Monitor liver enzymes and hepatic function at baseline and during treatment. Reduce dose or discontinue depending on severity.
• Renal toxicity has occurred in patients receiving interferon alfa products, including Besremi. Monitor serum creatinine at baseline and during therapy. Discontinue if severe renal impairment develops.
• Dental and periodontal toxicities may occur in patients receiving interferon alfa products, including Besremi. These toxicities may include dental and periodontal disorders, which may lead to loss of teeth. Advise patients on good oral hygiene and to have regular dental examinations.
• Dermatologic toxicity has occurred in patients receiving interferon alfa products, including Besremi. These toxicities have included skin rash, pruritus, alopecia, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, and hyperhidrosis. Consider discontinuing if clinically significant dermatologic toxicity.
• Besremi may impact the ability to drive and use machinery. Patients should not drive or use heavy machinery until they know how Besremi affects their abilities.
• Based on the mechanism of action, Besremi can cause fetal harm when administered to a pregnant woman. Besremi. Advise females of reproductive potential to use an effective method of contraception during treatment with Besremi and for at least 8 weeks after the final dose.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• influenza-like symptoms or other adverse reactions.

Management of overdosage:

• There is no antidote to Besremi overdosage.
• In case of an overdose, frequently monitor signs and symptoms for adverse reactions.

Can this medicine be used in pregnancy?

• Besremi may harm your unborn baby and may cause loss of your pregnancy (miscarriage).
• Before you start using Besremi your healthcare provider should do a pregnancy test.
• You should use effective birth control during treatment and for at least 8 weeks after your final dose of Besremi. Talk to your healthcare provider about birth control choices for you during treatment with Besremi.
• Besremi can affect your menstrual cycles and may cause your menstrual periods to stop.

Can this medicine be used in children?

• It is not known if Besremi is safe and effective in children.

What are the active and inactive ingredients in this medicine?

• Active ingredient: ropeginterferon alfa-2b-njft
• Inactive ingredients: benzyl alcohol, glacial acetic acid, polysorbate 80, sodium acetate, sodium chloride, Water for Injection.

Who manufactures and distributes this medicine?

• Manufactured by: PharmaEssentia Corporation 2F-5 No. 3 YuanQu Street Nangang Dist. Taipei, Taiwan
• Distributed by: PharmaEssentia USA Corporation, 35 Corporate Dr, Suite 325, Burlington, MA , USA

• Besremi is a trademark/registered trademark of PharmaEssentia

What should I know about storage and disposal of this medication?

• Store in a refrigerator at 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light.
• Do not freeze.

• Dailymed label info on Ropeginterferon alfa-2b
• FDA Ropeginterferon alfa-2b

Ropeginterferon alfa-2b Resources
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Ropeginterferon alfa-2b Resources
Latest articles Most recent articles Ongoing trials	Wikipedia