Besremi

About Ropeginterferon alfa-2b-njft

• Ropeginterferon alfa-2b, known as Besremi, is an injectable medication approved for treating polycythemia vera. 
• The drug, classified as an interferon, received approval in the European Union in February 2019 and later in the United States in November 2021. 
• Notably, it holds the distinction of being the first FDA-approved medication for polycythemia vera, irrespective of prior treatment history, and is the inaugural interferon therapy specifically endorsed for this condition. 
• Belonging to type I interferons, interferon alfa exerts its effects in the bone marrow by binding to the interferon alfa receptor (IFNAR). 
• This binding initiates a downstream signaling cascade involving Janus kinase 1 (JAK1), tyrosine kinase 2 (TYK2), and activator of transcription (STAT) proteins. 
• The resulting nuclear translocation of STAT proteins regulates distinct gene-expression programs, inducing various cellular effects. 
• However, the precise mechanisms underlying the therapeutic effects of interferon alfa in polycythemia vera are not fully understood.

Strength: 

The injectable medication is available in a single-dose prefilled syringe, containing a solution with a concentration of 500 micrograms per milliliter (mcg/mL).

Recommended Dosage:

Besremi is administered through subcutaneous injection, a process feasible for healthcare professionals, patients, or caregivers, given proper training. To ensure eligibility for self-administration or caregiver involvement, individual suitability must be assessed. The prefilled syringe, kept in its carton, should be laid flat for 15-30 minutes before use to attain room temperature. 

Visual inspection is crucial; cloudy or discolored solutions, particulate matter, or damaged syringes should be avoided. Syringe preparation involves unscrewing the cap, attaching the covered needle, and choosing an injection site. Air bubbles are moved to the top, and the injection dose is set by aligning the gray stopper with the prescribed dose marking. The injection is administered at a chosen site, and used syringes are disposed of in an FDA-cleared sharps container, with the needle covered by the pink shield. The process ensures proper administration and disposal, emphasizing patient safety.

• The suggested initial dosage involves administering 100 micrograms through subcutaneous injection every two weeks, or 50 micrograms if the patient is concurrently receiving hydroxyurea. 
• The dose can be raised by 50 micrograms biweekly, with a maximum limit of 500 micrograms, until hematological parameters stabilize. 
• Dosing should be interrupted or discontinued in the event of specific adverse reactions.

Important:

Prior to initiating Besremi treatment, it is crucial to promptly inform your doctor of any adverse reactions you may experience. If you observe any unusual symptoms during the course of treatment, seek immediate consultation with your doctor. Furthermore, before commencing the treatment, disclose any pre-existing health conditions you may have. Your doctor needs to be aware of your overall health status to ensure the safe and effective administration of Besremi. Open communication about your health is vital for personalized care and to address any potential concerns that may arise during the treatment process.

Warnings & Precautions

• Besremi injection is contraindicated in individuals with a history or presence of severe psychiatric disorders, including severe depression, suicidal ideation, or suicide attempts. 
• Hypersensitivity to interferon or any component of Besremi, hepatic impairment (Child-Pugh B or C), and a history or presence of active serious or untreated autoimmune disease are also contraindications. 
• The potential risk of severe neuropsychiatric, autoimmune, ischemic, and infectious disorders is associated with interferon alfa products. 
• It is crucial to closely monitor individuals undergoing treatment and consider discontinuation in the presence of persistently severe or worsening signs or symptoms related to these disorders. 
• Immunocompromised transplant recipients should be closely monitored, and therapy may need to be adjusted. 
• Various adverse events, such as depression, endocrine disorders, cardiovascular issues, decreased peripheral blood counts, hypersensitivity reactions, pancreatitis, colitis, pulmonary toxicity, ophthalmologic toxicity, hyperlipidemia, hepatotoxicity, renal toxicity, dental and periodontal toxicity, dermatologic toxicity, and effects on driving and operating machinery, should be carefully monitored, with appropriate action taken if necessary. 
• This comprehensive monitoring and contraindication list underscores the importance of cautious use and regular evaluation during Besremi therapy. 
• Monitor individuals taking CYP450 substrates with a narrow therapeutic index for adverse reactions, assessing the necessity for adjusting the dose of the concurrent drug. 
• Exercise caution with myelosuppressive agents, avoiding their use, and closely observe patients receiving the combination for signs of excessive myelosuppression. 
• Refrain from using narcotics, hypnotics, or sedatives concurrently, and carefully monitor patients receiving the combination for potential excessive central nervous system toxicity.

Common Besremi Side Effects:

• Tiredness
• Weakness
• Fever
• Chills
• Muscle aches
• Joint pain
• Itching
• Sore throat
• Headache
• Nausea
• Diarrhea
• Dizziness
• Fatigue
• Injection site reactions
• Decreased appetite
• Hair loss
• Fluid retention (edema)
• High blood pressure (hypertension)
• Muscle spasms
• Rash
• Urinary tract infection (UTI)

Use in Specific Population

• Limited information is available regarding the use of Besremi  in pregnant individuals, and there is insufficient understanding of the potential risks for major birth defects, miscarriage, or other adverse outcomes for both maternal and fetal health. 
• There is no available data on the presence of Besremi in human or animal milk, its effects on the breastfed child, or its impact on milk production. Due to the potential for serious adverse reactions in breastfed children from Besremi, women are advised not to breastfeed during treatment and for 8 weeks after the final dose. 
• Female patients of reproductive potential should use effective contraception during Besremi treatment and for at least 8 weeks after the final dose. 
• Besremi can disrupt the menstrual cycle based on its mechanism of action. Safety and effectiveness in pediatric patients have not been established. 
• No dose adjustment is required for patients with an estimated glomerular filtration rate (eGFR) of ≥30 mL/min. 
• Besremi is contraindicated in patients with hepatic impairment (Child-Pugh B or C). Increased liver enzyme levels have been observed, and if progressive and persistent, dose reduction is recommended. 
• If liver enzyme increase is clinically significant despite dose reduction or evidence of hepatic impairment (Child-Pugh B or C), discontinuation of Besremi is recommended. Clinical trials have been conducted with Besremi.

Storage and Handling

• 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.
• Keep the medicine away from pets and children.