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Safety Information
Important Notice
Please review the full safety information below before continuing.
Indication
BESREMI® (ropeginterferon alfa-2b) is indicated for the treatment of adults with polycythemia vera.
Serious Warnings and Precautions
BESREMI® (ropeginterferon alfa-2b), may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many cases, but not all cases, these disorders resolve after stopping interferon therapy.
Contraindications
BESREMI® is contraindicated in patients with: present or previous severe psychiatric disorders (particularly severe depression, suicidal ideation or suicide attempt); decompensated cirrhosis (Child-Pugh B or C); history of or active serious or untreated autoimmune disease; immunosuppressed transplant recipients; pre-existing uncontrolled thyroid disease; severe pre-existing cardiovascular disease, (i.e., uncontrolled hypertension, congestive heart failure [≥ NYHA class 2], serious arrhythmia, significant coronary artery stenosis, unstable angina) or recent stroke or myocardial infarction; and severe/end stage renal disease (GFR < 30 mL/min).
Relevant Warnings and Precautions
- Monitoring/Titration: Efficacy in reducing cardiovascular/thromboembolic risk may not be fully established during titration. Monitor CBCs (hematocrit, leukocytes, platelets) regularly; phlebotomy may be required as rescue treatment.
- Cardiovascular: Associated with cardiomyopathy, MI, atrial fibrillation, and ischemic coronary artery disorders. Monitor patients with pre-existing cardiovascular history closely.
- Dental and periodontal disorders: Loss of teeth and dry mouth associated with long-term treatment may have a damaging effect on teeth and mucous membranes of the mouth.
- Ability to drive or use machines: Patients who experience dizziness, somnolence or hallucination during BESREMI® therapy should be advised to avoid driving or using machines.
- Endocrine/Metabolic: Treat and control pre-existing thyroid disease prior to therapy. Do not initiate in patients with poorly controlled diabetes; discontinue if diabetes develops and cannot be medically managed.
- Hepatotoxicity: Can cause significant liver enzyme increases and hepatic decompensation. Monitor liver function regularly; discontinue if enzyme elevations are progressive/clinically significant or if decompensation occurs.
- Other Serious Risks: Pancreatitis, fatal/serious ulcerative or hemorrhagic/ischemic colitis, serious acute hypersensitivity reactions, and severe eye disorders (e.g., retinopathy, retinal detachment/occlusion which may cause blindness) have occurred.
- Skin disorders: Skin disorders such as pruritus, alopecia, rash, erythema, psoriasis, xeroderma, hyperkeratosis, hyperhidrosis, some of which may be related to the disease; discontinue treatment if these appear or worsen.
- CNS Effects: Depression, suicidal ideation, suicide attempts, aggression, bipolar disorder, mania, and confusion have been observed.
- Respiratory: Lung infiltration, pneumonitis, pneumonia, or pulmonary arterial hypertension have been reported rarely.
- Renal: Monitor renal function.
- Pregnancy & Lactation: Not recommended during pregnancy. Verify pregnancy status before initiating in women of childbearing potential; effective contraception must be used. Consult with physician prior to breastfeeding.
Dosing and Administration Considerations
BESREMI® is administered by subcutaneous injection every 2 weeks during titration. The recommended starting dosage of BESREMI® for patients who are not already on hydroxyurea is 100 mcg. Increase dose by 50 mcg every 2 weeks (maximum of 500 mcg) until hematological parameters are stabilized. When transitioning to BESREMI® from hydroxyurea, start BESREMI® at 50 mcg by subcutaneous injection every two weeks in combination with hydroxyurea. Gradually taper off the hydroxyurea by reducing the total biweekly dose by 20-40% every two weeks during Weeks 3-12 until the hematological parameters are stabilized. Discontinue hydroxyurea by Week 13. After at least 1 year of hematological stability on a steady dose of BESREMI®, the dosing interval may be expanded to every 4 weeks. Monitor CBCs, every 2 weeks during titration/modification and every 3-6 months during maintenance.
For More Information:
Please consult the BESREMI® Product Monograph for complete information relating to contraindications, Serious Warnings and Precautions, other relevant warnings and precautions, adverse reactions, drug interactions, dosing and administration, and conditions of clinical use. The Product Monograph is available through Health Canada’s Drug Product Database, at www.besremipm.ca, or by calling FORUS Therapeutics Inc. at 1-866-542-7500.
