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Besremi is a brand name for Ropeginterferon Alfa-2b. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated under supervision of a physician experienced in the management of the disease. 3 Posology Titration phase The dose is titrated individually with a recommended starting dose of 100 micrograms (or 50 micrograms in patients under another cytoreductive therapy).
The dose should be gradually increased by 50 micrograms every two weeks (in parallel, other cytoreductive therapy should be decreased gradually, as appropriate) until stabilisation of the haematological parameters is achieved (haematocrit < 45%, platelets < 400 × 109/L and leukocytes < 10 × 109/L).
The maximum recommended single dose is 500 micrograms injected every two weeks. Phlebotomy as rescue treatment to normalise blood hyperviscosity may be necessary. 5 years. After that, the dose may be adapted and/or the administration interval prolonged up to every four weeks, as appropriate for the patient.
If adverse events develop during therapy, the administered dose should be reduced or treatment discontinued temporarily until adverse events abate; further, treatment should be re-initiated with a lower dose than the dose that caused adverse events.
If an increase of haematological parameters (haematocrit, platelets, leukocytes) is observed, the dose and/or dosing interval needs to be adapted individually. , Child-Pugh A), another pegylated interferon alfa medicinal product (pegylated interferon alfa-2a) has been shown to be safe.
No ropeginterferon alfa-2b dose adjustment is required for adult patients with mild liver impairment. 3). Increased liver enzyme levels have been observed in patients treated with ropeginterferon alfa-2b. When the increase in liver enzyme levels is progressive and persistent, the dose should be reduced.
4). 2). No dose adjustment for ropeginterferon alfa-2b is required for adult patients with mild (GFR 60- 89 mL/min) or moderate (GFR 30-59 mL/min) renal impairment. A reduced starting dose for ropeginterferon alfa-2b of 50 micrograms is recommended for patients with severe (GFR 15- 29 mL/min) renal impairment.
3). 2). Obese or underweighted patients The pharmacokinetic profile of ropeginterferon alfa-2b has not been determined in obese and underweighted patients. No recommendation on dose adjustment for ropeginterferon alfa-2b can be given for these patients.
1%). 6%). Tabulated list of adverse reactions Following treatment-related adverse reactions were reported with ropeginterferon alfa-2b in clinical studies in 178 polycythaemia vera adult patients. Adverse reactions are listed by system organ class 1/100 to < 1/1 000 to < 1/10 000 to < 1/1 000), very rare (< 1/10 000) or not known (cannot be estimated from available data).
System organ class Frequency Adverse reaction Infections and infestations common respiratory tract infection, influenza, rhinitis, fungal skin infection uncommon oral herpes, herpes zoster, oral candidiasis, sinusitis, oesophageal candidiasis, vulvovaginal mycotic infection, hordeolum, onychomycosis Blood and lymphatic system disorders very common leukopenia, thrombocytopenia common pancytopenia, neutropenia, anaemia Immune system disorders uncommon sarcoidosis very rare idiopathic or thrombotic thrombocytopenic purpura# not known Vogt-Koyanagi-Harada disease#, acute hypersensitivity reactions#** Endocrine disorders common hypothyroidism, hyperthyroidism, thyroiditis uncommon Basedow's disease, diabetes mellitus# Metabolism and nutrition disorders common hypertriglyceridaemia, decreased appetite Psychiatric disorders common depression, aggression#, insomnia, anxiety, mood altered, mood swings, mood disorders uncommon suicide attempt#, suicidal ideation#, confusional state#, acute stress disorder, hallucination, emotional distress, nervousness nightmare, irritability rare bipolar disorder#, mania# 9 Nervous system disorders common headache, dizziness, hypoesthesia, somnolence, paraesthesia uncommon polyneuropathy, peripheral motor neuropathy, radiculopathy, migraine, mental impairment, tremor, aura Eye disorders common dry eye uncommon retinal haemorrhage#, retinal exudates#, visual impairment, visual acuity reduced, vision blurred, ocular discomfort, eczema eyelids rare retinopathy#, optic neuropathy#, retinal artery occlusion#, retinal vein occlusion#, very rare blindness# not known retinal detachment# Ear and labyrinth disorders uncommon deafness, tinnitus, vertigo Cardiac disorders common atrial fibrillation uncommon myocardial infarction#, atrioventricular block, intracardiac thrombus, aortic valve incompetence, cardiovascular disorder rare cardiomyopathy#, angina pectoris# very rare myocardial ischemia# Vascular disorders common microangiopathy uncommon Raynaud's phenomenon, hypertension, haematoma, flushing Respiratory, thoracic and mediastinal disorders common dyspnoea uncommon pneumonitis, cough, epistaxis, throat irritation very rare lung infiltration# not known pulmonary fibrosis#, pneumonia#, pulmonary arterial hypertension#* Gastrointestinal disorders common diarrhoea, nausea, abdominal pain, constipation, abdominal distension, dry mouth uncommon gastritis, abdominal wall disorder, flatulence, frequent bowel movements, odynophagia, gingival bleeding not known tooth disorder#, periodontal disease# Hepatobiliary disorders very common gamma-glutamyltransferase increased common liver disorder, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased uncommon hepatotoxicity, hepatitis toxic, hepatomegaly, porphyria non-acute rare hepatic failure# Skin and subcutaneous tissue disorders common pruritus, alopecia, rash, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, hyperhidrosis, dry skin uncommon photosensitivity reaction, skin exfoliation, nail dystrophy not known skin depigmentation# Musculoskeletal and connective tissue disorders very common arthralgia, myalgia common Sjogren's syndrome, arthritis, pain in extremity, musculoskeletal pain, bone pain, muscle spasms uncommon muscular weakness, neck pain, groin pain Renal and urinary disorders uncommon cystitis haemorrhagic, dysuria, micturition urgency, urinary retention 10 Reproductive system and breast disorders uncommon erectile dysfunction, haematospermia General disorders and administration site conditions very common influenza-like illness, fatigue common pyrexia, injection site reaction, asthenia, chills, general physical health deterioration, injection site erythema uncommon injection site pain, injection site pruritus, sensitivity to weather change not known: tongue hyperpigmentation# Investigations common antithyroid antibody positive, blood thyroid stimulating hormone increased, body temperature increased, antinuclear antibody positive, blood lactate dehydrogenase increased, weight decreased uncommon platelet count increased, blood uric acid increased, Coombs test positive #Reported as adverse reactions during treatment with other interferon alfa medicinal products.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 2) results in a prolonged time to reach the individual optimal dose compared to hydroxycarbamide.
6 months of treatment. , hydroxycarbamide) may be preferred in patients for whom an early reduction in elevated blood counts is necessary to prevent thrombosis and bleeding. During the titration phase the efficacy to reduce the cardiovascular and thromboembolic risk of the underlying disease may not be fully established.
Patients should be closely monitored, particularly during the titration phase; complete blood counts including determination of haematocrit level, leukocyte and platelet counts should be performed regularly also after the individual optimal dose has been established.
Phlebotomy as rescue treatment to normalise blood hyperviscosity may be necessary. 3). Patients who develop symptoms indicative of a thyroid dysfunction during ropeginterferon alfa-2b therapy, should evaluate their thyroid stimulating hormone (TSH) levels.
If TSH levels can be controlled within the normal range, the therapy can be continued. 8). Patients with this condition who cannot be effectively controlled by medicinal products should not begin ropeginterferon alfa-2b therapy. Patients who develop this condition during treatment and cannot be controlled by medicinal products should discontinue ropeginterferon alfa-2b therapy.
8). Other CNS effects, including suicidal ideation, attempted suicide, aggression, bipolar disorder, mania and confusion have been observed with other interferon alfa medicinal products. Patients should be closely monitored for any symptoms of psychiatric disorders and therapeutic management should be considered by the treating physician if such symptoms emerge.
If psychiatric symptoms worsen, it is recommended to discontinue ropeginterferon alfa-2b therapy. 3). 8). Patients with pre-existing or a history of cardiovascular disorders should be closely monitored during ropeginterferon alfa-2b therapy.
5) • Decompensated cirrhosis of the liver (Child-Pugh B or C) • End stage renal disease (GFR < 15 mL/min)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4 Paediatric population The safety and efficacy of Besremi in children and adolescents has not been established. 4). 2). Method of administration For subcutaneous use. The medicinal product is intended for long-term treatment and can be administered by a physician, nurse, family member or patient when trained in the administration of subcutaneous injections with the pre-filled pen.
The instructions for use in the package leaflet should be followed. The recommended injection site is the abdominal skin around but not within 5 cm of the navel or the thigh. Do not inject into an area where the skin is irritated, reddened, bruised, infected, or scarred.
The pen allows for adjustable dosing increments in the range of 50 to 250 micrograms or 50 to 500 micrograms.
*Class label for interferon medicinal products, see below pulmonary arterial hypertension. , urticaria, angioedema, bronchoconstriction, or anaphylaxis. Description of selected adverse reactions Most common adverse reactions The most common adverse reactions (including number of patients, incidence rate, severity grade, necessity for dose adaptation and outcome) reported during the ropeginterferon alfa-2b clinical development program are summarised in Table 1.
Table 1. Most common adverse reactions during ropeginterferon alfa-2b treatment. ADR >10% PT N (%) N = 178 IR CTCAE intensity N (%) Dose reduced N (%) Medicinal Product interrupted N (%) Medicinal Productdisc […]
3). 8). Patients who develop respiratory symptoms should be monitored closely and if necessary, ropeginterferon alfa-2b therapy should be discontinued. 8). Patients should have eye examinations before and during ropeginterferon alfa-2b therapy, specifically in those patients with retinopathy associated disease such as diabetes mellitus or hypertension.
Any patient reporting a decrease or loss of vision or reporting other eye symptoms should have an immediate eye examination. Discontinuation of ropeginterferon alfa-2b should be considered in patients who develop new or worsening eye disorders.
, urticaria, angioedema, bronchoconstriction, anaphylaxis) have been rarely observed with other interferon alfa medicinal products. If this occurs, ropeginterferon alfa-2b therapy must be discontinued and appropriate medical therapy instituted immediately.
Transient rashes do not necessitate interruption of treatment. 6 Liver function Interferon alfa therapy has been associated with hepatotoxicity characteried by potentially significant increases in liver enzymes. 8). 3 times the upper limit of normal), 3 times the upper limit of normal) and bilirubin (> 2 times the upper limit of normal) levels have been observed in patients treated with ropeginterferon alfa-2b.
These elevations were mostly transient and occurred during the first treatment year. 8). Liver enzymes and hepatic function should be regularly controlled in patients with long- term ropeginterferon alfa-2b therapy. Treatment with ropeginterferon alfa-2b should be discontinued when, despite dose reduction, the increase in liver enzyme levels is progressive and clinically significant.
In patients who develop evidence of […]