Methoxy polyethylene glycol-epoetin beta

Thông tin thuốc gốc
Chỉ định và Liều dùng
Intravenous, Subcutaneous
Anaemia associated with chronic kidney disease
Adult: Dosage is individualised and adjusted according to target Hb concentration. In patients who are not currently treated with an erythropoiesis stimulating agent (ESA): Patients not on dialysis: Initially, 1.2 mcg/kg once every month via single SC inj in the abdomen, arm or thigh. Alternatively, initiate at 0.6 mcg/kg once every 2 weeks via single SC inj (in the abdomen, arm or thigh) or IV inj. Patients on dialysis: Initially, 0.6 mcg/kg once every 2 weeks as a single SC inj (in the abdomen, arm or thigh) or IV inj. Doses may be adjusted by approx 25% at monthly intervals if needed. Maintenance dose: After reaching the target Hb concentration, administer once monthly using the dose equal to twice the previous once-every-2-week dose then subsequently titrate as necessary. In patients who are currently treated with an ESA (e.g. epoetin alfa or darbepoetin alfa): Initially, the dose is based on the total weekly dose of the previous ESA at the time of substitution. Inject the 1st dose at the next scheduled dose of the previously administered ESA. Administer once a month or once every 2 weeks as a single SC inj (in the abdomen, arm or thigh) or single IV inj. Doses may be adjusted by approx 25% at monthly intervals if needed and should not be adjusted more often than once every 4 weeks. Use the lowest necessary dose to reduce the need for RBC transfusions. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).
Child: 3 months-17 years Dosage is individualised and adjusted according to target Hb concentration. In patients who are currently being treated with an ESA: Initially, the dose is based on the total weekly dose of the previous ESA at the time of substitution. Administer once every 4 weeks via IV or SC inj; maintain the same route of administration as the previous ESA. Doses may be adjusted by approx 25% if needed and should not be adjusted more often than once every 4 weeks. Use the lowest necessary dose to reduce the need for RBC transfusions. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).
Các sản phẩm có chứa hoạt chất Methoxy polyethylene glycol-epoetin beta tại Việt Nam?
Chống chỉ định
Uncontrolled hypertension; pure red cell aplasia (PRCA) after ESA treatment.
Thận trọng
Patient with current or history of CV disease and stroke; cancer, seizures; haemoglobinopathies; bleeding or a recent history of bleeding requiring transfusion; bone marrow fibrosis, haemolysis, severe Al overload due to treatment of renal failure. Not indicated and not recommended for anaemia due to cancer chemotherapy or as a substitute for RBC transfusions in patients who require immediate correction of anaemia. Rule out Fe, folic acid and vitamin B12 deficiencies before treatment initiation. Pre-filled syringes are not for administration of partial doses. Children. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: Serious allergic reactions (e.g. anaphylactic reactions, angioedema, bronchospasm, tachycardia, pruritus, rash, urticaria), hypertension, hypertensive encephalopathy; seizures; pure red cell aplasia (PRCA); increased risk of tumour progression or recurrence.
Blood and lymphatic system disorders: Thrombocytopenia.
Gastrointestinal disorders: Diarrhoea, vomiting, constipation, abdominal pain.
Musculoskeletal and connective tissue disorders: Muscle spasm, back pain, limb pain.
Nervous system disorders: Headache.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, URTI, cough.
Potentially Fatal: CV events, including MI, stroke, VTE, thrombosis of vascular access and other thromboembolic events (particularly when administered to a target Hb >12 g/dL); severe cutaneous adverse reactions (e.g. erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome); CV complications (due to excessive increase in Hb level) related to misuse.
Chỉ số theo dõi
Obtain Hb levels at least weekly after initiation of therapy and dosage adjustments until stable, then at least monthly. Monitor blood pressure and Fe stores (including transferrin saturation and serum ferritin). Assess for signs and symptoms of seizures and hypersensitivity reactions.
Tác dụng
Description:
Mechanism of Action: Methoxy polyethylene glycol-epoetin beta is an erythropoiesis stimulating agent (ESA). It stimulates erythropoiesis through interaction with the erythropoietin receptor on progenitor cells present in the bone marrow, thereby increasing red blood cell production.
Onset: Hb increase (after a single initial dose): 7-15 days.
Pharmacokinetics:
Absorption: Absolute bioavailability: Approx 60% (SC). Time to peak plasma concentration: 72 hours (SC).
Excretion: Elimination half-life: 119 hours (IV); 124 hours (SC).
Bảo quản
Store between 2-8°C. Do not freeze. Protect from light. May store below 30°C for 1 single period of 1 month. Do not shake.
Phân loại MIMS
Các tác nhân tạo máu
Phân loại ATC
B03XA03 - methoxy polyethylene glycol-epoetin beta ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Tài liệu tham khảo
Anon. Methoxy Polyethylene Glycol-Epoetin Beta. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 08/07/2024.

Brayfield A, Cadart C (eds). Methoxy Polyethylene Glycol-Epoetin Beta. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/07/2024.

Joint Formulary Committee. Methoxy Polyethylene Glycol-Epoetin Beta. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/07/2024.

Methoxy Polyethylene Glycol-Epoetin Beta. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 08/07/2024.

Methoxy Polyethylene Glycol-Epoetin Beta. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 08/07/2024.

Mircera 360 micrograms/0.6 mL Solution for Injection in Pre-filled Syringe (Roche Products Limited). MHRA. https://products.mhra.gov.uk. Accessed 08/07/2024.

Mircera Injection, Solution (Vifor [International] Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/07/2024.

Mircera Solution for Injection in Pre-filled Syringe (Roche [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 08/07/2024.

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