Mepolizumab: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Malaysia prescribing information.

Generic Medicine Info

Indications and Dosage

Subcutaneous
Severe eosinophilic asthma

Adult: As an adjunctive treatment for refractory cases: 100 mg once every 4 weeks. Assess the need for continued therapy at least annually based on patient's disease severity and level of control of exacerbations.
Child: 6-11 years As an adjunctive treatment for refractory cases: 40 mg once every 4 weeks; ≥12 years Same as adult dose.

Subcutaneous
Chronic rhinosinusitis with nasal polyps

Adult: As an adjunctive treatment to intranasal corticosteroids for cases in which systemic corticosteroids and/or surgery can not provide adequate disease control: 100 mg once every 4 weeks.

Subcutaneous
Eosinophilic granulomatosis with polyangiitis

Adult: As an adjunctive treatment for relapsing-remitting or refractory cases: 300 mg (3 separate 100 mg inj, each inj site is separated by at least 5 cm) once every 4 weeks. Assess the need for continued therapy at least annually based on patient's disease severity and improvement of symptom control.

Subcutaneous
Hypereosinophilic syndrome

Adult: As adjunctive treatment for inadequately controlled cases without an identifiable non-haematologic secondary cause: 300 mg (3 separate 100 mg inj, each inj site is separated by at least 5 cm) once every 4 weeks. Assess the need for continued therapy at least annually based on patient's disease severity and improvement of symptom control.
Child: ≥12 years Same as adult dose.

Reconstitution

Lyophilised powder for inj: Reconstitute vial with 1.2 mL sterile water for inj to yield a final concentration of 100 mg/mL. Direct the stream of the diluent vertically onto the middle of the lyophilised cake. Dissolve the powder by gently swirling the vial for 10 seconds with a circular motion at intervals of 15 seconds, typically within 5 minutes. Do not shake.

Contraindications

Hypersensitivity.

Special Precautions

Patient with parasitic/helminth infection. Not indicated for the treatment of acute asthma symptoms or exacerbations (including status asthmaticus). Children. Pregnancy and lactation.

Adverse Reactions

Significant: Acute and delayed systemic reactions including hypersensitivity (e.g. urticaria, rash, anaphylaxis, angioedema, bronchospasm, hypotension); asthma-related adverse symptoms or exacerbations, herpes zoster infection.
Gastrointestinal disorders: Upper abdominal pain.
General disorders and administration site conditions: Fever, fatigue, local inj site reactions (e.g. burning sensation, erythema, itching, pain, swelling), systemic non-allergic administration-related reactions (e.g. flushing, myalgia, rash).
Musculoskeletal and connective tissue disorders: Back pain, arthralgia, muscle spasms.
Nervous system disorders: Headache.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Lower respiratory tract infection, pharyngitis, nasal congestion, oropharyngeal pain.
Skin and subcutaneous tissue disorders: Eczema.

Monitoring Parameters

Monitor pulmonary function tests (e.g. peak flow, FEV₁). Assess for signs of hypersensitivity reactions (including delayed reactions). Monitor for marker of deteriorating asthma condition (i.e. increased use of short-acting β₂-agonist inhalers).

Action

Description:
Mechanism of Action: Mepolizumab is a humanised monoclonal antibody (IgG₁ kappa) that selectively binds to human interleukin-5 (IL-5) and inhibits its binding to the α chain of the IL-5 receptor complex expressed on the surface of eosinophils. This action results in reduced production and survival of eosinophils and decreased eosinophil-mediated inflammation.
Pharmacokinetics:
Absorption: Bioavailability: 74-80%. Time to peak plasma concentration: 4-8 days.
Distribution: Volume of distribution: Approx 3.6 L.
Metabolism: Degraded by proteolytic enzymes that are widely distributed in the body and not limited to hepatic tissue.
Excretion: Terminal elimination half-life: 16-22 days.

Storage

Pre-filled syringe/autoinjector: Store between 2-8°C. Do not freeze. If needed, may store unopened cartons at room temperature (up to 30°C) for up to 7 days. Protect from light and heat. Do not shake. Unopened vial: Store between 2-8°C or below 25°C. Do not freeze. Protect from light. Reconstituted vials: Use immediately; if necessary, may store below 30°C for up to 8 hours. Do not freeze.

MIMS Class

Antiasthmatic & COPD Preparations

ATC Classification

R03DX09 - mepolizumab ; Belongs to the class of other systemic drugs used in the treatment of obstructive airway diseases.

References

Anon. Mepolizumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 13/12/2022.

Anon. Mepolizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/12/2022.

Buckingham R (ed). Mepolizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/12/2022.

GlaxoSmithKline NZ Limited. Nucala Powder for Injection and Solution for Injection data sheet 5 October 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 13/12/2022.

Joint Formulary Committee. Mepolizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/12/2022.

Nucala 100 mg Solution for Injection in Pre-filled Syringe (GlaxoSmithKline UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 13/12/2022.

Nucala 100 mg/mL Solution for Injection in Pre-filled Pen; Solution for Injection in Pre-filled Syringe (GlaxoSmithKline Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 13/12/2022.

Nucala Injection, Powder, for Solution; Injection, Solution (GlaxoSmithKline LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 13/12/2022.

Disclaimer: This information is independently developed by MIMS based on Mepolizumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com