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Mepolizumab

Class
Biologic agents
Subclass
Anti-IL-5 monoclonal antibodies
Substance name
Mepolizumab
Brand names
Nucala®
Common formulations
Powder for parenteral solution
Dosage and administration
Adults patients
Treatment
Eosinophilic granulomatosis with polyangiitis
300 mg SC q4 weeks
Administered as 3 separate 100 mg injections at least 5 cm apart. Administered into the upper arm, thigh, or abdomen.
Hypereosinophilic syndrome
300 mg SC q4 weeks
Administered as 3 separate 100 mg injections at least 5 cm apart. Administered into the upper arm, thigh, or abdomen.
Adjunctive treatment
Chronic rhinosinusitis with nasal polypsMaintenance therapy, if intranasal corticosteroids are ineffective or contraindicated
100 mg SC q4 weeks
Administered into the upper arm, thigh, or abdomen.
Severe asthma phenotypesEosinophilic phenotype, maintenance therapy
100 mg SC q4 weeks
Administered into the upper arm, thigh, or abdomen.
COPDEosinophilic phenotype, maintenance therapyOff-label
100 mg SC q4 weeks
Administered into the upper arm, thigh, or abdomen.
Indications for use
Labeled indications
Adults
Treatment of eosinophilic granulomatosis with polyangiitis
Treatment of hypereosinophilic syndrome
Adjunctive treatment for chronic rhinosinusitis with nasal polyps (maintenance therapy), if intranasal corticosteroids are ineffective or contraindicated
Adjunctive treatment for severe asthma phenotypes (eosinophilic phenotype, maintenance therapy)
Off-label indications
Adults
Adjunctive treatment for COPD (eosinophilic phenotype, maintenance therapy)
Safety risks
Contraindications
Hypersensitivity to mepolizumab or its components
Acute bronchospasm or status asthmaticus
Do not use mepolizumab for the treatment of acute conditions, such as acute asthma symptoms, exacerbations, acute bronchospasm, or status asthmaticus.
Warnings and precautions
Corticosteroid withdrawal
Use caution in patients on corticosteroid treatment, as reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by corticosteroids. Do not discontinue systemic or ICSs abruptly upon initiation of mepolizumab therapy.
Drug hypersensitivity reaction
Maintain a high level of suspicion, as mepolizumab has been associated with anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, and skin rash, typically within hours of administration, but delayed onset has also been observed.
Helminthiasis
Maintain a high level of suspicion, as eosinophils are also involved in the immunological response to certain helminth infections. Treat patients with pre-existing helminth infections before initiating mepolizumab therapy. Discontinue mepolizumab in patients becoming infected with helminth while on mepolizumab therapy and not responding to anti-helminth treatment, until the infection resolves.
Herpes zoster
Maintain a high level of suspicion, as mepolizumab has been associated with an increased risk of herpes zoster infection. Consider offering vaccination if appropriate.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
No guidance available. Mepolizumab is not cleared renally.
Renal replacement therapy
Any modality
No guidance available.
Hepatic impairment
Any severity
No guidance available. Hepatic impairment is unlikely to have any effect on the elimination of mepolizumab.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B1
Insufficient evidence. Monoclonal antibodies cross the placenta, with transport increasing as pregnancy progresses, so any potential fetal effects are likely to be greater during the second and third trimesters. The 2020 ERS/TSANZ task force statement suggests that mepolizumab is possibly safe during pregnancy.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
Headache, injection site reactions
Common 1-10%
Allergic rhinitis, asthenia, Acute cystitis, drug hypersensitivity reaction, eczema, influenza virus infection, ⊕ anti-mepolizumab antibodies, pruritus, abdominal pain, arthralgia, back pain, diarrhea, dizziness, dyspnea, acute otitis media, gastroenteritis, lower respiratory tract infection, nasal congestion, pharyngitis, dry nose, epigastric pain, fatigue, fever, muscle spasms, myalgia, angioedema, bronchospasm, hypotension, urticaria, skin rash, itching, throat pain, toothache, vomiting, urinary tract infections
Uncommon < 1%
Herpes zoster
Unknown frequency
Anaphylaxis
Interactions
Drug(s)
Check Interactions
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