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Nucala
mepolizumab
Adult Dosing .
Dosage forms: INJ (auto-injector): 100 mg; INJ (pre-filled syringe): 100 mg per mL; INJ (vial): 100 mg per mL
severe eosinophilic asthma, maintenance tx
- [100 mg SC q4wk]
chronic rhinosinusitis w/ nasal polyps, maintenance tx
- [100 mg SC q4wk]
eosinophilic COPD, maintenance tx
- [100 mg SC q4wk]
eosinophilic granulomatosis w/ polyangiitis
- [300 mg SC q4wk]
hypereosinophilic syndrome
- [300 mg SC q4wk]
- Info: for pts w/ dz for at least 6mo w/o identifiable non-hematologic secondary cause
renal dosing
- [see below]
- CrCl >50: no adjustment; CrCl <50: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ (auto-injector): 100 mg; INJ (pre-filled syringe): 40 mg per 0.4 mL, 100 mg per mL; INJ (vial): 100 mg per mL
severe eosinophilic asthma, maintenance tx
- [6-11 yo]
- Dose: 40 mg SC q4wk
- [12 yo and older]
- Dose: 100 mg SC q4wk
hypereosinophilic syndrome
- [12 yo and older]
- Dose: 300 mg SC q4wk; Info: for pts w/ dz for at least 6mo w/o identifiable non-hematologic secondary cause
renal dosing
- [see below]
- CrCl >50: no adjustment; CrCl <50: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- status asthmaticus
- asthma, acute
- bronchospasm, acute
- COPD, acute
- caution: helminth infection risk
Drug Interactions .
Overview
mepolizumab
IL-5 antagonist
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- anaphylaxis
- angioedema
- herpes zoster
- helminth infection
Common Reactions
- headache
- injection site rxn
- oropharyngeal pain
- back pain
- arthralgia
- fatigue
- diarrhea
- cough
- UTI
- extremity pain
- hypersensitivity rxn
- influenza
- upper abdominal pain
- pruritus
- eczema
- muscle spasm
- nasal dryness
- rash
- dyspnea
- asthenia
- URI sx
- dizziness
- ear infection
- gastroenteritis
- lower respiratory infection
- nausea
- fever
- vomiting
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy, esp. in 2nd and 3rd trimesters; inadequate human data available, though likely to cross placenta in 2nd and 3rd trimesters based on human data w/ other monoclonal antibodies; no known risk of fetal harm based on animal data at 9x MRHD (300 mg dose)
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: proteolytic degradation; CYP450: unknown
Excretion: non-renal; Half-life: 16-22 days
Subclass: Interleukin-5 (IL-5) Antagonists
Mechanism of Action
binds to and interferes with interleukin-5 cytokine, reducing eosinophil production and survival (monoclonal antibody)
Formulary .
No Formulary Selected
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