Mepolizumab
Generic Name: mepolizumab
Brand Names:
Nucala
11 DESCRIPTION Mepolizumab is a humanized IL-5 antagonist monoclonal antibody. Mepolizumab is produced by recombinant DNA technology in Chinese hamster ovary cells. Mepolizumab has a molecular weight of approximately 149 kDa. NUCALA for injection is a sterile, preservative-free, white to off-white, lyophilized powder in a single-dose vial for subcutaneous injection after reconstitution.
Overview
11 DESCRIPTION Mepolizumab is a humanized IL-5 antagonist monoclonal antibody. Mepolizumab is produced by recombinant DNA technology in Chinese hamster ovary cells. Mepolizumab has a molecular weight of approximately 149 kDa. NUCALA for injection is a sterile, preservative-free, white to off-white, lyophilized powder in a single-dose vial for subcutaneous injection after reconstitution.
Uses
1 INDICATIONS AND USAGE NUCALA is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for: • Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. ( 1.1 ) • Add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP). ( 1.2 ) • Add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. ( 1.3 ) • The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
Dosage
2 DOSAGE AND ADMINISTRATION • Severe asthma in patients aged 12 years and older: 100 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • Severe asthma in patients aged 6 to 11 years: 40 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • CRSwNP: 100 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • COPD: 100 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • EGPA: 300 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • HES: 300 mg administered subcutaneously once every 4 weeks. ( 2.1 ) 2.1 Recommended Dosage NUCALA is for subcutaneous use only, and should be injected into the upper arm, thigh, or abdomen [see Dosage and Administration ( 2.2 , 2.3 )]. Table 1.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: • Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] • Opportunistic infections: herpes zoster [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (incidence ≥5%): • Asthma: Headache, injection site reaction, back pain, and fatigue. ( 6.1 ) • CRSwNP: Oropharyngeal pain and arthralgia. ( 6.1 ) • COPD: Back pain, diarrhea, and cough. ( 6.1 ) • EGPA and HES: Most common adverse reactions are similar to asthma. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS Formal drug interaction trials have not been performed with NUCALA.
Warnings
5 WARNINGS AND PRECAUTIONS • Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of NUCALA. Discontinue NUCALA in the event of a hypersensitivity reaction. ( 5.1 ) • Herpes zoster infections have occurred in patients receiving NUCALA. Consider vaccination if medically appropriate. ( 5.3 ) • Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA. Decrease corticosteroids gradually, if appropriate. ( 5.4 ) • Treat patients with pre-existing helminth infections before therapy with NUCALA. If patients become infected while receiving treatment with NUCALA and do not respond to anti-helminth treatment, discontinue NUCALA until parasitic infection resolves. 4 CONTRAINDICATIONS NUCALA is contraindicated in patients with a history of hypersensitivity to mepolizumab or excipients in the formulation [see Warnings and Precautions ( 5.1 ), Description ( 11 )] . History of hypersensitivity to mepolizumab or excipients in the formulation. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary The data on pregnancy exposure are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING NUCALA for Injection NUCALA (mepolizumab) for injection is a sterile, preservative-free, white to off-white, lyophilized powder for reconstitution and subcutaneous injection in a single-dose glass vial with a flip-off seal. The vial stopper is not made with natural rubber latex.
Frequently Asked Questions
What is Mepolizumab used for?▼
1 INDICATIONS AND USAGE NUCALA is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for: • Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. ( 1.1 ) • Add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP). ( 1.2 ) • Add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. ( 1.3 ) • The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
What are the side effects of Mepolizumab?▼
6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: • Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] • Opportunistic infections: herpes zoster [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (incidence ≥5%): • Asthma: Headache, injection site reaction, back pain, and fatigue. ( 6.1 ) • CRSwNP: Oropharyngeal pain and arthralgia. ( 6.1 ) • COPD: Back pain, diarrhea, and cough. ( 6.1 ) • EGPA and HES: Most common adverse reactions are similar to asthma. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Mepolizumab during pregnancy?▼
8.1 Pregnancy Risk Summary The data on pregnancy exposure are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy.
What are the important warnings for Mepolizumab?▼
5 WARNINGS AND PRECAUTIONS • Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of NUCALA. Discontinue NUCALA in the event of a hypersensitivity reaction. ( 5.1 ) • Herpes zoster infections have occurred in patients receiving NUCALA. Consider vaccination if medically appropriate. ( 5.3 ) • Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA. Decrease corticosteroids gradually, if appropriate. ( 5.4 ) • Treat patients with pre-existing helminth infections before therapy with NUCALA. If patients become infected while receiving treatment with NUCALA and do not respond to anti-helminth treatment, discontinue NUCALA until parasitic infection resolves. 4 CONTRAINDICATIONS NUCALA is contraindicated in patients with a history of hypersensitivity to mepolizumab or excipients in the formulation [see Warnings and Precautions ( 5.1 ), Description ( 11 )] . History of hypersensitivity to mepolizumab or excipients in the formulation. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.