NUCALA (mepolizumab) by GSK



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Indications & Usage

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.
  • Add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP).
  • The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
  • The treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.

 

Limitations of use: Not for relief of acute bronchospasm or status asthmaticus.

 

 

Please see full Prescribing Information and Patient Information for NUCALA.

Dosage & Administration

DOSAGE AND ADMINISTRATION

  • Severe asthma in patients aged 12 years and older: 100 mg administered subcutaneously once every 4 weeks.
  • Severe asthma in patients aged 6 to 11 years: 40 mg administered subcutaneously once every 4 weeks.
  • CRSwNP: 100 mg administered subcutaneously once every 4 weeks.
  • EGPA: 300 mg as 3 separate 100-mg injections administered subcutaneously once every 4 weeks.
  • HES: 300 mg as 3 separate 100-mg injections administered subcutaneously once every 4 weeks.

 

DOSAGE FORMS AND STRENGTHS

  • For injection: 100 mg of lyophilized powder in a single-dose vial for reconstitution.
  • Injection: 100 mg/mL, single-dose prefilled autoinjector or single-dose prefilled syringe.
  • Injection: 40 mg/0.4 mL, single-dose prefilled syringe.

 

 

Please see full Prescribing Information and Patient Information for NUCALA.

Contraindications

CONTRAINDICATIONS

History of hypersensitivity to mepolizumab or excipients in the formulation.

 

 

Please see full Prescribing Information and Patient Information for NUCALA.

Warnings & Precautions

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.
  • Do not use to treat acute bronchospasm or status asthmaticus.
  • Herpes zoster infections have occurred in patients receiving NUCALA. Consider vaccination if medically appropriate.
  • Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA. Decrease corticosteroids gradually, if appropriate.
  • 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.

 

 

Please see full Prescribing Information and Patient Information for NUCALA.

Adverse Reactions

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥5%):

  • Asthma: Headache, injection site reaction, back pain, and fatigue.
  • CRSwNP: Oropharyngeal pain and arthralgia.
  • EGPA and HES: Most common adverse reactions are similar to asthma.

 

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

 

Please see full Prescribing Information and Patient Information for NUCALA.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Produced in USA.

 

Please see full Prescribing Information and Patient Information for NUCALA.

 

Indication and Important Safety Information


Indications

NUCALA is indicated for the:

  • add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.
  • add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.
  • treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
  • treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.

Important Safety Information

CONTRAINDICATIONS

NUCALA should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
Hypersensitivity reactions (eg, anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred with NUCALA. These reactions generally occur within hours of administration but can have a delayed onset (ie, days). If a hypersensitivity reaction occurs, discontinue NUCALA.

Acute Asthma Symptoms or Deteriorating Disease
NUCALA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

Opportunistic Infections: Herpes Zoster
Herpes zoster infections have occurred in patients receiving NUCALA. Consider vaccination if medically appropriate.

Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA. Decreases in corticosteroid doses, if appropriate, should be gradual and under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection
Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. If patients become infected while receiving NUCALA and do not respond to anti-helminth treatment, discontinue NUCALA until infection resolves.

ADVERSE REACTIONS

Most common adverse reactions (≥5%) in patients receiving NUCALA:

  • Severe asthma trials: headache, injection site reaction, back pain, fatigue
  • CRSwNP trial: oropharyngeal pain, arthralgia
  • EGPA and HES trials (300 mg of NUCALA): no additional adverse reactions were identified to those reported in severe asthma clinical trials

Systemic reactions, including hypersensitivity, occurred in clinical trials in patients receiving NUCALA. Manifestations included rash, pruritus, headache, myalgia, flushing, urticaria, erythema, fatigue, hypertension, warm sensation in trunk and neck, cold extremities, dyspnea, stridor, angioedema, and multifocal skin reaction. A majority of systemic reactions were experienced the day of dosing.

USE IN SPECIFIC POPULATIONS

A pregnancy exposure registry monitors pregnancy outcomes in women with asthma exposed to NUCALA during pregnancy. To enroll call 1-877-311-8972 or visit www.mothertobaby.org/asthma.

The data on pregnancy exposures are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as the pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters.

 

Please see full Prescribing Information and Patient Information for NUCALA.