Mepolizumab

Mepolizumab is used for add-on maintenance treatment of patients with eosinophilic phenotype asthma and adults with eosinophilic granulomatosis with polyangiitis (EGPA).

• Mepolizumab is available under the following different brand names: Nucala.

Common side effects of mepolizumab include:

• Headache
• Injection site reactions
• Systemic allergic/nonallergic reactions
• Back pain
• Fatigue
• Hypersensitivity reactions
• Influenza
• Urinary tract infection (UTI)
• Upper abdominal pain
• Itching
• Eczema
• Muscle spasms

Other side effects of mepolizumab include:

• Abdominal pain
• Allergic rhinitis
• Asthenia
• Bronchitis
• Cystitis
• Dizziness
• Shortness of breath
• Ear infection
• Gastroenteritis
• Lower respiratory tract infection
• Musculoskeletal pain
• Nasal congestion
• Runny and stuffy nose
• Toothache
• Viral infection
• Viral respiratory tract infection

Other (post-marketing) side effects of mepolizumab reported include:

• Hypersensitivity reactions, including anaphylaxis

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosages of Mepolizumab:

Adult and Pediatric Dosage Forms and Strengths

Injection, Lyophilized Powder for Reconstitution

• 100 mg/vial

Injection, Solution

• 100 mg/mL
• Available as a single-dose prefilled autoinjector or syringe

Dosage Considerations – Should be Given as Follows:

Severe Asthma

• Add-on maintenance treatment of patients with an eosinophilic phenotype
• Adults and children 12 years and older: 100 mg subcutaneously (SC) every 4 weeks
• Children 6-11 years: 40 mg SC every 4 weeks
• Children under 6 years: Safety and efficacy not established

Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss Syndrome)

• Indicated for adults with eosinophilic granulomatosis with polyangiitis (EGPA)
• 300 mg SC every 4 weeks (i.e., as 3 separate 100-mg SC injections)

Dosage Modifications

Renal Impairment

• No dosage adjustment is provided in the manufacturer's labeling; dosage adjustment may not be necessary; the drug is not really eliminated

Hepatic impairment

• No dosage adjustment is provided in the manufacturer's labeling; dosage adjustment may not be necessary; the drug is degraded by proteolytic enzymes, which are not restricted to hepatic tissue

Dosing Considerations

Limitations of use

• Not for relief of acute bronchospasm or status asthmaticus
• Not for the treatment of other eosinophilic conditions

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Mepolizumab has no listed severe interactions with other drugs.
• Mepolizumab has no listed serious interactions with other drugs.
• Mepolizumab has no listed moderate interactions with other drugs.
• Mepolizumab has no listed mild interactions with other drugs.

Warnings

• This medication contains mepolizumab. Do not take Nucala if you are allergic to mepolizumab or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• No information is available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Mepolizumab?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Mepolizumab?"

Cautions

• Hypersensitivity reactions (e.g., angioedema, bronchospasm, low blood pressure, hives, rash) were reported; these reactions generally occur within hours of administration, but in some instances can have a delayed onset (i.e., days); discontinue the drug in the event of a hypersensitivity reaction
• Not for the treatment of acute asthma symptoms or acute exacerbations; do not use to treat acute bronchospasm or status asthmaticus; instruct patients to seek immediate medical advice if their asthma remains uncontrolled or worsens after initiating mepolizumab
• In clinical trials, 2 serious adverse reactions of herpes zoster occurred during treatment compared with none in placebo; consider varicella vaccination if medically appropriate before initiating treatment
• Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of mepolizumab; reductions in corticosteroid dose, if appropriate, should be gradual and performed 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
• Eosinophils may be involved in the immunological response to some helminth infections; patients with known parasitic infections were excluded from participation in clinical trials; treat patients with preexisting helminth infection before initiating mepolizumab; if helminth infection occurs while receiving mepolizumab that does not respond to treatment, discontinue mepolizumab until the infection resolves

Pregnancy and Lactation

• Data on pregnancy exposure from the clinical trials are insufficient to inform on the drug-associated risk of mepolizumab use during pregnancy. Monoclonal antibodies, such as mepolizumab, are linearly transported across the placenta as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters of pregnancy. Healthcare providers can enroll patients or encourage patients to enroll themselves by 1-877-311-8972 or www.mothertobaby.org/asthma.
• It is unknown if mepolizumab is distributed in human breast milk. However, mepolizumab is a humanized monoclonal antibody (IgG1 kappa), and immunoglobulin G (IgG) is present in human milk in small amounts. Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for mepolizumab, and any potential adverse effects on the breastfed infant from mepolizumab or the underlying maternal condition.