Mepolizumab

Mepolizumab is a prescription medication indicated for:

• Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype.
• Treatment of adults 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
• Add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults with inadequate response to nasal corticosteroids.
• Add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

Mepolizumab is available under the following different brand names: Nucala

Common side effects of Mepolizumab include:

• headache
• injection site reactions (pain, redness, swelling, itching, or a burning feeling at the injection site)
• back pain
• fatigue
• mouth/throat pain 
• joint pain
• diarrhea
• cough

Serious side effects of Mepolizumab include:

• severe hypersensitivity reactions, including anaphylaxis, may cause swelling of the face, mouth, and tongue, breathing problems, fainting, dizziness, feeling lightheaded (low blood pressure), rash, or hives
• herpes zoster infections 

Rare side effects of Mepolizumab include:

• none 

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, coordination loss, 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, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, lyophilized powder for reconstitution

• 100 mg/vial

Injection, solution

• 100 mg/mL; single-dose prefilled autoinjector or syringe
• 40 mg/0.4 mL; single-dose prefilled syringe

Severe Asthma

Adult dosage

• 100 mg SC every 4 weeks

Pediatric dosage

• Children below 6 years of age: Safety and efficacy not established
• Children 6 to 11 years of age: 40 mg SC every 4 weeks
• Children aged 12 years and above: 100 mg SC every 4 weeks

Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss Syndrome)

Adult dosage

• 300 mg SC every 4 weeks (i.e., as 3 separate 100-mg SC injections)

Hypereosinophilic Syndrome

Adult and pediatric dosage

• 300 mg SC every 4 weeks (ie, as 3 separate 100-mg SC injections)

Chronic Rhinosinusitis with Nasal Polyps

Adult dosage

• 100 mg SC every 4 weeks 

Chronic Obstructive Pulmonary Disease

Adult dosage

• 100 mg SC every 4 weeks 

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Visit the RxList Drug Interaction Checker for any drug interactions. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of hypersensitivity to mepolizumab or its excipients

Effects of drug abuse

• None

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

• Hypersensitivity reactions (e.g., angioedema, bronchospasm, hypotension, urticaria, rash) 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

Acute asthma or COPD symptoms

• Not for treatment of acute symptoms or acute exacerbations of asthma or COPD
• Do not use to treat acute bronchospasm or status asthmaticus
• Instruct patients to seek immediate medical advice if their asthma or COPD remains uncontrolled or worsens after initiating mepolizumab

Herpes zoster

• In clinical trials, 2 serious adverse reactions of herpes zoster occurred during treatment, compared with none in the placebo group
• Consider varicella vaccination if medically appropriate before initiating treatment

Reduction of corticosteroid dosage

• Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of mepolizumab
• Reductions in the corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a clinician
• Dose reduction may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy

Parasitic (helminth) infection

• 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 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 drug-associated risk
• 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

Pregnancy exposure registry

• Healthcare providers can enroll patients or encourage patients to enroll themselves by calling 1-877-311-8972 or visiting www.mothertobaby.org/asthma

Clinical considerations

• In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate
• Closely monitor the level of asthma control in pregnant women, and treatment is adjusted as necessary to maintain optimal control

Lactation

• Unknown if 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
• Present in the milk of cynomolgus monkeys postpartum following dosing during pregnancy; levels in milk were 0.5% or less of the maternal serum concentration
• Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition