Mepolizumab Side Effects

In Summary

More frequently reported side effects include: injection site reaction. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to mepolizumab: subcutaneous powder for solution

Along with its needed effects, mepolizumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking mepolizumab:

• Blurred vision
• confusion
• cough
• difficulty with breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• hives or welts, itching, or skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• painful blisters on the trunk of the body
• redness of the skin
• sweating
• tightness in the chest
• unusual tiredness or weakness

Some side effects of mepolizumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• headache

• Back pain
• bladder pain
• bloody or cloudy urine
• chills
• cough
• diarrhea
• difficult, burning, or painful urination
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• joint pain
• loss of appetite
• lower back or side pain
• muscle aches and pains
• muscle spasms
• nausea
• runny nose
• shivering
• skin rash, encrusted, scaly, and oozing
• sore throat
• sweating
• trouble sleeping
• upper abdominal or stomach pain
• vomiting

For Healthcare Professionals

Applies to mepolizumab: subcutaneous powder for injection

General

The more commonly reported side effects were headache, injection site reactions, and back pain.^[Ref]

Nervous system

Dizziness occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.^[Ref]

Very common (10% or more): Headache (up to 19%)
Frequency not reported: Dizziness^[Ref]

Hypersensitivity

Common (1% to 10%): Systemic non-allergic/administration-related reactions (including rash, flushing, myalgia), systemic/hypersensitivity reactions (including rash, pruritus, headache, myalgia)
Frequency not reported: Allergic rhinitis, angioedema, urticaria^[Ref]

Many systemic reactions occurred on the day of dosing. Systemic reactions occurred in 10% of patients treated with this drug compared to 7% of placebo-treated patients. Non-allergic reactions occurred in 2% of patients given this drug versus 3% of patients with placebo; allergic systemic reactions occurred in 1% and 2% of patients given this drug or placebo, respectively.

Allergic rhinitis occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.^[Ref]

Local

Common (1% to 10%): Injection site reactions (e.g., pain, swelling, erythema, itching, burning)^[Ref]

Injection site reactions occurred in 8% and 3% of patients given this drug or placebo, respectively. The reactions more commonly occurred within the first 3 injections, with a decrease in frequency on subsequent injections.^[Ref]

Immunologic

In a clinical trial, 6% of patients developed anti-mepolizumab antibodies; these antibodies were shown to slightly increase drug clearance, but the clinical relevance is unknown.

Viral infection occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.^[Ref]

Common (1% to 10%): Influenza, anti-mepolizumab antibody formation
Frequency not reported: Viral infection^[Ref]

Dermatologic

Common (1% to 10%): Pruritus, eczema
Frequency not reported: Rash, flushing, herpes zoster reaction^[Ref]

Rash and herpes zoster occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, muscle spasms
Frequency not reported: Musculoskeletal pain, myalgia^[Ref]

Musculoskeletal pain occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.^[Ref]

Gastrointestinal

Gastroenteritis, abdominal pain, nausea, toothache, and vomiting occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.^[Ref]

Common (1% to 10%): Upper abdominal pain
Frequency not reported: Gastroenteritis, abdominal pain, nausea, toothache, vomiting^[Ref]

Other

Common (1% to 10%): Fatigue, pyrexia
Frequency not reported: Asthenia, ear infection^[Ref]

Asthenia, ear infection, and pyrexia occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection^[Ref]

Respiratory

Bronchitis, dyspnea, lower respiratory tract infection, nasal congestion, nasopharyngitis, pharyngitis, and viral respiratory tract infection occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.^[Ref]

Common (1% to 10%): Lower respiratory tract infection, pharyngitis, nasal congestion
Frequency not reported: Bronchitis, dyspnea, nasopharyngitis, viral respiratory tract infection, bronchospasm^[Ref]

Cardiovascular

Frequency not reported: Hypotension^[Ref]

Renal

Frequency not reported: Cystitis^[Ref]

Cystitis occurred in at least 3% of patients treated with this drug in a controlled, long-term clinical study.^[Ref]

Some side effects of mepolizumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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