Nucala Side Effects

Generic name: mepolizumab

Medically reviewed by Drugs.com. Last updated on Nov 18, 2023.

Note: This document provides detailed information about Nucala Side Effects associated with mepolizumab. Some dosage forms listed on this page may not apply specifically to the brand name Nucala.

Applies to mepolizumab: subcutaneous powder for solution, subcutaneous solution.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have cough, rash, itching skin, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine will not stop an asthma attack that has already started. Your doctor may prescribe another medicine for you to use in case of an asthma attack.

This medicine may lead to herpes zoster infection (shingles). You may receive a vaccine before you start treatment. Tell your doctor if you have not had either chickenpox or the chickenpox vaccine.

If you use a corticosteroid medicine (inhaled or taken by mouth) to control your asthma, keep using it unless your doctor tells you otherwise.

Common side effects of Nucala

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:

Serious side effects of Nucala

Along with its needed effects, mepolizumab (the active ingredient contained in Nucala) 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 immediately if any of the following side effects occur while taking mepolizumab:

For healthcare professionals

Applies to mepolizumab: subcutaneous powder for injection, subcutaneous solution.

General adverse events

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

Nervous system

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

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

• Common (1% to 10%): Influenza, anti-mepolizumab (the active ingredient contained in Nucala) antibody formation
• Frequency not reported: Viral infection^[Ref]

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]

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

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

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]

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

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

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]

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]

See also:

Frequently asked questions

• How does the Nucala copay card work and do I qualify?
• How long does it take for Nucala to work?
• Can Nucala cause weight gain?
• Can Nucala be self-administered? How is it injected?
• How does Nucala (mepolizumab) work? What is the MOA?
• What is Nucala (mepolizumab) used for and how is it given?

Further information

Nucala side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer