Nucala (Mepolizumab)

What are the Indications for Nucala?

Nucala is indicated for the treatment of severe asthma in patients aged 12 years and older who have an eosinophilic phenotype. This drug is used as an add-on therapy for those who have not achieved adequate control of their asthma symptoms with inhaled corticosteroids and long-acting beta-agonists.

Nucala is also indicated for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disorder that is characterized by inflammation of the blood vessels and the accumulation of eosinophils in various organs.

How is Nucala used?

Storage

Nucala should be stored in its original carton in the refrigerator at a temperature between 2°C and 8°C (36°F to 46°F) away from light. Nucala should not be stored in the freezer. If needed, Nucala that has not been opened may be stored at room temperature up to 86°F (30°C) for up to 7 days.

Once you’ve taken the prefilled autoinjector out of the carton, it must be used within 8 hours. After 8 hours, the prefilled autoinjector must be thrown away even if there is still some medication left.

Keep out of reach of children and pets.

Instruction

Follow the patient information pamphlet that comes with your medication. Before using this medication, take the vial out of the refrigerator and allow it to warm to room temperature for approximately 30 minutes.

Nucala can be administered by a healthcare professional, or caregiver, or you can administer it yourself. Nucala needs to be injected under the skin of your stomach, thigh, or upper arm every 4 weeks. The medication should not be shaken, and any unused portions should be discarded.

Dosage

Nucala is a clear, colorless solution that is available in the following strengths and forms:

• 40 mg/0.4 mL single-dose vial
• 100 mg of lyophilized powder in a single-dose vial for reconstitution
• 100 mg/mL single-dose prefilled autoinjector or syringe

The recommended dose is dependent on age and indication. Do not change your dosage and take more than what is prescribed without consulting with your doctor.

Severe Asthma

12 years or older: The recommended dose is 100 mg injected under the skin once a month, every 4 weeks.

6 – 11 years old: The recommended dose is 40 mg injected under the skin once a month, every 4 weeks.

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

The recommended dose is 100 mg injected under the skin once a month, every 4 weeks.

Eosinophilic Granulomatosis (EGPA)

The recommended dose is 300 mg injected under the skin once a month, every 4 weeks.

Hypereosinophilic Syndrome (HES)

The recommended dose is 300 mg injected under the skin once a month, every 4 weeks.

Side Effects

It’s important to understand that although Nucala is FDA-approved, it comes with side effects that may or may not affect you.

Before starting Nucala, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to Nucala, side effects may go away.

Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own:

• Headache
• Injection site reactions – swelling, itching, and redness
• Back pain
• Fatigue

Serious Side Effects

Severe adverse reactions while using Nucala can occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

• Severe allergic reaction: severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.
• Herpes zoster infections

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before using Nucala, tell your doctor or pharmacist:

• If you are allergic to any medications such as Nucala
• If you have a parasitic infection
• If you are pregnant or expect to become pregnant
• If you are breastfeeding or plan to breastfeed

Asthma Management

Nucala should not be used to treat asthma attacks as it is not a fast-acting medication. Nucala is taken as an add-on or secondary medication only to manage symptoms and do not replace your current asthma medications. Continue taking all of your current asthma medications, including inhaled corticosteroids, long-acting beta-agonists, and rescue inhalers, while receiving treatment.

Corticosteroid

If you are taking corticosteroids while on Nucala, do not discontinue the use of corticosteroids unless directed by your doctor. Stopping the treatment of corticosteroids can cause serious withdrawal symptoms including nausea, vomiting, and lightheadedness.

Parasitic Infection

If you have a parasitic infection, particularly a helminth (worm) infection, Nucala should not be taken until the infection has been treated. Taking it may weaken your body’s ability to fight off the parasitic infection. If you get a parasitic infection while taking it, contact your doctor immediately.

Shingles or Herpes Zoster Infection

Taking Nucala can increase your chance of being infected with shingles. Consult with your doctor to determine if vaccination is needed before taking it.

Pregnant or Planning to Become Pregnant

It is not known if Nucala may harm your unborn baby. If you are pregnant or planning to become pregnant while taking Nucala, talk to your doctor about the best course of action before taking it.

Breastfeeding

It is not known if Nucala passes into breast milk. If you are breastfeeding or considering breastfeeding while taking Nucala, talk to your doctor for the best course of action before taking it.

Interactions & Contraindications

There is limited data to determine if there are any drug interactions with Nucala. Before using Nucala, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.