Mepolizumab

Mepolizumab is used to treat the following eosinophil-related conditions: severe eosinophilic asthma, eosinophilic COPD, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). It can be self-administered by subcutaneous injection every 4 weeks, or a healthcare provider or caregiver can give it. The brand name is Nucala.

• The autoinjector version is approved for individuals 12 and older, while the prefilled syringe can be used for children as young as 6.

Mepolizumab is an interleukin inhibitor that works by lowering the number of eosinophils in your blood. These are white blood cells that cause inflammation in your body. The drug blocks a protein called interleukin-5 (IL-5) that normally tells eosinophils to grow and multiply. This mechanism means fewer eosinophils and less inflammation.

The FDA approved mepolizumab on November 4, 2015, under the brand Nucala, made by GlaxoSmithKline (GSK). There is no generic or biosimilar.

Mepolizumab is approved for:

• Severe asthma with an eosinophilic phenotype in adults and children aged 6 years and older as an add-on maintenance treatment. It is not a rescue medicine for acute bronchospasm or status asthmaticus
• Inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype in adults as an add-on maintenance treatment
• Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults aged 18 years and older whose disease is not controlled with nasal corticosteroids, as an add-on maintenance treatment. Nucala helps reduce symptoms (such as nasal congestion, nasal discharge, mucus in the throat, and loss of smell) and may help prevent surgery for nasal polyps
• Eosinophilic granulomatosis with polyangiitis (EGPA) in adults
• Hypereosinophilic syndrome [HES] in adults and children 12 years and older that has been present for 6 months or longer without an identifiable non-hematologic secondary cause.

Mepolizumab is not FDA-approved in:

• Children younger than 12 years with hypereosinophilic syndrome (HES)
• Children younger than 6 years with severe Asthma
• Children and adolescents younger than 18 years with COPD, EGPA, or CRSwNP.

Mepolizumab is injected under the skin, usually once every 4 weeks.

• It can be self-administered after training or given by a healthcare provider.
• Injections are given under the skin of your thigh or stomach (abdomen), or a caregiver can give the injection in the back of your upper arm.
• Mepolizumab may be prescribed as a single-dose prefilled autoinjector for people 12 years and older or as a single-dose prefilled syringe for people 6 and older.

Read the Instructions for Use in the mepolizumab Package Insert that comes with Mepolizumab for details about the right way to give your injections at home.

• Each mepolizumab prefilled syringe or autoinjector is for one use only. Throw it away after one use, even if there is still medicine left inside.

Mepolizumab is not a rescue medicine for asthma attacks. Only use a fast acting bronchodilator such as albuterol for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Do not use mepolizumab if you are allergic to mepolizumab, Nucala, or any inactive ingredients in the injection.

To make sure mepolizumab is safe for you, tell your doctor about all your medical conditions, including if you:

• have or have had a parasite infection (such as roundworms or tapeworms)
• are taking oral or inhaled corticosteroid medicines
• have a history of herpes zoster (also called shingles).
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

You may need a zoster (shingles) vaccine before you start using mepolizumab.

Pregnancy

It is not known if mepolizumab may harm your unborn baby. Tell your doctor if you become pregnant while using mepolizumab. Your name may be listed on a pregnancy registry to track the effects of mepolizumab on the baby.

Breastfeeding

You and your healthcare provider should decide if you will use mepolizumab and breastfeed. You should not do both without talking with your healthcare provider first.

The most common side effects of mepolizumab are:

• Headaches
• Fatigue
• Throat discomfort
• Musculoskeletal pain
• Injection site reactions.

Serious side effects and warnings

Mepolizumab can cause the following serious side effects.

Allergic reactions. Mepolizumab may cause serious hypersensitivity reactions, including potentially life-threatening anaphylaxis. These reactions can develop within hours or even days after your injection. Seek emergency medical help immediately if you notice:

• Skin reactions (hives, rash)
• Breathing difficulties (wheezing, chest tightness)
• Dizziness or feeling faint
• Facial swelling, especially lips, tongue, or throat.

Herpes Zoster (Shingles) risk. Patients receiving Nucala have an increased risk of developing herpes zoster infections that can cause shingles. Contact your healthcare provider if you develop:

• Skin blisters or sores
• Unusual itching, tingling sensations
• Burning pain
• A distinctive rash on your face or torso.

Steroid medication warning: If you're currently using oral or inhaled steroids alongside mepolizumab, never stop them suddenly without medical supervision. Consult your healthcare provider about proper tapering protocols.

This information doesn't cover all possible side effects of mepolizumab. For comprehensive information, always consult the official Nucala Prescribing Information. Report any adverse reactions to your doctor or the FDA's MedWatch program at 1-800-FDA-1088.

Dose of mepolizumab for severe eosinophilic asthma

• Adults and children 12 years and older: 100 mg SC 1 time every 4 weeks.
• Children aged 6 to 11 years: 40 mg SC 1 time every 4 weeks.

Dose of mepolizumab for chronic obstructive pulmonary disease (COPD) in adults

• 100 mg SC 1 time every 4 weeks.

Dose of mepolizumab for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults

• 100 mg SC 1 time every 4 weeks.

Dose of mepolizumab for eosinophilic granulomatosis with polyangiitis (EGPA) in adults

• 300 mg (as 3 separate 100mg injections) SC every 4 weeks.

Dose of mepolizumab for hypereosinophilic syndrome (HES)

• Adults and children aged 12 and older: 300 mg (as 3 separate 100mg injections) SC every 4 weeks.

If you miss a dose, inject a dose as soon as possible. Then continue (resume) your injection on your regular dosing schedule.

If you do not notice that you have missed a dose until it is time for your next scheduled dose, then inject the next scheduled dose as planned. Do not use two doses at one time. If you are not sure when to inject mepolizumab, call your healthcare provider.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• an oral (taken by mouth) or inhaled steroid medicine.

Other drugs may interact with mepolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your healthcare providers about all medicines you use now and any medicine you start or stop using.

Store the mepolizumab prefilled syringe or mepolizumab autoinjector in the original carton in a refrigerator. Do not freeze or shake the medicine.

• After removing the medicine from the carton, you must use the syringe or autoinjector within 8 hours.

You may store the prefilled syringe or autoinjector in the unopened carton at room temperature for up to 7 days.

• Throw away a syringe or autoinjector left out of the refrigerator for more than 7 days.

Safely throw away medicine that is out of date or no longer needed.

Keep out of the reach of children.

Mepolizumab is only available as the brand Nucala.

Active Ingredient: mepolizumab.

Inactive Ingredients (Nucala vials): polysorbate 80, sodium phosphate dibasic heptahydrate, and sucrose.

Inactive Ingredients (Nucala prefilled autoinjectors and prefilled syringes): citric acid monohydrate, EDTA, disodium dihydrate, polysorbate 80, sodium phosphate dibasic heptahydrate, and sucrose.

Mepolizumab for injection is available as:

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

Mepolizumab is made by GlaxoSmithKline (GSK) LLC, under the brand Nucala. GSK is located in Philadelphia, PA.