Mepolizumab

What is Mepolizumab?

• Mepolizumab (Nucala) is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) is used with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older.

What are the uses of this medicine?

• This medicine is used for the add-on maintenance treatment of severe asthma in people 6 years of age and older whose asthma is not controlled with their current asthma medicines. Nucala helps prevent severe asthma attacks (exacerbations).
• Nucala is not used to treat sudden breathing problems that occur with asthma.
• for add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults whose disease is not controlled with nasal corticosteroids. Nucala helps reduce symptoms (e.g., nasal congestion, nasal discharge, mucus in the throat, loss of smell). Nucala helps reduce the size of your nasal polyps and the use of oral corticosteroid medicines. Nucala helps prevent surgery for your nasal polyps.
• for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA). Nucala helps reduce symptoms and flares, and it may allow your healthcare provider to reduce your oral corticosteroid medicine.
• for the treatment of people 12 years of age and older with hypereosinophilic syndrome (HES). Nucala helps reduce symptoms and prevent flares.

How does this medicine work?

• Mepolizumab (me" poe liz' ue mab) is a recombinant, fully humanized monoclonal antibody to IL-5 which binds to the circulating cytokine and blocks its ability to cause maturation and proliferation of eosinophils.
• IL-5 is a cytokine growth and stimulating factor which has a selective role in recruiting eosinophils from the bone marrow and promoting their differentiation, activation and survival.
• Mepolizumab lowers eosinophil counts in patients with hypereosinophilia and also in normal, healthy controls.
• Therapy with mepolizumab has been shown to reduce the requirement for inhaled corticosteroids and lower the frequency of exacerbations of eosinophilic asthma and other conditions associated with severe hypereosinophilia.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with a history of hypersensitivity to mepolizumab or excipients in the formulation.

What drug interactions can this medicine cause?

• Formal drug interaction trials have not been performed with Nucala.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

Recommended Dosage: Severe Asthma Adults and Adolescents Aged 12 Years and Older

• The recommended dosage of Nucala in adults and adolescents aged 12 years and older is 100 mg administered once every 4 weeks by subcutaneous injection into the upper arm, thigh, or abdomen.

Pediatric Patients Aged 6 to 11 Years

• The recommended dosage of Nucala for injection in pediatric patients aged 6 to 11 years is 40 mg administered once every 4 weeks by subcutaneous injection into the upper arm, thigh, or abdomen.

Chronic Rhinosinusitis with Nasal Polyps

• The recommended dosage of Nucala is 100 mg administered once every 4 weeks by subcutaneous injection into the upper arm, thigh, or abdomen.

Eosinophilic Granulomatosis with Polyangiitis

• The recommended dosage of Nucala is 300 mg administered once every 4 weeks by subcutaneous injection as 3 separate 100-mg injections into the upper arm, thigh, or abdomen.

Hypereosinophilic Syndrome

• The recommended dosage of Nucala is 300 mg administered once every 4 weeks by subcutaneous injection as 3 separate 100-mg injections into the upper arm, thigh, or abdomen.

Administration

• Your healthcare provider will prescribe the dose that is right for you depending on what you are being treated for.

When injection is given by a healthcare provider:

• A healthcare provider will inject Nucala under your skin (subcutaneously) every 4 weeks.

When injection is given by a patient or patient caregiver with a prefilled syringe or prefilled autoinjector:

• Use Nucala every 4 weeks exactly as your healthcare provider tells you to.
• Read the Instructions for Use that comes with Nucala for instructions about the right way to give your injections at home.
• Nucala may be prescribed as a single-dose prefilled autoinjector or as a single-dose prefilled syringe for people 12 years of age and older.
• Before you use Nucala, your healthcare provider will show you or your caregiver how to give the injections.
• You should inject Nucala under your skin (subcutaneously) into your thigh or stomach (abdomen). Also, a caregiver may give the injection in your upper arm.
• 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. If you are not sure when to inject Nucala, call your healthcare provider.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 100 mg of lyophilized powder in a single-dose vial for reconstitution.
• Injection: 100 mg/mL, single-dose, prefilled autoinjector or single-dose prefilled syringe.

This medicine is available in fallowing brand namesː

• Nucala

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• injection site reactions (pain, redness, swelling, itching, or a burning feeling at the injection site)
• back pain
• tiredness (fatigue)
• Mouth/throat pain
• joint pain have been reported with CRSwNP.

Nucala can cause serious side effects, including:

• allergic (hypersensitivity) reactions, including anaphylaxis
• herpes zoster infections

What special precautions should I follow?

• Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred following administration of Nucala. Discontinue Nucala in the event of a hypersensitivity reaction.
• Nucala should not be used to treat acute asthma symptoms or acute exacerbations. Do not use Nucala to treat acute bronchospasm or status asthmaticus.
• Herpes zoster has occurred in subjects receiving Nucala 100 mg in controlled clinical trials . Consider vaccination if medically appropriate.
• Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with Nucala. Decrease corticosteroids gradually, if appropriate.
• Treat patients with pre-existing helminth infections before therapy with Nucala. If patients become infected while receiving treatment with Nucala and do not respond to anti-helminth treatment, discontinue Nucala until parasitic infection resolves.

What to do in case of emergency/overdose?

Management of overdosage:

• There is no specific treatment for an overdose with mepolizumab.
• If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.

Can this medicine be used in pregnancy?

• The data on pregnancy exposure are insufficient to inform on drug-associated risk.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women with asthma exposed to Nucala during pregnancy. Healthcare providers can enroll patients or encourage patients to enroll themselves by calling 1-877-311-8972.

Can this medicine be used in children?

Severe Asthma

• The safety and effectiveness of Nucala for severe asthma, and with an eosinophilic phenotype, have been established in pediatric patients aged 6 years and older.
• The safety and effectiveness in pediatric patients aged younger than 6 years with severe asthma have not been established.

Chronic Rhinosinusitis with Nasal Polyps

• The safety and effectiveness in patients aged younger than 18 years with CRSwNP have not been established.

Eosinophilic Granulomatosis with Polyangiitis

• The safety and effectiveness in patients aged younger than 18 years with EGPA have not been established.

Hypereosinophilic Syndrome

• The safety and effectiveness of Nucala for HES have been established in adolescent patients aged 12 years and older.
• The safety and effectiveness in pediatric patients aged younger than 12 years with HES have not been established.

What are the active and inactive ingredients in this medicine?

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

Who manufactures and distributes this medicine?

Manufactured by: GlaxoSmithKline LLC, Philadelphia, PA 19112, U.S.

Distributed by: GlaxoSmithKline, Research Triangle Park, NC

What should I know about storage and disposal of this medication?

• Store prefilled autoinjectors and prefilled syringes in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Keep prefilled autoinjectors and prefilled syringes in the original carton until time of use to protect from light.
• Do not freeze. Do not shake. Keep away from heat.
• If necessary, an unopened carton can be stored outside the refrigerator at up to 86°F (30°C) for up to 7 days.
• Safely throw away prefilled autoinjectors and prefilled syringes if the unopened carton is left out of the refrigerator for more than 7 days.
• Prefilled autoinjectors and prefilled syringes must be used within 8 hours after you take them out of the carton. Safely throw away if not used within 8 hours.
• Safely throw away medicine that is out of date or no longer needed.
• Keep Nucala and all medicines out of the reach of children.

• Dailymed label info on Mepolizumab
• FDA Mepolizumab