Mepolizumab

Mepolizumab may be found in some form under the following brand names:

• Nucala

Tell your doctor if you are breastfeeding or plan to breastfeed. You and your doctor should decide if you will use mepolizumab and breastfeed. You should not do both without talking with your doctor first.

Mepolizumab is part of the drug class:

• Interleukin inhibitors

This is not a complete list of Mepolizumabdrug interactions. Ask your doctor or pharmacist for more information.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

No formal drug interaction studies to date.1

• Recombinant DNA-derived humanized interleukin-5 (IL-5) receptor antagonist monoclonal antibody and IgG1 kappa immunoglobulin.1

• Inhibits IL-5 binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface.1 6 7 11

• Blocks IL-5 signaling that interferes with growth, differentiation, recruitment, activation, and survival of eosinophils and decreases eosinophil-mediated inflammation.1 6 7 8 11

• Risk of hypersensitivity reactions.1 Importance of patients informing clinicians if hypersensitivity reactions (e.g., angioedema, bronchospasm, hypotension, urticaria, rash) occur.1 (See Sensitivity Reactions under Cautions.)

• Importance of informing patients that mepolizumab does not relieve acute asthma symptoms or exacerbations.1 Advise patients to contact their clinician if asthma remains uncontrolled or worsens after treatment initiation.1

• Possible increased risk of herpes zoster infections.1 Importance of patients informing clinicians if they do not have a history of varicella infection or vaccination.1

• Importance of informing patients with asthma receiving inhaled or systemic corticosteroids not to discontinue or reduce corticosteroid dosage since withdrawal symptoms or worsening of asthma may occur; change corticosteroid dosage only under direct supervision of a clinician.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Importance of clinicians informing women about the manufacturer's pregnancy registry and encouraging patient enrollment.1 (See Pregnancy under Cautions.)

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

• If you have an allergy to this medicine or any part of mepolizumab.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Dizziness or passing out.

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, adjustment based on renal function is unlikely to be necessary as mepolizumab is not renally eliminated.

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, adjustment based on hepatic function is unlikely to be necessary as mepolizumab is degraded by widely distributed proteolytic enzymes which are not restricted to hepatic tissue.

SubQ: Administer via SubQ injection into the upper arm, thigh, or abdomen using a polypropylene syringe fitted with a 21- to 27-gauge 0.5 inch (13 mm) needle. Do not shake the reconstituted solution as this could lead to product foaming or precipitation.

Concerns related to adverse effects:

• Hypersensitivity reactions: Hypersensitivity reactions (eg, angioedema, bronchospasm, hypotension, urticarial, rash) may occur, typically within hours of administration. Delayed hypersensitivity reactions, occurring days after administration, have also been reported. Discontinue use in patients who experience a hypersensitivity reaction.

• Infection: Herpes zoster: Use may result in an opportunistic infection of herpes zoster; consider herpes zoster vaccination prior to initiation of therapy with mepolizumab.

Disease-related concerns:

• Asthma: Not indicated for the treatment of acute asthma symptoms (eg, acute bronchospasm) or acute exacerbations, including status asthmaticus. Appropriate rescue medication should be available. Patients who experience continued uncontrolled asthma or worsening of symptoms following treatment initiation with mepolizumab should seek medical attention.

• Helminth infections: It is unknown if administration of mepolizumab will influence a patient's response against parasitic infections. Therefore, patients with preexisting helminth infections should undergo treatment of the infection prior to initiation of mepolizumab therapy. Patients who become infected during mepolizumab treatment and do not respond to anti-helminth therapy should discontinue mepolizumab until the infection resolves.

Concurrent drug therapy issues:

• Corticosteroids: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of mepolizumab. Reductions in corticosteroid dose should be gradual, if appropriate. Clinicians should note that a reduction in corticosteroid dose may be associated with withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Other warnings/precautions:

• Limitation of use: Eosinophilic conditions: Mepolizumab is not indicated for the treatment of other eosinophilic conditions.

FEV1, peak flow, and/or other pulmonary function tests. Monitor for increased use of short-acting beta2-agonist inhalers; may be a marker of a deteriorating asthma condition.

Administration advice:
-This drug should be reconstituted and administered by a health care provider.
-Discard if cloudy, milky, or particulate matter remains in solution after reconstitution.
-Subcutaneous administration in upper arm, thigh, or abdomen is preferred.

Storage requirements:
-Lyophilized powder: Protect from light; do not freeze.
-Reconstituted solution: Do not freeze; discard if not used within 6 to 8 hours of reconstitution.

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.

General:
-This drug should not be used to treat other eosinophilic conditions, acute asthma, bronchospasm, or status asthmaticus.
-Avoid decreasing or discontinuing corticosteroids during initiation of this drug.
-This drug may interfere with helminth infections.
-Hypersensitivity reactions may occur up to days after administration.
-This drug should be prescribed by healthcare professionals experienced in the diagnosis and treatment of severe asthma.

Monitoring:
-Signs and symptoms of uncontrolled or worsening asthma
-Signs and symptoms of an allergic reaction (e.g., facial swelling, rash, hypotension, hives)

Patient advice:
-Warn patients to avoid interruptions or abrupt discontinuation of corticosteroids.
-Instruct patients to notify their healthcare provider upon signs and symptoms of worsening asthma or allergic reaction.
-Patients should be advised to speak to their healthcare provider if pregnant, intend to become pregnant, or are breastfeeding.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: -The effects in the nursing infant are unknown.

Animal studies have shown that this drug is excreted in maternal milk at concentrations of less than 0.5% of those detected in plasma. This drug is a monoclonal antibody (IgG1 kappa) and immunoglobulin G is present in human milk; however, there are no data regarding the presence of this drug in human milk.