mepolizumab

REMS

Severe asthma that is of an eosinophilic phenotype (as add-on maintenance treatment).
Eosinophilic granulomatosis with polyangiitis.
Hypereosinophilic syndrome with a duration of ≥6 mo that has no identifiable, non-hematologic, secondary cause.
Chronic rhinosinusitis with nasal polyps in patients with an inadequate response to nasal corticosteroids (as add-on maintenance treatment).

Action ⬆ ⬇

Interleukin-5 (IL-5) antagonist that inhibits binding of IL-5 to the surface of the eosinophil, which reduces the production and survival of eosinophils.

Therapeutic effects:

Decreased incidence of asthma exacerbations and reduction in use of maintenance oral corticosteroid therapy.
Prolonged duration of remission and reduction in use of maintenance oral corticosteroid therapy in eosinophilic granulomatosis with polyangiitis.
Reduction in hypereosinophilic syndrome flares.
Reduction in nasal polyps and nasal obstruction.

Pharmacokinetics ⬆ ⬇

Absorption: 80% absorbed following SUBQ administration.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Degraded by proteolytic enzymes located throughout the body.

Half-Life: 16–22 days

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	unknown	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Acute bronchospasm or status asthmaticus.

Use Cautiously in:

OB: Safety not established in pregnancy; expected to cross the placenta (potential effects likely to be greater during 2nd and 3rd trimesters);
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children <18 yr (eosinophilic granulomatosis with polyangiitis), <12 yr (hypereosinophilic syndrome), or <6 yr (severe asthma of an eosinophilic phenotype).

Adv. Reactions/Side Effects ⬆ ⬇

Derm: flushing, rash

Local: injection site reactions

MS: back pain, myalgia

Neuro: headache, fatigue

Misc: herpes zoster infection, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

Severe Asthma

SC (Adults and Children ≥12 yr): 100 mg every 4 wk.
SC (Children 6–11 yr): 40 mg every 4 wk.

Eosinophilic Granulomatosis with Polyangiitis

SC (Adults ): 300 mg every 4 wk.

Hypereosinophilic Syndrome

SC (Adults and Children ≥12 yr): 300 mg every 4 wk.

Chronic Rhinosinusitis with Nasal Polyps

SC (Adults ): 100 mg every 4 wk.

Availability ⬆ ⬇

Lyophilized powder for injection: 100 mg/vial
Solution for injection: 40 mg/0.4 mL (prefilled syringes); 100 mg/mL (prefilled autoinjectors and prefilled syringes)

Assessment ⬆ ⬇

Assess respiratory status (rate, breath sounds, degree of dyspnea, pulse) periodically during therapy.
Monitor for signs and symptoms of hypersensitivity reactions (anaphylaxis, angioedema, bronchospasm, urticaria, rash) following injection. Reactions usually occur within hrs, but may have a delayed onset (days). Discontinue mepolizumab if hypersensitivity reaction occurs.
Assess for and treat parasitic infections prior to therapy. If infected during therapy and unresponsive to antihelminth treatment, discontinue mepolizumab until infection resolves.

Implementation ⬆ ⬇

Only administer in a health care setting by a health care professional able to manage anaphylaxis. Mepolizumab is for prevention; do not use to treat acute bronchospasm or status asthmaticus.
- Consider administration of varicella vaccination prior to starting therapy.
- Do not abruptly stop systemic or inhaled corticosteroids when starting therapy. May ↓ corticosteroid doses gradually under direct supervision of health care professional. Corticosteroid ↓ may lead to systemic withdrawal symptoms and/or unmask conditions previously suppressed.
Reconstitution: Reconstitute with 1.2 mL of sterile water for injection using a 2- or 3-mL syringe and a 21-gauge needle.Concentration: 100 mg/mL. Direct stream into center of cake. Swirl gently for 10 sec until powder is dissolved; do not shake. Reconstitution takes 5 min or more. Solution is clear to opalescent and colorless to pale yellow or pale brown; do not administer if solution is discolored, cloudy, or contains particles. Stable for 8 hr if refrigerated.
SC: Using a 21- to 27-gauge needle, administer 1 mL for the 100 mg dose or 0.4 mL for the 40 mg dose once every 4 wk into upper arm, thigh, or abdomen. 100 mg/mL prefilled autoinjector and prefilled syringe are for use by adults and children 12 yr and older. The 40 mg/0.4 mL prefilled syringe is for children 6-11 yr (must be administered by health care professional or parent caregiver).
- Remove prefilled autoinjector from refrigerator 30 min before injection and allow to sit to warm to room temperature; do not warm in any other way.
- 300 mg dose must be given as three separate 100-mg injections at least 2 inches apart.

Patient/Family Teaching ⬆ ⬇

Explain purpose of mepolizumab to patient. Administer missed doses as soon as possible; if next dose is already due administer as planned. Instruct patient to read Patient Information before starting therapy.
May be self-administered by adults and adolescents 12 yrs or older using the prefilled auto-injector and prefilled syringe. Remove autoinjector from refrigerator 30 min before injection; do not warm in any other way. Inspect window of autoinjector; solution is clear to opalescent, colorless to pale yellow to pale brown in color. Do not administer solutions that are discolored or contain particulate matter. Inject into thigh or abdomen, 2 inches from navel, or upper arm if administered by caregiver. If multiple injections are needed, separate each injection by at least 2 inches. Avoid areas that are tender, bruised, red, or hard.
Inform patient of risk and signs and symptoms of anaphylaxis. Instruct patient to notify health care professional immediately if signs and symptoms of hypersensitivity reactions (swelling of face, mouth, tongue, fainting, dizziness, feeling lightheaded, hives, breathing problems, rash) occur.
Advise patient to notify health care professional if asthma remains uncontrolled or worsens after starting therapy.
Caution patient not to reduce corticosteroid dose unless instructed by health care professional.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Avoid breastfeeding during therapy.

Evaluation/Desired Outcomes ⬆ ⬇

Decreased incidence of asthma exacerbations and reduction in use of maintenance oral corticosteroid therapy.
Reduction in hypereosinophilic syndrome flares.
Reduction in nasal polyps and nasal obstruction.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0173- GlaxoSmithKline LLC
- 0173-0881- Nucala
  - 0173-0881-01- 1 VIAL in 1 CARTON (0173-0881-01) > 1 mL in 1 VIAL

0173- GlaxoSmithKline LLC
- 0173-0881- Nucala
  - 0173-0881-61- 1 VIAL in 1 CARTON (0173-0881-61) > 1 mL in 1 VIAL

0173- GlaxoSmithKline LLC
- 0173-0892- Nucala
  - 0173-0892-01- 1 SYRINGE in 1 CARTON (0173-0892-01) > 1 mL in 1 SYRINGE

0173- GlaxoSmithKline LLC
- 0173-0892- Nucala
  - 0173-0892-42- 1 SYRINGE in 1 CARTON (0173-0892-42) > 1 mL in 1 SYRINGE

0173- GlaxoSmithKline LLC
- 0173-0892- Nucala
  - 0173-0892-61- 1 SYRINGE in 1 CARTON (0173-0892-61) > 1 mL in 1 SYRINGE

0173- GlaxoSmithKline LLC
- 0173-0892- Nucala
  - 0173-0892-63- 1 SYRINGE in 1 CARTON (0173-0892-63) > 1 mL in 1 SYRINGE

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇