benralizumab

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.
Reduction in use of maintenance oral corticosteroid therapy in patients with asthma.
Induction of remission in eosinophilic granulomatosis with polyangiitis.

Pharmacokinetics ⬆ ⬇

Absorption: 58% absorbed following SUBQ administration.

Distribution: Minimally distributed to tissues.

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

Half-Life: 15 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:

Pre-existing helminth infections;
OB: Use during pregnancy only if potential maternal benefit outweighs potential fetal risk;
Lactation: Safety not established in breastfeeding;
Pedi: Children <6 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

EENT: pharyngitis

Neuro: headache

Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS, ANGIOEDEMA, URTICARIA, AND RASH), injection site reactions

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

Asthma

SC (Adults and Children ≥12 yr): 30 mg every 4 wk for first three doses, then 30 mg every 8 wk thereafter.
SC (Children 6–11 yr and ≥35 kg): 30 mg every 4 wk for first three doses, then 30 mg every 8 wk thereafter.
SC (Children 6–11 yr and <35 kg): 10 mg every 4 wk for first three doses, then 10 mg every 8 wk thereafter.

Eosinophilic Granulomatosis with Polyangiitis

SC (Adults ): 30 mg every 4 wk.

Availability ⬆ ⬇

Solution for injection (prefilled syringes or autoinjectors): 10 mg/0.5 mL; 30 mg/mL

Assessment ⬆ ⬇

Assess lung sounds, BP, and HR periodically during therapy. Note amount, color, and character of sputum produced.
Monitor for signs and symptoms of hypersensitivity reactions (rash, pruritus, hives, swelling of face and neck, dyspnea, fainting, dizziness, light-headedness) periodically during therapy; usually occur within hrs, but may occur days after injection. Discontinue medication and provide supportive care if reaction occurs.

Implementation ⬆ ⬇

Treat pre-existing helminth infections before starting therapy.
Prefilled syringe is for administration by a health care professional. Autoinjector can be administered by patient or caregiver with training. Autoinjector should be administered by health care professional or caregiver for children aged 6–11 yr weighing ≥35 kg.
SC: Asthma: Administer every 4 wk for the 1st three doses and every 8 wk thereafter in upper arm, thigh, or abdomen. Eosinophilic Granulomatosis with Polyangiitis: Administer every 4 wk in upper arm, thigh, or abdomen.
- Store in refrigerator; protect from light. Do not freeze or shake. Leave carton at room temperature for 30 min before administration. Solution is clear to opalescent, colorless to slightly yellow; may contain a few translucent or white to off-white particles. Do not administer if liquid is cloudy, discolored, or contains large particles or foreign particulate matter. Do not expel the air bubble prior to administration. Pinch skin to inject medication.

Patient/Family Teaching ⬆ ⬇

Explain the purpose and side effects of benralizumab to patient. Instruct patient in correct technique for injection, care, and disposal of equipment. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Advise patient that benralizumab should not be used to treat an acute asthma attack. Patient should continue asthma medications, including corticosteroids, unless otherwise instructed by health care professional.
Advise patient to stop using medication and notify health care professional immediately if signs and symptoms of hypersensitivity reactions occur.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any OTC medications or alcoholic beverages concurrently with this therapy. Caution patient also to avoid smoking and other respiratory irritants.
Instruct patient whose systemic corticosteroids have been recently reduced or withdrawn to carry a warning card indicating the need for supplemental systemic corticosteroids in the event of stress or severe asthma attack unresponsive to bronchodilators.
Advise patient to have helminth infections treated before starting benralizumab therapy.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Encourage health care professional or pregnant patients to enroll in pregnancy registry to monitor outcomes of women exposed to benralizumab during pregnancy by calling 1-877-311-8972 or visiting mothertobaby.org/Fasenra.

Evaluation/Desired Outcomes ⬆ ⬇

Decreased incidence of asthma exacerbations. Reduction in use of maintenance oral corticosteroid therapy.
Induction of remission in eosinophilic granulomatosis with polyangiitis.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0310- AstraZeneca Pharmaceuticals LP
- 0310-1730- FASENRA
  - 0310-1730-30- 1 SYRINGE, GLASS in 1 CARTON (0310-1730-30) > 1 mL in 1 SYRINGE, GLASS

0310- AstraZeneca Pharmaceuticals LP
- 0310-1730- FASENRA
  - 0310-1730-85- 1 SYRINGE, GLASS in 1 CARTON (0310-1730-85) > 1 mL in 1 SYRINGE, GLASS

0310- AstraZeneca Pharmaceuticals LP
- 0310-1830- FASENRA
  - 0310-1830-30- 1 CARTRIDGE in 1 CARTON (0310-1830-30) > 1 mL in 1 CARTRIDGE

0310- AstraZeneca Pharmaceuticals LP
- 0310-1830- FASENRA
  - 0310-1830-85- 1 CARTRIDGE in 1 CARTON (0310-1830-85) > 1 mL in 1 CARTRIDGE

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇