Fasenra

Indications and Usage                                                                             09/2024

Dosage and Administration                                                    04/2024

Dosage and Administration, EGPA                                                      09/2024

FASENRA is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for:

• •add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. (1.1)
• •treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). (1.2)

Not for relief of acute bronchospasm or status asthmaticus. (1.1)

Administer by subcutaneous injection.

• •Recommended dosage is 30 mg every 4 weeks for first 3 doses followed by once every 8 weeks thereafter.

• •
  Weighing Less Than 35 kg
  : the recommended dosage is 10 mg every 4 weeks for first 3 doses followed by once every 8 weeks thereafter.
• •
  Weighing 35 kg or More
  : the recommended dosage is 30 mg every 4 weeks for first 3 doses followed by once every 8 weeks thereafter.

Recommended dosage is 30 mg every 4 weeks. (2.2)

See full prescribing information for administration instructions of FASENRA prefilled syringe and FASENRA PEN. ( 2.4, 2.5)

Injection: clear to opalescent, colorless to slightly yellow solution and may contain a few translucent or white to off‑white particles available as:

• •10 mg/0.5 mL solution in a single-dose prefilled syringe.
• •30 mg/mL solution in a single-dose prefilled syringe.
• •30 mg/mL solution in a single-dose autoinjector FASENRA PEN.

The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. In a prenatal and postnatal development study conducted in cynomolgus monkeys, there was no evidence of fetal harm with IV administration of benralizumab throughout pregnancy at doses that produced exposures up to approximately 310 times the exposure at the maximum recommended human dose (MRHD) of 30 mg SC [see

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.

In a prenatal and postnatal development study, pregnant cynomolgus monkeys received benralizumab from beginning on GD20 to GD22 (dependent on pregnancy determination), on GD35, once every 14 days thereafter throughout the gestation period and 1-month postpartum (maximum 14 doses) at doses that produced exposures up to approximately 310 times that achieved with the MRHD (on an AUC basis with maternal IV doses up to 30 mg/kg once every 2 weeks). Benralizumab did not elicit adverse effects on fetal or neonatal growth (including immune function) up to 6.5 months after birth. There was no evidence of treatment-related external, visceral, or skeletal malformations. Benralizumab was not teratogenic in cynomolgus monkeys. Benralizumab crossed the placenta in cynomolgus monkeys. Benralizumab concentrations were approximately equal in mothers and infants on postpartum day 7, but were lower in infants at later time points. Eosinophil counts were suppressed in infant monkeys with gradual recovery by 6 months postpartum; however, recovery of eosinophil counts was not observed for one infant monkey during this period.