벤라리주맙

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 ) • treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause. ( 1.3 ) Limitations of Use : Not for relief of acute bronchospasm or status asthmaticus. (1.1) 1.1 Asthma FASENRA is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. Limitations of Use: • FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus. 1.2 Eosinophilic Granulomatosis with Polyangiitis FASENRA is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). 1.3 Hypereosinophilic Syndrome FASENRA is indicated for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause.

is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients [see Warnings and Precautions (5.1) ] . Known hypersensitivity to benralizumab or excipients. (4)

• Hypersensitivity reactions: Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. Discontinue in the event of a hypersensitivity reaction. (5.1) • Reduction in Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Decrease corticosteroids gradually, if appropriate. (5.3) • Parasitic (Helminth) Infection: Treat patients with pre-existing helminth infections before therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until the parasitic infection resolves. (5.4) 5.1 Hypersensitivity Reactions Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred following administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, FASENRA should be discontinued [see Contraindications (4) ] . 5.2 Acute Asthma Symptoms or Deteriorating Disease FASENRA should not be used to treat acute asthma symptoms or acute exacerbations. Do not use FASENRA to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with FASENRA. 5.3 Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled …

8.1 Pregnancy Risk Summary 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 subcutaneously (see Data) . In …