Benralizumab

Indications

Benralizumab is used for: Severe asthma

Adult Dose

Subcutaneous Asthma Indicated for add-on maintenance treatment of severe asthma in patients with an eosinophilic phenotype aged >12 years The recommended dosage is 30 mg every 4 weeks for the first 3 doses followed by once every 8 weeks thereafter.

Child Dose

Subcutaneous Asthma Child 6 Years to 11 Years of Age: Weighing Less Than 35 kg: the recommended dosage is 10 mg every 4 weeks for the 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 the first 3 doses followed by once every 8 weeks thereafter. Child 12 Years of Age and Older: The recommended dosage is 30 mg every 4 weeks for the first 3 doses followed by once every 8 weeks thereafter.

Renal Dose

Renal impairment Based on population pharmacokinetic analysis, clearance was comparable with CrCl of 30-80 mL/min and patients with normal renal function Data are limited with CrCl <30 mL/min; however, benralizumab is not cleared renally

Administration

SC Preparation Instruct patients regarding SC injection technique and proper disposal of syringe and needles Prior to administration, warm by leaving carton at room temperature for about 30 minutes Once removed from the refrigerator, administer within 24 hr or discard into sharps container Visually inspect; solution should appear clear to opalescent, colorless to slightly yellow, and may contain a few translucent or white to off-white particles Do not use if solution is cloudy, discolored, or if it contains large particles or foreign particulate matter SC Administration For subcutaneous use only Administer SC in upper arm, thigh, or abdomen

Contra Indications

Hypersensitivity to benralizumab or any of its excipients

Precautions

Hypersensitivity reactions: Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred after administration of Benralizumab. Discontinue in the event of a hypersensitivity reaction. Reduction in Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with Benralizumab. Decrease corticosteroids gradually, if appropriate. Parasitic (Helminth) Infection: Treat patients with pre-existing helminth infections before therapy with Benralizumab. If patients become infected while receiving Benralizumab and do not respond to anti-helminth treatment, discontinue Benralizumab until the parasitic infection resolves.

Pregnancy-Lactation

Pregnancy No data are available regarding use in pregnant women Monoclonal antibodies 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 women with poorly or moderately controlled asthma, evidence demonstrates an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate; closely monitor in pregnant women and adjust treatment as necessary Lactation No information is available regarding the presence of benralizumab in human or animal milk, and the effects of benralizumab on the breastfed infant and on milk production are not known Humanized monoclonal antibodies and immunoglobulin G are present in human milk in small amounts The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition

Interactions

Adverse Effects

Side effects of Benralizumab : 1-10% Headache (8%) Pharyngitis (5%) Pyrexia (3%) Hypersensitivity reactions (3%)

Mechanism of Action

Interleukin (IL)-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa); the IL-5 receptor is expressed on the surface of eosinophils and basophils; reduces eosinophils and basophils through antibody-dependent cell-mediated cytotoxicity (ADCC)