Fasenra Injection

Benralizumab

30mg/ml

AstraZeneca AB.

Pack size	1 Pre-Filled Syringe
Dispensing mode	POM
Source	SWEDEN
Agent	Modern Pharmaceutical Co.
Retail Price	12103.00 AED

Indications

Fasenra Injection is used for: Severe asthma

Adult Dose

Asthma Indicated for add-on maintenance treatment of severe asthma in patients with an eosinophilic phenotype aged >12 years 30 mg SC q4weeks for the first 3 doses, THEN q8weeks thereafter Hepatic impairment: IgG monoclonal antibodies are not primarily cleared via hepatic pathway; changes in hepatic function are not expected to influence benralizumab clearance

Child Dose

Asthma Indicated for add-on maintenance treatment of severe asthma in patients with an eosinophilic phenotype aged >12 years <12 years: Safety and efficacy not established >12 years: 30 mg SC q4weeks for the first 3 doses, THEN q8weeks 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 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 (eg, anaphylaxis, angioedema, urticaria, rash) reported; these reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days); discontinue if hypersensitivity occurs Do not discontinue systemic or inhaled corticosteroids abruptly upon initiating benralizumab; corticosteroid dose reductions, if appropriate, should be gradual and performed under the direct supervision of a physician; monitor for systemic withdrawal symptoms and/or unmasking of conditions previously suppressed by systemic corticosteroid therapy Eosinophils may be involved in the immunological response to some helminth infections; unknown if benralizumab influences immunologic response against helminth infections; treat patients with preexisting helminth infections before initiating therapy; if parasitic infection occurs while receiving treatment and does not respond to antihelminth treatment, discontinue benralizumab until infection resolves Avoid use in acute asthma symptoms or acute exacerbations; do not use to treat acute bronchospasm or status asthmaticus

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)

Note

Fasenra 30mg/ml Injection manufactured by AstraZeneca AB. . Its generic name is Benralizumab. Fasenra is availble in United Arab Emirates. Farmaco UAE drug index information on Fasenra Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.