NEW PRODUCT: Exdensur for severe asthma/chronic rhinosinusitis with nasal polyps

Exdensur for severe asthma/chronic rhinosinusitis with nasal polypsdepemokimab 100 mg/mL solution for subcutaneous (SC) injection; 1 mL prefilled pen (autoinjector) or 1 mL prefilled syringe, GlaxoSmithKline.INDICATIONS 1. An add-on maintenance treatment in adults and adolescents (≥ 12 years of age) with severe asthma characterized by an eosinophilic phenotype and inadequately controlled by medium- to high-dose inhaled corticosteroids plus another asthma controller. Not indicated for the relief of acute bronchospasm or status asthmaticus. 2. An add-on maintenance treatment with intranasal corticosteroids in adults with severe chronic rhinosinusitis with nasal polyps inadequately controlled by systemic corticosteroids and/or surgery.ACTION A long-acting monoclonal antibody that targets human interleukin-5 (IL-5), a key cytokine involved in eosinophilic inflammation. May exert its therapeutic effect in asthma and chronic rhinosinusitis with nasal polyps by blocking IL-5 signaling to reduce the production and survival of eosinophils.DOSAGE Severe asthma (adults and adolescents ≥ 12 years of age): 100 mg SC every six months. Chronic rhinosinusitis with nasal polyps (adults): 100 mg SC every six months.ADMINISTRATION Administer SC into the upper arm, thigh or abdomen. May be self-administered or given by a caregiver with appropriate training.ADVERSE EFFECTS MOST COMMON: (all ≤ 2%): Pruritus, administration-related systemic reactions (e.g., headache, fatigue, rash) and injection site reactions (e.g., pain, erythema, swelling, itching). MOST SERIOUS: Cases of elevated liver enzymes, some with features of autoimmune hepatitis (causal relationship not established). Hypersensitivity reactions, such as anaphylaxis, have been reported with other monoclonal antibodies that target IL-5.DRUG INTERACTIONS None established. Expected to have a low potential for drug-drug interactions.STORAGE Store under refrigeration (2°C–8°C), protected from light. May be removed from the refrigerator and kept in the unopened carton for up to seven days at room temperature (up to 30°C), when protected from light. Discard if left out of the refrigerator for more than seven days. Must be administered within eight hours once the carton is opened.

NEW PRODUCT: Exdensur for severe asthma/chronic rhinosinusitis with nasal polyps

Register for free access or login.

Related Topics