Latest drug indications: Key updates for June/July

Dupixent dupilumab solution for SC injection, Sanofi-aventis. EXPANDED INDICATION Now indicated as an add-on maintenance treatment in patients six years of age or older with severe asthma (with a type 2/eosinophilic phenotype) or oral corticosteroiddependent asthma. (Formerly approved for this indication only in patients ≥ 12 years of age; also approved earlier for use in the treatment of moderate-to-severe atopic dermatitis in patients 6 years of age or older, and as an add-on maintenance treatment with intranasal corticosteroids in adults with severe chronic rhinosinusitis with nasal polyposis.) DOSAGE Asthma (children 6–11 years of age): dosage is based on body weight. 15 kg to < 30 kg—100 mg SC every other week or 300 mg SC every four weeks 30 kg to < 60 kg—200 SC mg every other week or 300 mg SC every four weeks ≥ 60 kg—200 mg SC every other week. For children 6–11 years of age, a caregiver should administer the SC injection into the thigh, abdomen or upper arm, using a single-use prefilled syringe. COMMENTS A new 100 mg/0.67 mL singleuse syringe has been approved by Health Canada, but will not be available in Canada at this time. Read: QUIZ: The latest on monkeypox prevention Gardasil 9 human papillomavirus 9-valent vaccine, recombinant, suspension for intramuscular injection, Merck. NEW INDICATION Prevention of infection caused by the human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 included in the vaccine and the following diseases associated with HPV types 16, 18, 31, 33, 45, 52 and 58: oropharyngeal and other head and neck cancers, in individuals 9–45 years of age. Issued market authorization with conditions, pending the results of trials to verify the vaccine’s clinical benefit. (Approved earlier [without conditions] for prevention of cervical, vulvar, vaginal and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; genital warts [condyloma acuminata] caused by HPV types 6 and 11; precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, including cervical adenocarcinoma in situ, cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia and anal intraepithelial neoplasia.) DOSAGE Three-dose series: 0.5 mL intramuscularly at 0, 2 and 6 months. Alternate schedule for individuals 9–14 years of age: Two 0.5 mL doses, with the second dose given five to 13 months after the first dose. Administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. Jardiance empagliflozin tablets, Boehringer Ingelheim. EXPANDED INDICATION Now indicated in adults as an adjunct to standard of care therapy for the treatment of chronic heart failure (with any ejection fraction). (Formerly indicated only for the treatment of heart failure with reduced ejection fraction. Also indicated for use in the treatment of type 2 diabetes to improve glycemic control and to reduce the incidence of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease.) Read: eTick mobile app now available for free tick identification in Canadian provinces DOSAGE Heart failure: 10 mg once daily, at any time of day, with or without food. Keytruda pembrolizumab solution for infusion, Merck. NEW INDICATIONS 1. Treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumours express PD-L1 (CPS ≥ 1) as determined by a validated test, in combination with chemotherapy with or without bevacizumab. 2. Treatment of adults with high-risk, early-stage, triple-negative breast cancer, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery. (Also approved earlier for numerous other indications; consult product monograph for details). DOSAGE Cervical cancer (persistent, recurrent or metastatic) or high-risk, earlystage, triple-negative breast cancer: 200 mg every three weeks or 400 mg every six weeks as an intravenous infusion over 30 minutes. Consult product monograph for full details. Libtayo cemiplimab for injection, Sanofi Genzyme. NEW INDICATION Treatment of adults with cervical cancer who have progressed on or after prior platinum-based chemotherapy and who require additional systemic therapy to treat recurrent or metastatic disease. (Also approved earlier for use in the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma [with conditions], nonsmall cell lung cancer, and locally advanced basal cell carcinoma.) Read: Are targeted anti-inflammatory therapies triggering inflammatory-based skin reactions? DOSAGE Cervical cancer: 350 mg every three weeks administered as an intravenous infusion over 30 minutes. Continue treatment for 96 weeks or until disease progression or unacceptable toxicity. Skyrizi risankizumab solution for SC injection, AbbVie. NEW INDICATION Treatment of adults with active psoriatic arthritis. Can be used alone or in combination with a conventional nonbiologic diseasemodifying antirheumatic drug (e.g., methotrexate). (Originally indicated only for use in the treatment of adults with moderate to severe plaque psoriasis.) DOSAGE Active psoriatic arthritis: 150 mg administered by SC injection at Weeks 0 and 4, and every 12 weeks thereafter. May be self-administered after proper training in SC injection technique. Tecentriq atezolizumab concentrate for solution for infusion, Hoffmann-La Roche. INDICATION REMOVED The following indication, which was originally issued market authorization with conditions, has been removed from the product monograph: Treatment locally advanced or metastatic urothelial carcinoma in adults who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Trikafta elexacaftor/tezacaftor/ivacaftor tablets and ivacaftor tablets, Vertex Pharmaceuticals. EXPANDED INDICATION Treatment of cystic fibrosis in patients six years of age or older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. (Originally indicated only in patients 12 years of age or older.) DOSAGE 6 to < 12 years weighing < 30 kg: Morning dose—two elexacaftor 50 mg/ tezacaftor 25 mg/ivacaftor 37.5 mg tablets; Evening dose—one ivacaftor 75 mg tablet. 6 to

Latest drug indications: Key updates for June/July

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