Seven new indications for drugs doctors and pharmacists should know about

Alecensaroalectinib capsules, Hoffmann-La Roche.NEW INDICATION Adjuvant treatment following tumour resection in patients with stage IB (tumours ≥ 4 cm) to IIIA ALK-positive nonsmall cell lung cancer (NSCLC). (Also indicated for the treatment of NSCLC in other situations; consult product monograph.)DOSAGE 600 mg (four 150 mg capsules) orally, twice daily with food.HyQvianormal immunoglobulin (human) and recombinant human hyaluronidase solution for SC infusion, Takeda.EXPANDED INDICATION Replacement therapy for primary humoral immunodeficiency and secondary humoral immunodeficiency in adults and children ≥ 2 years of age. (Originally indicated for use in adults only.)DOSAGE Consult product monograph for details. Administered by SC infusion. The two components must be infused sequentially, beginning with the hyaluronidase component.Keytrudapembrolizumab solution for infusion, Merck.EXPANDED INDICATION Adjuvant treatment of adults and children (≥ 12 years of age) with Stage IIB, IIC or III melanoma following complete resection. (Originally approved only for Stage IIB and IIC; also approved earlier for numerous other indications; consult product monograph for details.)DOSAGE Adjuvant treatment in Stage IIB, IIC or III melanoma: Adults—200 mg every three weeks or 400 mg every six weeks. Children (≥ 12 years)—2 mg/kg (maximum 200 mg) every three weeks. Administer as an intravenous infusion over 30 minutes.Opdivonivolumab for injection, Bristol-Myers Squibb.NEW INDICATION First-line treatment of unresectable or metastatic urothelial carcinoma in adults, in combination with cisplatin and gemcitabine. (Also approved earlier for numerous other indications; consult product monograph for details.)DOSAGE Nivolumab 360 mg administered intravenously over 30 minutes, in combination with cisplatin and gemcitabine on the same day every three weeks for up to six cycles. Then continue treatment with single agent nivolumab 240 mg every two weeks or 480 mg every four weeks administered intravenously over 30 minutes until disease progression, unacceptable toxicity, or up to two years from the first dose.Rybrevantamivantamab for injection, Johnson & Johnson (formerly Janssen).NEW INDICATION First-line treatment of locally advanced or metastatic nonsmall cell lung cancer (NSCLC) in adults with activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations, in combination with carboplatin and pemetrexed. (Originally approved [with conditions] for this indication in patients whose disease had progressed on or after platinum-based chemotherapy.)DOSAGE Consult product monograph for details.Tagrissoosimertinib tablets, AstraZeneca.NEW INDICATION First-line treatment of locally advanced or metastatic nonsmall cell lung cancer (NSCLC) in patients whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, in combination with pemetrexed and platinum-based chemotherapy. (Also approved earlier for use in NSCLC in other situations; consult product monograph for details.)DOSAGE First-line treatment of locally advanced or metastatic NSCLC: 80 mg once daily, with or without food, at the same time each day. Swallow tablets whole with water; do not crush, split or chew.Trikaftaelexacaftor/tezacaftor/ivacaftor tablets or granules and ivacaftor tablets or granules, Vertex Pharmaceuticals.EXPANDED INDICATION Now indicated for the treatment of cystic fibrosis in patients aged two years or older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene. (Formerly indicated only for patients with at least one F508del mutation in the CFTR gene.)DOSAGE Varies according to body weight, hepatic function and concomitant medications; consult product monograph for details.

Seven new indications for drugs doctors and pharmacists should know about

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