Rybrevant

In combination w/ lazertinib for 1st-line treatment of adults w/ advanced NSCLC w/ EGFR Exon 19 deletions or Exon 21 L858R substitution mutations; w/ carboplatin & pemetrexed for adults w/ advanced NSCLC w/ EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including EGFR tyrosine kinase inhibitor; w/ carboplatin & pemetrexed for 1st-line treatment of adults w/ advanced NSCLC w/ activating EGFR Exon 20 insertion mutations. Monotherapy for adults w/ advanced NSCLC w/ activating EGFR Exon 20 insertion mutations, after failure of platinum-based therapy.

IV infusion Administer via peripheral line on wk 1 & 2, & via central line for subsequent wk when infusion-related reaction (IRR) is lower. Premed: Diphenhydramine 25-50 mg or equiv, & acetaminophen 650-1,000 mg. Administer all doses orally 30-60 min prior to infusion, or as IV 15-30 min prior to infusion. Dexamethasone 20 mg or equiv as IV 60-120 min prior to infusion, & 10 mg or equiv as IV 45-60 min prior to infusion. Administer at initial dose (wk 1, days 1 & 2) & optional for subsequent doses. Recommended dose: Monotherapy or in combination w/ lazertinib Adult weighing ≥80 kg 1,400 mg (4 vials), <80 kg 1,050 mg (3 vials). Dosing schedule: Wk 1-4: Wkly (total of 4 doses): Wk 1: Split infusion on days 1 & 2; wk 2-4: Infusion on day 1. Wk 5 onwards: Every 2 wk starting at wk 5. Combination w/ carboplatin & pemetrexed Adult weighing ≥80 kg 1,750 mg (5 vials) wkly (total of 4 doses) from wk 1-4. Wk 1: Split infusion on days 1 & 2; wk 2-4: Infusion on day 1, & 2,100 mg (6 vials) every 3 wk starting at wk 7 onwards, <80 kg 1,400 mg (4 vials) wkly (total of 4 doses) from wk 1-4. Wk 1: Split infusion on days 1 & 2; wk 2-4: Infusion on day 1, & 1,750 mg (5 vials) every 3 wk starting at wk 7 onwards.

Hypersensitivity.

Permanently discontinue treatment for recurrent grade 3 or 4 IRRs; confirmed ILD or ILD-like adverse reactions. Discontinue treatment in recurrent VTE events despite anticoagulation; confirmed TEN. Interrupt infusion at 1st sign of IRRs; if ILD/pneumonitis symptoms develop. Withhold treatment for VTE events associated w/ clinical instability. Reduce dose, interrupt, or permanently discontinue treatment based on severity of skin & nail reactions. VTE events including DVT & pulmonary embolism, & fatal events in combination w/ lazertinib. Rash (including dermatitis acneiform), pruritus & dry skin. Eye disorders including keratitis. Contains polysorbate 80 which may cause hypersensitivity reactions. Patients on controlled Na diet. Monitor patients for symptoms of ILD/pneumonitis (eg, dyspnoea, cough, fever); signs & symptoms of VTE. Administer antihistamines, antipyretics, & glucocorticoids to reduce risk of IRR; prophylactic dosing of either direct acting oral anticoagulant or LMWH in patients w/ VTE. Limit sun exposure during & for 2 mth after therapy, wear protective clothing & use broad-spectrum UVA/UVB sunscreen. Apply alcohol-free emollient cream for dry areas. Consider prophylactic approach to rash prevention w/ oral (eg, doxycycline or minocycline) & topical antibiotic, & topical corticosteroids. Promptly refer patients presenting w/ severe rash w/ atypical appearance or distribution or lack improvement w/in 2 wk to dermatologist; w/ worsening eye symptoms to ophthalmologist. Discontinue use of contact lenses until eye symptoms are evaluated. Not recommended in concomitant use w/ vit K antagonist. Moderate influence on ability to drive & use machines. Severe renal & moderate or severe hepatic impairment. Women of child-bearing potential should use effective contraception during & for 3 mth after treatment cessation. Not to be given during pregnancy; may cause fetal harm. Lactation. No relevant use in paed patients.

Hypoalbuminaemia, decreased appetite, hypocalcaemia, hypokalaemia, hypomagnesaemia; dizziness; diarrhoea, stomatitis, nausea, constipation, vomiting, abdominal pain; increased ALT, AST & blood alkaline phosphatase; rash, nail toxicity, dry skin, pruritus; oedema, fatigue, pyrexia; IRR. Visual impairment, growth of eyelashes, other eye disorders, keratitis; ILD/pneumonitis; haemorrhoids. In combination w/ carboplatin & pemetrexed: Neutropenia, thrombocytopenia. In commbination w/ lazertinib: Paraesthesia; hepatoxicity; muscle spasm. Palmar-plantar erythrodysaesthesia, urticaria. In combination w/ lazertinib/carboplatin & pemetrexed: VTE. Monotherapy: TEN.

Avoid use of live or live-attenuated vaccines.

Targeted Cancer Therapy

L01FX18 - amivantamab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.

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