Respiratory and thoracic cancers:
Indications for RYBREVANT:
Locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, in patients whose disease has progressed on or after platinum-based chemotherapy.
Confirm presence of EGFR exon 20 insertion mutations. Premedicate with antihistamine (oral or IV), antipyretic (oral or IV) prior to all infusions, and glucocorticoid (IV) at initial dose (Week 1 on Days 1 and 2 only) and as needed for subsequent infusions. Initiate treatment by IV infusion via peripheral line on Weeks 1 and 2, then may be administered via central line for subsequent weeks. <80kg (Week 1): 350mg on Day 1, then 700mg on Day 2; (Weeks 2–4): 1050mg once weekly; (subsequent weeks): 1050mg every 2 weeks. ≥80kg (Week 1): 350mg on Day 1, then 1050mg on Day 2; (Weeks 2–4): 1400mg once weekly; (subsequent weeks): 1400mg every 2 weeks. Continue until disease progression or unacceptable toxicity. Infusion rates, dose modifications for adverse reactions: see full labeling.
Monitor for infusion-related reactions; interrupt if suspected; reduce infusion rate or permanently discontinue based on severity. Have resuscitative measures available. Monitor for interstitial lung disease (ILD)/pneumonitis; withhold immediately if suspected; permanently discontinue if confirmed. Ocular toxicity (eg, keratitis, uveitis, blurred vision, visual impairment) or dermatologic reactions (eg, rash, dermatitis acneiform, pruritus, dry skin, toxic epidermal necrolysis) may occur; withhold, reduce dose or permanently discontinue based on severity. Promptly refer to a dermatologist if severe rash, atypical appearance or distribution occurs, or lack of improvement within 2 weeks. Advise patients to limit sun exposure during and for 2 months after treatment. Severe renal impairment (CrCl 15–29mL/min), moderate (total bilirubin 1.5–3×ULN) to severe (total bilirubin >3×ULN) hepatic impairment: not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after the last dose).
Bispecific EGF and MET receptor-directed antibody.
Do not infuse concomitantly with other agents in the same IV line.
Rash, infusion-related reactions, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, vomiting, Grade 3 or 4 lab abnormalities (decreased lymphocytes, decreased albumin, decreased phosphate, decreased potassium, increased alkaline phosphatase, increased glucose, increased gamma-glutamyl transferase, decreased sodium); ILD/pneumonitis, pulmonary embolism, pneumonia.
Generic Drug Availability:
Single-dose vial (7mL)—1