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.

Adult Dosage:

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.

Children Dosage:

Not established.

RYBREVANT Warnings/Precautions:

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).

RYBREVANT Classification:

Bispecific EGF and MET receptor-directed antibody.

RYBREVANT Interactions:

Do not infuse concomitantly with other agents in the same IV line.

Adverse Reactions:

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:

NO

How Supplied:

Single-dose vial (7mL)—1

Pricing for RYBREVANT

7ml of 350mg/7ml vial (Qty: 1)
Appx. price $3056
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