Rybrevant Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Rybrevant Indications
Indications
In combination with carboplatin and pemetrexed for the first-line treatment of adults with 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. As a single agent for adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Rybrevant Dosage and Administration
Adult
Confirm presence of EGFR exon 20 insertion mutations in tumor or plasma specimens. 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 upon re-initiation after prolonged dose interruptions, then 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. In combination therapy: infuse pemetrexed first, carboplatin second, and amivantamab last; see full labeling. First-line NSCLC: <80kg (Week 1): 350mg on Day 1, then 1050mg on Day 2; (Weeks 2–4): 1400mg once weekly on Day 1; (Weeks 5–6): no dose; (Week 7 onwards): 1750mg every 3 weeks thereafter; ≥80kg (Week 1): 350mg on Day 1, then 1400mg on Day 2; (Weeks 2–4): 1750mg once weekly on Day 1; (Weeks 5–6): no dose; (Week 7 onwards): 2100mg every 3 weeks thereafter. Previously treated NSCLC: <80kg (Week 1): 350mg on Day 1, then 700mg on Day 2; (Weeks 2–5): 1050mg once weekly on Day 1; (Week 6): no dose; (Week 7 onwards): 1050mg every 2 weeks thereafter; ≥80kg (Week 1): 350mg on Day 1, then 1050mg on Day 2; (Weeks 2–5): 1400mg once weekly on Day 1; (Week 6): no dose; (Week 7 onwards): 1400mg every 2 weeks thereafter. Continue until disease progression or unacceptable toxicity. Infusion rates, dose modifications for adverse reactions: see full labeling.
Children
Rybrevant Contraindications
Not Applicable
Rybrevant Boxed Warnings
Not Applicable
Rybrevant Warnings/Precautions
Warnings/Precautions
Rybrevant Pharmacokinetics
Distribution
Volume of distribution: 5.34 ± 1.81 L.
Elimination
Half-life: 13.7 days. Mean linear clearance: 0.266 L/day.
Rybrevant Interactions
Interactions
Rybrevant Adverse Reactions
Adverse Reactions
Rybrevant Clinical Trials
See Literature
Rybrevant Note
Not Applicable
Rybrevant Patient Counseling
See Literature
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