Rybrevant Dosage/Direction for Use

RYBREVANT should be administered by a healthcare professional with appropriate medical support to manage infusion-related reactions (IRRs) if they occur (see Precautions).
Administer pre-infusion medications (see Pre-infusion medications as follows).
When considering the use of RYBREVANT, EGFR Exon 20 insertion mutation presence should be established using a validated test (see Pharmacology: Pharmacodynamics: Pharmacodynamic effects and Clinical studies under Actions).
Dosage - adults (≥18 years): The recommended dose of RYBREVANT is provided in Table 2, and the dosing schedule is provided in Table 3, (see Infusion Rates - Table 5). (See Tables 2 and 3.)

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It is recommended that patients are treated with RYBREVANT until unacceptable toxicity or lack of clinical benefit.
Pre-infusion medications: Prior to initial infusion of RYBREVANT (Week 1, Days 1 and 2), administer antihistamines, antipyretics, and glucocorticoids to reduce the risk of IRRs. For subsequent doses, administer antihistamines and antipyretics. Administer antiemetics as needed. (See Table 4.)

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Infusion Rates: Administer RYBREVANT infusion intravenously according to the infusion rates in Table 5. Due to the frequency of IRRs at the first dose, infusion via a peripheral vein at Week 1 and Week 2 should be considered to minimize drug exposure in the event of an IRR; infusion via central line may be administered for subsequent weeks. It is recommended for the first dose to be diluted as close to administration as possible to allow for maximal flexibility in IRR management. (See Table 5.)

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Missed dose(s): If a planned dose of RYBREVANT is missed, the dose should be administered as soon as possible and the dosing schedule should be adjusted accordingly, maintaining the treatment interval.
Dose modifications: The recommended dose reductions for adverse reactions (see Table 7) are listed in Table 6. (See Table 6.)

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The recommended dosage modifications for adverse reactions are provided in Table 7. (See Table 7.)

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Special populations: Pediatrics (17 years of age and younger): The safety and efficacy of RYBREVANT have not been established in pediatric patients.
Elderly (65 years of age and older): Of the 362 patients treated with RYBREVANT in EDI1001, 41% were 65 years of age or older, and 12% were 75 years of age or older. No overall differences in safety or effectiveness were observed between these patients and younger patients. No dosage adjustment is necessary (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No formal studies of amivantamab in patients with renal impairment have been conducted. Based on population pharmacokinetic (PK) analyses, no dosage adjustment is necessary for patients with mild or moderate renal impairment. No data are available in patients with severe renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No formal studies of amivantamab in patients with hepatic impairment have been conducted. Based on population PK analyses, no dosage adjustment is necessary for patients with mild hepatic impairment. No data are available in patients with moderate or severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).