Dosing
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NERLYNX is to be taken orally, once a day, as six 40 mg tablets, continuously for one year5
NERLYNX must be taken with food, preferably in the morning
If a dose is missed or regurgitated due to vomiting, NERLYNX is to be resumed the next day
Tablets should be swallowed whole, and should not be crushed or dissolved
Grapefruit and pomegranate in any form should be avoided
NERLYNX does not require any special temperature storage conditions
Adjusting daily dose can improve tolerability and adherence5
Management of some adverse reactions may require dose interruption and/or dose reduction.5
In case of Grade 3 toxicity:
Stop NERLYNX until recovery to Grade 0–1 or baseline within 3 weeks. Then resume NERLYNX at the next lower dose level. If Grade 3 toxicity does not recover within 3 weeks, discontinue permanently. Discontinue NERLYNX for patients unable to tolerate 120 mg daily or who fail to recover to Grade 0–1 from treatment toxicity, or for toxicities resulting in a treatment delay >3 weeks.5
Dose adjustments for specific populations5
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Elderly
No dose adjustment is required.
There is no data in patients ≥85 years of age.
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Renal impairment
No dose adjustment is required for patients with mild to moderate renal impairment.
NERLYNX has not been studied in patients with severe renal impairment (eGFR ≤29 mL/ min/1.73 m2) including patients on dialysis. Treatment is not recommended for these patients.
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Hepatic impairment
No dose adjustment is required for patients with Child-Pugh A or B (mild to moderate). Treatment of patients with Child-Pugh C hepatic impairment is contraindicated.
Dose adjustments for general hepatotoxicity5
Hepatotoxicity has been reported in patients treated with NERLYNX.
Liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin should be monitored at 1 week, then monthly for the first 3 months and every 6 weeks thereafter while on treatment or as clinically indicated.5
