Elinzanetantdosage

The recommended dosage is 120 mg (two 60 mg capsules) orally once daily at bedtime with or without food. Swallow capsules whole. Do not cut, crush, or chew capsules. See full prescribing information for LYNKUET dosage modification due to drug interactions.

2.1 Recommended

Evaluation and Testing Before Initiation of LYNKUET Exclude pregnancy in females of reproductive potential, Warnings and Precautions, and Use in Specific Populations ]. Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury [including serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), serum alkaline phosphatase (ALP), and serum bilirubin (total and direct)] before initiating treatment with LYNKUET. Do not start LYNKUET if ALT or AST is ≥ 2 times upper limit of normal (ULN) or if the total bilirubin is ≥ 2 times ULN.

2.2 Recommended

Dosage The recommended dosage of LYNKUET is 120 mg (two 60 mg capsules) orally once daily at bedtime at about the same time each day. If a dose is missed at bedtime, take the next dose as scheduled on the following day. Do not take two doses on the same day to make up for a missed dose. Take LYNKUET with or without food. Take LYNKUET with water and swallow capsules whole. Do not cut, crush or chew capsules.

2.3 Dosage Modifications for

Drug Interactions Dosage modifications for concomitant use with specific drugs are provided in Table 1.

Table 1: Dosage Modifications for Drug Interactions Concomitant Drug LYNKUET Dosage Strong CYP3A4 inhibitors and grapefruit (juice) Avoid concomitant use Moderate CYP3A4 inhibitors 60 mg (one capsule) orally once daily at bedtime. After discontinuation of the moderate CYP3A4 inhibitor (after 3 to 5 half-lives of the inhibitor), LYNKUET should be used at the usual dosage of 120 mg once daily. Strong and Moderate CYP3A4 inducers Avoid concomitant use