APREPITANT

APREPITANT- aprepitant capsule
APREPITANT — aprepitant
Torrent Pharmaceuticals Limited

1 INDICATIONS AND USAGE

1.1 Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)

Aprepitant capsules, in combination with other antiemetic agents, is indicated in patients 12 years of age and older for the prevention of:

• acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.

• nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

1.2 Prevention of Postoperative Nausea and Vomiting (PONV)

Aprepitant capsules are indicated in adults for the prevention of postoperative nausea and vomiting.

1.3 Limitation of Use

• Aprepitant has not been studied for the treatment of established nausea and vomiting.

• Chronic continuous administration of Aprepitant is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use.

2 DOSAGE AND ADMINISTRATION

2.1 Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)

Adults and Pediatric Patients 12 Years of Age and Older

The recommended oral dosage of Aprepitant capsules, dexamethasone, and a 5-HT3 antagonist in adults and pediatric patients 12 years of age and older who can swallow oral capsules, for the prevention of nausea and vomiting associated with administration of HEC or MEC is shown in Table 1 or Table 2, respectively.

Table 1: Recommended Dosing for the Prevention of Nausea and Vomiting Associated with HEC

* Administer aprepitant capsules 1 hour prior to chemotherapy treatment on Days 1, 2, and 3. If no chemotherapy is given on Days 2 and 3, administer APREPITANT capsules in the morning.

†Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. A 50% dosage reduction of dexamethasone is recommended to account for a drug interaction with aprepitant [see Clinical Pharmacology (12.3)].

Population Day 1 Day 2 Day 3 Day 4
Aprepitant capsules* Adults and Pediatric Patients 12 Years and Older 125 mg orally 80 mg orally 80 mg orally none
Dexamethasone Adults 12 mg orally 8 mg orally 8 mg orally 8 mg orally
Pediatric Patients 12 Years and Older If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 [see Clinical Studies (14.3)].†
5-HT3 antagonist Adults and Pediatric Patients 12 Years and Older See selected 5-HT3 antagonist prescribing information for the recommended dosage none none none
Table 2: Recommended Dosing for the Prevention of Nausea and Vomiting Associated with MEC

* Administer aprepitant capsules 1 hour prior to chemotherapy treatment on Days 1, 2, and 3. If no chemotherapy is given on Days 2 and 3, administer aprepitant capsules in the morning.

Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1. A 50% dosage reduction of dexamethasone is recommended to account for a drug interaction with aprepitant [see Clinical Pharmacology (12.3)] .

Population Day 1 Day 2 Day 3
Aprepitant capsules* Adults and Pediatric Patients 12 Years and Older 125 mg orally 80 mg orally 80 mg orally
Dexamethasone Adults 12 mg orally none none
Pediatric Patients 12 Years and Older If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 [see Clinical Studies (14.3)].†
5-HT3 antagonist Adults and Pediatric Patients 12 Years and Older See selected 5-HT3 antagonist prescribing information for the recommended dosage none none

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