Aprepitant

APREPITANT- aprepitant capsule
APREPITANT-
Glenmark Pharmaceuticals Inc., USA

1 INDICATIONS AND USAGE

1.1 Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)

Aprepitant capsules, in combination with other antiemetic agents, are 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 Limitations 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 Recommended Dosage For 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

Population

Day 1

Day 2

Day 3

Day 4

Aprepitant capsules*

Adultsand 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

* 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)].

Table 2: Recommended Dosing for the Prevention of Nausea and Vomiting Associated with MEC

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 the selected 5-HT3 antagonist prescribing information for recommended dosage

none

none

* 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)].

2.2 Recommended Dosage For Postoperative Nausea and Vomiting (PONV)

The recommended oral dosage of aprepitant capsules in adults is 40 mg within 3 hours prior to induction of anesthesia.

2.4 Administration Instructions

Aprepitant capsules can be administered with or without food.

Aprepitant capsules

Swallow capsules whole.

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