Emend
INDICATIONS
EMEND, in combination with other antiemetic agents, is indicated for the:
- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin
- prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (see DOSAGE AND ADMINISTRATION).
EMEND is indicated for the prevention of postoperative nausea and vomiting (see DOSAGE AND ADMINISTRATION).
DOSAGE AND ADMINISTRATION
- Prevention of Chemotherapy Induced Nausea and Vomiting
EMEND is given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3antagonist. The recommended dose of EMEND is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg once daily in the morning on Days 2 and 3.
In clinical studies, the following regimen was used for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:
| Day 1 | Day 2 | Day 3 | Day 4 | |
| EMEND* | 125 mg | 80 mg | 80 mg | none |
| Dexamethasone** | 12 mg orally | 8 mg orally | 8 mg orally | 8 mg orally |
| Ondansetron† | 32 mg IV | none | none | none |
| *EMEND was administered orally 1 hour prior to chemotherapy
treatment on Day 1 and in the morning on Days 2 and 3. **Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The dose of dexamethasone was chosen to account for drug interactions. † Ondansetron was administered 30 minutes prior to chemotherapy treatment on Day 1. |
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In a clinical study, the following regimen was used for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:
| Day 1 | Day 2 | Day 3 | |
| EMEND* | 125 mg | 80 mg | 80 mg |
| Dexamethasone** | 12 mg orally | none | none |
| Ondansetron† | 2 x 8 mg orally | none | none |
| *EMEND was administered orally 1 hour prior to chemotherapy
treatment on Day 1 and in the morning on Days 2 and 3. **Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone was chosen to account for drug interactions. † Ondansetron 8-mg capsule was administered 30 to 60 minutes prior to chemotherapy treatment and one 8-mg capsule was administered 8 hours after the first dose on Day 1. |
|||
- Prevention of Postoperative Nausea and Vomiting
The recommended oral dosage of EMEND is 40 mg within 3 hours prior to induction of anesthesia.
General Information
EMEND has not been studied for the treatment of established nausea and vomiting.
Chronic continuous administration is not recommended (see PRECAUTIONS).
See PRECAUTIONS: DRUG INTERACTIONS for additional information on dose adjustment for corticosteroids when coadministered with EMEND.
Refer to the full prescribing information for coadministered antiemetic agents.
EMEND may be taken with or without food. No dosage adjustment is necessary for the elderly.
No dosage adjustment is necessary for patients with renal insufficiency or for patients with end stage renal disease undergoing hemodialysis.
No dosage adjustment is necessary for patients with mild to moderate hepatic insufficiency (Child-Pugh score 5 to 9). There are no clinical data in patients with severe hepatic insufficiency (Child-Pugh score > 9).
HOW SUPPLIED
No. 3854 - 80 mg capsules: White, opaque, hard gelatin capsule with “461” and “80 mg” printed radially in black ink on the body. They are supplied as follows:
NDC 0006-0461-02 unit-of-use bi-fold package of 2
NDC 0006-0461-30 bottles of 30 (with desiccant)
NDC 0006-0461-06 unit-dose package of 6.
No. 3855 - 125 mg capsules: Opaque, hard gelatin capsule with white body and pink cap with “462” and “125 mg” printed radially in black ink on the body. They are supplied as follows:
NDC 0006-0462-30 bottles of 30 (with desiccant)
NDC 0006-0462-06 unit-dose package of 6.
No. 3862 - Unit-of-use tri-fold pack containing one 125 mg capsule and two 80 mg capsules.
NDC 0006-3862-03.
No. 6741 - 40 mg capsules: Opaque, hard gelatin capsule with white body and mustard yellow cap with “464” and “40 mg” printed radially in black ink on the body. They are supplied as follows:
NDC 0006-0464-10 unit-of-use package of 1
NDC 0006-0464-05 unit-dose package of 5.
Storage
Bottles: Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. The desiccant should remain in the original bottle.
Blisters: Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Merck and co Inc., Whitehouse Station, NJ 08889 USA. FDA revision date: 11/15/2007
Generic Name: Aprepitant
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Emend
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