A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Emend Indications, Dosage, Storage, Stability - Aprepitant
Emend Indications, Dosage, Storage, Stability - Aprepitant
INDICATIONSAND USAGE
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 (see DOSAGE
AND ADMINISTRATION).
DOSAGE AND ADMINISTRATION
EMEND is given for 3 days as part of a regimen that includes
a corticosteroid and a 5-HT3 antagonist. 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. EMEND has not been studied for
the treatment of established nausea and vomiting.
In clinical studies, the following regimen was used:
| |
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.
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 0006-0461-30 bottles of 30 (with desiccant)
NDC 0006-0461-05 unit-dose packages of 5.
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 0006-0462-05 unit-dose packages of 5. No. 3862 -Unit-of-usetri-fold
pack containing one 125 mg capsule and two 80 mg capsules. NDC 0006-3862-03.
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]. RX only
MERCK& CO., INC., Whitehouse Station, NJ
08889, USA, Issued March 2003 Printed in USA
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