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 Warnings, Precautions, Pregnancy, Nursing, Abuse - Aprepitant
Emend Warnings, Precautions, Pregnancy, Nursing, Abuse - Aprepitant
WARNINGS
No specific information available.
PRECAUTIONS
General
EMEND should be used with caution in patients receiving concomitant
medicinal products, including chemotherapy agents that are primarily metabolized
through CYP3A4. Inhibition of CYP3A4 by aprepitant could result in elevated
plasma concentrations of these concomitant medicinal products. The effect of
EMEND on the pharmacokinetics of orally administered CYP3A4 substrates is expected
to be greater than the effect of EMEND on the pharmacokinetics of intravenously
administered CYP3A4 substrates (see PRECAUTIONS,
Drug Interactions).
Chemotherapy agents that are known to be metabolized by CYP3A4
include docetaxel, paclitaxel, etoposide, irinotecan, ifosfamide, imatinib,
vinorelbine, vinblastine and vincristine. In clinical studies, EMEND was administered
commonly with etoposide, vinorelbine, or paclitaxel. The doses of these agents
were not adjusted to account for potential drug interactions.
Due to the small number of patients in clinical studies who
received the CYP3A4 substrates docetaxel, vinblastine, vincristine, or ifosfamide,
particular caution and careful monitoring are advised in patients receiving
these agents or other chemotherapy agents metabolized primarily by CYP3A4 that
were not studied (see PRECAUTIONS, Drug
Interactions).
Chronic continuous use of EMEND for prevention of nausea and
vomiting is not recommended because it has not been studied and because the
drug interaction profile may change during chronic continuous use.
Coadministration of EMEND with warfarin may result in a clinically
significant decrease in International Normalized Ratio (INR) of prothrombin
time. In patients on chronic warfarin therapy, the INR should be closely monitored
in the 2-week period, particularly at 7 to 10 days, following initiation of
the 3-day regimen of EMEND with each chemotherapy cycle (see PRECAUTIONS,
Drug Interactions).
The efficacy of oral contraceptives during administration
of EMEND may be reduced. Although effects on contraception with a 3-day
regimen of EMEND given concomitantly with oral contraceptives has not
been studied, alternative or back-up methods of contraception should be
used (see PRECAUTIONS, Drug
Interactions). There are no clinical or pharmacokinetic data in
patients with severe hepatic insufficiency (Child-Pugh score > 9).
Therefore, caution should be exercised when EMEND is administered in these
patients (see CLINICAL PHARMACOLOGY,
Special Populations, Hepatic Insufficiency and DOSAGE
AND ADMINISTRATION).
INFORMATION FOR PATIENTS
Physicians should instruct their patients to read the patient
package insert before starting therapy with EMEND and to reread it each time
the prescription is renewed.
Patients should be instructed to take EMEND only as prescribed.
Patients should be advised to take their first dose (125 mg) of EMEND 1 hour
prior to chemotherapy treatment.
EMEND may interact with some drugs including chemotherapy;
therefore, patients should be advised to report to their doctor the use of any
other prescription, non-prescription medication or herbal products.
Patients on chronic warfarin therapy should be instructed to
have their clotting status closely monitored in the 2-week period, particularly
at 7 to 10 days, following initiation of the 3-day regimen of EMEND with each
chemotherapy cycle.
Administration of EMEND may reduce the efficacy of oral contraceptives.
Patients should be advised to use alternative or back-up methods of contraception.
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