FOSAPREPITANT-AFT POWDER FOR INJECTION 150MGVIAL

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

FOSAPREPITANT DIMEGLUMINE 245.3MG EQV FOSAPREPITANT

Verfügbar ab:

APEX PHARMA MARKETING PTE. LTD.

ATC-Code:

A04AD12

Darreichungsform:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Zusammensetzung:

FOSAPREPITANT DIMEGLUMINE 245.3MG EQV FOSAPREPITANT 150MG/VIAL

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

Prescription Only

Hergestellt von:

QILU PHARMACEUTICAL (HAINAN) CO., LTD.

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

2022-01-24

Fachinformation

Page 1 of 22
PRODUCT INFORMATION
FOSAPREPITANT-AFT (FOSAPREPITANT DIMEGLUMINE)
POWDER FOR INJECTION
1.
NAME OF THE MEDICINE
Fosaprepitant dimeglumine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Fosaprepitant-AFT 150 mg for intravenous administration
contains 245.3 mg of
fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant free
acid.
Excipients with known effect:
Anhydrous lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Fosaprepitant-AFT is a white to off-white lyophilized powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fosaprepitant-AFT, in combination with a corticosteroid and a 5-HT3
antagonist, is indicated for the
prevention of acute and delayed nausea and vomiting associated with
initial and repeat courses of:
•
highly emetogenic cancer chemotherapy (see Section 4.2 Dose and Method
of
Administration)
•
moderately emetogenic cancer chemotherapy (see Section 4.2 Dose and
Method of
Administration).
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
Fosaprepitant-AFT, for administration by intravenous infusion, is a
lyophilised prodrug of aprepitant
containing polysorbate 80.
AFT Pharmaceuticals Ltd
Date: 11/01/2022
Product name (SG)
Active ingredient xx mg/mL
Dosage form, container
1.4.3.1 pI-clean
CODE - short description (00XX) / Pg. 1
Page 2 of 22
Fosaprepitant-AFT 150 mg is administered on day 1 as an infusion over
20-30 minutes initiated
approximately 30 minutes prior
to chemotherapy. Fosaprepitant-AFT
should be administered in
conjunction with a corticosteroid and a 5-HT
3
antagonist as specified in Tables 1 and Table 2. The
package insert for the co-administered 5-HT
3
antagonist must be consulted prior to initiation of
treatment with Fosaprepitant-AFT 150 mg.
TABLE 1:
Recommended dosing for the prevention of nausea and vomiting
associated with highly
emetogenic cancer chemotherapy
DAY 1
DAY 2
DAY 3
DAY 4
FOSAPREPITANT-AFT
150 mg IV
none
none
none
DEXAMETHASONE**
12 mg orally
8 mg orally
8 mg orally
bid
8 mg orally
bid
5-HT
3
ANTAGONIST
See th