FOSAPREPITANT-AFT fosaprepitant (as dimeglumine) 150 mg powder for injection vial

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

fosaprepitant dimeglumine, Quantity: 245.3 mg (Equivalent: fosaprepitant, Qty 150 mg)

Доступна с:

AFT Pharmaceuticals Pty Ltd

Фармацевтическая форма:

Injection, powder for

состав:

Excipient Ingredients: dilute hydrochloric acid; polysorbate 80; lactose; disodium edetate; sodium hydroxide

Администрация маршрут:

Intravenous Infusion

Штук в упаковке:

1 vial

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Fosaprepitant-AFT, 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 (see Section 4.2 Dose and Method of Administration),? moderately emetogenic cancer chemotherapy (see Section 4.2 Dose and Method of Administration).

Обзор продуктов:

Visual Identification: White to off-white lyophilized powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Статус Авторизация:

Registered

Дата Авторизация:

2022-10-04

тонкая брошюра

Fosaprepitant-AFT
1
FOSAPREPITANT-AFT
_Fosaprepitant dimeglumine _
_ _
_ _
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
Fosaprepitant-AFT contains the active ingredient Fosaprepitant
dimeglumine. Fosaprepitant-AFT in combination with other
medicines, is used to prevent nausea (feeling sick) and vomiting
associated with cancer chemotherapy.
For more information, see Section 1. Why am I using Fosaprepitant-AFT?
in the full CMI.
Do not use if you have ever had an allergic reaction to Fosaprepitant
dimeglumine or any of the ingredients listed at the end of
the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Fosaprepitant-AFT? in the full CMI.
Some medicines may interfere with Fosaprepitant-AFT and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
Fosaprepitant-AFT 150 mg may be given to you as an infusion over 20-30
minutes approximately 30 minutes before you start
your chemotherapy treatment.
More instructions can be found in Section 4. How do I use
Fosaprepitant-AFT? in the full CMI.
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Fosaprepitant-AFT.
•
Women taking oral contraceptive pills for birth control should also
use other methods of
contraception during treatment with Fosaprepitant-AFT and for one
month following the last dose of
Fosaprepitant-AFT. This is because oral contraceptive pills may not
work as well when using
Fosaprepitant-AFT
•
If you become pregnant while using Fosaprepitant-AFT, tell your doctor
immediately.
DRIVING OR USING
MACHINES
•
Fosaprepitant-AFT generally does not cause any problems with your
ability to drive a car or operate
machinery. However, as with many medicines, it may cause certain side
effects in some

Характеристики продукта

Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
FOSAPREPITANT-AFT (FOSAPREPITANT (AS DIMEGLUMINE))
POWDER FOR INJECTION
1.
NAME OF THE MEDICINE
Fosaprepitant (as 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
Lactose
For the full list of excipients, see section 6.1 List of excipients.
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 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 (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.
Page 2 of 23
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
product information 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 the product information
for the
selected 5-HT
3
antagonist for appropriate
dosing information.
none
none
none
** Dexamethasone should be administered