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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Reach Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

FOSAPREPITANT MSN, 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).

Product summary:

Visual Identification: White to off-white sterile lyophilised cake or powder in a 10 mL type-I clear vial with bromobutyl rubber stopper and sealed with aluminium flip off seal.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-10-19

Patient Information leaflet

FOSAPREPITANT®
1
FOSAPREPITANT MSN
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 MSN contains the active ingredient fosaprepitant (as
dimeglumine). FOSAPREPITANT MSN is used for
chemotherapy induced nausea and vomiting.
For more i
nformation, see Section 1. Why am I using FOSAPREPITANT MSN? in the
full CMI.
Do not use if you have ever had an allergic reaction to fosaprepitant
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 am
given FOSAPREPITANT MSN?
in th
e full CMI.
Some medicines may interfere with FOSAPREPITANT MSN and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in th
e full CMI.
•
FOSAPREPITANT MSN is to be given intravenously by your doctor and it
contains 150 mg of fosaprepitant as the active
ingredient.
•
FOSAPREPITANT MSN must only be administered by your doctor or nurse.
More instructions can be found in Section 4. How is FOSAPREPITANT MSN
given? in th
e full CMI.
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
FOSAPREPITANT MSN.
•
Women taking oral contraceptive pills for birth control should also
use other methods of
contraception during treatment with FOSAPREPITANT MSN and for one
month following the last dose
of FOSAPREPITANT MSN.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how
FOSAPREPITANT MSN affects you.
•
FOSAPREPITANT MSN generally does not cause any problems with your
ability to drive a car or
operate machinery.
STORAGE
•
FOSAPREPITANT MSN will be stored in the pharmacy or on the ward in the
hospital.
•
It is kept in a refrigerator where the temperature stays between
2-8°C.
For more information, see Section 5. What s