Ivemend 150mg powder for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fosaprepitant dimeglumine

Available from:

Merck Sharp & Dohme Ltd

INN (International Name):

Fosaprepitant dimeglumine

Dosage:

150mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5013945002584

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
IVEMEND
® 150 MG POWDER FOR SOLUTION FOR INFUSION
fosaprepitant
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist, or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist, or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What IVEMEND is and what it is used for
2.
What you need to know before you use IVEMEND
3.
How to use IVEMEND
4.
Possible side effects
5.
How to store IVEMEND
6.
Contents of the pack and other information
1.
WHAT IVEMEND IS AND WHAT IT IS USED FOR
IVEMEND contains the active substance fosaprepitant which is converted
to aprepitant in your body.
It belongs to a group of medicines called "neurokinin 1 (NK
1
) receptor antagonists". The brain has a
specific area that controls nausea and vomiting. IVEMEND works by
blocking signals to that area,
thereby reducing nausea and vomiting. IVEMEND is used in adults,
adolescents, and children aged 6
months or older IN COMBINATION WITH OTHER MEDICINES to prevent nausea
and vomiting caused by
chemotherapy (cancer treatment) that is a strong or moderate trigger
of nausea and vomiting.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IVEMEND
DO NOT USE IVEMEND:

if you are allergic to fosaprepitant, aprepitant, or to polysorbate 80
or any of the other
ingredients (listed in section 6).

with medicines containing pimozide (used to treat psychiatric
illnesses), terfenadine and
astemizole (used for hay fever and other allergic conditions),
cisapride (used for treating
digestive problems). Tell your doctor if you are taking these
medicines since the treatment must
be modified before you start using IVEMEND.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist, or nurse before using IVEMEND.
Before treatment with this medicine, tell your doctor if you

Summary of Product characteristics

OBJECT 1
IVEMEND 150 MG POWDER FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 15-May-2018 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
IVEMEND
®
150 mg powder for solution for infusion.
2. Qualitative and quantitative composition
Each vial contains fosaprepitant dimeglumine equivalent to 150 mg
fosaprepitant, which corresponds to
130.5 mg of aprepitant. After reconstitution and dilution 1 ml of
solution contains 1 mg fosaprepitant (1
mg/ml) (see section 6.6).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for infusion.
White to off-white amorphous powder.
4. Clinical particulars
4.1 Therapeutic indications
Prevention of nausea and vomiting associated with highly and
moderately emetogenic cancer
chemotherapy in adults and paediatric patients aged 6 months and
older.
IVEMEND 150 mg is given as part of a combination therapy (see section
4.2).
4.2 Posology and method of administration
Posology
_Adults _
The recommended dose is 150 mg administered as an infusion OVER 20-30
MINUTES on Day 1, initiated
approximately 30 minutes prior to chemotherapy (see section 6.6).
IVEMEND should be administered in
conjunction with a corticosteroid and a 5-HT3 antagonist as specified
in the tables below.
The following regimens are recommended for the prevention of nausea
and vomiting associated with
emetogenic cancer chemotherapy.
_Highly Emetogenic Chemotherapy Regimen_
Day 1
Day 2
Day 3
Day 4
IVEMEND
150 mg intravenously
none
none
none
Dexamethasone
12 mg orally
8 mg orally
8 MG ORALLY TWICE
DAILY
8 MG ORALLY TWICE
DAILY
5-HT
3
antagonists Standard dose of 5-HT
3
antagonists. See the
product information for
the selected 5-HT
3
antagonist for
appropriate dosing
information
none
none
none
DEXAMETHASONE should be administered 30 minutes prior to chemotherapy
treatment on Day 1 and in the
morning on Days 2 to 4. Dexamethasone should also be administered in
the evenings on Days 3 and 4.
The dose of dexamethasone accounts for active substance interactio