Pemetrexed 500mg powder for concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pemetrexed disodium

Available from:

Dr Reddy's Laboratories (UK

ATC code:

L01BA04

INN (International Name):

Pemetrexed disodium

Dosage:

500mg

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: 08010300

Patient Information leaflet

WHAT IS IN THIS LEAFLET
1.
WHAT PEMETREXED IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU
USE PEMETREXED
3.
HOW TO USE PEMETREXED
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PEMETREXED
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT PEMETREXED IS AND WHAT IT IS
USED FOR
Pemetrexed is a medicine used in the treatment
of cancer.
Pemetrexed is given in combination with cisplatin,
another anti-cancer medicine, as treatment for
malignant pleural mesothelioma, a form of cancer
that affects the lining of the lung, to patients who
have not received prior chemotherapy.
Pemetrexed is also given in combination with
cisplatin for the initial treatment of patients with
advanced stage of lung cancer.
Pemetrexed can be prescribed to you if you have
lung cancer at an advanced stage if your disease
has responded to treatment or it remains largely
unchanged after initial chemotherapy.
Pemetrexed is also a treatment for patients with
advanced stage of lung cancer whose disease has
progressed after other initial chemotherapy has
been used.
2.
WHAT YOU NEED TO KNOW BEFORE YOU
USE PEMETREXED
DO NOT USE PEMETREXED IF YOU:
•
are ALLERGIC to pemetrexed or any of the other
ingredients of this medicine (listed in section 6)
•
are BREAST-FEEDING; you must discontinue
breast-feeding during treatment with Pemetrexed
•
have recently received or are about to receive
a VACCINE AGAINST YELLOW FEVER.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR HOSPITAL PHARMACIST
BEFORE RECEIVING PEMETREXED IF YOU:
•
currently have or have previously had
PROBLEMS WITH YOUR KIDNEYS, as you may not
be able to receive Pemetrexed
•
have had or are going to have RADIATION
THERAPY, as there may be an early or late
radiation reaction with Pemetrexed
•
have BEEN RECENTLY VACCINATED, as this can
possibly cause bad effects with Pemetrexed
•
have HEART DISEASE or a history of heart disease
•
have an accumulation of FLUID AROUND YOUR
LUNGS; your doctor may decide to remove the
fluid before giving you Pemetrexed.
BLOOD TESTS
Before each i

Summary of Product characteristics

OBJECT 1
PEMETREXED DR. REDDY'S 500 MG POWDER FOR
CONCENTRATE FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 08-May-2018 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Pemetrexed Dr. Reddy's 500 mg Powder For Concentrate For Solution For
Infusion
2. Qualitative and quantitative composition
Each vial contains 500 mg of pemetrexed (as pemetrexed ditromethamine
dihydrate).
After reconstitution (see section 6.6), each vial contains 25 mg/ml of
pemetrexed.
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion.
White to either light yellow or green-yellow lyophilised cake or
powder.
4. Clinical particulars
4.1 Therapeutic indications
Malignant pleural mesothelioma
Pemetrexed in combination with cisplatin is indicated for the
treatment of chemotherapy naïve patients
with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed in combination with cisplatin is indicated for the first
line treatment of patients with locally
advanced or metastatic non-small cell lung cancer (NSCLC) other than
predominantly squamous cell
histology (see section 5.1).
Pemetrexed is indicated as monotherapy for the maintenance treatment
of locally advanced or metastatic
non-small cell lung cancer other than predominantly squamous cell
histology in patients whose disease
has not progressed immediately following platinum-based chemotherapy
(see section 5.1).
Pemetrexed is indicated as monotherapy for the second line treatment
of patients with locally advanced or
metastatic non-small cell lung cancer other than predominantly
squamous cell histology (see section 5.1).
4.2 Posology and method of administration
Posology:
Pemetrexed must only be administered under the supervision of a
physician qualified in the use of anti-
cancer chemotherapy.
Pemetrexed in combination with cisplatin
The recommended dose of Pemetrexed is 500 mg/m
2
of body surface area (BSA) administered as an
intravenous infusion over 10 minutes