Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)

Keskeiset tiedot

  • Kauppanimi:
  • Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)
  • Käyttää:
  • Ihminen
  • medicin tyyppi:
  • allopaattisten huumeiden

Asiakirjat

Lokalisointi

  • Saatavana:
  • Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)
    Euroopan unioni
  • Kieli:
  • englanti

Terapeuttinen tiedot

  • Terapeuttinen ryhmä:
  • ANTIMETABOLITES, Folic acid analogues
  • Terapeuttinen alue:
  • Carcinoma, Non-Small-Cell Lung, Mesothelioma
  • Käyttöaiheet:
  • Malignant pleural mesotheliomaPemetrexed Hospira UK Limited in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Hospira UK Limited in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see SmPC section 5.1).Pemetrexed Hospira UK Limited 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 SmPC section 5.1).Pemetrexed Hospira UK Limited 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 SmPC section 5.
  • Tuoteyhteenveto:
  • Revision: 6

Tila

  • Lähde:
  • EMA - European Medicines Agency
  • Valtuutuksen tilan:
  • Authorised
  • Myyntiluvan numero:
  • EMEA/H/C/004488
  • Valtuutus päivämäärä:
  • 23-04-2017
  • EMEA-koodi:
  • EMEA/H/C/004488
  • Viimeisin päivitys:
  • 24-09-2019

Julkisesta arviointikertomuksesta

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

EMA/147008/2017

EMEA/H/C/004488

EPAR summary for the public

Pemetrexed Hospira UK Limited

pemetrexed

This is a summary of the European public assessment report (EPAR) for Pemetrexed Hospira UK

Limited. It explains how the Agency assessed the medicine to recommend its authorisation in the EU

and its conditions of use. It is not intended to provide practical advice on how to use Pemetrexed

Hospira UK Limited.

For practical information about using Pemetrexed Hospira UK Limited, patients should read the

package leaflet or contact their doctor or pharmacist.

What is Pemetrexed Hospira UK Limited and what is it used for?

Pemetrexed Hospira UK Limited is a cancer medicine used to treat two types of lung cancer:

malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by

exposure to asbestos), where it is used together with cisplatin in patients who have not received

chemotherapy before and whose cancer cannot be removed by surgery;

advanced non-small-cell lung cancer of the kind known as ‘non-squamous’, where it is used either

in combination with cisplatin in previously untreated patients or on its own in patients who have

previously received cancer treatment. It can also be used as a maintenance treatment in patients

who have received platinum-based chemotherapy.

Pemetrexed Hospira UK Limited contains the active substance pemetrexed. It is a ‘generic medicine’.

This means that Pemetrexed Hospira UK Limited contains the same active substance and works in the

same way as a ‘reference medicine’ already authorised in the European Union (EU) called Alimta. For

more information on generic medicines, see the question-and-answer document here.

Pemetrexed Hospira UK Limited

EMA/147008/2017

Page 2/3

How is Pemetrexed Hospira UK Limited used?

Pemetrexed Hospira UK Limited is available as a powder that is made up into a solution for infusion

(drip) into a vein. The medicine can only be obtained with a prescription and should only be given

under the supervision of a doctor who is qualified in the use of chemotherapy.

The recommended dose is calculated using the patient’s height and weight. It is given once every three

weeks as an infusion lasting 10 minutes. To reduce side effects, patients should take a corticosteroid (a

type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of

vitamin B12 during treatment with Pemetrexed Hospira UK Limited. When Pemetrexed Hospira UK

Limited is given with cisplatin, an ‘anti-emetic’ medicine (to prevent vomiting) and fluids (to prevent

dehydration) should also be given before or after the cisplatin dose.

Treatment should be delayed or stopped, or the dose reduced, in patients whose blood counts are

abnormal or who have certain other side effects. For more information, see the summary of product

characteristics (also part of the EPAR).

How does Pemetrexed Hospira UK Limited work?

The active substance in Pemetrexed Hospira UK Limited is a cytotoxic medicine (a medicine that kills

cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites’. In the body,

pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved

in producing ‘nucleotides’ (the building blocks of DNA and RNA, the genetic material of cells). As a

result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells

from dividing and multiplying. The conversion of pemetrexed into its active form occurs more readily in

cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a

longer duration of action in cancer cells. This results in the division of cancer cells being reduced, while

normal cells are only slightly affected.

How has Pemetrexed Hospira UK Limited been studied?

Studies on the benefits and risks of the active substance in the approved uses have already been

carried out with the reference medicine, Alimta, and do not need to be repeated for Pemetrexed

Hospira UK Limited.

As for every medicine, the company provided studies on the quality of Pemetrexed Hospira UK Limited.

There was no need for ‘bioequivalence’ studies to investigate whether Pemetrexed Hospira UK Limited

is absorbed similarly to the reference medicine to produce the same level of the active substance in the

blood. This is because Pemetrexed Hospira UK Limited is given by infusion into a vein, so the active

substance is delivered straight into the bloodstream.

What are the benefits and risks of Pemetrexed Hospira UK Limited?

Because Pemetrexed Hospira UK Limited is a generic medicine, its benefits and risks are taken as being

the same as the reference medicine’s.

Why is Pemetrexed Hospira UK Limited approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance

with EU requirements, Pemetrexed Hospira UK Limited has been shown to be comparable to Alimta.

Therefore, the CHMP’s view was that, as for Alimta, the benefit outweighs the identified risk. The

Committee recommended that Pemetrexed Hospira UK Limited be approved for use in the EU.

Pemetrexed Hospira UK Limited

EMA/147008/2017

Page 3/3

What measures are being taken to ensure the safe and effective use of

Pemetrexed Hospira UK Limited?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Pemetrexed Hospira UK Limited have been included in the summary of product

characteristics and the package leaflet.

Other information about Pemetrexed Hospira UK Limited

The European Commission granted a marketing authorisation valid throughout the European Union for

Pemetrexed Hospira UK Limited on 24 April 2017.

The full EPAR for Pemetrexed Hospira UK Limited can be found on the Agency’s

website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For

more information about treatment with Pemetrexed Hospira UK Limited, read the package leaflet (also

part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency’s website.

This summary was last updated in 04/2017.

Pakkausseloste: aineet, käyttöaiheet, annostus, yhteisvaikutukset, haittavaikutukset, raskaus, imetys

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion

Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion

Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion

pemetrexed

Read all of this leaflet carefully before you start receiving 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

What Pemetrexed Pfizer is and what it is used for

What you need to know before you use Pemetrexed Pfizer

How to use Pemetrexed Pfizer

Possible side effects

How to store Pemetrexed Pfizer

Contents of the pack and other information

1.

What Pemetrexed Pfizer is and what it is used for

Pemetrexed Pfizer is a medicine used in the treatment of cancer.

Pemetrexed Pfizer 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 Pfizer is also given in combination with cisplatin for the initial treatment of patients with

advanced stage of lung cancer.

Pemetrexed Pfizer 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 Pfizer 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 Pfizer

Do not use Pemetrexed Pfizer

if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in

section 6).

if you are breast-feeding; you must discontinue breast-feeding during treatment with

Pemetrexed Pfizer.

if you 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 Pfizer.

If you currently have or have previously had problems with your kidneys, talk to your doctor or

hospital pharmacist as you may not be able to receive Pemetrexed Pfizer.

Before each infusion you will have samples of your blood taken to evaluate if you have sufficient

kidney and liver function and to check that you have enough blood cells to receive Pemetrexed Pfizer.

Your doctor may decide to change the dose or delay treating you depending on your general condition

and if your blood cell counts are too low. If you are also receiving cisplatin, your doctor will make

sure that you are properly hydrated and receive appropriate treatment before and after receiving

cisplatin to prevent vomiting.

If you have had or are going to have radiation therapy, please tell your doctor, as there may be an early

or late radiation reaction with Pemetrexed Pfizer.

If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects

with Pemetrexed Pfizer.

If you have heart disease or a history of heart disease, please tell your doctor.

If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid

before giving you Pemetrexed Pfizer.

Children and adolescents

There is no relevant use of pemetrexed in the paediatric population.

Other medicines and Pemetrexed Pfizer

Please tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as

medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased

without a doctor’s prescription (such as ibuprofen). There are many sorts of NSAIDs with different

durations of activity. Based on the planned date of your infusion of pemetrexed and/or on the status of

your kidney function, your doctor needs to advise you on which medicines you can take and when you

can take them. If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.

Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other

medicines, including medicines obtained without a prescription.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor. The

use of pemetrexed should be avoided during pregnancy. Your doctor will discuss with you the

potential risk of taking pemetrexed during pregnancy. Women must use effective contraception during

treatment with pemetrexed.

Breast-feeding

If you are breast-feeding, tell your doctor. Breast-feeding must be discontinued during pemetrexed

treatment.

Fertility

Men are advised not to father a child during and up to 6 months following treatment with pemetrexed

and should therefore use effective contraception during treatment with pemetrexed and for up to

6 months afterwards. If you would like to father a child during the treatment or in the 6 months

following receipt of treatment, seek advice from your doctor or pharmacist. You may want to seek

counselling on sperm storage before starting your therapy.

Driving and using machines

Pemetrexed Pfizer may make you feel tired. Be careful when driving a car or using machines.

3.

How to use Pemetrexed Pfizer

The dose of Pemetrexed Pfizer is 500 milligrams for every square metre of your body’s surface area.

Your height and weight are measured to work out the surface area of your body. Your doctor will use

this body surface area to work out the right dose for you. This dose may be adjusted, or treatment may

be delayed depending on your blood cell counts and on your general condition. A hospital pharmacist,

nurse or doctor will have mixed the Pemetrexed Pfizer powder with water for injections and 5%

glucose solution for injection before it is given to you.

You will always receive Pemetrexed Pfizer by infusion into one of your veins. The infusion will last

approximately 10 minutes.

Use in combination with cisplatin

The doctor or hospital pharmacist will work out the dose you need based on your height and weight.

Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after

the infusion of Pemetrexed Pfizer has finished. The infusion of cisplatin will last approximately

2 hours.

You should usually receive your infusion once every 3 weeks.

Additional medicines

Corticosteriods: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of

dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day

after Pemetrexed Pfizer treatment. This medicine is given to you to reduce the frequency and severity

of skin reactions that you may experience during your anticancer treatment.

Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin

containing folic acid (350 to 1,000 micrograms) that you must take once a day while you are taking

Pemetrexed Pfizer. You must take at least 5 doses during the seven days before the first dose of

Pemetrexed Pfizer. You must continue taking the folic acid for 21 days after the last dose of

Pemetrexed Pfizer. You will also receive an injection of vitamin B

(1,000 micrograms) in the week

before administration of Pemetrexed Pfizer and then approximately every 9 weeks (corresponding to 3

courses of Pemetrexed Pfizer treatment). Vitamin B

and folic acid are given to you to reduce the

possible toxic effects of the anticancer treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You must contact your doctor immediately if you notice any of the following:

Fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs

of infection (since you might have less white blood cells than normal which is very common).

Infection (sepsis) may be severe and could lead to death.

If you start feeling chest pain (common) or having a fast heart rate (uncommon).

If you have pain, redness, swelling or sores in your mouth (very common).

Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation

(common), or fever (common). Rarely, skin reactions may be severe and could lead to death.

Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson syndrome

or toxic epidermal necrolysis).

If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you

might have less haemoglobin than normal which is very common).

If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop,

reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal

which is very common).

If you experience sudden breathlessness, intense chest pain or cough with bloody sputum

(uncommon) (may indicate a blood clot in the blood vessels of the lungs).

Side effects with pemetrexed may include:

Very common (may affect more than 1 in 10 people)

Low white blood cells

Low haemoglobin level (anaemia)

Low platelet count

Diarrhoea

Vomiting

Pain, redness, swelling or sores in your mouth

Nausea

Loss of appetite

Fatigue (tiredness)

Skin rash

Hair loss

Constipation

Loss of sensation

Kidney: abnormal blood tests

Common (may affect up to 1 in 10 people)

Allergic reaction: skin rash / burning or prickling sensation

Infection including sepsis

Fever

Dehydration

Kidney failure

Irritation of the skin and itching

Chest pain

Muscle weakness

Conjunctivitis (inflamed eye)

Upset stomach

Pain in the abdomen

Taste change

Liver: abnormal blood tests

Watery eyes

Increased skin pigmentation

Uncommon (may affect up to 1 in 100 people)

Acute renal failure

Fast heart rate

Inflammation of the lining of the oesophagus (gullet) has been experienced with pemetrexed /

radiation therapy.

Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or

rectal bleeding)

Interstitial pneumonitis (scarring of the air sacs of the lung)

Oedema (excess fluid in body tissue, causing swelling). Some patients have experienced a heart attack,

stroke or “mini-stroke” while receiving pemetrexed usually in combination with another anticancer

therapy.

Pancytopenia- combined low counts of white cells, red cells and platelets

Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy) may

occur in patients who are also treated with radiation either before, during or after their pemetrexed

therapy.

Extremity pain, low temperature and discolouration have been reported.

Blood clots in the lung blood vessels (pulmonary embolism)

Rare (may affect up to 1 in 1,000 people)

Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been

exposed to radiotherapy, from days to years after the radiation.

Bullous conditions (blistering skin diseases)-including Stevens-Johnson syndrome and toxic epidermal

necrolysis

Haemolytic anaemia (anaemia due to destruction of red blood cells)

Hepatitis (inflammation of the liver)

Anaphylactic shock (severe allergic reaction)

Not known: frequency cannot be estimated from the available data

Lower limb swelling with pain and redness

Increased urine output

Thirst and increased water consumption

Hypernatraemia – increased sodium in blood

Inflammation of the skin, mainly of the lower limb with swelling, pain and redness

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.

By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Pemetrexed Pfizer

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The

expiry date refers to the last day of that month.

Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion

Store the 100 mg vial below 30°C.

Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion

The 500 mg vial does not require any special storage conditions.

Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion

The 1,000 mg vial does not require any special storage conditions.

Reconstituted and infusion solutions: When prepared as directed

,

chemical and physical in-use

stability has been demonstrated for 24 hours at refrigerated temperature (2°C to 8°C) and at 25°C.

From a microbiological point of view, the product should be used immediately. If not used

immediately, in-use storage times and conditions prior to use are the responsibility of the user and

would not be longer than 24 hours at 2°C to 8°C.

The reconstituted solution is clear and ranges in colour from colourless to yellow or green-yellow

without adversely affecting product quality. Parenteral medicines must be inspected visually for

particulate matter and discolouration prior to administration. If particulate matter is observed, do not

administer.

This medicine is for single use only; any unused solution must be disposed of in accordance with local

requirement.

6.

Contents of the pack and other information

What Pemetrexed Pfizer contains

The active substance is pemetrexed.

Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion

Each vial contains 100 milligrams of pemetrexed (as pemetrexed ditromethamine).

Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion

Each vial contains 500 milligrams of pemetrexed (as pemetrexed ditromethamine).

Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion

Each vial contains 1,000 milligrams of pemetrexed (as pemetrexed ditromethamine).

After reconstitution as directed, the solution contains 25 mg/ml of pemetrexed. Further dilution by a

healthcare provider is required prior to administration.

The other ingredient is mannitol.

What Pemetrexed Pfizer looks like and contents of the pack

Pemetrexed Pfizer is a powder for concentrate for solution for infusion in a glass vial. It is a white to

either light yellow or green-yellow lyophilised powder.

Each pack contains one glass vial of 100 mg, 500 mg or 1,000 mg pemetrexed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer

Hospira UK Limited

Horizon

Honey Lane

Hurley

Maidenhead

SL6 6RJ

United Kingdom

Pfizer Service Company BVBA

Hoge Wei 10

1930 Zaventem

Belgium

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

BE

Pfizer SA/NV

Tél/Tel: + 32 2 554 62 11

LU

Pfizer SA/NV

Tél/Tel: + 32 2 554 62 11

BG

Пфайзер Люксембург САРЛ, Клон България

Тел.: +359 2 970 4333

LT

Pfizer Luxembourg SARL filialas Lietuvoje

Tel. + 370 52 51 4000

CZ

Pfizer, spol. s r.o.

Tel: +420-283-004-111

HU

Pfizer Kft.

Tel: + 36 1 488 37 00

DK

Pfizer ApS

Tlf: + 45 44 20 11 00

MT

Drugsales Ltd

Tel: + 356 21 419 070/1/2

DE

Pfizer Pharma PFE GmbH

Tel: + 49 (0) 800 8535555

NL

Pfizer bv

Tel: +31 (0)10 406 43 01

EE

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

NO

Pfizer AS

Tlf: +47 67 52 61 00

EL

Pfizer ΕΛΛΑΣ A.E.

Τηλ.: +30 210 6785 800

AT

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15-0

ES

Pfizer, S.L.

Tel: +34 91 490 99 00

PL

Pfizer Polska Sp. z o.o.

Tel: +48 22 335 61 00

FR

Pfizer

Tél: + 33 (0) 1 58 07 34 40

PT

Laboratórios Pfizer, Lda.

Tel: + 351 21 423 55 00

HR

Pfizer Croatia d.o.o.

Tel: +385 1 3908 777

RO

Pfizer România S.R.L.

Tel: +40 (0)21 207 28 00

IE

Pfizer Healthcare Ireland

Tel: 1800 633 363 (toll free)

+44 (0) 1304 616161

SI

Pfizer Luxembourg SARL

Pfizer, podružnica za svetovanje s področja

farmacevtske dejavnosti, Ljubljana

Tel: +386 (0)1 52 11 400

IS

Icepharma hf.

Sími: +354 540 8000

SK

Pfizer Luxembourg SARL, organizačná zložka

Tel: +421–2–3355 5500

IT

Pfizer Italia Srl

Tel: +39 06 33 18 21

FI

Pfizer PFE Finland Oy

Puh/Tel: +358 (0)9 430 040

CY

Pharmaceutical Trading Co Ltd

Τηλ: 24656165

SE

Pfizer AB

Tel: +46 (0)8 550 520 00

LV

Pfizer Luxembourg SARL filiāle Latvijā

Tel.: +371 670 35 775

UK

Hospira UK Ltd

Tel: + 44 (0) 1628 515500

This leaflet was last revised in month YYYY

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Instructions for use, handling and disposal

1. Use aseptic technique during the reconstitution and further dilution of pemetrexed for intravenous

infusion administration.

2. Calculate the dose and the number of Pemetrexed Pfizer vials needed. Each vial contains an excess

of pemetrexed to facilitate delivery of label amount.

3. Pemetrexed Pfizer must only be reconstituted with sterile water for injections.

Pemetrexed Pfizer 100mg vial:

Reconstitute each 100 mg vial with 4.2 ml of sterile water for injections, resulting in a solution

containing 25 mg/ml pemetrexed.

Pemetrexed Pfizer 500mg vial:

Reconstitute each 500 mg vial with 20 ml of sterile water for injections, resulting in a solution

containing 25 mg/ml pemetrexed.

Pemetrexed Pfizer 1,000mg vial:

Reconstitute each 1,000 mg vial with 40 ml of sterile water for injections, resulting in a solution

containing 25 mg/ml pemetrexed.

Gently swirl each vial until the powder is completely dissolved. The resulting solution is clear and

ranges in colour from colourless to yellow or green-yellow without adversely affecting product

quality. The pH of the reconstituted solution is between 5.7 and 7.7.

Further dilution is required.

4. Pemetrexed Pfizer must only be further diluted with 5% glucose solution, without preservative. The

appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 5%

glucose solution for injection, without preservative, and administered as an intravenous infusion

over 10 minutes.

5. Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride-

and polyolefin- lined administration sets and infusion bags. Pemetrexed is incompatible with

diluents containing calcium, including lactated Ringer’s Injection and Ringer’s Injection

6. Parenteral medicinal products must be inspected visually for particulate matter and discolouration

prior to administration. If particulate matter is observed, do not administer.

7. Pemetrexed solutions are for single use only.

Any unused medicinal product or waste material must be disposed of in accordance with local

requirements.

Preparation and administration precautions:

As with other potentially toxic anti-cancer agents, care

should be exercised in the handling and preparation of pemetrexed infusion solutions. The use of

gloves is recommended. If a pemetrexed solution contacts the skin, wash the skin immediately and

thoroughly with soap and water. If pemetrexed solutions contact the mucous membranes, flush

thoroughly with water. Pemetrexed is not a vesicant. There is not a specific antidote for extravasation

of pemetrexed. There have been few reported cases of pemetrexed extravasation, which were not

assessed as serious by the investigator. Extravasation should be managed by local standard practice as

with other non-vesicants.