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PEMETREXED ACTAVIS 1000MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): PEMETREXED DISODIUM

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Package leaflet: Information for the user
Pemetrexed 100mg, 500mg and 1000mg Powder for Concentrate for Solution for Infusion
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 or pharmacist.
If you get any side effects, talk to your doctor or nurse or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
The full name of this medicine is Pemetrexed 100mg, 500mg and 1000mg Powder for Concentrate for
Solution for Infusion but within the leaflet it will be referred to as Pemetrexed Powder.

What is in this leaflet:
1.
What Pemetrexed Powder is and what it is used for
2.
What you need to know before you use Pemetrexed Powder
3.
How to use Pemetrexed Powder
4.
Possible side effects
5.
How to store Pemetrexed Powder
6.
Contents of the pack and other information

1.

What Pemetrexed Powder is and what it is used for

Pemetrexed Powder is a medicine used in the treatment of cancer. It contains the active substance
pemetrexed. Pemetrexed belongs to a group of medicines known as folic acid analogues and disrupts
processes that are essential for cell replication.
Pemetrexed Powder 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 Powder is also given in combination with cisplatin for the initial treatment of patients with
advanced stage of lung cancer.
Pemetrexed Powder 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 Powder 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 Powder

Do not use Pemetrexed Powder
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
Powder.
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 Powder.
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 Powder.
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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 Powder. 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 Powder.
If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with
Pemetrexed Powder.
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 Powder.
Children and adolescents
There is no relevant use of Pemetrexed Powder in the paediatric population.
Other medicines and Pemetrexed Powder
Please tell your doctor if you are taking any medicines 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 Powder 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.
Like other chemotherapy medicines Pemetrexed Powder is not recommended with live attenuated vaccines.
Inactive vaccines should be used where possible.
Tell your doctor or hospital pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor and ask for
advice before taking this medicine. The use of Pemetrexed Powder should be avoided during pregnancy.
Your doctor will discuss with you the potential risk of taking Pemetrexed Powder during pregnancy. Women
must use effective contraception during treatment with Pemetrexed Powder.
Breast-feeding
If you are breast-feeding, tell your doctor.
Breast-feeding must be discontinued during Pemetrexed Powder treatment.
Fertility
Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed
Powder and should therefore use effective contraception during treatment with Pemetrexed Powder 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 Powder may make you feel tired. Be careful when driving a car or using machines.

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Pemetrexed Powder contains sodium
One vial of 100mg contains approximately 11.29mg sodium per vial.
One vial of 500mg contains approximately 53.77mg sodium per vial. To be taken into consideration by
patients on a controlled sodium diet.
One vial of 1000mg contains approximately 107.54mg sodium per vial. To be taken into consideration by
patients on a controlled sodium diet.

3.

How to use Pemetrexed Powder

Pemetrexed Powder powder for concentrate for solution for infusion will always be given to you by a
healthcare professional. The dose of Pemetrexed Powder 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 Powder with 9mg/ml (0.9 %) sodium chloride
solution for injection before it is given to you.
You will always receive Pemetrexed Powder by infusion into one of your veins. The infusion will last
approximately 10 minutes.
When using Pemetrexed Powder 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 Powder 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 Powder 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 1000 micrograms) that you must take once a day while you are taking
Pemetrexed Powder. You must take at least 5 doses during the seven days before the first dose of
Pemetrexed Powder. You must continue taking the folic acid for 21 days after the last dose of Pemetrexed
Powder. You will also receive an injection of vitamin B12 (1000 micrograms) in the week before
administration of Pemetrexed Powder and then approximately every 9 weeks (corresponding to 3 courses of
Pemetrexed Powder treatment). Vitamin B12 and folic acid are given to you to reduce the possible toxic
effects of the anticancer treatment.
Your condition will be closely monitored during treatment. This routinely involves blood tests, including
checks on your liver and kidney function. Your dose may be changed or treatment delayed depending on
results from these tests.
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:

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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)

Other side effects with Pemetrexed Powder 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, peeling of the skin
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
Hives
Chest pain
Muscle weakness
Conjunctivitis (inflamed eye)
Upset stomach
Pain in the abdomen
Taste change
Liver: abnormal blood tests
Watery eyes
Dizziness
Uncommon (may affect up to 1 in 100 people)
Acute renal failure
Fast or irregular heart rate

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Inflammation of the lining of the oesophagus (gullet) has been experienced with Pemetrexed Powder /
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 Powder
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 Powder 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
Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells)
Hepatitis (inflammation of the liver)
Anaphylactic shock (severe allergic reaction)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in the leaflet. You can also report side effects directly via the Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Pemetrexed Powder

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 label and carton after ‘EXP’. The expiry
date refers to the last day of that month.
Keep the vial in the outer carton in order to protect from light.
This medicinal product does not require any special temperature storage conditions.
Reconstituted and infusion solutions
When prepared as directed, reconstituted and infusion solutions of Pemetrexed Powder contain no
antimicrobial preservatives. Chemical and physical in-use stability of reconstituted and infusion solutions of
pemetrexed were demonstrated for 3 days at room temperature at normal lighting conditions and 14 days at
refrigerated temperature (2-8°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, unless reconstitution / dilution has taken
place in controlled and validated aseptic conditions.
Pemetrexed should not been used if there are any signs of particles.
This medicine is for single use only; any unused solution must be disposed of in accordance with local
requirement.

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6.

Contents of the pack and other information

What Pemetrexed Powder contains
The active substance is pemetrexed.
Pemetrexed 100mg: Each vial contains 100milligrams of pemetrexed (as pemetrexed disodium
hemipentahydrate).
Pemetrexed 500mg: Each vial contains 500milligrams of pemetrexed (as pemetrexed disodium
hemipentahydrate).
Pemetrexed 1000mg: Each vial contains 1000milligram of pemetrexed (as pemetrexed disodium
hemipentahydrate).
After reconstitution, the solution contains 25mg/ml of pemetrexed. Further dilution by a healthcare provider
is required prior to administration.
The other ingredients are mannitol, hydrochloric acid and sodium hydroxide.
What Pemetrexed Powder looks like and contents of the pack
Pemetrexed Powder is a powder for concentrate for solution for infusion in a vial. It is a white to either
yellow or greenish-yellow lyophilisate powder.
Pemetrexed Powder is in colourless glass vials (type I) with type I rubber (bromobutyl) lyo-stopper and an
aluminium cap with polypropylene disk. Vials are sheathed in protective sleeve.
Each pack of Pemetrexed Powder consists of one Pemetrexed Powder vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
MA holder

Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
S.C. SINDAN-PHARMA S.R.L.
11th Ion Mihalache Boulevard
011171, Bucharest 1
Romania

This leaflet was last revised in March 2016

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The following information is intended for medical or healthcare professionals only:
Instructions for use, handling and disposal.
1.

Use aseptic techniques during the reconstitution and further dilution of pemetrexed for intravenous
infusion administration.

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2.

Calculate the dose and the number of Pemetrexed Powder vials needed. Each vial contains an excess
of pemetrexed to facilitate delivery of the label amount.

3.

Reconstitute 100mg vials with 4.2ml of 9mg/ml (0.9 %) sodium chloride solution for injection,
without preservative, resulting in a solution containing 25mg/ml pemetrexed.
Reconstitute 500mg vials with 20ml of 9mg/ml (0.9 %) sodium chloride solution for injection,
without preservative, resulting in a solution containing 25mg/ml pemetrexed.
Reconstitute 1000mg vials with 40ml of 9mg/ml (0.9 %) sodium chloride solution for injection,
without preservative, resulting in a solution containing 25mg/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 6.6 and 7.8. Further dilution is required.

4.

The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100ml with
9mg/ml (0.9%) sodium chloride 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 should 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 product or waste material should be
disposed of in accordance with local requirements.

Preparation and administration precautions: As with other potentially toxic anticancer 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 a 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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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