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PEMETREXED ZENTIVA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): PEMETREXED DISODIUM HEMIPENTAHYDRATE

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Package leaflet: Information for the user
Pemetrexed 100 mg powder for concentrate for solution for infusion
Pemetrexed 500 mg powder for concentrate for solution for infusion
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 further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
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 is
it 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 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

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Do not use pemetrexed
• 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.
• if you have recently received or are about to
receive a vaccine against yellow fever.
Warnings and Precautions
Talk to your doctor or pharmacist before using
pemetrexed if:
• you currently have or have previously had
problems with your kidneys, as you may not
be able to receive pemetrexed. 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. 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.
• you have had or are going to have radiation
therapy, as there may be an early or late
radiation reaction with pemetrexed.
• you have been recently vaccinated, as this
can possibly cause bad effects with
pemetrexed.
• you have heart disease or a history of heart
disease.
• you have an accumulation of fluid around
your lungs, as your doctor may decide to
remove the fluid before giving you
pemetrexed.
Children and adolescents
There is no relevant use of pemetrexed in the
paediatric population.
Other medicines and pemetrexed
Tell your doctor or pharmacist if you are using,
have recently used or might use any other
medicines, including medicines obtained
without a prescription.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine. 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.
You should not breast-feed while using
pemetrexed. Discuss with your doctor when it is
safe to restart breast-feeding after finishing your
treatment.
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 may make you feel tired. Be careful
when driving a car or using machines.
Pemetrexed contains sodium
Pemetrexed 500 mg contains approximately
54 mg (2.35 mmol) sodium per vial. To be taken
into consideration by patients on a controlled
sodium diet.
Pemetrexed 100 mg contains approximately
11 mg (less than 1 mmol) sodium per vial, i.e.
essentially ‘sodium-free’.

3. How to use pemetrexed
Always use this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose of pemetrexed 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 9 mg/ml (0.9 %) sodium chloride
solution for injection before it is given to you.
You will always receive pemetrexed by infusion
into one of your veins. The infusion will last
approximately 10 minutes.
When using pemetrexed 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 has
finished. The infusion of cisplatin will last
approximately 2 hours.
You should usually receive your infusion once
every 3 weeks.

<--------------------------------------------------------------------------------------------------------------------resulting in a solution containing 25 mg/ml
The following information is intended for
pemetrexed.
medical or healthcare professionals only:
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.

Instructions for use, handling and disposal.
1.

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

2.

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

3.

Pemetrexed 100 mg:
Reconstitute each 100 mg vial with 4.2 ml
of 9 mg/ml (0.9%) sodium chloride
solution for injection, without preservative,
resulting in a solution containing 25 mg/ml
pemetrexed.
Pemetrexed 500 mg:
Reconstitute each 500 mg vial with 20 ml
of 9 mg/ml (0.9%) sodium chloride
solution for injection, without preservative,

4.

The appropriate volume of reconstituted
pemetrexed solution must be further
diluted to 100 ml with 9 mg/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.

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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.

In particular, tell your doctor if you are using
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 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.

Additional medicines
Corticosteroids
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 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. You
must take at least 5 doses during the seven days
before the first dose of pemetrexed. You must
continue taking the folic acid for 21 days after
the last dose of pemetrexed. You will also receive
an injection of vitamin B12 (1000 micrograms) in
the week before administration of pemetrexed
and then approximately every 9 weeks
(corresponding to 3 courses of pemetrexed
treatment). Vitamin B12 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.

The following side effects can occur during
treatment with pemetrexed:

CODE

Very common side effects (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 side effects (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
Uncommon side effects (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

Rare side effects (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)
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 this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at 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
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 pack.
This medicine does not require any special
storage conditions.
Reconstituted and infusion solutions: The product
should be used immediately. When prepared as
directed, chemical and physical in-use stability of
reconstituted and infusion solutions of pemetrexed
were demonstrated for 24 hours at refrigerated
temperature (2°C to 8°C).
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 100mg and 500mg
powder for solution for infusion contains
The active substance is pemetrexed.
Pemetrexed 100 mg: Each vial contains 100 mg
of pemetrexed (as pemetrexed disodium
hemipentahydrate).
Pemetrexed 500 mg: Each vial contains 500 mg
of pemetrexed (as pemetrexed disodium
hemipentahydrate).
After reconstitution, the solution contains 25 mg/ml
of pemetrexed. Further dilution by a healthcare
provider is required prior to administration.
The other ingredients are mannitol, hydrochloric
acid (for pH-adjustment) and sodium hydroxide
(for pH-adjustment).
What Pemetrexed 100mg and 500mg
powder for solution for infusion looks like
and contents of the pack
Pemetrexed is a powder for concentrate for
solution for infusion in a vial.
It is a white to light yellow powder.
Each pack of pemetrexed consists of
one pemetrexed vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
Manufacturer
Synthon Hispania SL, C/ Castelló no1, Pol.
Las Salinas, Sant Boi de Llobregat, 08830,
Barcelona, 08830, Spain
Or
Synthon, s.r.o., Brněnská 32/čp. 597,
678 01 Blansko, 678 01, Czech Republic
This leaflet was last revised in October 2015
’Zentiva’ is a registered trademark © 2015
Zentiva

<--------------------------------------------------------------------------------------------------------------------6. Parenteral medicinal products should be
cases of pemetrexed extravasation, which were
inspected visually for particulate matter
not assessed as serious by the investigator.
and discolouration prior to administration.
Extravasation should be managed by local
If particulate matter is observed, do not
standard practice as with other non-vesicants.
administer.
7.

Pemetrexed solutions are for single use
only. Any unused product or waste
material should be disposed of in
accordance with local requirements for
cytotoxic agents.

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

CODE

Tell your doctor straight away if you notice any
of the following symptoms:
• 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).

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)

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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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