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PEMETREXED BIOORGANICS 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 BioOrganics 100 mg powder for concentrate for solution for infusion
Pemetrexed
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.
2.
3.
4.
5.
6.

What Pemetrexed BioOrganics is and what it is used for
What you need to know before you use Pemetrexed BioOrganics
How to use Pemetrexed BioOrganics
Possible side effects
How to store Pemetrexed BioOrganics
Contents of the pack and other information

1.

What Pemetrexed BioOrganics is and what is it used for

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

Do not use Pemetrexed BioOrganics
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 BioOrganics.
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 BioOrganics if:

you currently have or have previously had problems with your kidneys, as you may not be able
to receive Pemetrexed BioOrganics. 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 BioOrganics. 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
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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 BioOrganics.
you have been recently vaccinated, as this can possibly cause bad effects with Pemetrexed
BioOrganics.
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 BioOrganics.

Children and adolescents
There is no relevant use of Pemetrexed BioOrganics in the paediatric population.
Other medicines and Pemetrexed BioOrganics
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines,
including medicines obtained without a prescription.
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 BioOrganics 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.
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
BioOrganics should be avoided during pregnancy. Your doctor will discuss with you the potential
risk of taking Pemetrexed BioOrganics during pregnancy. Women must use effective
contraception during treatment with Pemetrexed BioOrganics.
You should not breast-feed while using Pemetrexed BioOrganics. 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 BioOrganics and should therefore use effective contraception during treatment with
Pemetrexed BioOrganics 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 BioOrganics may make you feel tired. Be careful when driving a car or using machines.
Pemetrexed BioOrganics contains sodium
Pemetrexed BioOrganics 100 mg contains approximately 11 mg (less than 1 mmol) sodium per vial,
i.e. essentially ‘sodium-free’.

3.

How to use Pemetrexed BioOrganics

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 recommend dose of Pemetrexed BioOrganics 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.
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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 BioOrganics
powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.
You will always receive Pemetrexed BioOrganics by infusion into one of your veins. The
infusion will last approximately 10 minutes.
When using Pemetrexed BioOrganics 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 BioOrganics has finished. The infusion of cisplatin will last approximately
2 hours.
You should usually receive your infusion once every 3 weeks.
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
BioOrganics 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 BioOrganics. You
must take at least 5 doses during the seven days before the first dose of Pemetrexed BioOrganics. You
must continue taking the folic acid for 21 days after the last dose of Pemetrexed BioOrganics. You
will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of
Pemetrexed BioOrganics nd then approximately every 9 weeks (corresponding to 3 courses of
Pemetrexed BioOrganics 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.
Tell your doctor straight away if you notice any of the following symptoms:








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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).
M1.3.1_03.PXD.lyo100.001.04.UK.3327.01



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)

The following side effects can occur during treatment with pemetrexed:
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 BioOrganics / 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
BioOrganics 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 BioOrganics therapy ● Extremity pain, low temperature and
discolouration have been reported ● Blood clots in the lung blood vessels (pulmonary embolism)
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.
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 BioOrganics

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.

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6.

Contents of the pack and other information

What Pemetrexed BioOrganics contains
The active substance is pemetrexed.
Pemetrexed BioOrganics 100 mg: Each vial contains 100 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 BioOrganics looks like and contents of the pack
Pemetrexed BioOrganics is a powder for concentrate for solution for infusion in a vial.
It is a white to light yellow powder.
Each pack of Pemetrexed BioOrganics consists of one Pemetrexed BioOrganics vial
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
BioOrganics
Microweg 22
6545 CM, NIJMEGEN
The Netherlands
Manufacturer
Synthon Hispania S.L.
Castelló 1
Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain
Synthon s.r.o. Blansko
Brnenska 32/c.p. 597
678 01 Blansko
Czech Republic
This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria:
Belgium:
France:
Germany:
Italy:
The Netherlands:

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Pemetrexed BioOrganics <100 mg> Pulver zur Herstellung
eines Konzentrates zur Herstellung einer Infusionslösung
Pemetrexed BioOrganics <100 mg> poeder voor concentraat
voor oplossing voor intraveneuze infusie
Pemetrexed BioOrganics <100 mg>, poudre pour solution à
diluer pour perfusion
Pemetrexed BioOrganics <100 mg> Pulver zur Herstellung
eines Konzentrates zur Herstellung einer Infusionslösung
Pemetrexed BioOrganics
Pemetrexed BioOrganics <100 mg>, poeder voor concentraat
voor oplossing voor intraveneuze infusie
M1.3.1_03.PXD.lyo100.001.04.UK.3327.01

Spain:
United Kingdom:

Pemetrexed BioOrganics <100 mg> polvo para concentrado
para solución para perfusión EFG
Pemetrexed BioOrganics 100 mg powder for concentrate for
solution for infusion

This leaflet was last revised in 11/2015.

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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.

2.

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

3.

Pemetrexed BioOrganics <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.
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 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.

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 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 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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