PEMETREXED 25 mg /Ml Koncentrat Do Sporządzania Roztworu Infuzyjnego

Treść ulotki

1. Pemetrexed Mylan 25 mg/ml concentrate for solution for infusion
   1. What is Pemetrexed Mylan and what is it used for
   2. What you need to know before using Pemetrexed Mylan
   3. How to use Pemetrexed Mylan
   4. Possible side effects
   5. How to store Pemetrexed Mylan
   6. Contents of the pack and other information

Pemetrexed Mylan 25 mg/ml concentrate for solution for infusion

Generic medicine

Read this leaflet carefully before you receive this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Pemetrexed Mylan and what is it used for

Pemetrexed Mylan is a medicine used in the treatment of tumors.
Pemetrexed Mylan is administered in association with cisplatin, another drug
for cancer treatment, as treatment for malignant pleural mesothelioma, a form of tumor
that affects the tissue lining the lungs, to patients who have not received previous
chemotherapy.
Furthermore, Pemetrexed Mylan in association with cisplatin, is administered for
first-line therapy in patients affected by advanced stage lung cancer.
Pemetrexed Mylan may be prescribed in case of advanced stage lung cancer if
the disease has responded to treatment or if it remains largely unchanged after initial
chemotherapy.
Furthermore, Pemetrexed Mylan is a treatment for patients affected by advanced stage lung
cancer whose disease has progressed after a previous initial chemotherapeutic
treatment.

2. What you need to know before using Pemetrexed Mylan

Do not use Pemetrexed Mylan

• if you are allergic topemetrexed or any of the other ingredientsof this medicine (listed in section 6).
• if you are breast-feeding; you must stop breast-feeding during treatment with Pemetrexed Mylan.
• if you have recently had or are about to have a vaccination foryellow fever.

Warnings and precautions
Talk to your doctor or hospital pharmacist before receiving Pemetrexed Mylan.
If you have or have previously had kidney problems, tell your doctor or pharmacist
hospital pharmacist because you may not be able to receive Pemetrexed Mylan.
Before each infusion, blood tests will be performed to assess whether you have
sufficient kidney and liver function and to check that you have enough cells in your
blood to receive Pemetrexed Mylan. The doctor may decide to change the dose or
delay treatment depending on your general condition and if the number of cells in your
blood is too low. Also, if you are receiving cisplatin, the doctor must
ensure that you are adequately hydrated and that you receive appropriate treatment
before and after receiving cisplatin to prevent vomiting.
If you have had or will be undergoing radiation treatment, tell your doctor, as Pemetrexed Mylan
may cause an early or delayed reaction
due to radiation treatment.
If you have been vaccinated recently, tell your doctor, as Pemetrexed Mylan
this may cause adverse effects.
If you have heart disease or a history of heart disease, tell your doctor.
If you have fluid buildup around your lungs, your doctor may decide to
remove the fluid before giving you Pemetrexed Mylan.

Children and adolescents
There is no indication for specific use of Pemetrexed Mylan in the
pediatric population.

Other medicines and Pemetrexed Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including medicines you bought without a prescription.
Tell your doctor if you are taking any medicine for pain or inflammation(swelling), such as medicines called “non-steroidal
anti-inflammatory drugs” (NSAIDs), including medicines you bought without a prescription (such as
ibuprofen). There are many types of NSAIDs with different durations of action. Based on the date
scheduled for the Pemetrexed Mylan infusion and/or your kidney function, your doctor will need 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

Pregnancy
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breast-feeding, ask your doctor or pharmacist for advice before using
this medicine.
The use of Pemetrexed Mylan during pregnancy should be avoided. The doctor will talk to
you about the potential risk of taking Pemetrexed Mylan during pregnancy.
Women must use an effective method of contraception during treatment with
Pemetrexed Mylan.

Breast-feeding
If you are breast-feeding, tell your doctor.
Breast-feeding must be stopped during treatment with Pemetrexed Mylan.

Fertility
Men are advised not to father a child during treatment with Pemetrexed
Mylan and for 6 months afterwards and therefore to use effective contraception during
treatment with Pemetrexed Mylan and for 6 months afterwards. If you wish to father a child
during treatment or within the 6 months afterwards, ask your doctor or pharmacist for advice. You
are advised to ask about ways to store sperm before
starting therapy.

Driving and using machines
Pemetrexed Mylan can cause fatigue. Be careful when driving a vehicle or
using machines.

3. How to use Pemetrexed Mylan

The dose of Pemetrexed Mylan is 500 mg per each square meter of body surface area. Your
height and your weight will be measured to calculate your body surface area. The doctor
will use this body surface area to calculate the right dose for you. This dosage may
be adjusted or treatment may be delayed depending on blood tests and
your overall condition. A hospital pharmacist, a nurse or a doctor will have
mixed the Pemetrexed Mylan solution with a 5 % dextrose solution for
injectable preparations before administering it to you.
You will receive Pemetrexed Mylan always by infusion into a vein. The infusion will last about 10
minutes.

When Pemetrexed Mylan is used in combination with cisplatin
The doctor or the hospital pharmacist will calculate the dose you need based on your
height and your weight. Cisplatin is also administered by infusion into a vein, about
30 minutes after the Pemetrexed Mylan infusion has been completed. The cisplatin
infusion will last about 2 hours.
Usually you should receive the infusion once every 3 weeks.

Additional medicines

Corticosteroids
The doctor will prescribe steroid tablets (equivalent to 4 milligrams of dexamethasone
twice a day) that you will have to take the day before, the day of and the day after the
treatment with Pemetrexed Mylan. This medicine is given to you to reduce the
frequency and severity of skin reactions that may occur during cancer treatment.

Vitamin supplement
The doctor will prescribe folic acid (vitamin) or a multivitamin product containing
folic acid (350-1000 micrograms) orally that you must take once a day
while you are being treated with Pemetrexed Mylan. You must take at least 5 doses during the
seven days before the first dose of Pemetrexed Mylan. You must continue to take
folic acid for 21 days after the last dose of Pemetrexed Mylan. You will also
receive an injection of vitamin B (1000 micrograms) in the week before the
administration of Pemetrexed Mylan and then approximately every 9 weeks (corresponding to 3 treatment cycles with Pemetrexed Mylan). Vitamin B and folic acid are given to you
to reduce the possible toxic effects of cancer treatment.
If you have any questions about 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 everyone will experience them.
You should immediately contact your doctor if you notice any of the following side effects:

• Fever or infection(common): if you have a body temperature of 38°C or higher, sweating, or other signs of infection (as you may have fewer white blood cells than normal, which is very common). Infection (sepsis) can be serious and could lead to death.
• If you begin to experience chest pain(common) or have an increasedheart rate(uncommon).
• If you have pain, redness, swelling, or sores in your mouth(very common).
• Allergic reaction: if you develop a skin rash(very common)/a sensation ofburning or tingling(common), or fever(common). Rarely, skin reactions can be serious and could lead to death.
• Contact your doctor if a severe skin rash, or itching, or blistersappear (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• If you experience fatigue, feel faint, feel short of breatheasily, or are pale(as you may have less hemoglobin than normal, which is very common).
• If you experience bleeding from the gums, nose, or mouthor any bleeding that does not tend to stop, reddish orslightly pink urine, unexplained bruising(as you may have fewer platelets than normal, which is very common).
• If you experience sudden shortness of breath, severe chest pain, or have cough with blood in the sputum(uncommon) (this may indicate a blood clot in the pulmonary blood vessels).

The side effects with Pemetrexed Mylan can include:
Very common side effects (may affect more than 1 in 10 people)

• Low number of white blood cells
• Low level of hemoglobin (anemia)
• Low number of platelets
• Diarrhea
• Vomiting
• Pain, redness, swelling, or sores in the mouth
• Nausea
• Loss of appetite
• Fatigue (tiredness)
• Skin rash
• Hair loss
• Constipation
• Loss of sensation
• Kidneys: abnormal blood tests

Common side effects (may affect up to 1 in 10 people)

• Allergic reaction: skin rash/sensation of burning or tingling
• Infection including sepsis
• Fever
• Dehydration
• Kidney failure
• Skin irritation and itching
• Chest pain
• Muscle weakness
• Conjunctivitis (inflammation of the eyes)
• Stomach discomfort
• Abdominal pain
• Altered taste
• Liver: abnormal blood tests
• Increased tearing
• Increased skin pigmentation

Uncommon side effects (may affect up to 1 in 100 people)

• Acute kidney failure
• Increased heart rate
• Inflammation of the inner wall of the esophagus has occurred with Pemetrexed Mylan /radiant treatment.
• Colitis (inflammation of the inner wall of the colon which may be associated with intestinal or rectal bleeding)
• Interstitial pneumonia (small scars around the lung alveoli)
• Edema (excess fluid in body tissue, causing swelling). Some patients have had a heart attack, a stroke, even a mild one, during treatment with Pemetrexed Mylan, usually in association with another anticancer therapy.
• Pancytopenia - low combined count of white blood cells, red blood cells, and platelets.
• An actinic pneumonia (small scars around the lung alveoli, correlated with radiotherapy) may occur in patients undergoing radiant treatment before, during or after the infusion of Pemetrexed Mylan.
• Limb pain, low body temperature, and altered skin color have been reported.
• Blood clots in the pulmonary blood vessels (pulmonary embolism).

Rare side effects (may affect up to 1 in 1000 people)

• Recall phenomena from radiation (skin rash similar to a severe sunburn), which can occur in areas of the skin previously exposed to radiation for days to years after irradiation.
• Blistering (skin diseases that cause blisters) - including Stevens-Johnson syndrome and toxic epidermal necrolysis.
• Immuno-mediated hemolytic anemia (anemia due to the destruction of red blood cells).
• Hepatitis (inflammation of the liver).
• Anaphylactic shock (severe allergic reaction).

Not known:frequency cannot be estimated based on available data

• Swelling with pain and redness in the lower limbs.
• Increased urine production
• Thirst and increased water consumption
• Hypernatremia (high levels of sodium in the blood)
• Inflammation of the skin, especially in the lower limbs with swelling, pain and redness.

You may experience one of these symptoms and/or conditions. You should tell your doctor as
soon as possible when you start to have one of these side effects.
If you have any doubts about any side effect, talk to your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Pemetrexed Mylan

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 after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not freeze.
Diluted solutions: the product must be used immediately. When prepared according to
the instructions, the chemical and physical stability during use of diluted pemetrexed solutions is
demonstrated for 24 hours at refrigerator temperature. Store protected from light.
This medicine is for single use only. Any unused solution must
be disposed of in accordance with current local regulations.

6. Contents of the pack and other information

What Pemetrexed Mylan contains
The active ingredient is pemetrexed.
Each 4 ml vial of concentrate contains 100 mg of pemetrexed (as pemetrexed
disarginate).
Each 20 ml vial of concentrate contains 500 mg of pemetrexed (as pemetrexed
disarginate).
Each 40 ml vial of concentrate contains 1000 mg of pemetrexed (as
pemetrexed disarginate).
The solution contains 25 mg/ml of pemetrexed. Further dilution by healthcare professionals is necessary
before administration.
The other ingredients are L-arginine, L-cysteine, propylene glycol, citric acid and water for
injections.

Description of the appearance of Pemetrexed Mylan and contents of the pack
Pemetrexed Mylan is a clear solution, from colourless to light yellow to brown, from
brown-yellow to yellow-green. It is supplied in glass vials. Each pack contains:
1 vial of 4 ml (100 mg/4 ml)
1 vial of 20 ml (500 mg/20 ml)
1 vial of 40 ml (1000 mg/40 ml)
The vials are closed with a rubber stopper (bromobutyl), and a flip-off cap
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani, 20, 20124 Milan

Manufacturer
Synthon Hispania SL, C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat Barcelona 08830

• Spain Synthon BV, Microweg 22 Nijmegen 6545 CM - Netherlands Synthon, s.r.o., Brněnská 32/čp. 597 Blansko 678 01 - Czech Republic

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The following information is intended exclusively for healthcare professionals:
Instructions for use, handling and disposal

• 1. When diluting pemetrexed for intravenous infusion administration, use aseptic techniques.

• 2. Calculate the dose and the number of vials of Pemetrexed Mylan needed. Each vial contains an excess of pemetrexed to facilitate dispensing the amount indicated on the label. Each vial contains a solution containing 25 mg/ml of pemetrexed.
• 3. The appropriate volume of solution must be further diluted to 100 ml with a 5% dextrose solution for injection, without preservatives, and administered by intravenous infusion over 10 minutes.
• 4. Pemetrexed infusion solutions prepared as described above are compatible with polyvinyl chloride and polyolefin coated infusion bags and administration sets. Pemetrexed is incompatible with diluents containing calcium, including Ringer's Lactate for injection and Ringer's solution for injection.

Pemetrexed Mylan contains L-arginine as an excipient. L-arginine is incompatible with
cisplatin due to cisplatin degradation. This medicine should not be
mixed with other medicines. Intravenous infusion lines must be flushed
after administration of Pemetrexed Mylan

• 5. Before administration, parenteral medicines must be visually inspected for particles and colour changes. Do not administer if particles are observed.
• 6. Pemetrexed solutions are for single use only. Unused product and waste derived from this medicine must be disposed of in accordance with local regulations for cytotoxic agents.

Precautions for preparation and administration:As with other potentially toxic antineoplastic agents,
caution should be exercised when handling and preparing pemetrexed infusion solutions. The use of gloves is recommended. If a pemetrexed solution comes into contact with the skin, wash immediately and thoroughly with
water and soap. If pemetrexed solutions come into contact with mucous membranes, wash
thoroughly with water. Pemetrexed is not vesicant. There is no specific antidote
for pemetrexed extravasation. Some cases of pemetrexed extravasation have been reported that
were not considered serious by the investigator. Extravasation should be managed
according to standard procedures as for other non-vesicant agents.