Pemetrexed Sandoz

Leaflet attached to the packaging: information for the user

Pemetrexed Sandoz, 25 mg/ml, concentrate for solution for infusion

Pemetrexed

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Pemetrexed Sandoz is a medicine used to treat malignant tumors.
Pemetrexed Sandoz in combination with another anticancer medicine, cisplatin, is used to treat malignant pleural mesothelioma, a type of tumor that affects the membrane covering the lungs, in patients who have not previously received chemotherapy.
Pemetrexed Sandoz in combination with cisplatin is used as initial treatment in patients with advanced lung cancer.
Pemetrexed Sandoz may be prescribed to patients with advanced lung cancer who have responded to initial chemotherapy treatment or whose condition has not changed significantly after initial chemotherapy treatment.
Pemetrexed Sandoz is also used to treat patients with advanced lung cancer whose disease has progressed after initial chemotherapy with other medicines.
The medicine is intended for use only in adults.

2. Important information before using Pemetrexed Sandoz

When not to use Pemetrexed Sandoz

• if the patient is allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
• if the patient is breastfeeding. Breastfeeding should be discontinued during treatment with Pemetrexed Sandoz.
• in patients who have recently been vaccinated or are to be vaccinated against yellow fever.

Warnings and precautions

Before taking Pemetrexed Sandoz, the patient should discuss it with their doctor or hospital pharmacist.
Patients who have or have had kidney function disorders should inform their doctor or hospital pharmacist, as this may mean that they cannot take Pemetrexed Sandoz.
Before each infusion, medical staff will take blood samples from the patient to assess whether liver and kidney function are sufficient and whether there are enough blood cells to administer Pemetrexed Sandoz. Depending on the patient's overall condition and kidney function, the doctor may decide to change the dose or postpone treatment. If the patient is also being treated with cisplatin, the doctor will ensure that the patient is properly hydrated and receives appropriate anti-emetic treatment before and after cisplatin treatment.
Patients who have or will undergo radiotherapy should inform their doctor, as early or delayed radiation reactions may occur after taking Pemetrexed Sandoz.
Patients who have recently been vaccinated should inform their doctor, as administration of Pemetrexed Sandoz may cause side effects in them.
Patients with a history of heart disease should inform their doctor.
In case of fluid accumulation around the patient's lung, the doctor may decide to perform a procedure to drain the fluid before administering Pemetrexed Sandoz.

Children and adolescents

Pemetrexed Sandoz should not be used in children and adolescents, as there is no experience with the use of this medicine in children and adolescents under the age of 18.

Pemetrexed Sandoz and other medicines

The patient should inform their doctor about pain and anti-inflammatory medicines (e.g. anti-edema), such as non-steroidal anti-inflammatory drugs (NSAIDs), including those available without a prescription (such as ibuprofen). There are many types of non-steroidal anti-inflammatory drugs (NSAIDs) with different durations of action. Depending on the planned date of administration of Pemetrexed Sandoz and the patient's kidney function, the doctor will provide information on which medicines can be taken and when. In case of doubts about whether the medicines taken belong to the group of non-steroidal anti-inflammatory drugs (NSAIDs), the patient should ask their doctor or pharmacist.
The patient should inform their doctor if they are taking proton pump inhibitors (omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole) used to treat heartburn and acid reflux.
The patient should tell their doctor or hospital pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription.

Pregnancy, breastfeeding, and fertility

Pregnancy

If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should inform their doctor. Pemetrexed Sandoz should be avoided during pregnancy. The doctor will inform the patient about the potential risk associated with the use of Pemetrexed Sandoz during pregnancy. During treatment with Pemetrexed Sandoz and for 6 months after the last dose, women must use effective contraception.

Breastfeeding

Breastfeeding women should inform their doctor.
During treatment with Pemetrexed Sandoz, breastfeeding should be discontinued.

Fertility

Men are advised not to try to conceive a child during treatment and for 3 months after the end of treatment with Pemetrexed Sandoz, and to use effective contraception during this time. If a man wants to try to conceive a child during treatment with Pemetrexed Sandoz or within 3 months after the end of this treatment, he should consult his doctor or pharmacist. Pemetrexed Sandoz may affect fertility. Before starting treatment, patients should consult their doctor about sperm preservation.

Driving and using machines

Pemetrexed Sandoz may cause fatigue. The patient should be careful when driving or operating machinery.

Pemetrexed Sandoz contains sodium and propylene glycol

Pemetrexed Sandoz, 100 mg (vial 4 ml):
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. the medicine is considered "sodium-free".
This medicine contains 200 mg of propylene glycol in each vial.
Pemetrexed Sandoz, 500 mg (vial 20 ml):
This medicine contains 55.6 mg of sodium (main component of table salt) in each vial. This corresponds to 3% of the maximum recommended daily intake of sodium in the diet for adults.
This medicine contains 1000 mg of propylene glycol in each vial.
Pemetrexed Sandoz, 1000 mg (vial 40 ml):
This medicine contains 111.2 mg of sodium (main component of table salt) in each vial. This corresponds to 6% of the maximum recommended daily intake of sodium in the diet for adults.
This medicine contains 2000 mg of propylene glycol in each vial.

3. How to use Pemetrexed Sandoz

Pemetrexed Sandoz is administered only under the supervision of a doctor specializing in the use of chemotherapy.
The dose of Pemetrexed Sandoz is 500 milligrams per square meter of body surface area. The body surface area is calculated based on the patient's height and weight. The doctor will determine the appropriate dose based on the calculated body surface area. The dose may be changed or treatment may be postponed depending on the results of the blood morphology test and the patient's overall condition. Before administering Pemetrexed Sandoz, the hospital pharmacist, nurse, or doctor will mix the concentrate with 9 mg/ml (0.9%) sodium chloride injection solution or 50 mg/ml (5%) glucose injection solution.
Pemetrexed Sandoz is always administered by intravenous infusion. The infusion lasts about 10 minutes.
Using Pemetrexed Sandoz in combination with cisplatin
The doctor or hospital pharmacist will calculate the dose based on the patient's height and weight. Cisplatin is also administered by intravenous infusion. The cisplatin infusion starts about 30 minutes after the end of the Pemetrexed Sandoz infusion and lasts about two hours.
The infusion will usually be performed every 3 weeks.
Additional medicines
Corticosteroids: the doctor will prescribe steroids in tablets (in a dose equivalent to 4 milligrams of dexamethasone twice a day), which should be taken on the day before administration of Pemetrexed Sandoz, on the day of infusion, and the next day. These medicines are used to reduce the frequency and severity of skin reactions that may occur during anticancer treatment.
Vitamin supplementation: the doctor will prescribe folic acid (vitamin) or a multivitamin product containing folic acid (350 to 1000 micrograms), which should be taken orally once a day during treatment with Pemetrexed Sandoz. Within 7 days before the first administration of Pemetrexed Sandoz, the patient should take at least 5 doses of folic acid. Folic acid should be continued for 21 days after the last dose of Pemetrexed Sandoz. In the week before administration of Pemetrexed Sandoz, and then at intervals of about 9 weeks (corresponding to three cycles of chemotherapy with Pemetrexed Sandoz), patients will also receive vitamin B (1000 micrograms) by injection. The administration of vitamin B and folic acid is intended to reduce the possible side effects of anticancer medicines.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

In case of any of the following symptoms, the patient should immediately inform their doctor:

• Fever or infection(frequent or very frequent): if the patient has a fever of 38°C or higher, sweats, or other signs of infection (due to the possibility of a significant decrease in the number of white blood cells, which is a very frequent symptom). Infection (sepsis) can be severe and life-threatening.
• Chest pain(frequent) or rapid heartbeat (infrequent).
• Pain, redness, swelling, or ulcers in the mouth(very frequent).
• Allergic reaction: skin rash(very frequent) and (or) burning or tingling sensation(frequent) or fever (frequent). In rare cases, skin reactions can be severe and life-threatening. The patient should inform their doctor in case of severe rash, itching, or blisters(symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Feeling of fatigue, weakness, rapid onset of shortness of breathor pale skin (due to the possibility of a significant decrease in hemoglobin levels, which is a very frequent symptom).
• Bleeding from the gums, nose, or mouthor other bleeding that cannot be stopped, red or pink urine, unexpected bruising on the skin (due to the possibility of a significant decrease in the number of platelets, which is a frequent symptom).
• Sudden shortness of breath, severe chest painor coughing up blood-stained sputum (infrequent) (may indicate the presence of blood clots in the pulmonary blood vessels).

Possible side effects after administration of Pemetrexed Sandoz
Very frequent(may occur in more than 1 in 10 people)

• Infection
• Pharyngitis (sore throat)
• Decreased neutrophil count (a type of white blood cell)
• Decreased white blood cell count
• Decreased hemoglobin levels
• Pain, redness, swelling, or ulcers in the mouth
• Lack of appetite
• Vomiting
• Diarrhea
• Nausea
• Skin rash
• Peeling skin
• Abnormal blood test results indicating impaired kidney function
• Fatigue

Frequent(may occur in less than 1 in 10 people)

• Blood infection
• Fever with low neutrophil count (a type of white blood cell)
• Decreased platelet count
• Allergic reaction
• Fluid loss
• Taste disorders
• Damage to motor nerves, which can lead to weakness and muscle wasting, especially in the arms and legs
• Damage to sensory nerves, which can lead to loss of sensation, burning pain, and gait disturbances
• Dizziness
• Inflammation or swelling of the conjunctiva (the membrane lining the eyelids and covering the white of the eye)
• Dry eyes
• Excessive tearing
• Dryness of the conjunctiva (the membrane lining the eyelids and covering the white of the eye) and cornea (the transparent layer covering the front of the iris and pupil)
• Swelling of the eyelids
• Eye disorders with accompanying dryness, tearing, irritation, and (or) pain
• Heart failure (a condition that causes the heart muscle to become weak)
• Irregular heart rhythm
• Indigestion
• Constipation
• Abdominal pain
• Liver: increased levels of chemical compounds produced in the liver in the blood
• Increased skin pigmentation
• Itching skin
• Skin rash with target-like lesions
• Hair loss
• Hives
• Kidney failure
• Impaired kidney function
• Fever
• Pain
• Excessive fluid in the body's tissues, causing swelling
• Chest pain
• Inflammation and ulceration of the mucous membranes lining the digestive tract

Infrequent(may occur in less than 1 in 100 people)

• Decreased red blood cell, white blood cell, and platelet count
• Stroke
• A type of stroke in which a blood vessel supplying blood to the brain becomes blocked
• Bleeding in the brain
• Angina pectoris (chest pain caused by reduced blood flow to the heart)
• Heart attack
• Narrowing or blockage of the coronary arteries
• Rapid heartbeat
• Insufficient blood flow to the limbs
• Blockage of one of the pulmonary arteries
• Inflammation and scarring of the membrane lining the lungs, with accompanying breathing difficulties
• Passage of bright red blood from the anus
• Bleeding from the digestive tract
• Rupture of the intestinal wall
• Inflammation of the membrane lining the esophagus
• Inflammation of the membrane lining the large intestine, which may be accompanied by bleeding from the intestines or rectum (observed only in combination with cisplatin)
• Inflammation, swelling, redness, and ulcers of the mucous membranes caused by radiation therapy
• Radiation-induced lung inflammation

Rare(may occur in less than 1 in 1000 people)

• Breakdown of red blood cells
• Anaphylactic shock (a severe allergic reaction)
• Liver inflammation
• Redness of the skin
• Skin rash appearing in the area previously irradiated

Very rare(may occur in less than 1 in 10,000 people)

• Infections of the skin and soft tissues
• Stevens-Johnson syndrome (a severe skin and mucous membrane reaction that can be life-threatening)
• Toxic epidermal necrolysis (a severe skin reaction that can be life-threatening)
• Autoimmune disorders, resulting in skin rash and blistering lesions on the skin of the legs, arms, and abdomen
• Inflammation of the skin characterized by the presence of fluid-filled blisters
• Skin fragility, blisters, and scarring, as well as skin thickening
• Redness, pain, and swelling, mainly of the lower limbs
• Inflammation of the skin and subcutaneous tissue (pseudoskin inflammation)
• Inflammation of the skin
• Inflammation, itching, redness, cracking, and roughness of the skin
• Severe itching skin lesions

Frequency not known: cannot be estimated from the available data

• A type of diabetes caused by kidney damage
• Kidney damage resulting in the death of kidney tubule cells
• Increased urine production
• Thirst and increased water intake
• Hypernatremia - elevated sodium levels in the blood

Any of these symptoms and (or) conditions may occur. If the patient experiences any of these side effects, they should inform their doctor as soon as possible.
The patient should inform their doctor if they are concerned about any of these symptoms.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Pemetrexed Sandoz

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the month.
Unopened vial
Do not store above 25°C. Store in the original package to protect from light.
After first opening
The medicine should be used immediately. Any unused residue should be discarded.
After dilution
Vial 100 mg
It has been shown that the prepared infusion solution of Pemetrexed Sandoz is stable for 3 days at a temperature of 2°C to 8°C without access to light.
Vial 500 and 1000 mg
It has been shown that the prepared infusion solution of Pemetrexed Sandoz is stable for 7 days at room temperature without access to light and for 14 days at a temperature of 2°C to 8°C without access to light.
From a microbiological point of view, the medicine should be used immediately after preparation. If the medicine is not used immediately, the responsibility for the storage time and conditions before use lies with the user. The solution should not be stored for more than 24 hours at a temperature of 2°C to 8°C, unless it has been diluted in controlled and validated aseptic conditions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Pemetrexed Sandoz contains

The active substance is pemetrexed.
Each 1 ml of concentrate for solution for infusion contains 25 mg of pemetrexed (as pemetrexed disodium dihydrate).
Each 4 ml vial contains 100 mg of pemetrexed (as pemetrexed disodium dihydrate).
Each 20 ml vial contains 500 mg of pemetrexed (as pemetrexed disodium dihydrate).
Each 40 ml vial contains 1000 mg of pemetrexed (as pemetrexed disodium dihydrate).
The other ingredients are sodium thiosulfate (E 539), propylene glycol (E1520), 10% hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

What Pemetrexed Sandoz looks like and contents of the pack

Pemetrexed Sandoz is a concentrate for solution for infusion. Pemetrexed Sandoz is a clear, colorless to yellow or greenish-yellow solution, practically free from particulate matter.
Pemetrexed Sandoz is packaged in clear glass vials of type I, closed with a bromobutyl rubber stopper and an aluminum cap with a light blue flip-off cap.
Each vial contains 4 ml, 20 ml, or 40 ml of concentrate for solution for infusion.
Each pack of Pemetrexed Sandoz contains one vial of the medicine (with a protective sleeve or without).

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer

Ebewe Pharma Ges.m.b.H Nfg.KG
Mondseestrasse 11, Unterach
4866 Austria
Fareva Unterach GmbH
Mondseestraße 11
4866 Unterach, Austria

This product is authorized in the Member States of the European Economic Area (EEA) under the following names

Netherlands
Pemetrexed Sandoz 25 mg/ml, concentrate for solution for infusion
Austria
Pemetrexed Sandoz 25 mg/ml - concentrate for solution for infusion
Belgium
Pemetrexed Sandoz 25 mg/ml concentrate for solution for infusion
Bulgaria
Пеметрексед Сандоз 25 mg/ml концентрат за инфузионен разтвор
Denmark
Pemetrexed Hexal
Greece
Pemetrexed/EBEWE 25mg/ml πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση
Spain
Pemetrexed Ebewe 25mg/ml concentrado para solución para perfusión
Finland
Pemetrexed Hexal 25 mg/ml Infuusiokonsentraatti, liuosta varten
France
Pemetrexed GNR 25 mg/ml, solution à diluer pour perfusion
Ireland
Pemetrexed Rowex 25 mg/ml concentrate for solution for infusion
Iceland
Pemetrexed Hexal 25 mg/ml Koncentrat til infusionsvæske, opløsning
Italy
Pemetrexed Sandoz BV
Lithuania
Pemetrexed Ebewe 25mg/ml koncentratas infuziniam tirpalui
Norway
Pemetrexed Hexal
Poland
Pemetrexed Sandoz
Portugal
Pemetrexedo Sandoz
Romania
Pemetrexed Sandoz 25mg/ml concentrat pentru soluţie perfuzabilă
Sweden
Pemetrexed Hexal 25 mg/ml Koncentrat till infusionsvätska, lösning
Slovenia
Pemetreksed Sandoz 25 mg/ml koncentrat za raztopino za infundiranje

For more information about this medicine, please contact

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00
Date of last revision of the leaflet:07/2025
(logo of the marketing authorization holder)
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The following information is intended for healthcare professionals only:

Special precautions for preparation, administration, and disposal of the medicinal product

Solutions of pemetrexed are for single use only. Any unused medicinal product or waste materials should be disposed of in accordance with local regulations for cytotoxic medicines.

• 1. Dilution of pemetrexed concentrate to prepare the infusion solution should be performed under aseptic conditions.
• 2. The dose and number of vials of Pemetrexed Sandoz required should be calculated. Each vial contains slightly more pemetrexed concentrate than stated on the label, which makes it easier to withdraw the desired volume.
• 3. The appropriate volume of pemetrexed concentrate should be diluted to a volume of 100 ml with 9 mg/ml (0.9%) sodium chloride injection solution or 50 mg/ml (5%) glucose injection solution. The solution should be administered by intravenous infusion. The infusion lasts about 10 minutes.
• 4. Solutions of pemetrexed for infusion prepared as described above have been shown to be compatible with infusion bags and administration sets with an inner layer made of polyolefin.
• 5. Before administration, the medicinal product should be visually inspected for particulate matter and color changes. The medicinal product should not be administered if it contains visible particulate matter.

Precautions for preparation and administration of the medicinal product: As with other potentially toxic anticancer medicines, caution should be exercised when handling the product and preparing pemetrexed infusion solutions. Gloves should be worn. In case of skin contact with pemetrexed solution, the skin should be washed immediately and thoroughly with soap and water. In case of contact with the mucous membranes, the area of contact should be rinsed thoroughly with water. Pemetrexed does not cause blistering. There is no specific antidote in case of extravasation. There have been reports of rare cases of pemetrexed extravasation, which were not considered serious by the investigators. In case of extravasation, the same procedures should be followed as for other non-vesicant substances.