Pemetrexed Eugia

Package Leaflet: Information for the User

Pemetrexed Eugia, 100 mg, powder for concentrate for solution for infusion

Pemetrexed Eugia, 500 mg, powder for concentrate for solution for infusion

Pemetrexed

Read all of this leaflet carefully before taking 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Pemetrexed Eugia is and what it is used for
• 2. Before you take Pemetrexed Eugia
• 3. How to take Pemetrexed Eugia
• 4. Possible side effects
• 5. How to store Pemetrexed Eugia
• 6. Contents of the pack and other information

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

Pemetrexed Eugia is a medicine used to treat cancer.
Pemetrexed Eugia, in combination with another anticancer medicine, cisplatin, is used to treat malignant pleural mesothelioma, a type of cancer that affects the lining of the lungs, in patients who have not received prior chemotherapy.
Pemetrexed Eugia, in combination with cisplatin, is used as a first-line treatment for patients with advanced non-small cell lung cancer.
Pemetrexed Eugia may be used as a single treatment for patients with advanced non-small cell lung cancer who have received prior chemotherapy.

2. Before you take Pemetrexed Eugia

When not to take Pemetrexed Eugia

• if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding; you must stop breastfeeding during treatment with Pemetrexed Eugia.
• if you have recently been vaccinated or are going to be vaccinated against yellow fever.

Warnings and precautions

Before taking Pemetrexed Eugia, tell your doctor or hospital pharmacist.
If you have kidney problems, tell your doctor or hospital pharmacist, as you may not be able to receive Pemetrexed Eugia.
Before each infusion, your doctor will take blood samples to check that your liver and kidneys are working properly and that you have enough blood cells to receive Pemetrexed Eugia. Your doctor may decide to change the dose or delay treatment depending on your overall condition and blood cell counts.
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 received radiation therapy, tell your doctor, as you may have an early or late radiation reaction with Pemetrexed Eugia.
If you have recently been vaccinated, tell your doctor, as you may have side effects after receiving Pemetrexed Eugia.
If you have a history of heart disease, tell your doctor.
If you have fluid accumulation around the lungs, your doctor may decide to drain the fluid before giving you Pemetrexed Eugia.

Children and adolescents

Pemetrexed Eugia should not be used in children and adolescents because there is no experience with the use of this medicine in children and adolescents under 18 years of age.

Pemetrexed Eugia and other medicines

Tell your doctor about all medicines you are taking, including pain and anti-inflammatory medicines (such as non-steroidal anti-inflammatory drugs (NSAIDs), including those available without prescription (e.g., 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 Eugia and/or the patient's kidney function, the doctor will advise which medicines can be taken and when. If in doubt about which medicines are non-steroidal anti-inflammatory drugs (NSAIDs), ask your doctor or pharmacist.
Tell your doctor if you are taking proton pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole) used to treat heartburn and acid reflux.
Tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including those available without prescription.

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, tell your doctor.
Pemetrexed Eugia should not be used during pregnancy.
Your doctor will discuss the potential risks with you.
Women must use effective contraception during treatment with Pemetrexed Eugia and for 6 months after the last dose.

Breastfeeding

Women who are breastfeeding should tell their doctor.
Do not breastfeed during treatment with Pemetrexed Eugia.

Fertility

Men are advised not to father a child during treatment and for 3 months after treatment with Pemetrexed Eugia. Men should use effective contraception during and for 3 months after treatment with this medicine. If a man wishes to father a child during or within 3 months after treatment with Pemetrexed Eugia, he should consult his doctor or pharmacist. Pemetrexed Eugia may affect fertility. Before starting treatment, patients may seek advice on sperm conservation.

Driving and using machines

Pemetrexed Eugia may cause fatigue. Be careful when driving or using machines.

Pemetrexed Eugia contains sodium

Pemetrexed Eugia, 100 mg, powder for concentrate for solution for infusion
This medicine contains less than 1 mmol (23 mg) of sodium per vial, which is essentially sodium-free.
Pemetrexed Eugia, 500 mg, powder for concentrate for solution for infusion
This medicine contains 54 mg of sodium (main component of common salt) per vial, which corresponds to 2.7% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Pemetrexed Eugia

The dose of Pemetrexed Eugia is 500 milligrams per square meter of body surface area. The dose is calculated based on the patient's height and weight. The dose may be adjusted or treatment delayed based on blood cell counts and the patient's overall condition. Before administration, the hospital pharmacist, nurse, or doctor will dissolve the powder in 9 mg/ml (0.9%) sodium chloride injection solution.
Pemetrexed Eugia is always given as an intravenous infusion. The infusion takes about 10 minutes.
When used in combination with cisplatin:
The doctor or hospital pharmacist will calculate the dose based on the patient's height and weight. Cisplatin is also given as an intravenous infusion and is administered about 30 minutes after the end of the Pemetrexed Eugia infusion. The cisplatin infusion takes about 2 hours.
The infusion is usually given once every 3 weeks.
Additional medicines:
Corticosteroids: The doctor will prescribe steroids in tablet form (equivalent to 4 milligrams of dexamethasone twice daily) to be taken the day before, the day of, and the day after treatment with Pemetrexed Eugia. 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 oral folic acid (vitamin) or a multivitamin product containing folic acid (350 to 1000 micrograms) to be taken once daily during treatment with Pemetrexed Eugia. At least 5 doses of folic acid should be taken during the 7 days before the first dose of Pemetrexed Eugia. Folic acid should be continued for 21 days after the last dose of Pemetrexed Eugia. During the week before administration of Pemetrexed Eugia and then at approximately 9-week intervals (corresponding to 3 cycles of chemotherapy with Pemetrexed Eugia), patients will also receive vitamin B12 (1000 micrograms) by injection. The administration of vitamin B12 and folic acid is intended to reduce the possible side effects of anticancer medicines.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pemetrexed Eugia can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, tell your doctor immediately:

• Fever or infection (very common or common): if you have a fever of 38°C or higher, sweating, or other signs of infection (due to the possibility of a significant decrease in white blood cell count, which is very common). Infection (sepsis) can be severe and life-threatening.
• If you experience chest pain (common) or rapid heartbeat (uncommon).
• If you experience pain, redness, swelling, or ulcers in the mouth (very common).
• Allergic reaction: if you experience a skin rash (very common), burning or tingling sensation (common), or fever (common). Rarely, skin reactions can be severe and life-threatening. Tell your doctor if you experience severe rash, itching, or blisters (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• If you experience fatigue, fainting, shortness of breath, or pale skin (due to the possibility of a significant decrease in hemoglobin, which is very common).
• If you experience bleeding from the gums, nose, or mouth, or any bleeding that cannot be stopped, red or pink urine, or unexplained bruising (due to the possibility of a significant decrease in platelet count, which is common).
• If you experience sudden shortness of breath, severe chest pain, or coughing up blood (uncommon) (which may indicate a blood clot in the lungs).

Possible side effects of Pemetrexed Eugia include:
Very common(may affect more than 1 in 10 people):

• Infection
• Pharyngitis (sore throat)
• Low neutrophil count (a type of white blood cell)
• Low white blood cell count
• Low hemoglobin
• Pain, redness, swelling, or ulcers in the mouth
• Loss of appetite
• Nausea
• Vomiting
• Diarrhea
• Constipation
• Rash
• Peeling skin
• Abnormal liver function tests
• Fatigue

Common(may affect up to 1 in 10 people):

• Blood infection
• Fever with low neutrophil count
• Low platelet count
• Allergic reaction
• Dehydration
• Taste disturbance
• Nerve damage, which can cause weakness and wasting of muscles, mainly in the arms and legs
• Nerve damage, which can cause loss of sensation, burning pain, and unsteady gait
• Dizziness
• Inflammation or swelling of the conjunctiva (the membrane covering the white part of the eyes and the inside of the eyelids)
• Dry eyes
• Excessive tearing
• Dryness of the conjunctiva and cornea (the clear layer covering the front of the eye)
• Swelling of the eyelids
• Eyelid problems, including swelling, redness, and increased tearing
• Heart failure (a condition in which the heart does not pump blood as well as it should)
• Abnormal heart rhythm
• Indigestion
• Abdominal pain
• Liver problems, including elevated liver enzymes
• Increased skin pigmentation
• Itching
• Rash with ring-shaped lesions
• Hair loss
• Hives
• Kidney failure
• Kidney problems
• Fever
• Pain
• Excessive fluid in the body, leading to swelling
• Chest pain
• Inflammation and ulcers of the mucous membranes lining the digestive tract

Uncommon(may affect up to 1 in 100 people):

• Decreased blood cell count
• Stroke
• Blockage of a blood vessel in the brain
• Bleeding in the brain
• Chest pain (angina) caused by reduced blood flow to the heart

Rare(may affect up to 1 in 1,000 people):

• Breakdown of red blood cells
• Anaphylactic shock (a severe allergic reaction)
• Liver inflammation
• Redness of the skin
• Rash that appears on the skin in areas previously exposed to radiation

Very rare(may affect up to 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, which can cause skin rash and blistering lesions on the skin of the legs, arms, and abdomen
• Skin inflammation characterized by blisters
• Skin fragility, blisters, and scarring
• Redness, pain, and swelling, mainly of the lower limbs
• Skin inflammation and scarring
• Itching skin lesions

Frequency not known(frequency cannot be estimated from the available data):

• A type of diabetes caused by kidney problems
• Kidney problems, which can cause damage to the kidney cells

Any of these symptoms can occur. Tell your doctor immediately if you experience any of these side effects.
Tell your doctor if you are concerned about any of these side effects.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via phone: +48 22 492 13 01, fax: +48 22 492 13 09, or website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Pemetrexed Eugia

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 carton and vials after EXP.
The expiry date refers to the last day of that month.
100 mg:Store in a refrigerator (2°C - 8°C).
500 mg:No special storage instructions.
Reconstituted and diluted infusion solution: The chemical and physical stability of the reconstituted and diluted solution for infusion has been demonstrated for 24 hours at 2°C - 8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless reconstitution/dilution has been carried out in controlled and validated aseptic conditions.

6. Contents of the pack and other information

What Pemetrexed Eugia contains

The active substance is pemetrexed.
Pemetrexed Eugia, 100 mg: each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium 2.5 hydrate).
Pemetrexed Eugia, 500 mg: each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium 2.5 hydrate).
The reconstituted solution contains 25 mg/ml of pemetrexed. Further dilution is required before administration.
Other ingredients are mannitol, hydrochloric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).

What Pemetrexed Eugia looks like and contents of the pack

Powder for concentrate for solution for infusion.
A lyophilized cake or powder that is white to light yellow or greenish-yellow in color.
The medicine is available in packs of 1 vial.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Eugia Pharma (Malta) Ltd.
Vault 14, level 2
Valletta Waterfront
Floriana, FRN1914
Malta
e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Pemetrexed Eugia 500 mg/ 1000 mg poeder voor concentraat voor oplossing voor infusie
/ poudre pour solution à diluer pour perfusion / Pulver für ein Konzentrat zur Herstellung
einer Infusionslösung
Denmark:
Pemetrexed Aurobindo
France:
PEMETREXED ARROW 100 mg/ 500 mg/ 1000 mg poudre pour solution à diluer pour
perfusion
Germany:
Pemetrexed PUREN 100 mg/ 500 mg/ 1000 mg Pulver zur Herstellung eines
Konzentrates zur Herstellung einer Infusionslösung
Italy:
Pemetrexed Aurobindo
Poland:
Pemetrexed Eugia
Portugal: Pemetrexedo Eugia

Date of last revision of the leaflet: 02/2025

The following information is intended for healthcare professionals only:

Instructions for preparation, administration, and disposal of the medicine.

• 1. Preparation of the pemetrexed solution and further dilution of the infusion solution for intravenous administration should be carried out under aseptic conditions.
• 2. Calculate the dose and the number of vials of Pemetrexed Eugia required. Each vial contains an excess of pemetrexed to facilitate delivery of the dose stated on the label.
• 3. Pemetrexed Eugia, 100 mg: Dissolve the contents of each 100 mg vial in 4.2 ml of 9 mg/ml (0.9%) sodium chloride injection solution without preservatives. The resulting solution contains 25 mg/ml of pemetrexed.

Pemetrexed Eugia, 500 mg: Dissolve the contents of each 500 mg vial in 20 ml of 9 mg/ml (0.9%) sodium chloride injection solution without preservatives. The resulting solution contains 25 mg/ml of pemetrexed.
Gently rotate each vial until the powder is completely dissolved.
The reconstituted solution is clear and ranges in color from colorless to yellow or yellow-green, without any adverse effect on the quality of the product. The pH of the reconstituted solution ranges from 6.6 to 7.8. Further dilution is required.

• 4. The appropriate volume of the reconstituted pemetrexed solution should be further diluted to 100 ml with 9 mg/ml (0.9%) sodium chloride injection solution without preservatives for intravenous administration over 10 minutes.
• 5. Pemetrexed solutions for infusion prepared as directed are compatible with infusion sets and bags made of polyvinyl chloride (PVC) with polyolefin (PE) or PVC with polyethylene (PE) lined administration sets. Pemetrexed is incompatible with diluents containing calcium, including Ringer's solution and lactated Ringer's solution.
• 6. Before administration, visually inspect the reconstituted solution for particulate matter and discoloration. The solution should not be used if particulate matter is observed.
• 7. Pemetrexed solutions are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

Storage

The chemical and physical stability of the reconstituted and diluted solution for infusion has been demonstrated for 24 hours at 2°C - 8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless reconstitution/dilution has been carried out in controlled and validated aseptic conditions.

Precautions for handling and administration

As with other potentially toxic anticancer agents, care should be taken when handling and preparing Pemetrexed Eugia solutions for infusion.
It is recommended to wear gloves. In case of skin contact with the pemetrexed solution, wash the skin immediately and thoroughly with soap and water. In case of contact with the mucous membranes, flush the area with water. Pemetrexed is not a vesicant. There is no specific antidote for extravasation of pemetrexed. A few cases of extravasation of pemetrexed have been reported, but these were not assessed by investigators as serious.
In case of extravasation, act according to standard procedures, as with other non-vesicant drugs.