Pemetrexed Prasfarma 100 mg powder for concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pemetrexed Prasfarma 100 mg powder for concentrate for solution

for infusion EFG

pemetrexed

Read all of this leaflet carefully before you start receiving this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any adverse reactions, talk to your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Pemetrexed Prasfarma is a medicine used for the treatment of cancer.

Pemetrexed Prasfarma may be given together with cisplatin, another anticancer medicine, as treatment for malignant pleural mesothelioma, a type of cancer affecting the lining of the lung, in patients who have not received prior chemotherapy.

Pemetrexed Prasfarma may also be given together with cisplatin as initial treatment for patients with advanced-stage lung cancer.

Pemetrexed Prasfarma may be prescribed to you if you have advanced-stage lung cancer and your disease has responded to treatment or remains unchanged after initial chemotherapy.

Pemetrexed Prasfarma may also be given for the treatment of patients with advanced-stage lung cancer whose disease has progressed after having received prior initial chemotherapy treatment.

2. What you need to know before using Pemetrexed Prasfarma

Do not use Pemetrexed Prasfarma:

• if you are allergic (hypersensitive) to pemetrexed or to any of the other components of Pemetrexed Prasfarma (listed in section 6).
• if you are breastfeeding, you must interrupt breastfeeding during treatment with Pemetrexed Prasfarma.
• if you have recently received or are about to receive the yellow fever vaccine.

Warnings and precautions

Talk to your doctor or pharmacist before receiving Pemetrexed Prasfarma.

If you have had or currently have kidney problems, inform your doctor or hospital pharmacist, as you may not be able to receive Pemetrexed Prasfarma.

Before each infusion, you will need to provide blood samples to assess whether your kidney and liver function are adequate and to evaluate whether you have sufficient blood cells to receive Pemetrexed Prasfarma. Your doctor may decide to adjust your dose or delay treatment depending on your general condition and whether your blood cell count is too low. If you are also receiving cisplatin, your doctor will ensure that you are adequately hydrated and will administer appropriate treatment before and after cisplatin to prevent vomiting.

If you have received or are about to receive radiotherapy, please consult your doctor, as there may be an early or delayed interaction between radiation and Pemetrexed Prasfarma.

If you have been recently vaccinated, please consult your doctor, as this may potentially cause a negative interaction with Pemetrexed Prasfarma.

If you have heart disease or a history of heart disease, please consult your doctor.

If you have fluid accumulation around the lung, your doctor may decide to drain the fluid before administering Pemetrexed Prasfarma.

Children and adolescents

There are no relevant data available on the use of Pemetrexed Prasfarma in the pediatric population.

Use of Pemetrexed Prasfarma with other medicines

Inform your doctor if you are taking pain or anti-inflammatory (swelling) medicines, such as medicines known as “non-steroidal anti-inflammatory drugs” (NSAIDs), including those purchased without a prescription (such as ibuprofen). There are many types of NSAIDs with different durations of action. Based on the date of your Pemetrexed Prasfarma infusion and/or your kidney function status, your doctor will advise you which medicines you may take and when. If you are unsure, consult your doctor or pharmacist to determine whether any medicine you are taking is an NSAID.

Inform your doctor if you are taking medicines called proton pump inhibitors (omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole) used to treat stomach acid and acid reflux.

Inform your doctor or hospital pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor.

Pemetrexed Prasfarma should be avoided during pregnancy. Your doctor will inform you of the potential risks of taking Pemetrexed Prasfarma during pregnancy. Women should use effective contraception during treatment with Pemetrexed Prasfarma.

Breastfeeding

If you are breastfeeding, inform your doctor.

Breastfeeding must be interrupted during treatment with Pemetrexed Prasfarma.

Fertility

Male patients are advised not to father a child during treatment and for 6 months after treatment with Pemetrexed Prasfarma, and should therefore use effective contraception during treatment and for 6 months thereafter. If you wish to father a child during treatment or within 6 months after treatment, seek advice from your doctor or pharmacist. You may wish to request information about sperm preservation before starting treatment.

Driving and use of machines

Pemetrexed Prasfarma may cause tiredness. Be cautious when driving or operating machinery.

Pemetrexed Prasfarma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per vial; essentially, it is “sodium-free”.

3. How to use Pemetrexed Prasfarma

The dose of Pemetrexed Prasfarma is 500 milligrams per square meter of your body surface area. Your height and weight will be measured to calculate your body surface area. Your doctor will use this surface area to determine the correct dose for you. This dose may be adjusted or the treatment may be delayed depending on your blood cell counts and your general condition. The hospital pharmacist, nurse, or doctor will have mixed the Pemetrexed Prasfarma powder with a sodium chloride 9 mg/ml (0.9%) injection solution before administration.

Pemetrexed Prasfarma is always administered to you as an intravenous infusion (drip) into one of your veins. The infusion will last at least 10 minutes.

When using Pemetrexed Prasfarma in combination with cisplatin:

Your doctor or hospital pharmacist will calculate the dose you require based on your height and weight. Cisplatin is also administered by intravenous infusion and is given approximately 30 minutes after the Pemetrexed Prasfarma infusion has finished. The cisplatin infusion lasts approximately two hours.

You will normally receive your infusion once every three weeks.

Additional medication:

Corticosteroids: Your doctor will prescribe steroid tablets (equivalent to 4 milligrams of dexamethasone twice daily) to be taken the day before, the day of, and the day after treatment with Pemetrexed Prasfarma. Your doctor prescribes this medication to reduce the frequency and severity of skin reactions you may experience during your cancer treatment.

Vitamin supplement: Your doctor will prescribe oral folic acid (vitamin) or a multivitamin preparation containing folic acid (350 to 1,000 micrograms) to be taken once daily while you are receiving Pemetrexed Prasfarma. You must take at least five doses during the seven days prior to your first dose of Pemetrexed Prasfarma. You should continue taking folic acid for 21 days after your last dose of Pemetrexed Prasfarma. Additionally, you will receive an injection of vitamin B12 (1,000 micrograms) during the week before administration of Pemetrexed Prasfarma and then approximately every 9 weeks (corresponding to 3 treatment cycles of Pemetrexed Prasfarma). The vitamin B12 and folic acid are given to reduce the

potential toxic effects of cancer treatment.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

You should inform your doctor immediately if you notice any of the following symptoms:

• Fever or infection (frequent): if you have a 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). Infections (sepsis) can be severe and may lead to death.
• If you begin to feel chest pain (frequent) or your heart rate increases (uncommon).
• If you have pain, redness, swelling, or sores in the mouth (very common).
• Allergic reaction: if you develop a rash (very common), burning sensation or itching (common), or fever (common). In rare cases, skin reactions may be severe and may be fatal. Contact your doctor if you experience severe rash, itching, or blistering (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• If you feel tired or dizzy, are short of breath, or appear pale (due to lower than normal hemoglobin levels, which is very common).
• If you experience bleeding from gums, nose, or mouth, or any bleeding that does not stop, pink or red urine, or unexpected bruising (due to lower than normal platelet counts, which is very common).
• If you suddenly experience difficulty breathing, severe chest pain, or coughing up blood (uncommon) (this may indicate a blood clot in the lung veins).

Adverse effects with Pemetrexed Prasfarma may include:

Very common (may affect more than 1 in 10 people)

• Low white blood cell count
• Low hemoglobin levels (anemia)
• Low platelet count
• Diarrhea
• Vomiting
• Pain, redness, swelling, or sores in the mouth
• Nausea
• Loss of appetite
• Asthenia (tiredness)
• Skin rash
• Hair loss
• Constipation
• Loss of sensation
• Kidney: changes in blood tests

Common (may affect up to 1 in 10 people)

• Allergic reaction: rash / burning or itching sensation
• Infection including sepsis
• Fever
• Dehydration
• Kidney failure
• Skin irritation and itching
• Chest pain
• Muscle weakness
• Conjunctivitis (eye inflammation)
• Upset stomach
• Abdominal pain
• Changes in taste sensation
• Liver: changes in blood tests
• Watery eyes
• Increased skin pigmentation

Uncommon (may affect up to 1 in 100 people)

• Acute kidney failure
• Increased heart rate
• Inflammation of the esophageal mucosa (throat) following combination of Pemetrexed Prasfarma and radiotherapy.
• Colitis (inflammation of the mucosa of the large intestine, which may be accompanied by intestinal or rectal bleeding).
• Interstitial pneumonitis (hardening of the walls of the lung alveoli).
• Edema (excess fluid in body tissues causing swelling).
• Some patients have experienced heart attack, embolism, or "mini-embolism" while receiving Pemetrexed Prasfarma, usually in combination with another anticancer treatment. Pancytopenia: a combination of low white blood cell, red blood cell, and platelet counts. Radiation pneumonitis (scarring of the air sacs in the lung associated with radiotherapy) may occur in patients receiving radiation either before, during, or after treatment with Pemetrexed Prasfarma.
• Pain in the limbs, low body temperature, and changes in skin color have been reported.
• Blood clots in the lung veins (pulmonary embolism).

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

• Delayed skin toxicity (skin rash resembling a severe sunburn) that may appear in skin previously exposed to radiation, occurring days to years after radiation exposure.
• Bullous disorders (skin diseases with blister formation), including Stevens-Johnson syndrome and toxic epidermal necrolysis.
• Immune-mediated hemolytic anemia (destruction of red blood cells by antibodies).
• Hepatitis (liver inflammation).
• Anaphylactic shock (severe allergic reaction).

Frequency not known: frequency cannot be estimated from available data

Swelling of the lower limbs with pain and redness.

Increased urinary excretion.

Thirst and increased water intake.

Hypernatremia: elevated sodium levels in blood.

Skin inflammation, mainly in the lower limbs, with swelling, pain, and redness.

You may experience one or more of these symptoms and/or conditions. You should inform your doctor as soon as you begin to experience any of these adverse effects.

If you are concerned about any adverse effect, consult your doctor.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pemetrexed Prasfarma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and on the vial label after EXP.

This medicine does not require any special storage conditions.

Reconstituted solution and infusion solution: the medicine should be used immediately. When prepared as recommended, the chemical and physical in-use stability of the reconstituted solution and the infusion solution is 24 hours under refrigeration.

This medicine is for single use only. Any unused solution must be discarded according to local requirements for cytotoxic agents.

This medicine must not be used if the solution contains any particles.

This medicine is for single use only.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Pemetrexed Prasfarma

The active substance is pemetrexed.

Pemetrexed Prasfarma 100 mg: Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).

After reconstitution, the solution contains 25 mg/ml of pemetrexed. A further dilution must be performed by a healthcare professional prior to administration.

The other component is mannitol (E-421).

Appearance of the product and pack contents

Pemetrexed Prasfarma is a lyophilised powder for concentrate for solution for infusion in a glass vial. It is a white to pale yellow or greenish-yellow lyophilised powder.

Each pack of Pemetrexed Prasfarma contains one vial.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

PRASFARMA, S.L.U.

C/ Sant Joan 11-15

08560 Manlleu (Barcelona)

Spain

Manufacturer

PRASFARMA, S.L.U.

C/ Sant Joan 11-15

08560 Manlleu (Barcelona)

Spain

Date of the most recent review of this summary: January 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

This information is intended for healthcare professionals only:

Instructions for use, handling, and disposal

1. Use aseptic techniques during reconstitution and subsequent dilution of pemetrexed for administration by intravenous infusion.

2. Calculate the required dose and number of Pemetrexed Prasfarma vials needed. Each vial contains an overage of pemetrexed to facilitate administration of the required nominal amount.

3. Reconstitute each 100 mg vial with 4.2 ml of 0.9 % sodium chloride injection solution (9 mg/ml), preservative-free, to obtain a solution containing 25 mg/ml of pemetrexed.

Gently swirl the vial until the powder is completely dissolved. The resulting solution is clear, with a colour range varying from colourless to yellow or greenish-yellow, without negatively affecting the product quality. The pH of the reconstituted solution is between 6.7 and 7.8. Further dilution is required.

1. The appropriate volume of the reconstituted pemetrexed solution should be diluted to 100 ml with 0.9 % sodium chloride injection solution (9 mg/ml), preservative-free, and administered as a 10-minute intravenous infusion.

2. The pemetrexed infusion solution prepared as described above is compatible with polyvinyl chloride and polyolefin infusion bags and systems. Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer's injection and Ringer's injection.

3. Parenteral medicines should be visually inspected for particulate matter and discoloration prior to administration. If particulate matter is observed, the medicine must not be administered.

4. Pemetrexed solutions are for single use only. Unused medicine and materials must be disposed of according to local requirements for cytotoxic agents.

Precautions in preparation and administration: As with any other potentially toxic antineoplastic agent, special care should be taken in handling and preparing pemetrexed infusion solutions. The use of gloves is recommended. If pemetrexed solutions come into contact with the skin, wash immediately and thoroughly with soap and water. If pemetrexed solutions come into contact with mucous membranes, rinse thoroughly with water.

Pemetrexed is not a vesicant. There is no specific antidote for pemetrexed extravasation. Cases of pemetrexed extravasation have been reported, none of which were considered serious by the investigator. Extravasation should be managed according to standard clinical practice for non-vesicant drugs.