PEMETREXED GLENMARK 100 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Pemetrexed Glenmark100 mg powder for concentrate for solution for infusion EFG

Pemetrexed Glenmark500 mg powder for concentrate for solution for infusion EFG

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 any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

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

Pemetrexed is a medicine used to treat cancer.

This medicine may be given to you in combination with cisplatin, another anticancer medicine, as a treatment for malignant pleural mesothelioma, a type of cancer that affects the lining of the lungs, in patients who have not received chemotherapy before.

Pemetrexed may also be given to you in combination with cisplatin as an initial treatment for patients with advanced stages of lung cancer.

Pemetrexed may be prescribed for you if you have advanced lung cancer if your disease has responded to treatment or if it remains unchanged after initial chemotherapy.

Pemetrexed may also be given to you for the treatment of patients with advanced stages of lung cancer whose disease has progressed, who have already received other initial chemotherapy treatment.

2. What you need to know before you use Pemetrexed Glenmark

Do not use Pemetrexed Glenmark

• 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.
• if you have recently been given or are going to be given the yellow fever vaccine.

Warnings and precautions

Talk to your doctor or hospital pharmacist before you start using this medicine.

If you have or have had kidney problems, talk to your doctor or hospital pharmacist as you may not be able to receive pemetrexed.

Before each infusion, you will need to give blood samples to check if your kidney and liver function is sufficient and to check if you have enough blood cells to receive pemetrexed. Your doctor may decide to change your dose or delay treatment depending on your general condition and if your blood cell count is too low. If you are also receiving cisplatin, your doctor will make sure you are properly hydrated and receive appropriate treatment before and after receiving cisplatin to prevent vomiting.

If you have received or are going to receive radiotherapy, please talk to your doctor, as a reaction to radiation may occur with pemetrexed.

If you have been vaccinated recently, please talk to your doctor, as this may cause a negative effect with pemetrexed.

If you have a heart condition or a history of heart disease, please talk to your doctor.

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

Children and adolescents

This medicine must not be used in children or adolescents, as there is no experience with this medicine in children and adolescents under 18 years.

Other medicines and Pemetrexed Glenmark

Talk to your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called "non-steroidal anti-inflammatory medicines" (NSAIDs), including those bought without a prescription (such as ibuprofen). There are many classes of NSAIDs with different durations of action. Depending on the scheduled date for your pemetrexed infusion and/or the status of your kidney function, your doctor should advise you on which medicines you can use and when you can take them. If you are unsure, talk to your doctor or pharmacist in case any medicine you are taking is an NSAID.

Tell 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.

Tell your doctor or hospital pharmacist if you are taking, have recently taken, or might take any other medicine, including those bought without a prescription.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

The use of pemetrexed should be avoided during pregnancy. Your doctor will inform you of the possible risks of using pemetrexed during pregnancy. Women must use effective contraceptive methods during treatment and for up to 6 months after the last dose of pemetrexed.

Breastfeeding

If you are breastfeeding, tell your doctor.

Breastfeeding must be stopped during treatment with pemetrexed.

Fertility

Male patients are advised not to father a child during and up to 3 months after treatment with pemetrexed and, therefore, must use effective contraceptive methods during and up to 3 months after treatment with pemetrexed. If you wish to have a child during treatment or in the 3 months following treatment, seek advice from your doctor or pharmacist. Due to the possibility that treatment with pemetrexed may cause infertility, male patients are advised to seek advice on the possibility of going to a sperm bank before starting treatment.

Driving and using machines

Pemetrexed may make you feel tired. Be careful when driving a car or using machines.

Pemetrexed Glenmark contains sodium

Pemetrexed Glenmark 100 mg powder for concentrate for solution for infusion:

This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially "sodium-free".

Pemetrexed Glenmark 500 mg powder for concentrate for solution for infusion:

This medicine contains 54 mg of sodium (a major component of cooking/table salt) in each vial. This is equivalent to 2.7% of the maximum recommended daily intake of sodium for an adult.

3. How to use Pemetrexed Glenmark

The recommended dose of pemetrexed 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 body surface area to calculate the correct dose for you. This dose may be adjusted, or treatment may be delayed depending on your blood cell count and your general condition. The hospital pharmacist, nurse, or doctor will have mixed the pemetrexed powder with a solution of sodium chloride for injection 9 mg/ml (0.9%) before it is given to you.

You will always receive pemetrexed by infusion into one of your veins. The infusion will take about 10 minutes.

When using pemetrexed in combination with cisplatin:

Your doctor or hospital pharmacist will calculate the dose based on your height and weight. Cisplatin is also given by infusion into one of your veins and is given about 30 minutes after the pemetrexed infusion has finished. The cisplatin infusion will take about 2 hours.

You should usually receive your infusion once every 3 weeks.

Additional medication:

Corticosteroids: your doctor will prescribe steroid tablets (equivalent to 4 milligrams of dexamethasone twice a day) that you must take the day before, the day of, and the day after treatment with pemetrexed. This medicine is given to you to reduce the frequency and severity of skin reactions that you may experience during your anticancer treatment.

Vitamin supplement: your doctor will prescribe oral folic acid (vitamin) or a multivitamin that contains folic acid (350 to 1,000 micrograms) that you must take once a day while you are using pemetrexed. You must take at least 5 doses during the 7 days before the first dose of pemetrexed. You must continue taking folic acid during 21 days after the last dose of pemetrexed. In addition, you will receive a vitamin B12 injection (1,000 micrograms) in the week before pemetrexed administration and then approximately every 9 weeks (corresponding to 3 cycles of treatment with pemetrexed). Vitamin B12 and folic acid are given to you to reduce the possible toxic effects of 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.

You must tell your doctor immediately if you notice any of the following:

• Fever or infection (frequent or very frequent, respectively): 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 frequent). Infections (sepsis) can be serious and life-threatening.
• If you start feeling chest pain (frequent) or your heart beats faster (uncommon).
• If you have pain, redness, swelling, or sores in your mouth (very frequent).
• Allergic reaction: if you develop a rash (very frequent) / burning sensation or itching (frequent), or fever (frequent). In rare cases, skin reactions can be serious and life-threatening. Contact your doctor if you develop a severe rash, or itching, or blisters (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• If you feel tired, dizzy, short of breath, or pale (as you may have fewer red blood cells than normal, which is very frequent).
• If you experience bleeding from your gums, nose, or mouth, or any bleeding that does not stop, red or pink urine, unexpected bruising (as you may have fewer platelets than normal, which is frequent).
• If you experience sudden difficulty breathing, severe chest pain, or coughing up blood (uncommon) (may indicate that there is a blood clot in the lungs).

Side effects with pemetrexed may 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 levels
• Pain, redness, swelling, or sores in the mouth
• Lack of appetite
• Vomiting
• Diarrhea
• Nausea
• Rash
• Peeling skin
• Abnormal blood tests showing reduced kidney function
• Fatigue (tiredness)

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

• Blood infection
• Fever with low neutrophil count (a type of white blood cell)
• Low platelet count
• Allergic reaction
• Loss of body fluids
• Changes in taste
• Nerve damage that can cause muscle weakness and wasting (mainly in arms and legs)
• Nerve damage that can cause loss of sensation, burning pain, and unsteady walking
• Dizziness
• Inflammation or swelling of the conjunctiva (membrane covering the eyelids and the white part of the eye)
• Dry eyes
• Watery eyes
• Dryness of the conjunctiva (membrane covering the eyelids and the white part of the eye) and the cornea (transparent layer in front of the iris and pupil)
• Swelling of the eyelids
• Eye disorder with dryness, tearing, irritation, and/or pain
• Heart failure (a condition that affects the heart's pumping ability)
• Irregular heartbeat
• Indigestion
• Constipation
• Abdominal pain
• Liver: increase in chemicals in the blood produced by the liver
• Increased skin pigmentation
• Itching of the skin
• Rash on the body where each lesion looks like a target
• Hair loss
• Hives
• Kidney failure
• Fever
• Reduced kidney function
• Pain
• Excess fluid in body tissue, causing swelling
• Chest pain
• Inflammation and ulceration of the mucous membranes lining the digestive tract

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

• Decrease in the number of red blood cells, white blood cells, and platelets
• Ischemia
• Ischemia due to blockage of a cerebral artery
• Intracranial bleeding
• Angina (chest pain caused by reduced blood flow to the heart)
• Heart attack
• Narrowing or blockage of the coronary arteries
• Increased heart rate
• Poor distribution of blood to the limbs
• Blockage in one of the pulmonary arteries in the lungs
• Inflammation and scarring of the lining of the lungs with breathing difficulties
• Bright red blood loss from the anus
• Bleeding in the gastrointestinal tract
• Perforation of the intestine
• Inflammation of the lining of the esophagus
• Inflammation of the lining of the large intestine, which may be accompanied by intestinal or rectal bleeding (seen only in combination with cisplatin)
• Inflammation, swelling, redness, and erosion of the mucous membrane surface of the esophagus caused by radiotherapy
• Inflammation of the lung caused by radiotherapy

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

• Destruction of red blood cells
• Anaphylactic shock (severe allergic reaction)
• Inflammatory liver disease
• Redness of the skin
• Rash on the skin that develops in a previously irradiated area

Very rare(may affect up to 1 in 10,000 people):

• Infections of the skin and soft tissues
• Stevens-Johnson syndrome (a type of severe skin and mucous membrane reaction that can be life-threatening)
• Toxic epidermal necrolysis (a type of severe skin reaction that can be fatal)
• An autoimmune disorder that causes skin rashes and blisters on the legs, arms, and abdomen
• Inflammation of the skin characterized by the presence of blisters that are filled with fluid
• Frailty of the skin, blisters, and erosions and scarring of the skin
• Redness, pain, and swelling mainly of the lower limbs
• Inflammation of the skin and the fat under the skin (pseudocellulitis)
• Inflammation of the skin (dermatitis)
• The skin becomes inflamed, itchy, red, cracked, and rough
• Itchy patches

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

• A type of diabetes mainly derived from kidney disease
• A kidney disorder that involves the death of the epithelial tubular cells that form the renal tubules

You may experience some of these symptoms and/or situations. You should tell your doctor as soon as you start experiencing any of these side effects.

If you are concerned about any side effect, talk to your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pemetrexed Glenmark

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 and carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Reconstituted and infusion solution: this medicine should be used immediately. When prepared as indicated, the chemical and physical in-use stability of the reconstituted and infusion solution is 48 hours in refrigeration.

This medicine is for single use; the unused solution should be discarded in accordance with local regulations.

6. Container Content and Additional Information

Composition of Pemetrexed Glenmark

The active ingredient is pemetrexed.

• Pemetrexed Glenmark 100 mg: each vial contains pemetrexed disodium heptahydrate equivalent to 100 mg of pemetrexed.
• Pemetrexed Glenmark 500 mg: each vial contains pemetrexed disodium heptahydrate equivalent to 500 mg of pemetrexed.

After reconstitution, the solution contains 25 mg/ml of pemetrexed. Before administration, it is required that the healthcare professional perform another dilution.

The other components are mannitol (E 421), hydrochloric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).

Appearance of the Product and Container Content

Pemetrexed Glenmark is a powder for concentrate for solution for infusion in a vial. It is a white to pale yellow or yellowish-green lyophilized cake or powder.

It is available in packs of 1 vial.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Apis labor GmbH

Resslstraße 9

Ebenthal, 9065

Austria

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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

Germany: Pemetrexed Glenmark 100 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Pemetrexed Glenmark 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Spain: Pemetrexed Glenmark 100 mg powder for concentrate for solution for infusion EFG

Pemetrexed Glenmark 500 mg powder for concentrate for solution for infusion EFG

Sweden: Pemetrexed Glenmark 100 mg powder for concentrate for infusion solution

Pemetrexed Glenmark 500 mg powder for concentrate for infusion solution

Norway: Pemetrexed Glenmark 100 mg powder for concentrate for infusion solution

Pemetrexed Glenmark 500 mg powder for concentrate for infusion solution

Denmark: Pemetrexed Glenmark

Finland: Pemetrexed Glenmark 100 mg dry substance for intermediate concentrate for infusion solution

Pemetrexed Glenmark 500 mg dry substance for intermediate concentrate for infusion solution

Poland: Pemetrexed Glenmark

Italy: Pemetrexed Glenmark 100 mg powder for concentrate for infusion solution

Pemetrexed Glenmark 500 mg powder for concentrate for infusion solution

Date of the last revision of this prospectus:April 2025.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).