Pemetrexed Glenmark 10 mg/ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pemetrexed Glenmark 10 mg/ml solution for infusion

Read the entire leaflet carefully before you start using 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 or pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Pemetrexed is a medicine used to treat cancer.

This medicine 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 previous chemotherapy.

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

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

2. What you need to know before using Pemetrexed Glenmark

Do not use Pemetrexed Glenmark

• if you are allergic (hypersensitive) to pemetrexed or to any of the other ingredients of this medicine (listed in section 6).

-if you are breastfeeding; you must interrupt breastfeeding during treatment with pemetrexed.

-if you have recently received or are due to receive the yellow fever vaccine.

Warnings and precautions

Talk to your doctor or hospital pharmacist before starting Pemetrexed Glenmark.

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

Before each infusion, you will need to provide blood samples to assess whether your kidney and liver function are adequate and to check that you have enough blood cells to receive pemetrexed. Your doctor may decide to adjust 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 ensure that you are properly hydrated and that you receive appropriate treatment before and after receiving cisplatin to prevent vomiting.

If you have received or are due to receive radiotherapy, please consult your doctor, as pemetrexed may cause an early or delayed radiation reaction.

If you have recently been vaccinated, please consult your doctor, as this may potentially cause adverse effects with pemetrexed.

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.

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 of age.

Other medicines and Pemetrexed Glenmark

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Please consult your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called "non-steroidal anti-inflammatory drugs" (NSAIDs), including those obtained without a prescription (such as ibuprofen). There are many types of NSAIDs with different durations of action. Depending on the scheduled date for your pemetrexed infusion and/or your kidney function status, your doctor should advise you on which medicines you may use 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, lansoprazol, pantoprazole, and rabeprazole) used to treat stomach acid and acid reflux.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. The use of pemetrexed should be avoided during pregnancy. Your doctor will inform you about the potential risks of using pemetrexed during pregnancy. Women must use effective contraception during treatment and for 6 months after the last dose of pemetrexed.

Breastfeeding

If you are breastfeeding, inform your doctor.

Breastfeeding must be interrupted during treatment with pemetrexed.

Fertility

Male patients are warned not to father a child during and for 3 months after treatment with pemetrexed, and therefore must use effective contraception during and for 3 months after treatment with pemetrexed. If you wish to father a child during treatment or within 3 months after treatment, seek advice from your doctor or pharmacist. Due to the possibility that pemetrexed treatment may cause infertility, male patients are advised to seek counseling about the possibility of visiting a sperm bank before starting treatment.

Driving and using machines

Pemetrexed may cause tiredness. Be cautious if driving or using machines.

Pemetrexed Glenmark contains sodium

Pemetrexed Glenmark 10 mg/ml solution for infusion (100 mg/10 ml)

This medicine contains 90 mg of sodium (main component of table salt/cooking salt) per vial. This corresponds to 4.5% of the maximum daily recommended sodium intake for an adult.

Pemetrexed Glenmark 10 mg/ml solution for infusion (500 mg/50 ml)

This medicine contains 450 mg of sodium (main component of table salt/cooking salt) per vial. This corresponds to 22.5% of the maximum daily recommended sodium intake for an adult.

Pemetrexed Glenmark 10 mg/ml solution for infusion (850 mg/85 ml)

This medicine contains 765 mg of sodium (main component of table salt/cooking salt) per vial. This corresponds to 38.3% of the maximum daily recommended sodium intake for an adult.

Pemetrexed Glenmark 10 mg/ml solution for infusion (1000 mg/100 ml)

This medicine contains 900 mg of sodium (main component of table salt/cooking salt) per vial. This corresponds to 45% of the maximum daily recommended sodium intake for an adult.

3. How to use Pemetrexed

This medicine is a ‘ready-to-use solution’ for infusion and must not be further diluted. Further dilution may lead to significant underdosing in patients.

Always follow exactly the instructions given by your doctor for administering this medicine. If in doubt, consult your doctor again. No reconstitution is required prior to administration.

The recommended dose of pemetrexed is 500 milligrams per square metre 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 determine the correct dose for you. This dose may be adjusted, or treatment may be delayed, depending on your blood cell counts and your general condition.

Pemetrexed will always be administered to you by intravenous infusion. The infusion will last approximately 10 minutes.

When pemetrexed is used in combination with cisplatin:

The hospital doctor or pharmacist will calculate the appropriate dose based on your height and weight. Cisplatin is also administered by intravenous infusion and is given approximately 30 minutes after the pemetrexed infusion has finished. The cisplatin infusion will last 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 your pemetrexed treatment. This medicine is given to reduce the frequency and severity of skin reactions you may experience during your anticancer 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. You must take at least five doses during the seven days prior to your first dose of pemetrexed. You should continue taking folic acid for 21 days after your last dose of pemetrexed. In addition, you will receive an injection of vitamin B12 (1,000 micrograms) during the week before the first administration of pemetrexed, and then approximately every 9 weeks (corresponding to 3 treatment cycles of pemetrexed). Vitamin B12 and folic acid are administered to reduce potential toxic effects of anticancer treatment.

If you have any further questions about the use of this medicine, 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 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 common). Infections (sepsis) can be severe and may cause 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 serious and may cause death. Contact your doctor if you develop a severe rash, intense itching, or blisters (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• If you experience fatigue, dizziness, shortness of breath, or paleness (as you may have lower hemoglobin levels than normal, which is very common).
• If you experience bleeding from gums, nose or mouth, or any bleeding that does not stop, red or pink urine, or unexpected bruising (as you may have fewer platelets than normal, which is common).
• If you suddenly experience difficulty breathing, severe chest pain, or coughing up blood (uncommon) (this may indicate a blood clot in the veins of the lungs).

Adverse effects with pemetrexed may include:

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

Infection • Pharyngitis (sore throat) • Low neutrophil granulocyte count (a type of white blood cell) • Low white blood cell count • Low hemoglobin levels • Pain, redness, swelling, or sores in the mouth • Loss of appetite • Vomiting • Diarrhea • Nausea • Skin rash • Skin peeling • Abnormal blood tests showing reduced kidney function • Fatigue (tiredness).

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

• Blood infection • Fever with low neutrophil granulocyte count (a type of white blood cell) • Low platelet count • Allergic reaction • Loss of body fluids • Changes in taste sensation • Motor nerve damage that may cause muscle weakness and atrophy (mainly in arms and legs) • Sensory nerve damage that may cause loss of sensation, burning pain, and unsteady gait • Dizziness • Inflammation or swelling of the conjunctiva (the membrane lining the eyelids and covering the white part of the eye) • Dry eyes • Watery eyes • Dryness of the conjunctiva (the membrane lining the eyelids and covering the white part of the eye) and cornea (transparent layer covering the iris and pupil) • Eyelid swelling • Eye disorder with dryness, tearing, irritation, and/or pain • Heart failure (a condition affecting the pumping ability of the heart muscles) • Irregular heartbeat • Indigestion • Constipation • Abdominal pain • Liver: Increased levels of liver-produced chemicals in the blood • Increased skin pigmentation • Itching of the skin • Rash in which each lesion resembles a target • Hair loss • Hives • Kidney failure • Kid0ney failure • Fever • Reduced kidney function • Pain • Fluid accumulation in body tissues, 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 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) • Infarction • Narrowing or blockage of coronary arteries • Increased heart rate • Poor blood circulation to the extremities • Blockage in one of the pulmonary arteries in the lungs • Inflammation and scarring of the lung lining causing breathing problems • Bright red blood loss through the anus • Bleeding in the gastrointestinal tract • Intestinal perforation • Inflammation of the esophageal lining • Inflammation of the lining of the large intestine, which may be accompanied by intestinal or rectal bleeding (seen only in combination with cisplatin) • Inflammation, edema, erythema, and erosion of the esophageal mucosal surface caused by radiotherapy • Lung inflammation 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 • Skin rash developing in a previously irradiated area.

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

• Skin and soft tissue infections • Stevens-Johnson syndrome (a serious type of skin and mucous membrane reaction that may be life-threatening) • Toxic epidermal necrolysis (a serious type of skin reaction that may be fatal) • Autoimmune disorder causing skin rashes and blisters on legs, arms, and abdomen • Skin inflammation characterized by fluid-filled blisters • Skin fragility, blistering, erosions, and scarring of the skin • Redness, pain, and swelling mainly in the lower limbs • Inflammation of the skin and underlying fat (pseudocellulitis) • Skin inflammation (dermatitis) • Skin becomes inflamed, itchy, red, cracked, and rough • Intensely itchy spots.

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

A type of diabetes mainly caused by kidney disease • Kidney disorder involving death of the tubular epithelial cells forming the renal tubules.

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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 the carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicine in the infusion bag: this medicine must be used immediately. The chemical and physical in-use stability of the pemetrexed solution is 24 hours at room temperature or when refrigerated.

This medicine is for single use only; any unused solution must be discarded according to local requirements.

6. Contents of the pack and other information

Composition of Pemetrexed Glenmark

• The active substance is pemetrexed. Each ml contains 10 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).

Each 10 ml vial contains pemetrexed disodium hemipentahydrate equivalent to 100 mg of pemetrexed.

Each 50 ml vial contains pemetrexed disodium hemipentahydrate equivalent to 500 mg of pemetrexed.

Each 85 ml vial contains pemetrexed disodium hemipentahydrate equivalent to 850 mg of pemetrexed.

Each 100 ml vial contains pemetrexed disodium hemipentahydrate equivalent to 1000 mg of pemetrexed.

• The other components are mannitol, sodium chloride, L-cysteine hydrochloride, sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH), and water for injections.

Nature of the product and pack contents

Pemetrexed Glenmark is a clear solution, colourless to pale yellow - greenish yellow.

Pemetrexed Glenmark is available in glass vials closed with a greyish dark rubber stopper made of chlorobutyl rubber coated with FluroTec and sealed with a blue flip-off aluminum cap.

Each pack of Pemetrexed Glenmark contains one vial.

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Pemetrexed Glenmark 10 mg/ml Infusionslösung

Spain: Pemetrexed Glenmark 10 mg/ml Solution for infusion

Date of the most recent review of this leaflet: April 2025

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