Label: information for the user

Pemetrexed Glenmark 10 mg/ml infusion solution

Read this label carefully before you start using this medicine, because it contains important information for you.

-Keep this label, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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. Storage of Pemetrexed Glenmark

6. Contents of the pack and additional information

Pemetrexed is a medication used for the treatment of cancer.

This medication may be administered in combination with cisplatin, another anticancer medication, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lung lining, in patients who have not received prior chemotherapy.

Pemetrexed may also be administered in combination with cisplatin for the initial treatment of patients with advanced stages of lung cancer.

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

Pemetrexed may also be administered for the treatment of patients with advanced stage lung cancer whose disease has progressed, who have already received initial chemotherapy treatment.

Do not use Pemetrexed Glenmark

-if you areallergic (hypersensitive) to pemetrexed or any of the other components of this medication (listed in section 6).

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

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

Warnings and precautions

Consult your doctor or hospital pharmacist before starting to use Pemetrexed Glenmark.

If you have or have had kidney problems, consult your doctor or hospital pharmacist as it may be possible that you cannot receive pemetrexed.

Before each infusion, you will have to give blood samples to evaluate if your renal and hepatic function is sufficient and to check that 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 ensure that you are properly hydrated and receive the appropriate treatment before and after receiving cisplatin to prevent vomiting.

If you have received or are to receive radiation therapy, please consult your doctor, as it may cause an early or late radiation reaction with pemetrexed.

If you have recently been vaccinated, please consult your doctor, as it may cause a negative effect with pemetrexed.

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

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

Children and adolescents

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

Other medications and Pemetrexed Glenmark

Inform your doctor or pharmacist if you are taking, have taken recently or may take any other medication, including those purchased without a prescription. Please consult your doctor if you are taking any pain or anti-inflammatory medication (such as non-steroidal anti-inflammatory drugs or NSAIDs), including those purchased 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 renal function, your doctor should advise you on which medications you can use and when. If you are unsure, consult your doctor or pharmacist to see if any medication you are taking is an NSAID.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you may be pregnant or intend to become pregnant, consult your doctor before using this medication. The use of pemetrexed should be avoided during pregnancy. Your doctor will inform you of the possible risks of using pemetrexed during pregnancy. Women should use effective contraceptive methods during treatment and for 6 months after the last dose of pemetrexed.

Breastfeeding

If you are breastfeeding, inform your doctor.

Breastfeeding should be stopped during treatment with pemetrexed.

Fertility

Men are advised not to father a child during and for 3 months after treatment with pemetrexed and should use effective contraceptive methods during and for 3 months after treatment with pemetrexed. If you wish to have a child during treatment or in the 3 months following treatment, please consult your doctor or pharmacist.Due to the possibility of pemetrexed treatment causing infertility, it is recommended that male patients seek advice on the possibility of visiting a sperm bank before starting treatment.

Driving and operating machinery

Pemetrexed may cause fatigue. Be careful if you drive a car or use machines.

Pemetrexed Glenmark contains sodium

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

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

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

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

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

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

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

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

This medication is a ‘Ready-to-Use Solution’ for infusion and should not be diluted further. This may lead to a significant underdosing in patients.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.No reconstitution is necessary before administration.

The recommended dose of pemetrexed is 500 milligrams per square meter of your body surface. Your height and weight will be measured to calculate your body surface. Your doctor will use this body surface to calculate the correct dose for you. This dose may be adjusted, or treatment may be delayed depending on your blood cell count and overall condition.

You will always receive pemetrexed by infusion through one of your veins. The infusion will last approximately 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 administered by infusion through one of your veins and is administered approximately 30 minutes after you have completed the pemetrexed infusion. The cisplatin infusion will last approximately two hours.

You should normally receive your infusion once every three weeks.

Additional Medication:

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

Vitamin Supplement: Your doctor will prescribe oral folic acid (vitamin) or a multivitamin complex containing folic acid (350 to 1,000 micrograms) that you should take once a day while using pemetrexed. You should take at least five doses during the seven days before the first dose of pemetrexed. You should continue taking folic acid for 21 days after the last dose of pemetrexed. Additionally, you will receive an injection of vitamin B12 (1,000 micrograms) the week before pemetrexed administration and approximately every 9 weeks (corresponding to 3 treatment cycles with pemetrexed). Vitamin B12 and folic acid are given to reduce possible toxic effects of cancer treatment.

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

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

You must 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 (since you may have fewer white blood cells than normal, which is very frequent). Infections (sepsis) can be severe and cause death.

•If you start feeling chest pain (frequent) or your heart rate is faster (rare).

•If you have pain, redness, swelling, or sores in your mouth (very frequent).

•Allergic reaction: if you develop hives (very frequent) / burning or itching sensation (frequent), or fever (frequent). In rare cases, skin reactions can be severe and cause death. Contact your doctor if you present severe rash, or itching, or blistering (Stevens-Johnson syndrome or toxic epidermal necrolysis).

•If you experience fatigue, dizziness, if you lack breath, or if you are pale (since you may have fewer hemoglobin than normal, which is very frequent).

•If you experience bleeding gums, nose, or mouth, or any bleeding that does not stop, pink or red urine, unexpected bruises (since you may have fewer platelets than normal, which is frequent).

•If you experience sudden difficulty breathing, intense chest pain, or coughing up blood (rare) (it may indicate that there is a blood clot in the pulmonary veins).

The side effects of pemetrexed may include:

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

Infection • Pharyngitis (sore throat) • Low number of neutrophil granulocytes (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 test results showing reduced kidney function • Fatigue (tiredness).

Frequent(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 • Fluid loss • Taste alterations • Motor nerve damage that can cause muscle weakness and atrophy (debilitating) mainly in arms and legs • Sensory nerve damage that can cause numbness, burning pain, and unstable gait • Dizziness • Conjunctival inflammation or swelling (membrane covering the eyelids and the white part of the eye) • Dry eyes • Watery eyes • Dry conjunctiva (membrane covering the eyelids and the white part of the eye) and 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 (condition affecting the heart's pumping ability) • Irregular heart rhythm • Indigestion • Constipation • Abdominal pain • Liver: Increased substances in the blood produced by the liver • Increased skin pigmentation • Itching skin • Rash on the body where each lesion resembles a target • Hair loss • Urticaria • Kidney failure • Kidney failure • Fever • Reduced kidney function • Pain • Excess fluid in the body tissue, causing swelling • Chest pain • Inflammation and ulceration of the mucous membranes covering the digestive tract.

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

• Red blood cell destruction • Anaphylactic shock (severe allergic reaction) • Inflammatory liver disease • Skin redness • Rash on the skin that develops 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 severe skin and mucous membrane reaction that can be life-threatening) • Toxic epidermal necrolysis (a severe skin reaction that can be fatal) • Autoimmune disorder causing skin eruptions and blisters on the legs, arms, and abdomen • Skin inflammation characterized by the presence of blisters filled with fluid • Skin fragility, blisters, and erosions, and scars on the skin • Redness, pain, and swelling mainly in the lower limbs • Skin and subcutaneous fat inflammation (pseudocelulitis) • Skin inflammation (dermatitis) • The skin becomes inflamed, itches, becomes red, cracks, and becomes rough • Intensely itchy spots.

Frequency unknown(frequency cannot be estimated from available data):

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

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label and on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

This medication is for single use; unused solution must be disposed of according to local regulations.

Pemetrexed Glenmark Composition

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

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

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

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

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

• The other components are mannitol, sodium chloride, L-cysteine hydrochloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injection preparations.

Product Appearance and Packaging Contents

Pemetrexed Glenmark is a transparent, colorless to pale yellow-green solution.

Pemetrexed Glenmark is available in glass vials composed of a chlorobutyl rubber stopper coated with fluorotec gray-black and sealed with a blue flip-off type foil.

Each package of Pemetrexed Glenmark contains one vial.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell,

Germany

Responsible Manufacturer:

Apis labor GmbH

Resslstraße 9,

Ebenthal, 9065, Austria.

For further information about this medication, please contact the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

This medication is authorized in the European Economic Area member states with the following names:

Germany:Pemetrexed Glenmark 10 mg/ml Infusionslösung

Spain:Pemetrexed Glenmark 10 mg/ml Solución para perfusión

Last review date of this prospectus:January 2023

Further detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).