Pemetrexed Glenmark

Leaflet accompanying the packaging: information for the user

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

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

Pemetrexed

Read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Pemetrexed Glenmark is a medicine used to treat malignant tumors.
Pemetrexed Glenmark in combination with cisplatin, another anticancer medicine, is used to treat malignant pleural mesothelioma, a type of tumor that affects the lining of the lungs, in patients who have not previously received chemotherapy.
Pemetrexed Glenmark in combination with cisplatin is used as initial treatment in patients with advanced lung cancer.
Pemetrexed Glenmark may be prescribed to patients with lung cancer in advanced stages, in whom a response to treatment has been achieved or whose condition has not significantly changed after initial chemotherapy.
Pemetrexed Glenmark is also used to treat patients with lung cancer in advanced stages, in whom the disease has progressed after initial chemotherapy.

2. Important information before using Pemetrexed Glenmark

When not to use Pemetrexed Glenmark

• in patients who have recently been vaccinated or are to be vaccinated against yellow fever.

Warnings and precautions

Before starting treatment with Pemetrexed Glenmark, discuss it with your doctor, hospital pharmacist, or nurse.
If the patient currently has or has had kidney problems, consult a doctor or hospital pharmacist, as they may not be allowed to take Pemetrexed Glenmark.
Before each infusion, medical staff will take blood samples from the patient to assess whether liver and kidney function is normal and whether there is a sufficient number of blood cells to administer Pemetrexed Glenmark. The doctor may decide to change the dose or delay treatment depending on the patient's overall condition and low blood cell count. If the patient is also taking cisplatin, the doctor will ensure that the patient is properly hydrated and will administer appropriate treatment before and after receiving cisplatin to prevent vomiting.
If the patient has undergone or will undergo radiotherapy, inform the doctor, as an early or delayed radiation reaction may occur after using Pemetrexed Glenmark.
If the patient has recently been vaccinated, inform the doctor, as side effects may occur after administration of Pemetrexed Glenmark.
If the patient has or has had heart disease, inform the doctor.
If fluid accumulates around the patient's lungs, the doctor may decide to perform a procedure to remove the fluid before administering Pemetrexed Glenmark.

Children and adolescents

This medicine should not be used in children and adolescents, as there is no experience with its use in children and adolescents under 18 years of age.

Pemetrexed Glenmark and other medicines

Tell your doctor about all pain and anti-inflammatory medicines (anti-edema) you are taking, such as non-steroidal anti-inflammatory drugs (NSAIDs), including those available without a 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 Glenmark and/or the patient's kidney function, the doctor will provide information on which medicines can be taken and when. In case of doubt about whether the medicines being taken are non-steroidal anti-inflammatory drugs (NSAIDs), consult a doctor or pharmacist.
Inform your doctor if you are taking proton pump inhibitors (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 a prescription.

Pregnancy

If the patient is pregnant, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Pemetrexed Glenmark should not be used during pregnancy. The doctor will inform the patient about the possible risk associated with using the medicine during pregnancy. During treatment with Pemetrexed Glenmark and for 6 months after the last dose, women must use effective contraception.

Breastfeeding

If the patient is breastfeeding, inform the doctor.
During treatment with Pemetrexed Glenmark, breastfeeding should be discontinued.

Effects on fertility

It is recommended that men do not try to conceive a child during treatment and for 3 months after the end of treatment with Pemetrexed Glenmark. Men should use effective contraception during treatment with Pemetrexed Glenmark and for 3 months after the end of treatment. If a man wants to try to conceive a child during treatment with Pemetrexed Glenmark or within 3 months after the end of treatment, he should consult a doctor or pharmacist. Pemetrexed Glenmark may affect fertility. Before starting treatment, patients can consult a doctor about sperm preservation.

Driving and using machines

Pemetrexed Glenmark may cause fatigue. Be careful when driving a car or operating machinery.

Pemetrexed Glenmark contains sodium

Pemetrexed Glenmark, 100 mg, powder for concentrate for solution for infusion
This medicine contains less than 1 mmol (23 mg) of sodium per vial, which means the medicine 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 common salt) per vial, which corresponds to 2.7% of the maximum recommended daily intake of sodium for adults.

3. How to use Pemetrexed Glenmark

The dose of Pemetrexed Glenmark is 500 milligrams per square meter of the patient's body surface area. Based on the measurement of the patient's height and weight, their body surface area is calculated. The doctor will determine the dose of the medicine based on the calculated body surface area. This dose may be adjusted or treatment may be delayed depending on the blood cell count and the patient's overall condition. Before administering Pemetrexed Glenmark, the hospital pharmacist, nurse, or doctor will dissolve the powder in 9 mg/ml (0.9%) sodium chloride injection solution.
Pemetrexed Glenmark is always administered as an intravenous infusion. The infusion will last about 10 minutes.
Using Pemetrexed Glenmark with cisplatin:
The doctor or hospital pharmacist will calculate the dose based on the patient's height and weight. Cisplatin is also administered as an intravenous infusion and is administered about 30 minutes after the end of the Pemetrexed Glenmark infusion. The cisplatin infusion will last about 2 hours.
Usually, the infusion will be performed once every 3 weeks.
Additional medicines:
Corticosteroids: the doctor will prescribe the patient steroids in tablets (in a dose equivalent to 4 milligrams of dexamethasone twice a day), which the patient must take the day before the infusion, the day of the infusion, and the day after the infusion of Pemetrexed Glenmark. This medicine is used to reduce the frequency and severity of skin reactions that may occur during anticancer treatment.
Vitamin supplementation: the doctor will prescribe the patient oral folic acid (vitamin) or a multivitamin product containing folic acid (350 to 1000 micrograms), which should be taken once a day during treatment with Pemetrexed Glenmark. Within 7 days before the first administration of Pemetrexed Glenmark, at least 5 doses of folic acid should be taken. Folic acid intake should be continued for 21 days after the last dose of Pemetrexed Glenmark. In the week before administration of Pemetrexed Glenmark, and then at intervals of about 9 weeks (which corresponds to three cycles of chemotherapy with Pemetrexed Glenmark), patients will also receive vitamin B (1000 micrograms) injections. Vitamin B and folic acid are administered to reduce the possible side effects of anticancer medicines.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of any of the following symptoms, inform your doctor immediately:

• Fever or infection (very common or common): if the patient has a fever of 38°C or higher, sweating, or other signs of infection (because the patient may have fewer white blood cells than usual, which is very common). Infection (sepsis) can be severe and life-threatening.
• If the patient starts to feel chest pain (common) or rapid heartbeat (uncommon).
• If the patient experiences pain, redness, swelling, or ulcers in the mouth (very common).
• Allergic reaction: if the patient experiences a skin rash (very common) or a feeling of burning or stinging (common), or fever (common). Rarely, skin reactions can be severe and life-threatening. Inform your doctor if you experience a severe rash, itching, or blisters (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• If the patient experiences fatigue, fainting, shortness of breath, or paleness (because the patient may have lower hemoglobin levels than normal, which is very common).
• If the patient experiences bleeding from the gums, nose, or mouth, or any bleeding that cannot be stopped, red or pink urine, unexpected bruising (because the patient may have fewer platelets than normal, which is common).
• If the patient experiences 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 Glenmark 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 ulcers in the mouth
Lack of appetite
Vomiting
Diarrhea
Nausea
Skin rash
Peeling skin
Abnormal blood test results indicating impaired 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
Dehydration
Taste disturbances
Neuropathy (nerve damage) that can cause weakness and atrophy (wasting) of muscles, mainly in the arms and legs
Neuropathy (nerve damage) that can 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 of the eye)
Dry eyes
Tearing eyes
Dry conjunctiva (the membrane lining the eyelids and covering the white of the eye) and cornea (the transparent layer on the front of the iris and pupil)
Swelling of the eyelids
Eye disorders with dryness, tearing, irritation, and/or pain
Heart failure (a condition that causes weakness of the heart's pumping power)
Irregular heartbeat
Nausea
Constipation
Abdominal pain
Liver: increased levels of substances produced by the liver in the blood
Increased skin pigmentation
Itching skin
Rash on the body with ring-shaped lesions resembling a target
Hair loss
Hives
Kidney failure
Impaired kidney function
Fever
Pain
Excessive fluid in the body's tissues causing swelling
Chest pain
Inflammation and ulcers of the mucous membranes lining the digestive tract
Uncommon (may affect up to 1 in 100 people)
Decreased red blood cell, white blood cell, and platelet count
Stroke
A type of stroke in which a blood vessel supplying blood to the brain becomes blocked
Bleeding in the brain
Chest pain caused by reduced blood flow to the heart (angina)
Heart attack
Narrowing or blockage of the coronary arteries
Increased heart rate
Insufficient blood flow to the limbs
Blockage of one of the pulmonary arteries in the lungs
Inflammation and scarring of the membrane lining the lungs with breathing difficulties
Blood in the stool
Gastrointestinal bleeding
Rupture of the intestinal wall
Inflammation of the membrane lining the esophagus
Inflammation of the membrane lining the large intestine, which may be accompanied by bleeding from the intestines or rectum (observed only in combination with cisplatin)
Inflammation, swelling, redness, and ulcers of the mucous membrane of the esophagus caused by radiotherapy
Radiation-induced lung inflammation
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 appearing on the skin in the area previously irradiated
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 life-threatening)
Autoimmune disorders, resulting in a rash and blistering lesions on the skin of the legs, arms, and abdomen
Inflammation of the skin characterized by the presence of fluid-filled blisters
Skin fragility, blisters, and scarring
Redness, pain, and swelling, mainly of the lower limbs
Inflammation of the skin and subcutaneous fatty tissue (pseudosclerotic panniculitis)
Skin inflammation (dermatitis)
Inflammation, itching, redness, cracking, and roughness of the skin
Severe itching skin lesions
Frequency not known (frequency cannot be estimated from the available data)
A type of diabetes caused mainly by kidney disease
Kidney disorders, resulting in the death of kidney tubule epithelial cells
The patient may experience any of these symptoms and/or diseases. Inform your doctor as soon as possible if any of these side effects occur.
Inform your doctor if you are concerned about any of these symptoms.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Pemetrexed Glenmark

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Solutions for infusion after reconstitution: the product should be used immediately. The chemical and physical stability of pemetrexed solutions after reconstitution and for infusion, prepared according to the instructions, has been demonstrated for 48 hours if stored in a refrigerator.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pemetrexed Glenmark contains

The active substance 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. Further dilution by a healthcare professional is required before administration.
The other ingredients are mannitol (E421), hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH).

What Pemetrexed Glenmark looks like and contents of the pack

Pemetrexed Glenmark is a powder for concentrate for solution for infusion available in a vial.
The lyophilized mass or powder is white to light yellow or greenish-yellow in color.
Available pack sizes:
Available in packs of 1 vial in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer/Importer

Apis Labor GmbH
Resslstrasse 9
Zell
Ebenthal In Kaernten
9065 Austria

This medicine 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 polvo para concentrado para solución para perfusión
Pemetrexed Glenmark 500 mg polvo para concentrado para solución para perfusión
Sweden
Pemetrexed Glenmark 100 mg pulver till koncentrat till infusionsvätska, lösning
Pemetrexed Glenmark 500 mg pulver till koncentrat till infusionsvätska, lösning
Norway
Pemetrexed Glenmark 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Pemetrexed Glenmark 500 mg pulver til konsentrat til infusjonsvæske, oppløsning
Denmark
Pemetrexed Glenmark
Finland
Pemetrexed Glenmark 100 mg kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos
Pemetrexed Glenmark 500 mg kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos
Poland
Pemetrexed Glenmark
Italy
Pemetrexed Glenmark 100 mg polvere per concentrato per soluzione per infusione
Pemetrexed Glenmark 500 mg polvere per concentrato per soluzione per infusione

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

Glenmark Pharmaceuticals Sp. z o. o.
ul. Dziekońskiego 3
00-728 Warsaw
Email: poland.receptionist@glenmarkpharma.com
Date of last revision of the leaflet:March 2025
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Information intended for healthcare professionals only:

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

• 1. Reconstitution and further dilution of the pemetrexed solution for intravenous infusion should be performed under aseptic conditions.
• 2. Calculate the required dose and number of vials of Pemetrexed Glenmark. Each vial contains slightly more pemetrexed than stated, which facilitates delivery of the amount specified on the label.
• 3. Pemetrexed Glenmark, 100 mg Reconstitute the contents of the 100 mg vial with 4.2 ml of sodium chloride 9 mg/ml (0.9%) injection solution, resulting in a solution containing 25 mg/ml of pemetrexed.

Pemetrexed Glenmark, 500 mg
Reconstitute the contents of the 500 mg vial with 20 ml of sodium chloride 9 mg/ml (0.9%) injection solution, resulting in a solution containing 25 mg/ml of pemetrexed.
Each vial should be slowly rotated until the powder is completely dissolved. The prepared solution is clear, colorless to yellow or greenish-yellow, which does not affect the quality of the product. The pH value of the solution after reconstitution is between 6.6 and 7.8. The solution must be further diluted.

• 4. The appropriate volume of the reconstituted pemetrexed solution should be further diluted to a volume of 100 ml using sodium chloride 9 mg/ml (0.9%) injection solution, without preservatives, and administered as an intravenous infusion over 10 minutes.

• 5. Solutions for infusion with pemetrexed prepared as described above are compatible with infusion sets and infusion bags with an inner layer made of polyvinyl chloride and polyolefin.
• 6. Medicines for intravenous use should be inspected visually for particulate matter and color changes before administration. If the solution contains visible particles, the medicine should not be administered.
• 7. Pemetrexed solutions are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

Precautions during preparation and administration of the medicine:As with other potentially toxic anticancer medicines, caution should be exercised when handling the medicine and preparing solutions for infusion with pemetrexed. It is recommended to wear gloves. In case of contact with the pemetrexed solution on the skin, wash the skin immediately with soap and water. In case of contact with the pemetrexed solution on the mucous membranes, rinse the area of contact thoroughly with water. Pemetrexed is not a caustic agent. There is no specific antidote in case of accidental administration of pemetrexed outside the vessel. A few cases of accidental administration of pemetrexed outside the vessel have been reported, which were not assessed by investigators as serious. In case of extravasation, follow the applicable guidelines, as with extravasation of other non-vesicant substances.