Pemetrexed Fresenius Kabi
·
- Prescription status not stated
- Cancer treatments and immune-system medicines
- Active substance
- Pemetrexed
- Made by
- Fresenius Kabi Deutschland GmbH
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Pemetrexed Fresenius Kabi is a medicine used in the treatment of cancer.
- Pemetrexed Fresenius Kabi is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.
- Pemetrexed Fresenius Kabi is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
- Pemetrexed Fresenius Kabi can be prescribed to you if you have lung cancer at an advanced stage if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy.
- Pemetrexed Fresenius Kabi is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
From the package leaflet in EMA’s product information, p. 76 · 2025-02-12
Do not take it if
- if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
- if you are breast-feeding; you must discontinue breast-feeding during treatment with Pemetrexed Fresenius Kabi.
- if you have recently received or are about to receive a vaccine against yellow fever.
From the package leaflet in EMA’s product information, p. 76.
How to take it
These directions are for this exact strength and form. Another one is different.
- The dose of Pemetrexed Fresenius Kabi is 500 milligrams for every square metre of your body’s surface area. Your height and weight are measured to work out the surface area of your body. Your doctor will use this body surface area to work out the right dose for you. This dose may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition. A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed Fresenius Kabi powder with 5% glucose intravenous infusion before it is given to you.
- You will always receive Pemetrexed Fresenius Kabi by infusion into one of your veins. The infusion will last approximately 10 minutes.
- When using Pemetrexed Fresenius Kabi in combination with cisplatin:
- The doctor or hospital pharmacist will work out the dose you need based on your height and weight.
- Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Fresenius Kabi has finished. The infusion of cisplatin will last approximately 2 hours.
- You should usually receive your infusion once every 3 weeks.
- Additional medicines:
- Corticosteroids: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after Pemetrexed Fresenius Kabi treatment. This medicine is given to you to reduce the frequency and severity of skin reactions that you may experience during your anticancer treatment.
- Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are taking Pemetrexed Fresenius Kabi. You must take at least 5 doses during the seven days before the first dose of Pemetrexed Fresenius Kabi. You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Fresenius Kabi. You will also receive an injection of vitamin B (1000 micrograms) in the week before administration of Pemetrexed Fresenius Kabi and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Fresenius Kabi treatment).
- Vitamin B and folic acid are given to you to reduce the possible toxic effects of the anticancer treatment.
- If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
From the package leaflet in EMA’s product information, p. 78.
Warnings and precautions
- Talk to your doctor or hospital pharmacist before receiving Pemetrexed Fresenius Kabi.
- If you currently have or have previously had problems with your kidneys, talk to your doctor or hospital pharmacist as you may not be able to receive Pemetrexed Fresenius Kabi.
- Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive Pemetrexed Fresenius Kabi. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. If you are also receiving cisplatin, your doctor will make sure that you are properly hydrated and receive appropriate treatment before and after receiving cisplatin to prevent vomiting.
- If you have had or are going to have radiation therapy, please tell your doctor, as there may be an early or late radiation reaction with Pemetrexed Fresenius Kabi.
- If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with Pemetrexed Fresenius Kabi.
- If you have heart disease or a history of heart disease, please tell your doctor.
- If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you Pemetrexed Fresenius Kabi.
- Children and adolescents This medicine should not be used in children or adolescents, since there is no experience with this medicine in children and adolescents under 18 years of age.
From the package leaflet in EMA’s product information, p. 77.
Pregnancy and breastfeeding
- If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor. The use of Pemetrexed Fresenius Kabi should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Pemetrexed Fresenius Kabi during pregnancy. Women must use effective contraception during treatment with Pemetrexed Fresenius Kabi and for 6 months after receiving the last dose.
- Breast-feeding If you are breast-feeding, tell your doctor.
- Breast-feeding must be discontinued during treatment with Pemetrexed Fresenius Kabi.
- Fertility Men are advised not to father a child during and up to 3 months following treatment with Pemetrexed Fresenius Kabi and should therefore use effective contraception during treatment with Pemetrexed Fresenius Kabi and for up to 3 months afterwards. If you would like to father a child during the treatment or in the 3 months following receipt of treatment, seek advice from your doctor or pharmacist. Pemetrexed Fresenius Kabi can affect your ability to have children. Talk to your doctor to seek advice about sperm storage before starting your therapy.
From the package leaflet in EMA’s product information, p. 77–78.
Other medicines
- Tell your doctor if you are taking, have recently taken or might take any medicine for pain or inflammation (swelling), such as medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor’s prescription (such as ibuprofen). There are many sorts of NSAIDs with different durations of activity. Based on the planned date of your infusion of Pemetrexed Fresenius Kabi and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them. If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
- Please inform your doctor if you are taking medicines called proton pump inhibitors (omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole) used to treat heartburn and acid regurgitation.
- Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
From the package leaflet in EMA’s product information, p. 77.
Driving and using machines
Pemetrexed Fresenius Kabi may make you feel tired. Be careful when driving a car or using machines.
From the package leaflet in EMA’s product information, p. 78.
Side effects
- Like all medicines, this medicine can cause side effects, although not everybody gets them.
- You must contact your doctor immediately if you notice any of the following:
- Fever or infection (respectively, common or very common): if you have a temperature of 38ºC or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common). Infection (sepsis) may be severe and could lead to death.
- If you start feeling chest pain (common) or having a fast heart rate (uncommon).
- If you have pain, redness, swelling or sores in your mouth (very common).
- Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common). Rarely, skin reactions may be severe and could lead to death.
- Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis).
- If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
- If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is common).
- If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon) (may indicate a blood clot in the blood vessels of the lungs)
- Other side effects with pemetrexed may include:
- Very common (may affect more than 1 in 10 people)
- Infection Pharyngitis (a sore throat)
- Low number of neutrophil granulocytes (a type of white blood cell)
- Low white blood cells Low haemoglobin level Pain, redness, swelling or sores in your mouth Loss of appetite Vomiting Diarrhoea Nausea Skin rash Flaking skin Abnormal blood tests showing reduced functionality of kidneys Fatigue (tiredness)
- Common (may affect up to 1 in 10 people)
- Blood infection Fever with low number of neutrophil granulocytes (a type of white blood cell)
- Low platelet count Allergic reaction Loss of body fluids Taste change Damage to the motor nerves which may cause muscle weakness and atrophy (wasting) primary in the arms and legs)
- Damage to the sensory nerves that may cause lost of sensation, burning pain and unsteady gait Dizziness Inflammation or swelling of the conjunctiva (the membrane that lines the eyelids and covers the white of the eye Dry eye Watery eyes Dryness of the conjunctiva (the membrane that lines the eyelids and covers the white of the eye) and cornea (the clear layer in front of the iris and pupil.
- Swelling of the eyelids Eye disorder with dryness, tearing, irritation, and/or pain Cardiac Failure (Condition that affects the pumping power of your heart muscles)
- Irregular heart rhythm Indigestion Constipation Abdominal pain Liver: increases in the chemicals in the blood made by the liver Increased skin pigmentation Itchy skin Rash on the body where each mark resembles a bullseye Hair loss Hives Kidney stop working Reduced functionality of kidney Fever 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)
- Reduction in the number of red,white blood cells and platelets Stroke Type of stroke when an artery to the brain is blocked Bleeding inside the skull Angina (Chest pain caused by reduced blood flow to the heart)
- Heart attack Narrowing or blockage of the coronary arteries Increased heart rythm Deficient blood distribution to the limbs Blockage in one of the pulmonary arteries in your lungs Inflammation and scarring of the lining of the lungs with breathing problems Passage of bright red blood from the anus Bleeding in the gastrointestinal tract Ruptured bowel Inflammation of the lining of the oesophagus Inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding (seen only in combination with cisplatin)
- Inflammation, edema, erythema, and erosion of the mucosal surface of the esophagus caused by radiation therapy Inflammation of the lung caused by radiation therapy Rare (may affect up to 1 in 1,000 people)
- Destruction of red blood cells Anaphylactic shock (severe allergic reaction)
- Inflammatory condition of the liver Redness of the skin Skin rash that develops throughout a previously irradiated area Very rare (affect up to 1 of 10 000 people)
- Infections of skin and soft tissues Stevens-Johnson syndrome (a type of severe skin and mucous membranes reaction that may be life threatening)
- Toxic epidermal necrolysis (a type of severe skin reaction that may be life threatening)
- Autoimmune disorder that results in skin rashes and blistering on the legs, arms, and abdomen Inflammation of the skin characterized by the presence of bullae which are filled with fluid Skin fragility, blisters and erosions and skin scarring Redness, pain and swelling mainly of the lower limbs Inflammation of the skin and fat beneath the skin (pseudocellulitis)
- Inflammation of the skin (dermatitis)
- Skin to become inflamed, itchy, red, cracked, and rough Intensely itchy spots Not known (frequency cannot be estimated from the available data)
- Form of diabetes primarily due to pathology of the kidney Disorder of the kidneys involving the death of tubular epithelial cells that form the renal tubules You may have any of these symptoms and/or conditions. You must tell your doctor as soon as possible when you start experiencing any of these side effects.
- If you are concerned about any side effects, talk to your doctor.
- Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
From the package leaflet in EMA’s product information, p. 79–81.
How to store it
- 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 vial label and carton after ‘EXP’.
- The expiry date refers to the last day of that month.
- This medicine does not require any special storage conditions.
- Reconstituted and infusion solutions: The product should be used immediately. When prepared as directed, chemical and physical in-use stability of reconstituted solution of pemetrexed was demonstrated for 24 hours at refrigerated temperature. For infusion solution of pemetrexed, chemical and physical in-use stability was demonstrated for 21 days at refrigerated temperature and 7 days at 25°C.
- This medicine should not be used if there are any signs of particles.
- This medicine is for single use only.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
From the package leaflet in EMA’s product information, p. 81–82.
Other ingredients
Relevant if you react to a dye, a preservative, lactose or gluten.
- The other ingredients are mannitol, hydrochloric acid and trometamol.
- What Pemetrexed Fresenius Kabi looks like and contents of the pack Pemetrexed Fresenius Kabi is a powder for concentrate for solution for infusion in a glass vial. It is a white to off-white lyophilised powder or solid.
- It is available in packs of 1 vial.
From the package leaflet in EMA’s product information, p. 82.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
BulgariaNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Fresenius Kabi Deutschland GmbH |
|---|---|
| Active substance | Pemetrexed |
| Used in | Cancer treatments and immune-system medicines |
| Classification | L01BA04 · Cancer treatments and immune-system medicines |
| Generic | Yes — a generic medicine, according to the register |
| Authorised on | 2016-07-22 |
| Last updated by the regulator | 2025-02-12 |
| EMA product number | EMEA/H/C/003895 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.