Pemetrexed Kelix bio 100 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

Beipackzettel - Pemetrexed Kelix bio 100 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Package leaflet: Information for the user

pemetrexed

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 readit again.
– If you have any further questions, ask your doctor or pharmacist.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Pemetrexed Kelix bio is and what it is used for

Pemetrexed Kelix bio is a medicine used in the treatment of cancer.

Pemetrexed Kelix bio 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 Kelix bio is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.

Pemetrexed Kelix bio 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 Kelix bio is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.

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

– 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

Kelix bio.

– if you have recently received or are about to receive a vaccine against yellow fever.

Warnings and precautions

Talk to your doctor or pharmacist before receiving Pemetrexed Kelix bio

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 Kelix bio.

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 Kelix bio. 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 Kelix bio.

If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with Pemetrexed Kelix bio.

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 Kelix bio.

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.

Other medicines and Pemetrexed Kelix bio

Tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called “non-steroidal 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 Kelix bio 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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. The use of Pemetrexed Kelix bio should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Pemetrexed Kelix bio during pregnancy. Women must use effective contraception during treatment with Pemetrexed Kelix bio.

Breast-feeding

If you are breast-feeding, tell your doctor.

Breast-feeding must be discontinued during Pemetrexed Kelix bio treatment.

Fertility

Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed Kelix bio and should therefore use effective contraception during treatment with Pemetrexed Kelix bio and for up to 6 months afterwards. If you would like to father a child during the treatment or in the 6 months following receipt of treatment, seek advice from your doctor or pharmacist. You may want to seek counselling on sperm storage before starting your therapy.

Driving and using machines

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

Pemetrexed Kelix bio contains sodium

Pemetrexed Kelix bio 100 mg Powder for Concentrate for Solution for Infusion

This medicine contains less than 1 mmol sodium (23 mg) per 100 mg vial, that is to say essentially ‘sodium-free’.

Pemetrexed Kelix bio 500 mg Powder for Concentrate for Solution for Infusion

This medicine contains 54 mg sodium (main component of cooking/table salt) in each 500 mg vial. This is equivalent to 2,7 % of the recommended maximum daily dietary intake of sodium for an adult.

3. How to use Pemetrexed Kelix bio

The dose of Pemetrexed Kelix bio 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 Kelix bio powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.

You will always receive Pemetrexed Kelix bio by infusion into one of your veins. The infusion will last approximately 10 minutes.

When using Pemetrexed Kelix bio 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 Kelix bio 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 milligrams of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after Pemetrexed Kelix bio 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 Kelix bio. You must take at least 5 doses during the seven days before the first dose of Pemetrexed Kelix bio. You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Kelix bio. You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Pemetrexed Kelix bio and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Kelix bio treatment). Vitamin B12 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.

4. Possible 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).

Side effects with Pemetrexed Kelix bio 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 yourmouth
– 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 1000 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 might 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 to the `Federal Institute for Drugs and Medical Devices´ (Bundesinstitut für Arzneimittel und Medizinprodukte), Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, Germany, Website:By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pemetrexed Kelix bio

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

This medicine does not require any special storage conditions.

Reconstituted and diluted infusion solutions:

The product should be used immediately. When prepared as directed, chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature.

Do not use this medicine after the expiry date which is stated on the label and outer carton after “EXP”. The expiry date refers to the last day of that month.

This medicine is for single use only. Any unused solution or waste material must be disposed off in accordance with local requirements.

6. Contents of the pack and other information

Theactive substance is pemetrexed.

Pemetrexed Kelix bio 100 mg

Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium).

Pemetrexed Kelix bio 500 mg

Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium).

After reconstitution, the solution contains 25 mg/ml of pemetrexed. Further dilution by a healthcare provider is required prior to administration.

– The other ingredients are mannitol, hydrochloric acid and sodium hydroxide.

What Pemetrexed Kelix bio looks like and contents of the pack

Pemetrexed Kelix bio is a powder for concentrate for solution for infusion in a vial. It is a white to either light yellow or green-yellow lyophilised powder.

It is available in packs of 1 vial.

Marketing Authorisation Holder Kelix bio (Malta) Ltd.

HHF 014 Hal Far Industrial Estate

Hal Far, Birzebbugia BBG 3000

Malta

Manufacturer

Vitane PharmaGmbH

Pfaffenrieder Straße 7

82515 Wolfratshausen

Germany

Thymoorgan Pharmazie GmbH

Schiffgraben 23

38690 Goslar

Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany Pemetrexed Kelix bio 100 mg Pulver für ein Konzentrat zur Herstellung

einer Infusionslösung

Pemetrexed Kelix bio 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

This leaflet was last revised in 04/2023

The following information is intended for healthcare professionals only:

Instructions for use, handling and disposal

1. Use aseptic techniques during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
2. Calculate the dose and the number of Pemetrexed Kelix bio vials needed. Each vial contains an excess of pemetrexed to facilitate delivery of the label amount.
3. Pemetrexed Kelix bio: Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.

Pemetrexed Kelix bio: Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.

4. Gently swirl each vial until the powder is completely dissolved. The resulting solution is clear and ranges in colour from colourless to yellow or green-yellow without adversely affecting product quality. The pH of the reconstituted solution is between 6.6 and 7.8. Further dilution is required.
5. The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, and

administered as an intravenous infusion over 10 minutes.

6. Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags. Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer’s Injection and Ringer’s Injection.
7. Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.
8. Pemetrexed solutions are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.