Patient leaflet - PEMETREXED DR. REDDYS 1000 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
What Pemetrexed is and what it is used for
What you need to know before you use Pemetrexed
How to use Pemetrexed
Possible side effects
How to store Pemetrexed
Contents of the pack and other information
1. What Pemetrexed is and what it is used for
Pemetrexed is a medicine used in the treatment of cancer.
Pemetrexed 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 is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Pemetrexed 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 is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
Pregnancy
If you are pregnant, or think you may be pregnant, or are planning to have a baby, tell your doctor. The use of Pemetrexed should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Pemetrexed during pregnancy. Women must use effective contraception during treatment with Pemetrexed.
Breastfeeding
If you are breastfeeding, tell your doctor.
Breast-feeding must be discontinued during I Pemetrexed treatment.
Fertility
Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed and should therefore use effective contraception during treatment with Pemetrexed and for up to 6 months afterwards. If you would like to father a child during the treatment or in the 6 months after 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 may make you feel tired. Be careful when driving a car or using machines.
3.
How to use Pemetrexed
2. What you need to know before you use Pemetrexed
| Artwork | |
| Brand: | Dr Reddy’s |
| Product Name: | Pemetrexed |
| Strength: | 1000 mg |
| Form: | Powder For Concentrate For Solution For Infusion |
| Component: | Leaflet |
| Pack Size: | 1 Vial |
| Country: | UK |
| Date Created: | 23 MAR 2020 |
| Date Modified: | 25 SEP 2020 |
| Version: | 1.4 |
| Technical Information | |
| Die Cut | Guides | |
Do not use Pemetrexed if you:
- are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6)
- are breast-feeding; you must discontinue breast-feeding during treatment with Pemetrexed
- have recently received or are about to receive a vaccine against yellow fever.
Warnings and Precautions
Talk to your doctor or hospital pharmacist before receiving Pemetrexed 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
- have had or are going to have radiation therapy, as there may be an early or late radiation reaction with Pemetrexed
- have been recently vaccinated, as this can possibly cause bad effects with Pemetrexed
- have heart disease or a history of heart disease
- have an accumulation of fluid around your lungs; your doctor may decide to remove the fluid before giving you Pemetrexed.
Blood tests
Before each infusion you will have samples of your blood taken to check you have sufficient kidney and liver function and to check that you have enough blood cells to receive Pemetrexed. 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.
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
Please tell your doctor if you are taking 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 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 hospital pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
The dose of Pemetrexed 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 powder with 9 mg/ml (0.9%) sodium chloride solution for injection or glucose 50 mg/ml (5%) solution for infusion before it is given to you.
You will always receive Pemetrexed by infusion into one of your veins. The infusion will last approximately 10 minutes.
When using Pemetrexed 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 has finished. The infusion of cisplatin will last approximately 2 hours.
You should usually receive your infusion once every 3 weeks.
Additional medicines:
Corticosteriods: Your doctor will prescribe you steroid tablets (equivalent to 4 milligrams of dexamethasone twice a day) to take on the day before, on the day of, and the day after Pemetrexed treatment. This will reduce the frequency and severity of skin reactions that you may experience during your anticancer treatment.
Vitamin supplements: Your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) to take once a day while you are taking Pemetrexed. You must also take at least five doses of folic acid during the seven days before the first dose of Pemetrexed and must continue taking folic acid for 21 days after the last dose of Pemetrexed.
You will also have an injection of vitamin B12 (1000 micrograms) in the week before receiving Pemetrexed and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed 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 (common): if you have a temperature of 38°C or greater, sweating or other signs of infection (as this may mean you have less white blood cells than normal which is very common). Infection (sepsis) may be severe and could lead to death
- chest pain (common) or having a fast heart rate (uncommon)
- pain, redness, swelling or sores in your mouth (very common)
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- allergic reactions such as 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)
- tiredness, feeling faint, becoming easily breathless or if you look pale (as you may have less haemoglobin than normal which is very common)
- bleeding from the gums, nose or mouth or any bleeding that will not stop, reddish or pinkish urine, unexpected bruising (as you might have less platelets than normal which is very common)
- sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon). This may indicate a blood clot in the blood vessels of the lungs.
Side effects with Pemetrexed may include:
Very common (may affect more than 1 in 10 people)
- infection
- pharyngitis (sore throat)
- low number of neutrophil granulocytes (a type of white blood cells)
- low white blood cells
- low haemoglobin level
- loss of appetite
- pain, redness, swelling or sores in your mouth
- 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 cells)
- low platelet count
- allergic reaction
- loss of body fluids
- taste changes
- 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 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 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
- chest pain
- excess fluid in body tissue, causing swelling
- 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
- abnormal heart rhythm
- 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, oedema, erythema, and erosion of the mucosal surface of the oesophagus 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 (may affect up to 1 in 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 became 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
5. how to store pemetrexed
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 carton. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C and 2°C to 8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2°C to 8°C.
This medicine is for single use only; any unused solution must be disposed of in accordance with local requirements.
6. contents of the pack and other information
What Pemetrexed powder contains
The active substance is pemetrexed.
Pemetrexed 1000 mg: Each vial contains 1000 mg of pemetrexed (as pemetrexed ditromethamine dihydrate).
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, trometamol and hydrochloric acid (for pH adjustment).
What Pemetrexed powder looks like and contents of the pack
Pemetrexed is a powder for concentrate for solution for infusion in a vial. It is a white to either light yellow or green-yellow lyophilised cake or powder.
Each pack of Pemetrexed consists of one Pemetrexed vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United Kingdom
Manufacturer
betapharm Arzneimittel GmbH, Kobelweg 95, Augsburg, 86156, Germany
This leaflet was last revised in 09/2020.
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