100 mg and 500 mg powder for concentrate for infusion solution 
pemetrexed

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it 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 also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What ALIMTA is and what it is used for 
2. What you need to know before using ALIMTA 
3. How to use ALIMTA 
4. Possible side effects 
5. How to store ALIMTA 6. Contents of the pack 
and other ingredients information

1. What ALIMTA is and what it is used for

ALIMTA is a medicine used to treat cancer.

ALIMTA is given together with cisplatin, another anti-cancer medicine, for the treatment of malignant pleural mesothelioma, a form of lung cancer, to patients who have not previously received anticancer medicine.

ALIMTA is also used with cisplatin in the initial treatment of advanced lung cancer.

ALIMTA can be prescribed to you if you have advanced lung cancer and your disease has responded to treatment or if it is largely unchanged after initial drug treatment.

In addition, ALIMTA is used to treat advanced lung cancer whose disease has progressed, after other previous drug treatments have been used.

2. What you need to know before using ALIMTA

Do not use ALIMTA:

– if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of this medicine.

– if you are breast-feeding. You should stop breast-feeding during treatment with ALIMTA.

– if you have recently been vaccinated or are just about to be vaccinated against yellow fever.

Warnings and cautions

Talk to your doctor or pharmacist before receiving ALIMTA.

Talk to your doctor or pharmacist if you have or have had kidney problems, as you may not be able to get ALIMTA.

Before each infusion, blood samples will be taken to find out if the function of the kidneys and liver is sufficient and to check that the amount of blood cells is sufficient to obtain ALIMTA. Your doctor may choose to change the dose or postpone your treatment depending on your general condition and if your blood levels are too low. If you are also taking cisplatin, your doctor will make sure that you have been given enough fluids and that you will receive appropriate treatment before and after the cisplatin treatment to prevent vomiting.

If you have received radiation therapy or if such treatment is planned, tell your doctor, like radiation therapy and ALIMTA may cause immediate or late side effects.

If you have recently been vaccinated, you should tell your doctor, as ALIMTA in connection with vaccination may cause unwanted reactions.

Tell your doctor if you have, or have previously had, heart disease.

If you have accumulated fluid around your lungs, your doctor may decide to remove the fluid before treatment with ALIMTA.

Children and young people

This medicine should not be used by children or adolescents as there is no experience with the medicine in children and adolescents under 18 years of age.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, tell your doctor. Treatment with ALIMTA should be avoided during pregnancy. Your doctor will discuss any risks involved with ALIMTA during pregnancy. Women should use effective contraception during treatment with ALIMTA.

Breast-feeding

Tell your doctor if you are breast-feeding.

Breast-feeding should be discontinued during treatment with ALIMTA.

Fertility

Men are advised not to have children during and up to 6 months after ALIMTA treatment and should therefore use an effective method of contraception during ALIMTA treatment and up to 6 months after the end of treatment. If you plan to have children during treatment or the following 6 months after treatment, consult your doctor or pharmacist. You may want to seek advice on sperm preservation before starting treatment.

Driving and using machines

Treatment with ALIMTA may make you feel tired. Be careful when driving or using machines.

ALIMTA contains sodium

ALIMTA 100 mg powder for concentrate for solution for infusion

This medicine contains less than 1 mmol sodium (23 mg) per vial, ie essentially ‘sodium-free’.

ALIMTA 500 mg powder for concentrate for solution for infusion

This medicine contains 54 mg of sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 2.7% of the highest recommended daily intake of sodium for adults.

3. How to use ALIMTA

ALIMTA is given in a dose of 500 mg per square meter of body surface area. Your height and weight are used to calculate the body surface area. Your doctor will use the measurement of your body surface area to calculate the right dose for you. This dose can be adjusted or the treatment can be postponed depending on blood levels and your general condition. A hospital pharmacist, nurse, or doctor will have mixed the ALIMTA powder in sterile sodium chloride 9 mg/ml (0.9%) solution before giving it to you.

ALIMTA is always given as an infusion into a friend. Infusion one lasts for about 10 minutes.

When ALIMTA is given in combination with cisplatin:

Your doctor or hospital pharmacist will have calculated the required dose using your height and weight. Cisplatin is also given as an infusion into a vein and is given approximately 30 minutes after the end of the ALIMTA infusion. Infusion one of cisplatin lasts for about 2 hours.

You usually receive an infusion once every three weeks.

Other medicines:

Corticosteroids: Your doctor will prescribe steroid tablets (equivalent to 4 milligrams of dexamethasone twice daily). You should take these tablets the day before, on the day of treatment, and the day after treatment with ALIMTA. The tablets are given to reduce the frequency and severity of the skin reactions that may occur during treatment for cancer.

Vitamin supplement: Your doctor will prescribe a preparation of folic acid ( vitamin ) to be taken by mouth or a multivitamin preparation containing folic acid (350 to 1000 micrograms) that you should take once a day during treatment with ALIMTA. You must take at least 5 doses during the seven days preceding the first dose, one of ALIMTA. You should continue to take folic acid for 21 days after the end of ALIMTA dose one. You will also receive a vitamin B 12 – Injection (1000 micrograms) in the week prior to ALIMTA infusion done and then approximately every 9 weeks (equivalent to 3 courses of treatment with ALIMTA). Vitamin B 12 and folic acid are given to reduce the possible harmful effects of cancer treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should contact your doctor immediately if you notice any of the following side effects:

  • Fever or infection (common or very common): if you have a temperature of 38 ° C or more, sweating, or other signs of an infection (because you may have a lower white blood cell count than normal, which is very common). Infection one (blood poisoning) can be serious and lead to death.
  • If you start to feel chest pain (common) or have a fast heart rate (less common).
  • If you feel pain, redness, swelling, or soreness in your mouth (very common).
  • Allergic reaction: if you get a rash (very common) / burning or stinging sensation (common) or fever (common). Skin reactions can be severe and lead to death (rare). Contact your doctor if you get a lot of rash, itching, or blisters ( Stevens-Johnson syndrome or toxic epidermal necrolysis ).
  • If you get tired, feel weak, get short of breath easily, or if you look pale (because you may have less hemoglobin than normal, which is very common).
  • If it bleeds from the gums, nose, or mouth or you get any bleeding that does not want to stop, reddish or pinkish urine, unexpected bruising (because you may have fewer platelets than normal, which is common).
  • If you experience sudden shortness of breath, intense chest pain, or cough with bloody cough (less common) (may indicate a blockage in the blood vessels of the lungs).

Other side effects of ALIMTA that may occur:

Very common (may affect more than 1 user in 10)

Infection

Sore throat

A low number of neutrophils ( white blood cell type )

Low white blood cell count

Low hemoglobin ( anemia )

Pain, redness, swelling, or soreness in the mouth

Decreased appetite

Vomiting

Diarrhea

Nausea

Rash

Flaking skin

Abnormal blood counts showing reduced kidney function

Fatigue (fatigue)

Common (may affect up to 1 in 10 people)

Blood infection

Fever with low neutrophil count (a type of white blood cell )

Reduced platelet count

Allergic reaction

Dehydration

Taste changes

Muscle weakness due to damage to motor nerves, especially in the arms and legs

Loss of sensation, burning pain, and unsteady gait due to damage to sensory nerves

Dizziness

Inflammation or swelling of the conjunctiva ( membrane at the end of the eyelids and covering the eyes white)

Dry eyes

Tear-filled eyes

Dried conjunctiva ( membrane at the outer part of the eyelids and covering the eyes white and cornea (the clear layer that protects the iris and pupil )

Swollen eyelids

Eye problems, such as dryness, tearing, irritation, and/or pain.

Heart failure (a condition that affects the pumping power of your heart muscle)

Irregular heartbeat

Indigestion

Constipation

Abdominal pain

Liver: increase in the substances in the blood produced by the liver

Increased skin pigmentation

Itching

Rash on the body therewith red marks

Hair loss

Hives

Kidney failure

Decreased renal function

Fever

Pain

Excess fluid in body tissue, causing swelling

Chest pain

Inflammation and ulceration of the mucous membranes that line the digestive tract

Uncommon (may affect up to 1 in 100 people)

Reduction in the number of red and 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 decreased blood flow to the heart)

Myocardial infarction

Narrowing or blockage of the coronary arteries

Elevated heart rate

Reduced blood distribution to the limbs

Blood clots in the pulmonary blood vessels ( pulmonary embolism )

Inflammation and scarring of the lungs with respiratory problems

Passage of bright red blood from the anus

Bleeding in the gastrointestinal tract

Broken intestine

Inflammation of the esophageal mucosa (esophagus)

Colitis ( inflammation of the wall of the colon, which may be accompanied by bleeding from the intestines or rectum (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 conditions of the liver

Redness of the skin

Skin rash that may occur on skin that has previously been exposed to radiation therapy.

Very rare (may affect up to 1 in 10,000 people)

Infection s skin and soft tissue s

Stevens-Johnson syndrome (a type of severe reaction to skin and mucous membranes that can be life-threatening)

Toxic epidermal necrolysis (a type of severe skin reaction that can be life-threatening)

An autoimmune condition that results in skin rashes and blisters on legs, arms, and abdomen

Inflammation of the skin characterized by the presence of bullous conditions with fluid-filled blistering)

Fragile skin, blisters, and erosion as well as scarring of the skin

Redness, pain, and swelling mainly in the lower legs

Inflammation of the skin and fat under the skin (pseudo cellulite)

Inflammation of the skin ( dermatitis )

Skin that becomes inflamed, itchy, red, cracked, and rough

Intense itchy spots

Has been reported (occurs in an unknown number of users)

A form of diabetes that is primarily based on kidney pathology

Kidney disorder involving tubular epithelial cells (which form renal tubules) death.

You may get any of these symptoms and/or ailments. If you start to experience any of these side effects, talk to your doctor as soon as possible.

If you have any side effects, talk to your doctor.

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

5. How to store ALIMTA

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 bottle label and carton.

This medicine has no special storage instructions.

Dissolved drug and infusion solution: The drug should be used immediately. Chemical and physical shelf life for 24 hours in a refrigerator has been demonstrated for the reconstituted stock solution and the infusion solution of pemetrexed if reconstituted according to the instructions.

This medicine is for single use only. Any unused solution should be disposed of in accordance with local requirements.

6. Contents of the packaging and other information

Content declaration

The active substance is pemetrexed.

ALIMTA 100 mg: One vial contains 100 mg pemetrexed (as disodium pemetrexed).

ALIMTA 500 mg: One vial contains 500 mg of pemetrexed (as disodium pemetrexed).

After reconstitution, the solution contains 25 mg / ml pemetrexed. Further dilution of healthcare professionals is required before injection.

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

What the medicine looks like and the contents of the pack

ALIMTA is a powder for concentrate for solution for infusion in a vial. It is a white to light yellow or greenish-yellow, lyophilized powder.

Available in packs of 1 bottle.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Lilly France SAS, rue du Colonel Lilly, F-67640, Fegersheim, France

Contact the representative of the marketing authorization holder to find out more about this medicine:

Further information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

This leaflet was approved by September 2020 at the latest

The following information is intended for medical or healthcare professionals only

Instructions for use and handling and disposal

  1. Use aseptic technique during reconstitution and dilution of pemetrexed for intravenous infusion.
  2. Calculate the dose and number of vials of ALIMTA required. Each vial contains an excess of pemetrexed to facilitate withdrawal of the amount indicated on the label.
  3. ALIMTA 100 mg:Dissolve the powder in each vial (100 mg) in 4.2 ml of sterile sodium chloride 9 mg / ml (0.9%) solution without preservative . A solution containing 25 mg / ml pemetrexed is obtained. 
    ALIMTA 500 mg: 
    Dissolve the powder in each vial (500 mg) in 20 ml sterile sodium chloride 9 mg / ml (0.9%) solution without preservative . A solution containing 25 mg / ml pemetrexed is obtained.
    Gently swirl the bottle until the powder is completely dissolved. The solution obtained is clear and varies in color from colorless to yellow or greenish-yellow without adversely affecting the quality of the product. The pH of the dissolved solution is between 6.6 and 7.8. Further dilution is required.
  4. The volume of reconstituted pemetrexed solution taken should be further diluted to 100 ml with sterile sodium chloride 9 mg/ml (0.9%) solution without preservative and administered as an intravenous infusion over 10 minutes.
  5. Pemetrexed infusion solutions, prepared as above, are compatible with administration kits and infusion bags are internally coated with polyvinyl chloride and polyolefin. 
    Pemetrexed is incompatible with diluents containing calcium, including the infusion fluids Ringer-lactate and Ringer’s solution.
  6. Drugs administered parenterally should be visually inspected for particulate matter and discoloration prior to administration. If particles are observed, the solution 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 for use in administration and administration: As with other potentially toxic anticancer medicinal products, caution should be exercised when handling and preparing infusion solutions containing pemetrexed. The use of gloves is recommended. If pemetrexed solution comes in contact with the skin, wash the skin immediately and thoroughly with soap and water. If pemetrexed solution comes in contact with mucous membranes, rinse thoroughly with water. Pemetrexed does not cause blisters. There is no specific antidote for the extravasation of pemetrexed. A few isolated cases of pemetrexed extravasation have been reported but were not considered serious by the investigator. Extravasation should be treated according to local practice as other non-blowing agents.

Muhammad Nadeem

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