Pemetrexed Lilly - patient leaflet, side effects, dosage

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

Do not use Pemetrexed Lilly

• – if you are allergic (hypersensitive) 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 Lilly.

• – if you 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 Lilly.

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 Lilly.

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 Lilly. 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 m or late radiation reaction with Pemetrexed Lilly.

If you have been recently vaccinated, please tell your doctor, as this can possib with Pemetrexed Lilly.

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 deci before giving you Pemetrexed Lilly.

Children and adolescents

This medicine should not be used in children or adoles medicine in children and adolescents under 18 years o

Other medicines and Pemetrexed Lilly

Please tell your doctor if you are taking any

medicines called “nonsteroidal anti-infl without a doctor’s pres­cription (such as durations of activity. Based on the plan 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 tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy

If you are p ant, think you may be pregnant or are planning to have a baby, tell your doctor. The use of Pemetrexed Lilly should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Pemetrexed Lilly during pregnancy. Women must use effective contraception during treatment with Pemetrexed Lilly.

Breast-feeding

If you are breast-feeding, tell your doctor.

Breast-feeding must be discontinued during treatment with Pemetrexed Lilly.

Fertility

Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed Lilly and should therefore use effective contraception during treatment with Pemetrexed Lilly 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 Lilly may make you feel tired. Be careful when driving a car or using machines.

Pemetrexed Lilly contains sodium

Pemetrexed Lilly 100 mg powder for concentrate for solution for infusion

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

Pemetrexed Lilly 500 mg powder for concentrate for solution for infusion

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

3. How to use Pemetrexed Lillyurface area.octor will use, or treatment may ospital pharmacist,

The dose of Pemetrexed Lilly is 500 milligrams for every square metre of your bod Your height and weight are measured to work out the surface area of your body.

this body surface area to work out the right dose for you. This dose may be a be delayed depending on your blood cell counts and on your general conditi nurse or doctor will have mixed the Pemetrexed Lilly powder with 9 mg/ solution for injection before it is given to you.

You will always receive Pemetrexed Lilly by infusion into one approximately 10 minutes.

When using Pemetrexed Lilly 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 Lilly has finished. The infusion of cisplatin will last approximately 2 hours.

You should usually receive your infu

Additional medicines:

Corticosteriods: 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 Lilly treatment. This medicine is given to you to reduce the frequency and severity of skin reactions th u may experience during your anticancer treatment.

tion: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin (350 to 1000 micrograms) that you must take once a day while you are taking illy. You must take at least 5 doses during the seven days before the first dose of illy. You must continue taking the folic acid for 21 days after the last dose of d Lilly. You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Pemetrexed Lilly and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Lilly 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 38 °C 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 s (uncommon)(may indicate a blood clot in the blood vessels of the lungs)

the sensory nerves that may cause lost of sensation, burning pain and unsteady gait

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 l Inflammation and scarring of the lining of the lung Passage of bright red blood from the anus Bleeding in the gastrointestinal tract Ruptured bowel

Inflammation of the lining of the oesoph

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

to 1 in 1,000 people) blood cells

k (severe allergic reaction) ition of the liver

t 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 side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the 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.

5. How to store Pemetrexed Lilly

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.

This medicine does not require any special storage conditions.

Reconstituted and infusion solution: 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 (2 °C to 8 °C).

This medicine is for single use only; any unused solution must be disposed of in accordance with local requirement.

6. Contents of the pack and other information

What Pemetrexed Lilly contains

The active substance is pemetrexed.

Pemetrexed Lilly 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium).

Pemetrexed Lilly 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 (E421), hydrochloric acid and sodium hydroxide (see section 2 “Pemetrexed Lilly contains sodium”)

What Pemetrexed Lilly looks like and contents of the pack

Pemetrexed Lilly is a powder for concentrate for solution for infusion in a glass vial with rubber stopper. It is a white to either light yellow or green-yellow lyophilised powder.

It is available in packs of 1 vial.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Eli Lilly Nederland B.V.

Papendorpseweg 83

3528 BJ Utrecht

The Netherlands

Manufacturer

Lilly France S.A.S. rue du Colonel Lilly F-67640 Fegershe­im France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Bel­gien

Eli Lilly Benelux S.A/N.V.

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

ELI LILLY ČR, s.r.o.

Tel: + 420 234 664 111

Luxembourg

Eli Lilly B Tél/Tel:

agyarország illy Hungária Kft. el: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 60 00

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273

Eesti

Eli Lilly Nederla

Tel: + 372 6 817

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Nederland

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Österreich

Eli Lilly Ges.m.b.H.

Tel: + 43-(0) 1 711 780

España

Lilly S.A.

Tel: + 34–91–663 50 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel.: +48 22 440 33 00

Portugal

Lilly Portugal Produtos Farmacêuticos, Lda

Tel: + 351–21–4126600

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

România

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Island

Icepharma hf.

Simi + 354 540 8000

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0)1 580 00 10

Slovenská republika

Eli Lilly Slovakia s.r.o.

Tel: + 421 220 663 111

Italia

Eli Lilly Italia S.p.A.

Tel: + 39– 055 42571

Kùnpoç

Phadisco Ltd

Tql: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly (Suisse) S.A Pârstâvniecïba Latvijâ

Tel: + 371 6 7364000

This leaflet was last revised in <{MM/YYYY}>

The following information is intended for medical or 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 Lilly vials needed. Each vial contains an excess of pemetrexed to facilitate delivery of the label amount.

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