Gefitinib Genepharm

Gefitinib.

Gefitinib Genepharm is supplied as brown, round, biconvex, film coated tablets, embossed with "G" on one side and plain on the other.
The active substance is gefitinib. Each tablet contains 250 mg gefitinib.
Excipients/Inactive Ingredients: Tablet core: Microcrystalline cellulose, Lactose monohydrate, Povidone K30, Crospovidone, Sodium laurilsulfate, Sodium starch glycolate, Magnesium stearate.
Coating: Polyvinyl alcohol (E1203), Sodium laurilsulfate, Glycerol monocaprylocaprate, Titanium dioxide (E171), Talc (E553b), Iron oxide red (E172), Iron oxide yellow (E172), Iron oxide black (E172).

Gefitinib Genepharm contains the active substance gefitinib which blocks a protein called 'epidermal growth factor receptor' (EGFR). This protein is involved in the growth and spread of cancer cells.
Gefitinib Genepharm is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK.

Always take this medicine exactly as prescribed. Patients must be advised.
The recommended dose is one 250 mg tablet per day.
The tablet should be taken at about the same time each day.
The patient can take the tablet with or without food.
Antacids (to reduce the acid level of the stomach) should not be taken 2 hours before or 1 hour after taking Gefitinib Genepharm.
If the patient has trouble swallowing the tablet, dissolve it in half a glass of still (non-fizzy) water. Any other liquids should not be used. The tablet should not be crushed. The water should be swirled until the tablet has dissolved. This may take up to 20 minutes. The liquid should be drunk straight away. To make sure that the patient has drunk all of the medicine, the glass should be rinsed very well with half a glass of water and the patient should drink it.
Forgotten intake of Gefitinib Genepharm: What to do if the patient forgets to take a tablet depends on how long it is until the next dose.
If it is 12 hours or more until the next dose: the missed tablet should be taken as soon as remembered. Then, the next dose should be taken as usual.
If it is less than 12 hours until the next dose: the missed tablet should be skipped. Then, the next tablet should be taken at the usual time.
A double dose (two tablets at the same time) should not be taken to make up for a forgotten dose.
Patients must be advised regarding further questions on the use of this medicine.

If Gefitinib Genepharm was taken more than prescribed, patients must be advised to seek medical advice straight away.

Gefitinib Genepharm should not be taken: if the patient is allergic to gefitinib, or any of the other ingredients of this medicine (listed in Description); if the patient is breast-feeding.

Advise patients to talk to the doctor or pharmacist before taking Gefitinib Genepharm: if the patient has ever had any other lung problems. Some lung problems may get worse during treatment with Gefitinib Genepharm; if the patient has ever had problems with the liver.
Gefitinib Genepharm contains lactose: If the patient has been told by the doctor that they have an intolerance to some sugars, advise patient to contact the doctor before taking this medicine.
Gefitinib Genepharm contains sodium: This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially 'sodium-free'.
Driving and using machines: The patient may feel weak while taking treatment with Gefitinib Genepharm. If this happens, do not drive or use any tools or machines.
Use in Children: Gefitinib Genepharm is not indicated in children and adolescents under 18 years.

The patient must be advised before taking this medicine if she is pregnant, may become pregnant or is breast-feeding.
It is recommended that the patient avoid becoming pregnant during treatment with Gefitinib Genepharm because Gefitinib Genepharm could harm the baby.
Gefitinib Genepharm should not be taken if the patient is breast-feeding for the safety of the baby.

Like all medicines this medicine can cause side effects, although not everybody gets them.
Advise the patient to seek medical advice immediately in case of any of the following side effects (urgent medical treatment may be needed): Allergic reaction (common), particularly if symptoms include swollen face, lips, tongue or throat, difficulty to swallow, hives, nettle rash and difficulty breathing.
Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or fever. This may mean that the patient has an inflammation of the lungs called 'interstitial lung disease'. This may affect about 1 in 100 patients taking gefitinib and can be life-threatening.
Severe skin reactions (rare) affecting large areas of the body. The signs may include redness, pain, ulcers, blisters, and shedding of the skin. The lips, nose, eyes and genitals may also be affected. Dehydration (common) caused by long term or severe diarrhoea, vomiting (being sick), nausea (feeling sick) or loss of appetite.
Eye problems (uncommon), such as pain, redness, watery eyes, light sensitivity, changes in vision or ingrowing eyelashes. This may mean that the patient has an ulcer on the surface of the eye (cornea).
Advise the patient to seek medical advice immediately in case of any of the following side effects: Very common: side effects (may affect more than 1 in 10 people): Diarrhoea; Vomiting; Nausea; Skin reactions such as an acne-like rash, which is sometimes itchy with dry and/or cracked skin; Loss of appetite; Weakness; Red or sore mouth.
Increase of a liver enzyme known as alanine aminotransferase in a blood test; if too high, Gefitinib Genepharm may be discontinued.
Common: side effects (may affect up to 1 in 10 people): Dry mouth; Dry, red or itchy eyes; Red and sore eyelids; Nail problems; Hair loss; Fever; Bleeding (such as nose bleed or blood in the urine); Protein in the urine (shown in a urine test).
Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, Gefitinib Genepharm may be discontinued.
Increase of creatinine levels in a blood test (related to kidney function).
Cystitis (burning sensations during urination and frequent, urgent need to urinate).
Uncommon: side effects (may affect up to 1 in 100 people): Inflammation of the pancreas. The signs include very severe pain in the upper part of the stomach area and severe nausea and vomiting.
Inflammation of the liver. Symptoms may include a general feeling of being unwell, with or without possible jaundice (yellowing of the skin and eyes). This side effect is uncommon; however, some patients have died from this.
Gastrointestinal perforation.
Skin reaction on the palms of the hands and soles of the feet including tingling, numbness, pain, swelling or reddening (known as palmar-plantar erythrodysaesthesia syndrome or hand and foot syndrome).
Rare: side effects (may affect up to 1 in 1000 people): Inflammation of the blood vessels in the skin. This may give the appearance of bruising or patches of non-blanching rash on the skin.
Haemorrhagic cystitis (burning sensations during urination and frequent, urgent need to urinate with blood in the urine).
Reporting of side effects: Patients must be advised in case of any side effects. This includes any possible side effects not listed in this monograph. Side effects can be reported directly via the national reporting system. Reporting side effects can help provide more information on the safety of this medicine.

Advise the patient to tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
In particular, if the patient is taking any of the following medicines: Phenytoin or carbamazepine (for epilepsy); Rifampicin (for tuberculosis); Itraconazole (for fungal infections); Barbiturates (a type of medicine used for sleeping problems); Herbal remedies containing St John's wort (Hypericum perforatum, used for depression and anxiety); Proton-pump inhibitors, H₂-antagonists and antacids (for ulcers, indigestion, heartburn and to reduce acids in the stomach).
These medicines may affect the way Gefitinib Genepharm works.
Warfarin (a so-called oral anticoagulant, to prevent blood clots). If the patient is taking a medicine containing this active substance, blood tests may be needed more often.
If any of the previously mentioned applies to the patient, or if the patient is not sure, advise the patient to check with the doctor or pharmacist before taking Gefitinib Genepharm.

Store at temperature ≤ 25°C.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines that are no longer in use. These measures will help protect the environment.

Targeted Cancer Therapy

L01EB01 - gefitinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.

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