Inlyta
axitinib
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What Inlyta is and what it is used for
What you need to know before you take Inlyta
How to take Inlyta
Possible side effects
How to store Inlyta
Contents of the pack and other information
Inlyta is a medicine containing the active substance axitinib. Axitinib reduces the blood supply to the tumour and slows down the growth of cancer.
Inlyta is indicated for the treatment of advanced kidney cancer (advanced renal cell carcinoma) in adults, when another medicine (called sunitinib or a cytokine) is no longer stopping disease from progressing.
If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor.
If you are allergic to axitinib or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.
Inlyta can raise your blood pressure. It is important to check your blood pressure before you
take this medicine, and regularly while you are taking it. If you have high blood pressure (hypertension) you may be treated with medicines to reduce the blood pressure. Your doctor should make sure that your blood pressure is under control before starting Inlyta treatment, and while on treatment with this medicine.
Inlyta can cause thyroid gland problems. Tell your doctor if you get tired more easily, generally
feel colder than other people, or your voice deepens whilst taking this medicine. Your thyroid function should be checked before you take Inlyta and regularly while you are taking it. If your thyroid gland is not producing enough thyroid hormone before, or while on treatment with this medicine, you should be treated with thyroid hormone replacement.
Get emergency help right away and call your doctor if you get symptoms such as chest pain or pressure; pain in your arms, back, neck or jaw; shortness of breath; numbness or weakness on one side of your body; trouble talking; headache; vision changes; or dizziness while on treatment with this medicine.
Inlyta may increase your chance of bleeding. Tell your doctor if you have any bleeding, coughing up of blood or bloody sputum while on treatment with this medicine.
Inlyta may increase the risk of developing a hole in the stomach or intestine or formation of fistula (abnormal tube-like passage from one normal body cavity to another body cavity or the skin).
Tell your doctor if you have severe abdominal pain while on treatment with this medicine.
Your doctor should stop Inlyta at least 24 hours before your operation as it may affect wound healing. Your treatment with this medicine should be restarted when the wound has adequately healed.
Get emergency help right away and call your doctor. This could be a rare neurological side effect named posterior reversible encephalopathy syndrome.
Your doctor should do blood tests to check your liver function before and during treatment with Inlyta.
Inlyta is not recommended for people aged under 18. This medicine has not been studied in children and adolescents.
Some medicines may affect Inlyta, or be affected by it. Please tell your doctor, pharmacist or nurse about all the medicines you have recently taken, are currently taking, or plan to take, including medicines obtained without a prescription, vitamins, and herbal medicines. The medicines listed in this leaflet may not be the only ones that could interact with Inlyta.
The following medicines may increase the risk of side effects with Inlyta:
ketoconazole or itraconazole, used to treat fungal infections;
clarithromycin, erythromycin or telithromycin, antibiotics used to treat bacterial infections;
atazanavir, indinavir, nelfinavir, ritonavir or saquinavir, used to treat HIV infections/AIDS;
nefazodone, used to treat depression.
The following medicines may reduce the effectiveness of Inlyta:
rifampicin, rifabutin or rifapentin, used to treat tuberculosis (TB);
dexamethasone, a steroid medicine prescribed for many different conditions, including serious illnesses;
phenytoin, carbamazepine or phenobarbital, anti-epileptics used to stop seizures or fits;
St. John’s wort (Hypericum perforatum), a herbal product used to treat depression.
You should not take these medicines during your treatment with Inlyta. If you are taking any of them, tell your doctor, pharmacist or nurse. Your doctor may change the dose of these medicines, change the dose of Inlyta, or switch you to a different medicine.
Inlyta may increase side effects associated with theophylline, used to treat asthma or other lung diseases.
Do not take this medicine with grapefruit or grapefruit juice, as it may increase the chance of side effects.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Inlyta could harm an unborn baby or breast-fed baby.
Do not take this medicine during pregnancy. Talk to your doctor before taking it if you are pregnant or might become pregnant.
Use a reliable method of contraception while you are taking Inlyta and up to 1 week after the last dose of this medicine, to prevent pregnancy.
Do not breast-feed during treatment with Inlyta. If you are breast-feeding, your doctor should discuss with you whether to discontinue breast-feeding or discontinue Inlyta treatment.
If you experience dizziness and/or feel tired while on treatment with Inlyta, take special care when driving or using machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. You should check with your doctor, pharmacist or nurse if you are not sure.
The recommended dose is 5 mg twice a day. Your doctor may subsequently increase or decrease your dose depending on how you tolerate treatment with Inlyta.
Swallow the tablets whole with water, with or without food. Take the Inlyta doses approximately 12 hours apart.
If you accidentally take too many tablets or a higher dose than you need, contact a doctor for advice right away. If possible, show the doctor the pack, or this leaflet. You may require medical attention.
Take your next dose at your regular time. Do not take a double dose to make up for the forgotten tablets.
If you vomit, an additional dose should not be taken. The next prescribed dose should be taken at the
usual time.
If you are not able to take this medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor right away.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Other side effects with Inlyta may include:
High blood pressure, or increases in blood pressure
Diarrhoea, feeling or being sick (nausea or vomiting), stomach ache, indigestion, soreness of the mouth, tongue or throat, constipation
Shortness of breath, cough, hoarseness
Lack of energy, feeling weak or tired
Under-active thyroid gland (may show in your blood tests)
Redness and swelling of the palms of the hands or soles of the feet (hand-foot syndrome), skin rash, dryness of the skin
Joint pain, pain in hands or feet
Loss of appetite
Protein in the urine (may show in your urine tests)
Weight loss
Headache, taste disturbance or loss of taste
Dehydration (loss of body fluids)
Kidney failure
Flatulence (wind), haemorrhoids, bleeding from gums, bleeding from the rectum, a burning or stinging sensation in the mouth
Hyper-active thyroid gland (may show in your blood tests)
Sore throat or nose and throat irritation
Muscle pain
Nose bleeding
Skin itching, redness of the skin, hair loss
Ringing/sound in the ears (tinnitus)
Reduction in the number of red blood cells (may show in your blood tests)
Reduction in the number of blood platelets (cells that help blood to clot) (may show in your blood tests)
Presence of red blood cells in the urine (may show in your urine tests)
Changes in the levels of different chemicals/enzymes in the blood (may show in your blood tests)
Increase in the number of red blood cells (may show in your blood tests)
Swelling of the abdomen, legs, or ankles, protruding neck veins, excessive tiredness, shortness of breath (signs of heart failure events)
Fistula (abnormal tube like passage from one normal body cavity to another body cavity or the skin)
Dizziness
Inflammation of the gall bladder
Reduction in the number of white blood cells (may show in your blood tests)
An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this 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.
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 carton and on the blister foil or bottle after “EXP”. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not use any pack that is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active substance is axitinib. Inlyta film-coated tablets come in different strengths.
Inlyta 1 mg: each tablet contains 1 mg axitinib Inlyta 3 mg: each tablet contains 3 mg axitinib Inlyta 5 mg: each tablet contains 5 mg axitinib Inlyta 7 mg: each tablet contains 7 mg axitinib
The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose 2910 (15 mPa·s), titanium dioxide (E171), triacetin (E1518), iron oxide red (E172) (see section 2 Inlyta contains lactose).
Inlyta 1 mg film-coated tablets are red, oval and debossed with “Pfizer” on one side and “1 XNB” on the other. Inlyta 1 mg is available in bottles of 180 tablets and blisters of 14 tablets. Each blister pack contains 28 tablets or 56 tablets.
Inlyta 3 mg film-coated tablets are red, round and debossed with “Pfizer” on one side and “3 XNB” on the other. Inlyta 3 mg is available in bottles of 60 tablets and blisters of 14 tablets. Each blister pack contains 28 tablets or 56 tablets.
Inlyta 5 mg film-coated tablets are red, triangular and debossed with “Pfizer” on one side and
“5 XNB” on the other. Inlyta 5 mg is available in bottles of 60 tablets and blisters of 14 tablets. Each blister pack contains 28 tablets or 56 tablets.
Inlyta 7 mg film-coated tablets are red, diamond shaped and debossed with “Pfizer” on one side and “7 XNB” on the other. Inlyta 7 mg is available in bottles of 60 tablets and blisters of 14 tablets. Each blister pack contains 28 tablets or 56 tablets.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles
Belgium
Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Pfizer SA/NV
Tél/Tel: +32 (0)2 554 62 11
Pfizer Luxembourg SARL filialas Lietuvoje Tel. + 370 52 51 4000
Пфайзер Люксембург САРЛ, Клон България Тел.: +359 2 970 4333
Pfizer S.A.
Tél/Tel: +32 (0)2 554 62 11
Pfizer, spol. s r.o.
Tel: +420 283 004 111
Pfizer Kft.
Tel.: +36-1-488-37-00
Pfizer ApS
Tlf: +45 44 20 11 00
Vivian Corporation Ltd. Tel: +356 21344610
PFIZER PHARMA GmbH Tel: +49 (0)30 550055 51000
Pfizer BV
Tel: +31 (0)10 406 43 01
Pfizer Luxembourg SARL Eesti filiaal
Tel.: +372 666 7500
Pfizer AS
Tlf: +47 67 52 61 00
Pfizer Ελλάς A.E.
Τλ: +30 210 6785 800
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0
Pfizer S.L.
Tél: +34 91 490 99 00
Pfizer Polska Sp. z o.o. Tel.:+48 22 335 61 00
Pfizer
Tél: +33 (0)1 58 07 34 40
Laboratórios Pfizer, Lda. Tel: +351 21 423 5500
Pfizer Croatia d.o.o. Tel: + 385 1 3908 777
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00
Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free)
+44 (0)1304 616161
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0)1 52 11 400
Icepharma hf.
Sími: +354 540 8000
Pfizer Luxembourg SARL, organizačná zložka
Tel.: + 421 2 3355 5500
Pfizer S.r.l.
Tel: +39 06 33 18 21
Pfizer Oy
Puh./Tel: +358 (0)9 43 00 40
Pfizer Ελλάς Α.Ε. (Cyprus Branch) Τηλ: +357 22 817690
Pfizer AB
Tel: +46 (0)8 550 520 00
Pfizer Luxembourg SARL filiāle Latvijā Tel.: + 371 670 35 775
Pfizer Limited
Tel: +44 (0) 1304 616161