Inlyta

Package leaflet: Information for the patient

Inlyta 1 mg film-coated tablets, 3 mg film-coated tablets, 5 mg film-coated tablets, 7 mg film-coated tablets

axitinib
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

1. What Inlyta is and what it is used for
2. What you need to know before taking Inlyta
3. How to take Inlyta
4. Possible side effects
5. How to store Inlyta
6. Contents of the pack and other information

1. What Inlyta is and what it is used for

Inlyta is a medicine containing the active substance axitinib. Axitinib reduces the amount of blood reaching the tumour, thereby slowing its growth.
Inlyta is indicated for the treatment of advanced kidney cancer (advanced renal cell carcinoma) in adults, when another medicine (sunitinib or a cytokine) is no longer able to stop the progression of the disease.
If you have any doubts about how this medicine works or why it has been prescribed for you, please consult your doctor.

2. What you should know before taking Inlyta

Do not take Inlyta:
If you are allergic to axitinib or to any of the other ingredients of this medicine (listed in
section 6).
If you think you may be allergic, consult your doctor.

Warnings and precautions
Inform your doctor or nurse before taking Inlyta

• If you have high blood pressure. Inlyta can cause an increase in blood pressure. It is important that your doctor checks your blood pressure before you start taking this medicine, and regularly during treatment. If you have high blood pressure (hypertension), you may need to take medicines to
  reduce it. Your doctor must ensure that your blood pressure is under control both before and during
  treatment with Inlyta.

• If you have thyroid problems. Inlyta can cause thyroid problems. Inform your doctor if, while taking Inlyta, you become more easily tired, generally feel colder than other people, or your voice becomes lower. Thyroid function should be checked before starting Inlyta and regularly during treatment. If your thyroid gland does not produce enough thyroid hormone, either before or during treatment with this medicine, you may need to take a thyroid hormone replacement.

• If you have recently had problems due to blood clot formation in veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Go immediately to the emergency room and inform your doctor if, during treatment with Inlyta, you experience symptoms such as chest tightness or pain; pain in the arms, back, neck, or jaw; shortness of breath; numbness or weakness on one side of the body; difficulty speaking; vision changes; headache; or dizziness.

• If you have bleeding problems. Treatment with Inlyta may increase the risk of bleeding. Inform your doctor if you experience bleeding, coughing up blood, or coughing with blood-streaked sputum during treatment with this medicine.

• If you have or have had an aneurysm (dilation and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

• If you have severe stomach (abdominal) pain during treatment with this medicine, or if stomach pain does not go away. Treatment with Inlyta may increase the risk of stomach or intestinal perforation or the formation of fistulas (an abnormal passage that forms between two body cavities or between a cavity and the skin). Inform your doctor if you experience severe abdominal pain during treatment with this medicine.

• If you are about to undergo surgery or have non-healing wounds. Inlyta may affect wound healing; therefore, your doctor should stop treatment at least 24 hours before surgery. Once the wound has adequately healed, treatment with this medicine should be restarted.

• If you experience symptoms such as headache, confusion, seizures, or vision changes with or without concomitant high blood pressure during treatment with this medicine. Go immediately to the emergency room and inform your doctor. This could be a rare neurological side effect called reversible posterior encephalopathy syndrome.

• If you have liver problems. Your doctor should perform blood tests to check liver function before and during treatment with Inlyta.

• If you experience symptoms such as excessive fatigue, abdominal swelling, swelling in the legs or ankles, shortness of breath, or distended neck veins during treatment with this medicine. Inlyta may increase the risk of developing heart failure events. Your doctor should periodically monitor for signs or symptoms of heart failure throughout treatment with axitinib.

Use in children and adolescents
Inlyta is not recommended for patients under 18 years of age. This medicine has not been studied in children and adolescents.

Other medicines and Inlyta
Some medicines may affect Inlyta or may be affected by it. Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription, vitamins, and herbal preparations. The medicines listed in this leaflet may not be the only ones that 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 and AIDS infections;
• nefazodone, used to treat depression.

The following medicines may reduce the effectiveness of Inlyta:

• rifampicin, rifabutin, or rifapentine, used to treat tuberculosis (TB);
• dexamethasone, a corticosteroid used for various conditions, including some serious diseases;
• phenytoin, carbamazepine, or phenobarbital, medicines used to treat epilepsy, particularly seizures;
• St. John’s wort (Hypericum perforatum), an herbal preparation used to treat depression.

During treatment with Inlyta, you must not take these medicines. If you are taking any of these
medicines, inform your doctor, pharmacist, or nurse. Your doctor may decide to adjust the
dose of these medicines, adjust the dose of Inlyta, or switch the medicine.

Inlyta may increase the side effects associated with theophylline, used to treat asthma and other lung diseases.

Inlyta with food and drink
You should avoid consuming grapefruit or grapefruit juice during treatment with this
medicine, as it may increase the likelihood of side effects.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.
• Inlyta may harm the unborn baby or breastfed infant.
• This medicine must not be used during pregnancy. Consult your doctor before taking the medicine if you are pregnant or could become pregnant.
• During treatment with Inlyta, you must use a reliable method of contraception until one week after taking the last dose of the medicine to avoid pregnancy.
• You must not breastfeed during treatment with Inlyta. If you are breastfeeding, consult your doctor to decide whether to discontinue breastfeeding or treatment with Inlyta.

Driving and using machines
If you experience dizziness and/or unusual tiredness during treatment with Inlyta, exercise particular caution when driving or operating machinery.

Inlyta contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

Inlyta contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., essentially ‘sodium-free’.

3. How to take Inlyta

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor, pharmacist, or nurse.
The recommended dose is 5 mg twice daily. Your doctor may later decide to increase or decrease the dose based on your tolerance to treatment with Inlyta.
The tablets must be swallowed whole with water, with or without food. Take doses of Inlyta approximately 12 hours apart.
If you take more Inlyta than you should
If you accidentally take too many tablets or a higher dose than prescribed, contact your doctor immediately. If possible, show the doctor the medicine pack or this leaflet. Medical intervention may be necessary.
If you forget to take Inlyta
Take the next dose at your usual time. Do not take a double dose to make up for the missed dose.
If you vomit after taking Inlyta
If you vomit, do not take an additional dose. Take the next prescribed dose at your usual time.
If you stop taking Inlyta
If you are unable to take the medicine your doctor has prescribed, or if you think you no longer need it, contact your doctor immediately.
If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects could be serious. Contact your doctor immediately if you experience any of the
following serious side effects (see also section 2 “What you should know before taking Inlyta”):

• Heart failure events. Inform your doctor if you experience excessive tiredness, swelling in the abdomen, legs or ankles, shortness of breath, or bulging neck veins.

• Blood clots in veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Go immediately to the emergency room and contact your doctor if you experience symptoms such as chest tightness or pain; pain in the arms, back, neck, or jaw; shortness of breath; numbness or weakness on one side of the body; difficulty speaking; headache; vision changes; or dizziness.

• Bleeding. Contact your doctor immediately if, during treatment with Inlyta, you experience any of the following symptoms or have severe bleeding: black, tarry stools; coughing up blood or blood-streaked sputum; or changes in mental status.

• Stomach or intestinal perforation or development of a fistula (an abnormal passage that forms between two body cavities or between a body cavity and the skin). Contact your doctor immediately if you have severe abdominal pain.

• Severe increase in blood pressure (hypertensive crisis). Contact your doctor immediately if you have very high blood pressure, or severe headache or chest pain.

• Reversible swelling of the brain (reversible posterior encephalopathy syndrome). Go immediately to the emergency room and contact your doctor if you experience any of the following symptoms: headache, confusion, seizures, or vision changes, with or without high blood pressure.

Other side effects of Inlyta may include:

Very common: may affect more than 1 in 10 people

• High blood pressure or increases in blood pressure
• Diarrhoea, feeling unwell or malaise (nausea or vomiting), stomach ache, indigestion, mouth, tongue or throat pain, constipation
• Shortness of breath, cough, hoarseness
• Loss of strength, feeling weak or tired
• Reduced activity of the thyroid gland (may be detected in blood tests)
• Redness and swelling of the palms of the hands and soles of the feet (hand-foot syndrome), skin rash, dry skin
• Joint pain, pain in the hands or feet
• Loss of appetite
• Presence of protein in the urine (can be detected in urine tests)
• Weight loss
• Headache, taste disturbances or loss of taste

Common: may affect up to 1 in 10 people

• Dehydration (loss of body fluids)
• Kidney failure
• Flatulence (gas), haemorrhoids, bleeding gums, rectal bleeding, burning or irritation in the mouth
• Overactivity of the thyroid gland (can be detected in blood tests)
• Sore throat or nasal irritation, throat irritation
• Muscle pain
• Nosebleeds
• Itching, skin redness, hair loss
• Ringing or buzzing in the ears (tinnitus)
• Reduced number of red blood cells (can be detected in blood tests)
• Reduced number of platelets (cells that help blood to clot) (can be detected in blood tests)
• Presence of red blood cells in the urine (can be detected in urine tests)
• Changes in levels of various chemicals/enzymes in the blood (can be detected in blood tests)
• Increased number of red blood cells (can be detected in blood tests)
• Swelling in the abdomen, legs or ankles, bulging neck veins, excessive tiredness, shortness of breath (signs of heart failure events)
• Fistula (an abnormal passage that forms between two body cavities or between a body cavity and the skin)
• Dizziness
• Inflammation of the gallbladder

Uncommon: may affect up to 1 in 100 people

• Reduced number of white blood cells (can be detected in blood tests)

Not known: frequency cannot be estimated from the available data

• Enlargement and weakening of the wall of a blood vessel, or a tear in the wall of a blood vessel (aneurysms and arterial dissections).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Inlyta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack label, or vial 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 this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Inlyta contains

• The active substance is axitinib. Inlyta film-coated tablets are available in different strengths.
  Inlyta 1 mg: each tablet contains 1 mg of axitinib
  Inlyta 3 mg: each tablet contains 3 mg of axitinib
  Inlyta 5 mg: each tablet contains 5 mg of axitinib
  Inlyta 7 mg: each tablet contains 7 mg of axitinib

• The other ingredients are microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate, hypromellose 2910 (15 mPa·s), titanium dioxide (E171), triacetin (E1518), and red iron oxide (E172) (see section 2, Inlyta contains lactose).

Description of the appearance of Inlyta and package contents
Inlyta 1 mg is available as red, oval, film-coated tablets, with “Pfizer” imprinted on one side and “1 XNB” on the other. Inlyta 1 mg is available in bottles of 180 tablets and in blister packs of 14 tablets. Each blister pack contains 28 or 56 tablets.
Inlyta 3 mg is available as red, round, film-coated tablets, with “Pfizer” imprinted on one side and “3 XNB” on the other. Inlyta 3 mg is available in bottles of 60 tablets and in blister packs of 14 tablets. Each blister pack contains 28 or 56 tablets.
Inlyta 5 mg is available as red, triangular, film-coated tablets, with “Pfizer” imprinted on one side and “5 XNB” on the other. Inlyta 5 mg is available in bottles of 60 tablets and in blister packs of 14 tablets. Each blister pack contains 28 or 56 tablets.
Inlyta 7 mg is available as red, rhomboidal, film-coated tablets, with “Pfizer” imprinted on one side and “7 XNB” on the other. Inlyta 7 mg is available in bottles of 60 tablets and in blister packs of 14 tablets. Each blister pack contains 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgique/België/Belgien
Pfizer SA/NV
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel. +370 52 51 4000

България
Пфайзер Люксембург САРЛ, Клон България
Тел.: +359 2 970 4333

Luxembourg/Luxemburg
Pfizer S.A.
Tél/Tel: +32 (0)2 554 62 11

Česká republika
Pfizer, spol. s r.o.
Tel.: +420 283 004 111

Magyarország
Pfizer Kft.
Tel.: +36-1-488-37-00

Danmark
Pfizer ApS
Tlf: +45 44 20 11 00

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055 51000

Nederland
Pfizer BV
Tel: +31 (0)10 406 43 01

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel.: +372 666 7500

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ: +30 210 6785 800

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

España
Pfizer S.L.
Tél: +34 91 490 99 00

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

France
Pfizer Laboratoires
Tél: +33 (0)1 58 07 34 40

Portugal
Pfizer, Lda.
Tel: +351 21 423 5500

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Ireland
Pfizer Healthcare Ireland
Tel: 1800 633 363 (toll free)
+44 (0)1304 616161

Slovenija
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel.: +386 (0)1 52 11 400

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel.: +421 2 3355 5500

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Suomi/Finland
Pfizer Oy
Puh./Tel: +358 (0)9 43 00 40

Kύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ: +357 22 817690

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel.: +371 670 35 775

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0) 1304 616161

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.