Inlyta 1 mg film-coated tablets

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Inlyta 1mg film-coated tablets

Inlyta 3mg film-coated tablets

Inlyta 5mg film-coated tablets

Inlyta 7mg film-coated tablets

axitinib

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 that contains the active substance axitinib. Axitinib reduces the blood supply to the tumour and thereby reduces cancer growth.

Inlyta is indicated for the treatment of advanced renal cell carcinoma (advanced kidney cancer) in adults when other medicines (called sunitinib or cytokines) are unable to stop the progression of the disease.

If you have any questions about how this medicine works or why it has been prescribed for you, please consult your doctor.

2. What you need to 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

Consult your doctor or nurse before taking Inlyta:

• If you have high blood pressure.

Inlyta can increase blood pressure. It is important to monitor your blood pressure before starting treatment with this medicine and periodically during treatment. If you have high blood pressure (hypertension), you may be treated with medications that lower blood pressure. Your doctor must ensure your blood pressure is under control before starting treatment with Inlyta and during treatment with this medicine.

• If you have thyroid gland problems. Inlyta may cause thyroid gland problems. Contact your doctor if you feel unusually tired, are often colder than other people, or your voice becomes deeper while taking this medicine. Thyroid function should be monitored before treatment with Inlyta and periodically during treatment. If your thyroid gland does not produce enough thyroid hormone, you may be treated with thyroid hormone replacement therapy before or during treatment with this medicine.

• If you have recently had blood clotting problems in veins or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.

Call emergency services immediately and contact your doctor if you experience symptoms such as chest pain or pressure, arm, back, neck, or jaw pain, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, headache, vision changes, or dizziness while being treated with this medicine.

• If you have bleeding disorders.

Inlyta may increase the risk of bleeding. Inform your doctor if you experience bleeding, cough up blood, or have bloody sputum while being treated with this medicine.

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

• If during treatment with this medicine you experience severe or persistent stomach (abdominal) pain.

Inlyta may increase the risk of developing a stomach or intestinal ulcer or the formation of fistulas (an abnormal tube-like passage from one body cavity to another or to the skin). Consult your doctor if you experience severe abdominal pain while being treated with this medicine.

• If you are scheduled for surgery or have an unhealed wound. Your doctor must discontinue Inlyta at least 24 hours before surgery, as it may affect wound healing. Treatment with this medicine should be restarted once the wound has healed properly.

• If during treatment with this medicine you experience symptoms such as headache, confusion, seizures (epileptic fits), or vision changes, with or without high blood pressure.

Call emergency services immediately and contact your doctor. This may be a rare neurological side effect known as reversible posterior leukoencephalopathy syndrome.

• If you have liver problems.

Your doctor should perform blood tests to monitor liver function before and during treatment with Inlyta.

• If during treatment with this medicine you experience symptoms such as excessive fatigue, abdominal swelling, swelling of the legs or ankles, difficulty breathing, or prominent neck veins (distended neck veins).

Inlyta may increase the risk of heart failure events. Your doctor should monitor periodically for signs or symptoms of heart failure throughout treatment with axitinib.

Use in children and adolescents

Inlyta is not recommended for use in individuals under 18 years of age. This medicine has not been studied in children or adolescents.

Taking Inlyta with other medicines

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 need to take any other medicines, including over-the-counter medicines, vitamins, and herbal supplements. 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/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 steroid medicine prescribed for the treatment of various conditions, some of which are serious;
• phenytoin, carbamazepine, or phenobarbital, antiepileptic medicines used to prevent seizures or epileptic fits;
• St. John’s wort (Hypericum perforatum), a herbal remedy used to treat depression.

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

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

Taking Inlyta with food and drinks

Do not take this medicine with grapefruit or grapefruit juice, as it may increase the risk of adverse effects.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

• Inlyta could harm the unborn baby or breastfed infant.

• Do not take this medicine during pregnancy. If you are pregnant or think you may be pregnant, consult your doctor before taking it.

• During treatment with Inlyta and for at least 1 week after the last dose of this medicine, use a reliable method of contraception to prevent pregnancy.

• Do not breastfeed during treatment with Inlyta. If you are breastfeeding, your doctor will advise whether you should stop breastfeeding or stop treatment with Inlyta.

Driving and using machines

If you experience dizziness and/or feel tired while being treated with Inlyta, take special care when driving or operating machinery.

Inlyta contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Inlyta contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; therefore, it is essentially “sodium-free”.

3. How to take Inlyta

Follow exactly the instructions for using this medicine given by your doctor. If you are unsure, consult your doctor, pharmacist, or nurse again.

The recommended dose is 5 mg twice daily. Your doctor may subsequently increase or decrease your dose depending on how well you tolerate treatment with Inlyta.

Swallow the tablets whole with some water, with or without food. Take doses of Inlyta approximately every 12 hours.

If you take more Inlyta than you should

If you accidentally take more tablets or a higher dose than required, contact your doctor immediately for advice. If possible, show your doctor the packaging or this leaflet. You may require medical attention.

If you forget to take Inlyta

Take the next dose at your usual time. Do not take a double dose to make up for forgotten doses.

If you vomit while 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 this medicine as prescribed by your doctor, or think you no longer need it, contact your doctor immediately.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Some adverse effects may be serious. You must contact your doctor immediately if you experience any of the following serious adverse effects (see also section 2 “What you need to know before you start taking Inlyta”):

• Heart failure events. Consult your doctor if you experience excessive tiredness, swelling of 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. Call emergency services immediately and contact your doctor if you experience symptoms such as chest pain or pressure, arm, back, neck, or jaw pain, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, headache, vision changes, or dizziness.

• Bleeding. Inform your doctor if you experience any of these symptoms or develop a bleeding problem during treatment with Inlyta: black or tarry stools, coughing up blood or bloody sputum, or changes in mental status.

• Stomach or intestinal ulcer or formation of fistulas (an abnormal tube-like passage from a normal body cavity to another body cavity or to the skin). Consult your doctor if you have severe abdominal pain.

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

• Reversible brain disorder (posterior reversible encephalopathy syndrome). Call emergency services immediately and contact your doctor if you experience symptoms such as headache, confusion, seizures (epileptic fits), or vision changes, with or without high blood pressure.

Other adverse effects with Inlyta may include:

Very common: may affect more than 1 in 10 people

• High blood pressure or increases in blood pressure.
• Diarrhea, nausea or vomiting, stomach pain, indigestion, irritation of the mouth, tongue, or throat, constipation.
• Shortness of breath, cough, hoarseness.
• Lack of energy, feeling weak or tired.
• Low activity of the thyroid gland (can be seen in blood tests).
• Redness and swelling of the palms of the hands or soles of the feet (hand-foot syndrome), skin rash, dry skin.
• Joint pain, pain in the hands or feet.
• Loss of appetite.
• Protein in urine (can be seen in urine tests).
• Weight loss.
• Headache, altered taste, or loss of taste.

Common: may affect up to 1 in 10 people

• Dehydration (loss of body fluids).
• Kidney failure.
• Flatulence (gas), hemorrhoids, bleeding gums, rectal bleeding, burning or stinging sensation in the mouth.
• Hyperthyroidism (can be seen in blood tests).
• Sore throat or irritation of nose and throat.
• Muscle pain.
• Nosebleeds.
• Itching of the skin, skin redness, hair loss.
• Ringing or noises in the ears (tinnitus).
• Decrease in red blood cell count (can be seen in blood tests).
• Decrease in platelet count (blood cells that help blood clot) (can be seen in blood tests).
• Presence of red blood cells in urine (can be seen in urine tests).
• Changes in levels of different substances/enzymes in the blood (can be seen in blood tests).
• Increase in red blood cell count (can be seen in blood tests).
• Swelling of the abdomen, legs, or ankles, bulging neck veins, excessive tiredness, difficulty breathing (signs of heart failure events).
• Fistula (abnormal passage from a normal body cavity to another body cavity or to the skin).
• Dizziness.
• Inflammation of the gallbladder.

Uncommon: may affect up to 1 in 100 people

• Decrease in white blood cell count (can be seen in blood tests).

Frequency not known: cannot be estimated from available data

• Enlargement and weakening of a blood vessel wall or tearing of a blood vessel wall (aneurysms and arterial dissections).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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, or bottle after "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Do not use this medicine if it is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Inlyta

• The active substance is axitinib. Inlyta 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 components 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).

Nature of the product and contents of the pack

Inlyta 1 mg film-coated tablets are oval, red in colour, and marked with “Pfizer” on one side and “1 XNB” on the other. Inlyta 1 mg is available in bottles of 180 tablets and in blisters of 14 tablets. Each blister pack contains 28 or 56 tablets.

Inlyta 3 mg film-coated tablets are round, red in colour, and marked with “Pfizer” on one side and “3 XNB” on the other. Inlyta 3 mg is available in bottles of 60 tablets and in blisters of 14 tablets. Each blister pack contains 28 or 56 tablets.

Inlyta 5 mg film-coated tablets are triangular, red in colour, and marked with “Pfizer” on one side and “5 XNB” on the other. Inlyta 5 mg is available in bottles of 60 tablets and in blisters of 14 tablets. Each blister pack contains 28 or 56 tablets.

Inlyta 7 mg film-coated tablets are diamond-shaped, red in colour, and marked with “Pfizer” on one side and “7 XNB” on the other. Inlyta 7 mg is available in bottles of 60 tablets and in blisters of 14 tablets. Each blister pack contains 28 or 56 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg im Breisgau
Germany

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.eu游戏副本eu/.