Prospect: 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 this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1.What is Inlyta and for what it is used

2.What you need to know before starting to take Inlyta

3.How to take Inlyta

4.Possible adverse effects

1. Storage of Inlyta
2. Contents of the package and additional information

Inlyta is a medication that contains the active ingredient axitinib. Axitinib reduces blood supply to the tumor and reduces cancer growth.

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

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

Do not take Inlyta:

If you are allergic to axitinib or any of the other components of this medication (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 may increase blood pressure. It is essential to control your blood pressure before starting this medication and periodically during treatment. If you have high blood pressure (hypertension), you may be treated with medications that reduce blood pressure. Your doctor must ensure that your blood pressure is controlled before starting treatment with Inlyta and during treatment with this medication.

• If you have thyroid problems.
  Inlyta may cause thyroid problems. Contact your doctor if you find it easier to get tired, are usually colder than others, or your voice becomes deeper while taking this medication. Thyroid function should be controlled before starting treatment with Inlyta and periodically while taking it. If your thyroid gland does not produce enough thyroid hormone, you may be treated with thyroid hormone replacement before or during treatment with this medication.

• If you have had recent 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, speech problems, headache, changes in vision, or dizziness while taking this medication.

• If you have bleeding problems.

Inlyta may increase the risk of bleeding. Inform your doctor if you have bleeding, coughing up blood, or bloody sputum while taking this medication.

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

• If during treatment with this medication you experience severe stomach pain or stomach pain that does not go away.

Inlyta may increase the risk of developing stomach ulcers or the formation of fistulas (abnormal tube-like structure from a normal body cavity to another body cavity or to the skin). Consult your doctor if you experience severe abdominal pain while taking this medication.

• If you are to undergo surgery or have an open wound.
  Your doctor should stop Inlyta at least 24 hours before surgery, as it may affect wound healing. Treatment with this medication should be resumed when the wound is well-healed.

• If during treatment with this medication you experience symptoms such as headache, confusion, seizures (epileptic attacks), or changes in vision 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 medication you experience symptoms such as excessive fatigue, abdominal swelling, leg or ankle swelling, difficulty breathing, or protrusion of neck veins (very prominent veins).

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

Use in children and adolescents

Inlyta is not recommended for individuals under 18 years old. This medication has not been studied in children or adolescents.

Taking Inlyta with other medications

Some medications may affect Inlyta, or vice versa. Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications, vitamins, and herbal supplements. The medications listed in this prospectus may not be the only ones that interact with Inlyta.

The following medications 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;
• nefazodone, used to treat depression.

The following medications may reduce the effectiveness of Inlyta:

• rifampicin, rifabutin, or rifapentine, used to treat tuberculosis (TB);
• dexamethasone, a corticosteroid prescribed to treat various diseases, some of which are serious;
• phenytoin, carbamazepine, or phenobarbital, antiepileptic medications used to prevent seizures or epileptic attacks;
• St. John's Wort (Hypericum perforatum), a medicinal herb used to treat depression.

Do not take these medicationswhile taking Inlyta. If you are taking any of them, inform your doctor, pharmacist, or nurse. Your doctor may change the dose of these medications, change the dose of Inlyta, or switch to another medication.

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

Taking Inlyta with food and drinks

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

Pregnancy and breastfeeding

• Inlyta may harm the fetus or the breastfeeding baby.

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

• Use a reliable contraceptive method to avoid pregnancy during treatment with Inlyta and for 1 week after the last dose of this medication.

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

Driving and operating machinery

If you experience dizziness and/or feel tired while taking Inlyta, exercise extra caution when driving or operating machinery.

Inlyta contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Inlyta contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

The recommended dose is 5 mg twice a day. Your doctor may later increase or decrease your dose depending on how you tolerate the treatment with Inlyta.

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

If you take more Inlyta than you should

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

If you forget to take Inlyta

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

If you vomit while taking Inlyta

If you vomit, do not take an additional dose. You should take the next prescribed dose at the usual time.

If you interrupt treatment with Inlyta

If you are unable to take this medication as your doctor has prescribed, or think you no longer need it, contact your doctor immediately.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects can be serious. You should contact your doctor immediately if you experience any of the following serious side effects (see also the section2 “What you need to know before starting to take Inlyta”):

• Heart failure events. Consult your doctor if you feel excessive fatigue, abdominal swelling, leg or ankle swelling, difficulty breathing, or protrusion of neck veins.

• Blood clots in veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.Call the emergency service immediately and contact your doctor if you have 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, speech problems, headache, changes in vision, or dizziness.

• Bleeding.Inform your doctor if you have any of these symptoms or experience a bleeding problem during treatment with Inlyta: black or tarry stools, bloody cough or sputum with blood, or change in mental state.

• Ulcer in the stomach or intestine or formation of fistulas (abnormal tube-like structure from a normal body cavity to another body cavity or to the skin). Consult your doctor if you have intense 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 cerebral alteration (posterior reversible encephalopathy syndrome). Call the emergency service immediately and contact your doctor if you experience symptoms such as headache, confusion, seizures (epileptic attacks), or changes in vision with or without high blood pressure.

Other side 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, mouth, tongue, or throat irritation, constipation.
• Shortness of breath, cough, or hoarseness.
• Lack of energy, feeling weak or tired.
• Decreased thyroid gland activity (may 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, hand or foot pain.
• Loss of appetite.
• Protein in urine (may 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).
• Renal failure.
• Flatulence (gas), hemorrhoids, bleeding gums, rectal bleeding, burning or stinging sensation in the mouth.
• Hyperthyroidism (may be seen in blood tests).
• Sore throat or irritation of the nose and throat.
• Muscle pain.
• Nosebleeds.
• Itching or redness of the skin, hair loss.
• Tinnitus (ringing in the ears).
• Decreased white blood cell count (may be seen in blood tests).
• Decreased platelet count (cells that help blood clot) (may be seen in blood tests).
• Red blood cells in urine (may be seen in urine tests).
• Changes in levels of different substances/enzymes in the blood (may be seen in blood tests).
• Increased red blood cell count (may be seen in blood tests).
• Swelling of the abdomen, legs, or ankles, protrusion of neck veins, excessive fatigue, difficulty breathing (signs of heart failure events).
• Fistula (abnormal tube-like structure from a normal body cavity to another body cavity or to the skin).
• Dizziness.
• Biliary tract inflammation.

Rare: may affect up to 1 in 100 people

• Decreased white blood cell count (may be seen in blood tests).

Frequency not known: cannot be estimated from available data

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

Reporting side effects

If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack or bottle after “EXP”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not use this medication if it is damaged or shows signs of having been tampered with.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Inlyta

• The active ingredient is axitinib. Inlyta tablets are available in different concentrations.

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), iron oxide red (E172) (see section 2 Inlyta contains lactose).

Appearance of the product and contents of the package

Inlyta 1 mg tablets coated with a film are oval, red in color, and engraved 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 package with blisters contains 28 or 56 tablets.

Inlyta 3 mg tablets coated with a film are round, red in color, and engraved 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 package with blisters contains 28 or 56 tablets.

Inlyta 5 mg tablets coated with a film are triangular, red in color, and engraved 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 package with blisters contains 28 or 56 tablets.

Inlyta 7 mg tablets coated with a film are diamond-shaped, red in color, and engraved 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 package with blisters contains 28 or 56 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Responsible for manufacturing

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu / .