1 mg, 3 mg, 5 mg and 7 mg film-coated tablets
axitinib
1. What Inlyta is and what it is used for
Inlyta is a medicine that contains the active substance axitinib. Axitinib reduces blood flow to the tumor and causes cancer to grow more slowly.
Inlyta is intended for the treatment of advanced kidney cancer (advanced renal cell carcinoma) in adults when other medicines (sunitinib or cytokine ) can no longer prevent the disease from getting worse.
If you have any further questions on the use of this medicine, ask your doctor.
2. What you need to know before using Listen
Do not Listen:
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.
Warnings and cautions
Talk to a doctor or nurse before taking Inlyta:
- If you have high blood pressure .
Listening can raise your blood pressure . It is important that your blood pressure is measured before you take this medicine and regularly while you are taking it. If you have high blood pressure ( hypertension ), you can receive medication to lower your blood pressure . Your doctor should check that your blood pressure is under control before starting treatment with Inlyta, and while you are taking this medicine. - If you have thyroid problems.
Listening can cause thyroid problems. Tell your doctor if you get tired more easily, freeze more than others, or if your voice gets deeper while you are taking this medicine. Your thyroid function should be checked before taking Inlyta and regularly while you are taking the medicine. If your thyroid gland does not produce enough thyroid hormone before or during treatment with this medicine, you should be treated with hormone replacement therapy. - If you have recently had problems with blood clots in your veins or arteries (various types of blood vessels), including stroke , heart attack, embolism or thrombosis .Seek emergency care immediately and contact your doctor if you experience symptoms such as chest pain or pressure over the chest, pain in the arms, back, neck or jaw, shortness of breath, numbness or weakness in one half of the body, difficulty speaking, headache, vision changes or dizziness when you treated with this drug.
- If you have problems with bleeding.Listening may increase the risk of bleeding. Tell your doctor if you experience bleeding or coughing up blood or blood-mixed mucus while you are being treated with this medicine.
- If you have or have had an aneurysm (enlargement and weakening of a vessel wall) or a rupture in a vessel wall.
- If you get severe stomach pains or stomach pains during treatment with this medicine.Listening can increase the risk of a hole appearing in the stomach or intestines, or of fistula formation (an abnormal passage from a normal body cavity to another body cavity, or to the skin).
Tell your doctor if you experience severe stomach pain while being treated with this medicine.
- If you are going to have surgery or if you have a wound that has not healed.
The doctor should discontinue treatment with Inlyta at least 24 hours before the operation as the medicine may affect wound healing. Treatment can be resumed when the wound has healed sufficiently. - If you get symptoms such as headache, confusion, seizures or changes in vision, with or without high blood pressure, during treatment with this medicine .Seek emergency care immediately and contact your doctor. This can be a rare side effect that affects the nervous system and is called posterior reversible encephalopathy syndrome.
- If you have liver problems.Your doctor should take blood samples to examine your liver function before and during treatment with Inlyta.
- If you get symptoms such as excessive tiredness, swollen stomach, swollen legs or ankles, shortness of breath or protruding jugular veins during treatment with this medicine.Listening can increase the risk of heart failure events. Your doctor should regularly monitor you for signs and symptoms of heart failure during treatment with axitinib.
Children and young people
Listening is not recommended for children and young people under 18 years of age. This medicine has not been studied in children and adolescents.
Other medicines and Listen
Some medicines may affect Inlyta, or be affected by Inlyta. Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, vitamins, and herbal medicines. There may also be other medicines than those mentioned in this leaflet that may affect or be affected by Inlyta.
The following medicines may increase the risk of side effects from Inlyta:
- ketoconazole or itraconazole: medicines used to treat fungal infections
- clarithromycin, erythromycin or telithromycin: antibiotics for bacterial infections
- atazanavir, indinavir, nelfinavir, ritonavir or saquvinavir: used to treat HIV infections / AIDS
- nefazodone: antidepressant.
The following medicines may reduce the effect of Inlyta:
- rifampicin, rifabutin or rifapentin: medicines for tuberculosis ( TB )
- Dexamethasone: a steroid drug that is prescribed for many different conditions, including serious illnesses
- phenytoin , karbamezapin or fenofarbital: drugs for epilepsy to stop seizures
- St. John’s wort (Hypericum perforatum) : a natural remedy for depression.
You should not use these medicines when you are being treated with Inlyta. Tell your doctor, pharmacist, or nurse if you are taking any of these medicines. Your doctor may change the dose of one of these medicines, change the dose of one of Inlyta or give you another medicine.
Listening can increase the side effects associated with theophylline, which is used to treat asthma and other lung diseases.
Listen with food and drink
Do not take it with grapefruit or grapefruit juice, as it may increase the risk of side effects.
Pregnancy, breastfeeding and fertility
- 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.
- Lying down can harm an unborn baby or a breastfed infant.
- Do not take this medicine during pregnancy. Talk to your doctor before taking this medicine if you are pregnant or could become pregnant.
- Use a reliable method of contraception while taking Inlyta and up to one week after the last dose of one of the medicines, to prevent pregnancy.
- Do not breast-feed when you are being treated with Inlyta. If you are breast-feeding, your doctor should discuss with you whether breast-feeding or treatment with Inlyta should be stopped.
Driving and using machines
If you feel dizzy and/or tired during treatment with Inlyta, take special care when driving or using machines.
Inlyta contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Inlyta contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free.
3. How to take Listen
Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
The recommended dose is 5 mg twice daily. Your doctor may later increase or decrease the dose depending on how well you tolerate the treatment with Inlyta.
Swallow the tablets whole with water, with or without food. Take Inlyta- dose was approximately 12 hours apart.
If you take more Orlyta than you should
If you happen to take too many tablets or a higher dose than you need, contact a doctor immediately for advice. Show this information to your doctor, if possible. You may need medical attention.
If you forget to take Listen
Take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you vomit while taking Inlyta
If you vomit, do not take another dose. Take the next dose at the usual time.
If you stop taking Listen
If you can not take this medicine as prescribed by your doctor or if you feel you no longer need it, contact your doctor immediately.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious. You must contact your doctor immediately if you get any of the following serious side effects (see also section 2 “What you need to know before you take Inlyta”):
• Heart failure events. Tell your doctor if you experience excessive fatigue, swollen stomach, swollen legs or ankles, shortness of breath, or protruding jugular veins.
Blood clots in veins or arteries (different types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Seek emergency care immediately and contact your doctor if you experience symptoms such as chest pain or pressure over the chest, pain in the arms, back, neck, or jaw if you become short of breath, have numbness or weakness in one half of the body, have difficulty speaking, headache, vision changes or dizziness.
• Bleeding. Tell your doctor immediately if you experience any of the following symptoms or serious problems with bleeding when you are treated with Inlyta: black tarry stools, you cough up blood or blood-mixed mucus, or you experience changes in your mental health.
Holes in the stomach or intestines or fistula formation (abnormal passage from one normal body cavity to another body cavity or to the skin). Tell your doctor if you get severe stomach pain.
• Very high blood pressure (hypertensive crisis). Tell your doctor if you have very high blood pressure, severe headaches, or severe chest pain.
• Transient swelling of the brain (posterior reversible encephalopathy syndrome). Seek emergency care immediately and contact your doctor if you experience symptoms such as headache, confusion, seizures, or visual disturbances, with or without high blood pressure.
Other side effects of Inlyta can be:
Very common: may affect more than 1 user in 10
- High blood pressure , or increased blood pressure .
- Diarrhea, nausea or vomiting, stomach pain, indigestion, pain in the mouth, tongue or throat, constipation
- Shortness of breath, cough, hoarseness
- Weakness, weakness or fatigue
- Underactive thyroid gland (can be detected in blood tests)
- Redness and swelling in the palms or soles of the feet (hand-foot syndrome), rash, dry skin
- Joint pain, pain in hands or feet
- Poor appetite
- Protein in the urine (can be detected in urine samples)
- Weight loss
- Headache, taste changes or lost taste
Common: may affect up to 1 in 10 users
- Dehydration (fluid loss).
- Kidney failure .
- Flatulence, hemorrhoids , bleeding gums, bleeding from the rectum, a burning or stinging sensation in the mouth
- Overactive thyroid gland (can be detected in blood tests)
- Sore throat or nose and irritated throat
- Muscle pain
- Nasal blood
- Itching , redness of the skin, hair loss
- Ringing in the ears / -ringning ( tinnitus )
- Reduced number of red blood cells (can be detected in blood tests)
- Decreased platelet count (cells that help the blood to clot) (can be detected in blood tests)
- Red blood cells in the urine (can be detected in urine samples)
- Altered amount of certain chemical substances / enzymes in the blood (can be detected in blood tests)
- Increased number of red blood cells (can be detected in blood tests).
- Swollen stomach, swollen legs or ankles, protruding jugular veins, excessive fatigue, shortness of breath (signs of heart failure events).
- Fistula (abnormal passage from one 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
- Reduced white blood cell count (can be detected in blood tests).
Has been reported: occurs in an unknown number of users
- An enlargement and weakening of a vessel wall or a rupture in a vessel wall ( aneurysms and arterial dissections).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
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 which is stated on the carton and blister or can after EXP.
The expiration date is the last day of the specified month.
This medicine has no special storage instructions.
Do not use packaging that is damaged or appears to have been tampered with.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is axitinib. Listen to film-coated tablets are available in different strengths.Listen to 1 mg: each tablet contains 1 mg of axitinib.Listen to 3 mg: each tablet contains 3 mg of axitinib.Listen to 5 mg: each tablet contains 5 mg of axitinib.Listen to 7 mg: each tablet contains 7 mg of axitinib.
- The other ingredients are microcrystalline cellulose, lactose monohydrate , croscarmellose sodium, magnesium stearate, hypromellose 2910 (15 mPa · s), titanium dioxide (E171), triacetin (E1518) and red iron oxide (E172) (see section 2 “Inlyta contains lactose”).
What the medicine looks like and contents of the pack
Take 1 mg film-coated tablets are red, oval, and imprinted with “Pfizer” on one side and “1 XNB” on the other. Inlyta 1 mg is available in jars of 180 tablets and blister cards of 14 tablets. Each blister pack contains 28 or 56 tablets.
The 3 mg film-coated tablets are red, round, and imprinted with “Pfizer” on one side and “3 XNB” on the other. Inlyta 3 mg is available in jars of 60 tablets and blister cards of 14 tablets. Each blister pack contains 28 or 56 tablets.
Take 5 mg film-coated tablets are red, triangular, and imprinted with “Pfizer” on one side and “5 XNB” on the other. Inlyta 5 mg is available in jars of 60 tablets and blister cards of 14 tablets. Each blister pack contains 28 or 56 tablets.
Listen to 7 mg film-coated tablets that are red, diamond-shaped, and imprinted with “Pfizer” on one side and “7 XNB” on the other. Inlyta 7 mg is available in jars of 60 tablets and blister cards of 14 tablets. Each blister pack contains 28 or 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Establishment Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgique / België / BelgienPfizer SA / NVTel: +32 (0) 2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel: + 370 52 51 4000 |
| BulgariaPfizer Luxembourg SAARЛ, Clone of BulgariaTel: +359 2 970 4333 | Luxembourg / LuxemburgPfizer SATel: +32 (0) 2 554 62 11 |
| Czech RepublicPfizer, spol. s roTel: +420 283 004 111 | HungaryPfizer Kft.Tel .: + 36-1-488-37-00 |
| DenmarkPfizer ApSTel: +45 44 20 11 00 | MaltaVivian Corporation Ltd.Tel: +356 21344610 |
| GermanyPFIZER PHARMA GmbHTel: +49 (0) 30 550055 51000 | The NetherlandsPfizer BVTel: +31 (0) 10 406 43 01 |
| EestiPfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500 | NorwayPfizer ASTel: +47 67 52 61 00 |
| GreecePfizer Aλλάς AE:Ηλ: +30 210 6785 800 | AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0 |
| SpainPfizer SLTel: +34 91 490 99 00 | PolandPfizer Polska Sp. z ooTel .: +48 22 335 61 00 |
| FrancePfizerTel: +33 (0) 1 58 07 34 40 | PortugalPfizer Laboratories, Lda.Tel: +351 21 423 5500 |
| CroatiaPfizer Croatia dooTel: + 385 1 3908 777 | RomaniaPfizer Romania SRLTel: +40 (0) 21 207 28 00 |
| IrelandPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 | SloveniaPfizer Luxembourg SARLPfizer, for construction and pharmaceutical services, LjubljanaTel: + 386 (0) 1 52 11 400 |
| IcelandIcepharma hf.Phone: +354 540 8000 | Slovak RepublicPfizer Luxembourg SARL, organizerTel: + 421 2 3355 5500 |
| ItalyPfizer SrlTel: +39 06 33 18 21 | Finland / FinlandPfizer OyPuh./Tel: +358 (0) 9 43 00 40 |
| ΎπροςPfizer Αλλάς Α.Ε. (Cyprus Branch):Ηλ: +357 22 817690 | SwedenPfizer ABTel: +46 (0) 8 550 520 00 |
| LatviaPfizer Luxembourg SARL subsidiary LatvijāTel: + 371 670 35 775 | United Kingdom (Northern Ireland)Pfizer LimitedTel: +44 (0) 1304 616161 |