What is INLYTA (Axitinib)?
INLYTA is a prescription medicine used to treat advanced kidney cancer (advanced renal cell carcinoma or RCC) when one prior drug treatment for this disease has not worked.
It is not known if INLYTA is safe or effective in children.
What is the most important information I should know about INLYTA?
INLYTA can cause serious side effects. These serious side effects include:
- High blood pressure (hypertension). Your doctor should check your blood pressure regularly during treatment with INLYTA. If you develop blood pressure problems, your doctor may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with INLYTA.
- Thyroid gland problems. Your doctor should do blood tests to check your thyroid gland function before and during your treatment with INLYTA. Tell your doctor if you have any of the following symptoms during your treatment with INLYTA:
- Tiredness that worsens or that does not go away
- Feeling hot or cold
- Your voice deepens
- Weight gain or weight loss
- Hair loss
- Muscle cramps and aches
- Problem with blood clots in your veins or arteries. Get emergency help and call your doctor if you get any of the following symptoms:
- Chest pain or pressure
- Shortness of breath
- Trouble talking
- Vision changes
- Pain in your arms, back, neck or jaw
- Numbness or weakness on one side of your body
- Headache
- Bleeding. INLYTA can cause bleeding which can be serious, and sometimes lead to death. Call your doctor or get medical help if you develop any bleeding, including:
- unexpected bleeding or bleeding that lasts a long time
- Unusual bleeding from the gums
- Bleeding that is severe or you cannot control
- Bruises that happen without a known cause or get larger
- Vomit blood or your vomit looks like “coffee grounds”
- Menstrual bleeding or vaginal bleeding that is heavier than normal
- Red or black stools (looks like tar)
- pink or brown urine
- Cough up blood or blood clots
- Unexpected pain, swelling, or joint pain
- Headaches, feeling dizzy or weak
- Tear in your stomach or intestinal wall (perforation). Get medical help right away if you get the symptoms: Severe stomach (abdominal) pain or stomach pain that does not go away, Vomit blood, Red or black stools
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS).
- Increased protein in your urine
- Change in liver function.
- The most common side effects of INLYTA include:
- Diarrhea (frequent or loose bowel movements)
- High blood pressure
- Tiredness or feeling weak
- Decreased appetite
- Nausea
- Hoarseness
- Rash, redness, itching or peeling of your skin on your hands and feet
- Decreased weight
- Vomiting
- Constipation
How should I take INLYTA?
- Take INLYTA exactly as prescribed by your doctor.
- Your doctor may change your dose if needed.
- INLYTA can be taken with or without food.
- Take INLYTA 2 times a day approximately 12 hours apart.
- Swallow INLYTA tablets whole with a glass of water.
- Your doctor should check your blood pressure regularly during treatment with INLYTA.
- If you vomit or miss a dose of INLYTA, take your next dose at your regular time. Do not take two doses at the same time.
- If you take too much INLYTA, call your doctor or go to the nearest hospital emergency room right away
Important Safety Information
- Do not drink grapefruit juice or eat grapefruit. Grapefruit may increase the amount of INLYTA in your blood.
- If you vomit or miss a dose of INLYTA, take your next dose at your regular time. Do not take two doses at the same time.
- If you take too much INLYTA, call your doctor or go to the nearest hospital emergency room right away.
- Use effective birth control during your treatment with INLYTA.
- If your female partner becomes pregnant while you are taking INLYTA, tell your doctor right away
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking INLYTA?
Before you take INLYTA, tell your doctor if you:
- Have high blood pressure
- Have thyroid problems
- Have liver problems
- Have a history of blood clots in your veins or arteries (types of blood vessels), including stroke, heart attack, or change in vision
- Have any bleeding problems
- Have an unhealed wound
- Plan to have surgery. You should stop taking INLYTA at least 24 hours before planned surgery.
- Have any other medical conditions
- Are pregnant or plan to become pregnant. Taking INLYTA during pregnancy may cause the death of an unborn baby or birth defects. You should not become pregnant while taking INLYTA. Talk to your doctor if you are pregnant or plan to become pregnant.
- Are able to become pregnant. You should use effective birth control during your treatment with INLYTA. Talk to your doctor about birth control methods to prevent pregnancy while you are taking INLYTA.
- Are breastfeeding or plan to breastfeed. It is not known if INLYTA passes into your breast milk. You and your doctor should decide if you will take INLYTA or breastfeed. You should not do both.
- Use effective birth control during your treatment with INLYTA. Talk to your doctor about birth control methods.
- If your female partner becomes pregnant while you are taking INLYTA, tell your doctor right away.
- Especially tell your doctor if you take: Dexamethasone, St. John’s Wort (Hypericum perforatum), Medicine for: Asthma, Tuberculosis, Seizures, Bacterial infections, Fungal infections, Depression, HIV or AIDS
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
General information about INLYTA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INLYTA for a condition for which it was not prescribed. Do not give INLYTA to other people, even if they have the same symptoms you have. It may harm them.
What are the ingredients in INLYTA?
Active ingredient: Axitinib
Other ingredient: Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, and Opadry® II red 32K15441. The Opadry II red 32K15441 film coating contains: lactose monohydrate, HPMC 2910/Hypromellose 15cp, titanium dioxide, triacetin (glycerol triacetate), and red iron oxide.