Inlyta

Inlyta is a prescription medication used to treat advanced kidney cancer (advanced renal cell carcinoma or RCC) when one prior drug treatment for this disease has not worked. Inlyta belongs to a group of drugs called tyrosine kinase inhibitors, which work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

This medication comes in tablet form and is taken twice daily, with or without food. Inlyta tablets must be swallowed whole with a glass of water.

Common side effects of Inlyta include diarrhea, tiredness, and nausea.

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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Pfizer Laboratories Div Pfizer Inc.

• Pfizer Labs

Inlyta may cause serious side effects. See "Inlyta Precautions."

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Inlyta. For more information, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Inlyta and certain other medicines can affect each other causing serious side effects.

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

Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. If you are taking any medicines for the conditions listed above, your doctor might need to prescribe a different medicine or your dose of Inlyta may need to be changed. Talk with your doctor before you start taking any new medicine.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Inlyta may cause serious side effects, including:

• 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
  • pain in your arms, back, neck or jaw
  • shortness of breath
  • numbness or weakness on one side of your body
  • trouble talking
  • headache
  • vision changes
• 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, such as:
  • unusual bleeding from the gums
  • menstrual bleeding or vaginal bleeding that is heavier than normal
  • bleeding that is severe or you cannot control
  • pink or brown urine
  • red or black stools (looks like tar)
  • bruises that happen without a known cause or get larger
  • cough up blood or blood clots
  • vomit blood or your vomit looks like "coffee grounds"
  • 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 following symptoms:
  • severe stomach (abdominal) pain or stomach pain that does not go away
  • vomit blood
  • red or black stools
• Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome (RPLS) can happen while taking Inlyta. Call your doctor right away if you get:
  • headache
  • seizures
  • weakness
  • confusion
  • high blood pressure
  • blindness or change in vision
  • problems thinking
• Increased protein in your urine. Your doctor should check your urine for protein before and during your treatment with Inlyta. If you develop protein in your urine, your doctor may decrease your dose of Inlyta or stop your treatment.
• Change in liver function. Your doctor should do blood tests before and during your treatment with Inlyta to check your liver function.

Taking Inlyta during pregnancy may cause the death of an unborn baby or birth defects. You should not become pregnant while taking Inlyta. Use effective birth control while taking Inlyta.

Do not take Inlyta if you are allergic to any of its ingredients.

Do not drink grapefruit juice or eat grapefruit. Grapefruit may increase the amount of Inlyta in your blood.

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

For females, tell your doctor if you:

• are pregnant or plan to become pregnant. 
• are able to become pregnant. 
• are breastfeeding or plan to breastfeed.

For males:

• 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.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you:

• 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.

Tell your doctor if you 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.

• 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.

Take Inlyta exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended starting oral dose of Inlyta is 5 mg twice daily. Take Inlyta doses approximately 12 hours apart with or without food. Inlyta should be swallowed whole with a glass of water.

If you take too much Inlyta call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away

If Inlyta is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Inlyta at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Inlyta and all medicines out of the reach of children.