What is Inlyta used for?

Inlyta (axitinib) is commonly used to treat renal cell carcinoma (RCC).

Inlyta may also be used for other conditions as determined by your health care provider.

How does Inlyta work (mechanism of action)?

Inlyta is a type of medicine known as a tyrosine kinase inhibitor. It works by targeting specific proteins on cancer cells. By blocking the action of these proteins, Inlyta prevents new blood vessels from growing and can prevent cancer cells from growing or spreading.

How is Inlyta supplied (dosage forms)?

Brands and other names

• Inlyta

Dosage forms and strengths

• 1 mg, 5 mg oral tablets

How should I store Inlyta?

Inlyta should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Inlyta?

The most common side effects of Inlyta are listed below. Tell your health care provider if you have any of these side effects that bother you.

• Diarrhea


• High blood pressure (see below)


• Feeling unusually weak or tired


• Loss of appetite


• Nausea and vomiting


• Changes in your voice, including hoarseness


• Rash, redness, itching, or peeling of the skin on your hands and feet


• Weight loss


• Constipation

There may be other side effects of Inlyta that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Inlyta?

While less common, the most serious side effects of Inlyta are described below, along with what to do if they happen.

Severe Allergic Reactions. Inlyta may cause allergic reactions, which can be serious. Stop taking Inlyta and get help right away if you have any of the following symptoms of a serious allergic reaction.

• Breathing problems or wheezing


• Racing heart


• Fever or general ill feeling


• Swollen lymph nodes


• Swelling of the face, lips, mouth, tongue, or throat


• Trouble swallowing or throat tightness


• Itching, skin rash, or pale red bumps on the skin called hives


• Nausea or vomiting


• Dizziness, feeling lightheaded, or fainting


• Stomach cramps


• Joint pain

Increased Blood Pressure (Hypertension). Inlyta may increase your blood pressure or make it worse if you have a history of high blood pressure. Keep all appointments to have your blood pressure checked. Call your health care provider if your blood pressure increases while taking this medicine.

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If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but look out for and tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.

• Sudden severe headache


• Chest pain


• Dizziness or confusion


• Trouble breathing


• Nausea or vomiting


• Blurry or other changes to vision


• Anxiety


• Buzzing in the ears


• Nosebleed


• Feeling of skipped heartbeats

Blood Clots. Inlyta may cause a blood clot in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep vein thrombosis (DVT). Stop taking Inlyta and get emergency help if you have any of the following signs of blood clots. 

• Chest pain or pressure


• Fast or abnormal heartbeat


• Trouble breathing


• Pain in your back, jaw, throat, or arm


• Sweating, upset stomach, vomiting, or dizziness


• Sudden weakness on one side of your body


• Sudden and severe headache


• Slurred speech or trouble understanding speech


• Pain, swelling, or tenderness in your arm or leg


• Vision loss


• Bulging eyes 


• Double vision

Severe Bleeding. Inlyta can increase your risk of severe bleeding that can lead to death. It can also cause stomach bleeding, including tears (perforation) in your gut. Some people with serious bleeding may need a blood transfusion or surgery. Call your health care provider right away if you have any of the following signs of severe bleeding while taking Inlyta.

• Pink, red, or brown urine (pee)


• Vomit with blood that looks like coffee grounds 


• Red or black stools (looks like tar)


• Coughing up blood or blood clots


• Stomach pain that does not go away


• Upset stomach


• Feel faint or dizzy

Heart Failure. Inlyta may increase your risk of heart failure. Tell your health care provider right away if you have any of the following symptoms of heart failure.

• Shortness of breath or trouble breathing, especially while lying down


• Swelling in your feet, ankles, or legs


• Unusually fast weight gain


• Unusual tiredness

Changes in Thyroid Hormones. Inlyta can cause the function of your thyroid gland to change, which can lead to low thyroid levels (hypothyroidism) or high thyroid levels (hyperthyroidism). Keep all appointments to have your blood checked. Tell your health care provider if you have any of the following signs of changes in thyroid hormones.

• Weight gain or weight loss


• Feeling cold or hot


• Tiredness that does not go away or continues to worsen


• Constipation


• Feeling nervous or anxious


• Mood swings


• Hair loss


• Muscle aches or cramps

Wound Healing Issues. Inlyta can make it difficult for your body to heal wounds. Tell your health care provider if you have any planned or emergency surgeries or if you have any injuries that occur while taking Inlyta.

Posterior Reversible Encephalopathy Syndrome (PRES). Inlyta may cause a rare but serious brain condition called PRES. PRES involves swelling and narrowing of blood vessels in your brain. If PRES is not treated, it can lead to a stroke. Call your health care provider right away if you have the following symptoms of PRES.

• Changes in thinking or behavior


• Confusion or hallucinations


• Sudden decrease or change in vision


• Sudden severe headache


• Seizures

Protein in Urine. Inlyta rap can cause a high amount of protein in urine (proteinuria), which can be a sign of kidney damage. Tell your health care provider if you have the following symptoms of protein in your urine.

• Foamy or bubbly pee


• Swelling in your hands, feet, belly, or face


• Peeing more often than usual


• Shortness of breath


• Tiredness


• Loss of appetite

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Inlyta. Call your health care provider right away if you have any of the following symptoms of liver damage.

• Nausea or vomiting


• Stomach or belly pain


• Fever


• Weakness or unusual tiredness


• Itching


• Loss of appetite


• Light-colored poop


• Dark-colored urine (pee)


• Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Warnings & Precautions

Who should not use Inlyta?

Allergies to Ingredients. People who are allergic to any of the following should not take Inlyta.

• Axitinib


• Inlyta


• Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Inlyta.  

What should I know about Inlyta before using it?

Do not take Inlyta unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Inlyta with other people, even if they have the same condition as you. It may harm them.

Keep Inlyta out of the reach of children.

Swallow Inlyta whole with a full glass of water. Do not crush, split, dissolve, or chew the tablets. 

If you are able to get a partner pregnant, you should use condoms while taking Inlyta and for one week after your last dose. 

Inlyta may make it difficult for you to get pregnant or get your partner pregnant. If you have concerns, talk to your health care provider.

What should I tell my health care provider before using Inlyta?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Inlyta is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

• High blood pressure


• Thyroid problems


• Diabetes


• High levels of fats in your blood


• History of blood clots, including a previous stroke, heart attack, or changes in vision


• Heart problems, including heart failure


• Bleeding problems, including recent bleeding from your digestive system


• Current wounds that are healing


• Stomach or digestion problems


• Liver problems


• Recent or planned surgery

Other Medicines and Supplements. Inlyta may interact with other medicines and supplements. Before taking Inlyta, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Inlyta may cause harm to a fetus. Your health care provider will give you a test to make sure you are not pregnant before you start taking Inlyta. If you can get pregnant, you should use birth control while taking Inlyta and for one week after your last dose. Tell your health care provider right away if you are pregnant, think you may be pregnant, or plan to become pregnant.

Breastfeeding. It is not known if Inlyta passes into breast milk. Do not breastfeed while taking Inlyta and for two weeks after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Inlyta?

For more information about Inlyta, you can visit the drugmaker’s website at www.inlyta.com or call them at 877-0744-5675.

Interactions

Does Inlyta interact with foods or drinks?

Grapefruit interacts with Inlyta. Do not eat grapefruit or drink grapefruit juice while taking Inlyta. Grapefruit can interfere with your body’s ability to break down Inlyta, which can lead to high levels of the medicine and an increased risk of side effects. 

It is unknown if drinking alcohol will affect Inlyta, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does Inlyta interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Inlyta.

• St. John’s wort, which is a supplement that may be used for depression


• Ketoconazole, which is a medicine used for fungal infections


• Rifampin (Rifadin) or rifapentine (Priftin), which are medicines commonly used to treat an infection called tuberculosis


• Dexamethasone, which is a medicine for certain inflammatory conditions


• Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain


• Phenytoin (Dilantin, Phenytek, and others), which is a medicine to control seizures


• Phenobarbital, which is a medicine that may be used to treat seizures


• Rifabutin (Mycobutin), which is a medicine used to prevent Mycobacterium avium complex infection


• Bosentan (Tracleer), which is a medicine used to treat pulmonary arterial hypertension (PAH)


• Modafinil (Provigil), which is a medicine used to treat narcolepsy

Many other medicines may alter the blood levels of Inlyta. Tell your health care provider about all medicines that you take or have recently taken.