Axitinib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat advanced kidney cancer. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: axitinib, oral; Inlyta

What is this medicine used for?

This medicine is taken by mouth to treat advanced kidney cancer when one prior drug treatment for this disease has not worked.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A bleeding problem or blood clots
• A stroke or transient ischemic attack (TIA)
• A tear (perforation) in your stomach or intestine
• Heart failure or a heart attack
• High blood pressure
• Liver problems
• Thyroid problems

Tell your healthcare provider if you:

• Have had surgery within the last 7 days
• Are scheduled to have surgery
• Have any unhealed wounds

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Use effective birth control while you are taking this medicine. Talk with your healthcare provider if you need birth control. Do not breast-feed while you are receiving this medicine.

Males should use effective birth control during your treatment with this medicine. If your female partner becomes pregnant while you are taking this medicine, contact your healthcare provide right away.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Treatment will be continued for as long as you continue to benefit and can tolerate the side effects.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine is usually taken 2 times a day, about 12 hours apart. You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Do not break, crush, or chew the tablets. Swallow them whole with a glass of water.

What if I miss a dose?

If you miss a dose, or vomit after taking a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: dizziness, seizures, unusual bruising or bleeding.

What should I watch out for?

You need to have lab tests regularly to see how this medicine affects you. Keep all appointments for tests.

This medicine may increase your blood pressure. You may need to have your blood pressure checked regularly while you are taking this medicine. Talk with your healthcare provider about this. This medicine increases the risk for reversible posterior leukoencephalopathy syndrome (RPLS). Call your healthcare provider right away if you have:

• Headache
• Seizures
• Weakness
• Confusion
• Trouble seeing or changes in vision
• Problems thinking

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert. If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Severe stomach pain or swelling; dark urine; yellowing of the skin and eyes; unusual bruising or bleeding; unusual tiredness or weakness; unusual dizziness or fainting; chest pain; pain in your arms, back, neck or jaw; shortness of breath; pain, redness, warmth, or swelling in your leg; black or tarry bowel movements; red or brown urine; vomiting blood; severe stomach pain; problems with wound healing; feeling unusually hot or cold; confusion; seizures.

Other: Nausea, vomiting, diarrhea, mild dizziness, constipation, gas, mild headache, weight loss, tiredness, loss of appetite; rash, redness, itching or peeling of your skin on your hands and feet; muscle or joint pain; cough; dry skin; hoarseness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as azithromycin (Zithromax, Zmax), chloramphenicol, clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), nafcillin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desipramine (Norpramin), desvenlafaxine (Pristiq), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), mirtazapine (Remeron), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, venlafaxine (Effexor), vilazodone (Viibryd), and vortioxetine (Trintellix)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Aprepitant (Emend) and fosaprepitant (Emend)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as ado-trastuzumab (Kadcyla), axitinib (Inlyta), bosutinib (Bosulif), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), dasatinib (Sprycel), enzalutamide (Xtandi), erlotinib (Tarceva), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), pazopanib (Votrient), sorafenib (Nexavar), sunitinib (Sutent), and vemurafenib (Zelboraf)
• Colchicine (Colcrys)
• Corticosteroids such as betamethasone (Celestone), dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Doxepin (Silenor)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase), and zidovudine (Retrovir)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat pulmonary hypertension such as bosentan (Tracleer) and macitentan (Opsumit)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• St. John's wort
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.