Inlyta 1 mg tablet

Generic name:
Axitinib - oral

Pronunciation
(ax-I-ti-nib)

Brand name(s)
Inlyta

This medication is used to treat kidney cancer. Axitinib works by slowing or stopping the growth of cancer cells. It belongs to a class of drugs known as tyrosine kinase inhibitors.

Read the Patient Information Leaflet if available from your pharmacist before you start using axitinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually two times daily (about 12 hours apart). Swallow the tablet whole with a glass of water. Do not split or crush this medication.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). If you have certain side effects, your doctor may adjust your dose or stop treatment for some time.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

If you vomit your dose of axitinib, do not take an additional dose. Take your next dose at your regular scheduled time. Do not take two doses at the same time.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Nausea, vomiting, loss of appetite, dizziness, tiredness/weakness, weight loss, temporary hair loss, dry skin, cough, headache, altered sense of taste, hoarseness, constipation, or upset stomach may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Diarrhea is a common side effect that can cause dehydration. Drink plenty of fluids to reduce the risk of dehydration. Tell your doctor right away if you develop signs of dehydration (such as dizziness/lightheadedness, unusual dry mouth/thirst).

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of kidney problems (such as change in the amount of urine, foamy urine)
• muscle/joint pain
• swelling of ankles/feet/hands
• unusual tiredness
• shortness of breath
• easy bruising or bleeding (such as nose/gum bleeds, pink/dark urine)
• burning/sores/pain in the mouth or throat
• redness/blisters/swelling/pain on the palms of your hands or soles of your feet
• slow wound healing
• signs of an abnormal thyroid (such as unusual weight gain/loss, cold/heat intolerance, slow/fast/irregular heartbeat, unusual tiredness)
• signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

This medication may lower your ability to fight infections. This may make you more likely to get a serious infection or make any infection you have worse. Tell your doctor right away if have any signs of infection (such as sore throat that doesn't go away, fever, chills).

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

Rarely, axitinib may cause a condition known as RPLS (reversible posterior leukoencephalopathy syndrome). Get medical help right away if you develop headache that doesn't go away, seizures, sudden vision changes, mental/mood changes (such as confusion).

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs, legs, or eyes). You may be at increased risk for blood clots if you are severely dehydrated, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if any of these side effects occur:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• confusion
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• sudden/severe headaches
• trouble speaking
• weakness on one side of the body
• sudden vision changes

Get medical help right away if you have any very serious side effects, including:

• severe stomach/abdominal pain that doesn't go away
• signs of bleeding (such as bloody/black stools, vomit that looks like coffee grounds, coughing/vomiting up blood)
• sudden/severe back pain

Axitinib can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Side Effects section.

Before taking axitinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease
• kidney disease
• high blood pressure
• bleeding/clotting problems (such as bleeding from intestinal/stomach ulcers)
• blood vessel problems (such as an aneurysm or a tear/break in the aorta or other blood vessels)
• heart problems (such as heart failure, previous heart attack)
• thyroid problems

Axitinib can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using axitinib before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may cause wounds to heal slowly or poorly. Before having surgery, talk with your doctor about the risks and benefits of this medication. Your doctor may tell you to temporarily stop treatment with this medication at least 2 days before surgery. Ask your doctor for specific instructions about when to stop and when to restart treatment with axitinib. Tell your doctor right away if you have wounds that are not healing well.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using axitinib. Axitinib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Men and women using this medication should ask about reliable forms of birth control during treatment and for at least 1 week after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for at least 2 weeks after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of axitinib from your body, which may affect how axitinib works. Examples include rifamycins (such as rifampin, rifabutin, rifapentine), drugs to treat seizures (such as phenytoin, carbamazepine, phenobarbital), St. John's wort, bosentan, efavirenz, modafinil, nafcillin, etravirine, dexamethasone, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: seizures, extreme dizziness, vomiting blood.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, thyroid/kidney/liver/pancreatic function tests, complete blood counts, urine tests, blood mineral levels including sodium/potassium) should be done while you are taking this medication. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.