Inlyta Oral

Nausea, vomiting, loss of appetite, dizziness, tiredness/weakness, weight loss, temporary hair loss, cough, headache, altered sense of taste, hoarseness, constipation, or upset stomach may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Diarrhea is a common side effect that can cause a serious loss of body water (dehydration). Drink plenty of fluids to reduce the risk of dehydration. Tell your doctor immediately if you develop signs of dehydration (such as dizziness/lightheadedness, decreased amount of urine, unusual dry mouth/thirst).
Axitinib may cause a rash that is usually not serious. Mild to moderate skin reactions include dry skin or a mildly red/itchy rash. However, you may not be able to tell it apart from a rash that could be a sign of a severe reaction. Therefore, tell your doctor right away if you develop any rash.
Remember that your doctor has prescribed this medication because he or she 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: muscle/joint pain, foamy urine, swelling of ankles/feet/hands, easy bruising or bleeding (such as nose/gum bleeds, pink/dark urine), sores/pain in the mouth or throat, redness/blisters/swelling/pain on the palms of your hands or soles of your feet, signs of an abnormal thyroid (such as unusual weight gain/loss, cold/heat intolerance, slow/fast/irregular heartbeat, unusual tiredness).
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 fever, chills, persistent sore throat).
Axitinib may cause or worsen high blood pressure. Check your blood pressure regularly and tell your doctor right away of high results. Your doctor may start you on medication to lower your blood pressure.
Rarely, axitinib may cause a condition known as RPLS (reversible posterior leukoencephalopathy syndrome). Get medical help right away if you develop persistent headache, seizures, sudden vision changes, mental/mood changes (such as confusion).
This medication may rarely cause serious (possibly fatal) blood clots (such as stroke/TIA, heart attack, pulmonary embolism, deep vein thrombosis, retinal vein/artery occlusion). 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, slurred speech, 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 persistent stomach/abdominal pain, signs of bleeding (such as bloody/black stools, vomit that looks like coffee grounds, coughing/vomiting up blood).
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.
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), cancer that has spread to the brain and has not been treated.
Axitinib can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
This medication may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Axitinib should be stopped at least 24 hours before planned surgery.
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.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. To avoid pregnancy, both males and females using axitinib must use reliable form(s) of birth control during treatment. If you or your partner becomes pregnant or may be pregnant, tell your doctor right away. Consult your doctor for more details.
It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

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 azole antifungals (such as ketoconazole, itraconazole, voriconazole), macrolide antibiotics (such as clarithromycin), HIV protease inhibitors (such as ritonavir, atazanavir, nelfinavir, saquinavir, indinavir), rifamycins (such as rifampin, rifabutin, rifapentin), drugs to treat seizures (such as phenytoin, carbamazepine, phenobarbital), nefazodone, St. John\'s wort, telithromycin, bosentan, efavirenz, modafinil, nafcillin, etravirine, dexamethasone, among others.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: seizures, extreme dizziness, extreme/persistent headache, vomiting blood.

NOTES:
Do not share this medication with others.
Laboratory 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 performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE:
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.

STORAGE:
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.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (US) or 1-800-668-1507 (Canada).
Information last revised March 2012. Copyright(c) 2012 First Databank, Inc.