Inlyta (Axitinib) belongs to the group of cancer-fighting medications known as antineoplastics and more specifically to a class of medications called tyrosine kinase inhibitors. These medications disrupt cell communication to slow the growth of blood vessels that feed nutrients to cancer cells. By slowing the growth of these blood vessels, Inlyta (Axitinib) can help reduce the size of tumours, which are collections of cancer cells.

Inlyta (Axitinib) is used to treat kidney cancer that has spread to other parts of the body, called metastatic renal cell carcinoma, after other treatments have been tried.

Your doctor may have suggested Inlyta (Axitinib) for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Inlyta (Axitinib), speak to your doctor. Do not stop taking Inlyta (Axitinib) without consulting your doctor.

Do not give Inlyta (Axitinib) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Inlyta (Axitinib) if their doctor has not prescribed it.

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The recommended starting dose of Inlyta (Axitinib) is 5 mg taken by mouth twice daily. Your doctor may adjust your dose depending on how you tolerate Inlyta (Axitinib). Daily doses should not exceed 20 mg. Inlyta (Axitinib) can be taken with or without food. Swallow the tablets whole, with a glass of water. Do not take Inlyta (Axitinib) with grapefruit juice, since it may interact with Inlyta (Axitinib).

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Inlyta (Axitinib) exactly as prescribed by your doctor. If you miss a dose or vomit after a dose, skip the missed or vomited dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Inlyta (Axitinib) at room temperature (between 15°C and 30°C), in its original package, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Inlyta (Axitinib). If you are concerned about side effects, discuss the risks and benefits of Inlyta (Axitinib) with your doctor.

The following side effects have been reported by at least 1% of people taking Inlyta (Axitinib). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• Constipation
• cough
• decreased appetite
• decreased weight
• dehydration
• Diarrhea
• dizziness
• dry skin
• hair loss
• headache
• hemorrhoids
• hoarseness (disorder of the voice)
• itchy skin
• joint pain
• muscle pain
• nausea
• painful tongue
• pain in arms, hands, legs, or feet
• redness of skin
• ringing in the ears
• shortness of breath
• soreness of the mouth, tongue, or throat
• stomach pain
• taste disturbance
• tiredness or feeling weak
• upset stomach
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• high blood pressure
• rash, redness, itching, peeling, or burning of your skin (hand-foot syndrome)
• signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of a blood clot (e.g., sudden chest pain, shortness of breath, sudden leg pain, leg swelling, or leg redness)
• signs of decreased Thyroid function (e.g., tiredness, constipation, dry skin, weight gain)
• signs of overactive thyroid (e.g., rapid weight loss, sweating, fast heartbeat)
• signs of heart problems (e.g., fast, irregular heartbeat or pulse; chest pain; sudden weight gain; difficulty breathing; leg swelling)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
• signs of changes in liver function (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• symptoms of a neurological problem (e.g., headache, seizures, lethargy, confusion, blindness, and other visual disturbances)
• symptoms of a tear in the intestinal wall (perforation of the bowel; such as severe abdominal pain, Fever, rectal bleeding, nausea, vomiting)
• transient stroke-like episodes (e.g., sudden headache, dizziness, trouble speaking, trouble walking, numbness, or weakness)
• unexplained bleeding (e.g., nosebleeds, darkened urine or stools, coughing up blood)
• unexplained muscle aches or weakness or dark-coloured urine
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., swelling of face or throat, Hives, or difficulty breathing)
• signs of Heart Attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
• signs of a rare neurological disorder called reversible posterior leukoencephalopathy syndrome (RPLS; e.g., confusion, dizziness, headache, high blood pressure, seizures, vision problems or blindness)
• signs of Stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
• sudden severe pain in the back, chest, or abdomen

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Inlyta (Axitinib).

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1 mg
Each red, film-coated, oval tablet debossed with "Pfizer" on one side and "1 XNB" on the other contains 1 mg of Inlyta (Axitinib). Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and Opadry II red; Opadry II red film coating: HPMC 2910/Hypromellose 15cP, lactose monohydrate, titanium dioxide, triacetin (glycerol triacetate), and red iron oxide.

3 mg
Each red, film-coated, oval tablet debossed with "Pfizer" on one side and "3 XNB" on the other contains 3 mg of Inlyta (Axitinib). Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and Opadry II red; Opadry II red film coating: HPMC 2910/Hypromellose 15cP, lactose monohydrate, titanium dioxide, triacetin (glycerol triacetate), and red iron oxide.

5 mg
Each red, film-coated, triangular tablet debossed with "Pfizer" on one side and "5 XNB" on the other contains 5 mg of Inlyta (Axitinib). Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and Opadry II red; Opadry II red film coating: HPMC 2910/Hypromellose 15cP, lactose monohydrate, titanium dioxide, triacetin (glycerol triacetate), and red iron oxide.

7 mg
Each red, film-coated, oval tablet debossed with "Pfizer" on one side and "7 XNB" on the other contains 7 mg of Inlyta (Axitinib). Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and Opadry II red; Opadry II red film coating: HPMC 2910/Hypromellose 15cP, lactose monohydrate, titanium dioxide, triacetin (glycerol triacetate), and red iron oxide.

Do not take Inlyta (Axitinib) if you:

• are allergic to Inlyta (Axitinib) or any ingredients of the medication

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There may be an interaction between Inlyta (Axitinib) and any of the following:

• "azole" antifungal medications (e.g., fluconazole, itraconazole, ketoconazole)
• bisphosphonates (e.g., Alendronate, etidronate)
• Bosentan
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• Cobicistat
• conivaptan
• Deferasirox
• Dronedarone
• Enzalutamide
• grapefruit juice
• hepatitis B antivirals (e.g., dasabuvir, ombitasvir, paritaprevir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• lumacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin,)
• mifepristone
• Mitotane
• Modafinil
• Phenobarbital
• Phenytoin
• primidone
• procainamide
• rifabutin
• rifampin
• St. John's wort
• siltuximab
• Stiripentol
• Tocilizumab
• other tyrosine kinase inhibitors (e.g., Crizotinib, Dasatinib, imatinib)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Inlyta (Axitinib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Inlyta (Axitinib).

Bleeding: Inlyta (Axitinib) may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding and may increase your risk of bleeding. If you experience signs of bleeding (e.g., nosebleeds, blood in the urine or stools, darkened urine or stools), contact your doctor as soon as possible. Your doctor will perform regular blood tests to monitor you while you are taking Inlyta (Axitinib).

Blood Clots: Inlyta (Axitinib) may cause the formation of blood clots in the legs (deep vein thrombosis) that can move to the lungs (pulmonary Embolism). Blood clots can also cause a heart attack or a stroke. Contact your doctor as soon as possible if you have pain, redness, or swelling in your legs. If you develop chest pain and shortness of breath, seek immediate medical attention. Also seek immediate medical attention if you have sudden headache, dizziness, problems speaking, vision problems, or numbness or weakness, even if they are temporary. If you have had a blood clot in the past, discuss with your doctor how Inlyta (Axitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Inlyta (Axitinib), and whether any special monitoring is needed.

Hand-foot skin reaction: A rash on the palms of your hands as well as the soles of your feet may occur with Inlyta (Axitinib). It can vary in redness and itchiness, but it is possible that blistering and pain can develop. Speak to your doctor immediately if you develop a rash, pain, or blistering on your hands or feet.

Heart problems: Inlyta (Axitinib) can decrease heart function, which may lead to heart failure. If you experience symptoms of heart failure such as unusual tiredness, shortness of breath, or swelling of the feet and ankles, contact your doctor.

Inlyta (Axitinib) may also cause an abnormal heart rhythm, which often has no symptoms, or a decreased heart rate. If you experience fainting or chest pain while taking Inlyta (Axitinib), get immediate medical attention.

If you have a history of heart problems (e.g., heart Arrhythmias, Congestive Heart Failure, heart attack, heart bypass surgery), discuss with your doctor how Inlyta (Axitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Inlyta (Axitinib), and whether any special monitoring is needed.

High blood pressure: Your doctor may check your blood pressure before starting Inlyta (Axitinib) and then ask you to measure your blood pressure regularly while taking Inlyta (Axitinib). Some people taking Inlyta (Axitinib) develop very high blood pressure that requires adding blood pressure medications, changing the dose, or even stopping the medication for a period of time. Talk to your doctor if you have any concerns.

Lactose intolerance: Inlyta (Axitinib) contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency) you should not take Inlyta (Axitinib).

Liver function: People taking Inlyta (Axitinib) may have changes in liver function that produce abnormal liver test results or liver damage. Your doctor will recommend regular liver tests while you are taking Inlyta (Axitinib). If you have severe changes in liver function, your doctor may recommend that you take a lower dose of Inlyta (Axitinib) or stop taking it altogether.

Liver disease or reduced liver function may cause Inlyta (Axitinib) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Inlyta (Axitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Inlyta (Axitinib), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Inlyta (Axitinib).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain, or swelling and itchy skin, contact your doctor immediately.

Neurological problems: Rarely, patients may experience symptoms of a neurological disorder known as reversible posterior leukoencephalopathy syndrome (RPLS). If you have had this disorder before, discuss with your doctor how Inlyta (Axitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Inlyta (Axitinib), and whether any special monitoring is needed. RPLS can present with headache, seizure, lethargy, confusion, blindness, and other visual and neurologic disturbances. Tell your doctor if you experience any of these symptoms.

Tear in the intestines: Inlyta (Axitinib) is associated with intestinal perforation (tear in the intestinal wall). If you have symptoms of an intestinal tear such as abdominal pain, nausea, vomiting, or fever and chills, go see your doctor.

Thyroid problems: Inlyta (Axitinib) may cause changes to the levels of thyroid hormone in the body. Your doctor will monitor your thyroid function with blood tests before and during treatment with Inlyta (Axitinib). If you have symptoms of low thyroid such as dry skin, constipation, weight gain, or fatigue, or symptoms of overactive thyroid, such as increased sweating, fast heartbeat, or rapid weight loss, go see your doctor.

Wound healing complications: Inlyta (Axitinib) may decrease your ability for wound healing. Talk to your doctor if you have an unhealed wound following surgery or if you have a surgery scheduled.

Pregnancy: Inlyta (Axitinib) should not be used during pregnancy. Both men and women should use effective birth control during Inlyta (Axitinib) treatment. If you become pregnant while taking Inlyta (Axitinib), contact your doctor immediately.

Breast-feeding: It is not known if Inlyta (Axitinib) passes into breast milk. If you are a breast-feeding mother and are taking Inlyta (Axitinib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Inlyta (Axitinib) have not been established for children less than 18 years of age.

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