Generic Name and Formulations:
Axitinib 1mg, 5mg; tabs.
Company:
Pfizer Inc.
Indications for INLYTA:
Treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.
Adult Dose for INLYTA:
Take 12 hours apart. Swallow whole with a glass of water. Initially 5mg twice daily. If tolerated for at least two consecutive weeks with no adverse reactions >Grade 2, normotensive, and not receiving antihypertensives, may increase dose to 7mg twice daily, then 10mg twice daily. May reduce dose from 5mg twice daily to 3mg twice daily, then 2mg twice daily if additional dose reduction required. Concomitant strong CYP3A4/5 inhibitors: avoid; if warranted, decrease Inlyta dose by approximately ½. If strong CYP3A4/5 inhibitor discontinued, return Inlyta dose (after 3–5 half-lives of the inhibitor) to that used prior to CYP3A4/5 inhibitor initiation. Moderate hepatic impairment: decrease dose by approximately ½.
Children's Dose for INLYTA:
Not studied.
Pharmacological Class:
Kinase inhibitor.
Warnings/Precautions:
Control and monitor BP prior to and during therapy; discontinue if severe and persistent hypertension (despite antihypertensive therapy and dose reduction). Risk of thromboembolic events. Untreated brain metastasis, recent active GI bleed: not recommended. Interrupt therapy if bleeding requires medical intervention. GI perforation and fistula formation; monitor. Monitor thyroid, liver function (ALT, AST, bilirubin), and for proteinuria before starting therapy, then periodically. Reduce dose or temporarily interrupt for moderate to severe proteinuria. Risk of reversible posterior leukoencephalopathy syndrome (permanently discontinue if occurs). Stop treatment at least 24hrs prior to scheduled surgery. Severe hepatic impairment. End-stage renal disease. Pregnancy (Cat. D); avoid. Use adequate contraception during therapy. Nursing mothers: not recommended.
Interactions:
See Adult dose. Avoid strong CYP3A4/5 inhibitors (eg, grapefruit juice, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole), CYP3A4/5 inducers (eg, rifampin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentin, phenobarbital, St. John’s wort), moderate CYP3A4/5 inducers (eg, bosentan, efavirenz, etravirine, modafinil, nafcillin).
Adverse Reactions:
GI upset, hypertension, fatigue, decreased appetite, dysphonia, palmar-plantar erythrodysesthesia (hand-foot) syndrome, weight decreased, asthenia, constipation.
How Supplied:
Tabs 1mg—180; 5mg—60
INLYTA is a prescription medicine used to treat advanced kidney cancer (advanced renal cell carcinoma or RCC) when one prior drug treatment for this disease has not worked or has stopped working.
IMPORTANT SAFETY INFORMATION
Before you take INLYTA, tell your doctor if you:
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Have high blood pressure |
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Have thyroid problems |
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Have liver problems |
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Have a history of blood clots in your veins or arteries, including stroke, heart attack, or change in vision |
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Have any bleeding problems |
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Have an unhealed wound |
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Plan to have surgery. You should stop taking INLYTA at least 24 hours before planned surgery |
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Have any other medical conditions |
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Tell your doctor and pharmacist about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. INLYTA and certain other medicines can affect each other causing serious side effects. Talk with your doctor before you start taking any new medicine.
Especially tell your doctor if you take dexamethasone, St. John’s Wort (hypericum perforatum), or medicine for asthma, bacterial infections, depression, tuberculosis, fungal infections, HIV/AIDS, or seizures.
Do not drink grapefruit juice or eat grapefruit.
Pregnancy and breastfeeding. Women should not take INLYTA if they are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. Taking INLYTA during pregnancy may cause the death of an unborn baby or birth defects. Both men and women taking INLYTA should use effective birth control during treatment with INLYTA. Talk to your doctor about birth control methods, or if you are pregnant or plan to become pregnant.
INLYTA may cause serious side effects, including:
High blood pressure (hypertension). In a clinical study, hypertension occurred as early as 4 days into treatment. On average, this increase was seen within the first month of treatment. Your doctor should check your blood pressure regularly during treatment with INLYTA. If you develop blood pressure problems, your doctor may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with INLYTA.
Thyroid gland problems. Your doctor should do blood tests to check your thyroid gland function before and during your treatment with INLYTA. Tell your doctor if you have any of the following symptoms during your treatment with INLYTA:
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Tiredness that worsens or that does not go away |
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Feeling hot or cold |
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Your voice deepens |
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Weight gain or weight loss |
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Hair loss |
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Muscle cramps and aches |
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Problem with blood clots in your veins or arteries. Because this can be serious and sometimes lead to death, get emergency help and call your doctor if you get any of the following symptoms:
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Chest pain or pressure |
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Pain in your arms, back, neck or jaw |
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Shortness of breath |
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Numbness or weakness on one side of your body |
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Trouble talking |
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Headache |
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Vision changes |
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Bleeding. INLYTA can cause bleeding which can be serious, and sometimes lead to death. Call your doctor or get medical help if you develop any bleeding, including:
- Unexpected bleeding or bleeding that lasts a long time, such as:
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Unusual bleeding from the gums |
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Menstrual bleeding or vaginal bleeding that is heavier than normal |
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Bleeding that is severe or you cannot control |
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Pink or brown urine |
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Red or black stools (looks like tar) |
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Bruises that happen without a known cause or get larger |
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Cough up blood or blood clots |
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Vomit blood or your vomit looks like “coffee grounds” |
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Unexpected pain, swelling, or joint pain |
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Headaches, feeling dizzy or weak |
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Tear in your stomach or intestinal wall (perforation). Because this can be serious and sometimes lead to death, get medical help right away if you get the following symptoms:
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Severe stomach (abdominal) pain or stomach pain that does not go away |
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Vomit blood |
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Red or black stools |
Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome (RPLS) can happen while taking INLYTA. Call your doctor right away
if you get:
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Headache |
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Seizures |
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Weakness |
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Confusion |
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High blood pressure |
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Blindness or change in vision |
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Problems thinking |
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Increased protein in your urine. Your doctor should check your urine for protein before and during your treatment with INLYTA. If you develop protein in your urine, your doctor may decrease your dose of INLYTA or stop your treatment.
Change in liver function. Your doctor should do blood tests before and during your treatment with INLYTA to check your liver function.
The most common side effects of INLYTA include:
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Diarrhea |
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High blood pressure |
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Tiredness or feeling weak |
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Decreased appetite |
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Nausea |
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Hoarseness |
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Decreased weight |
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Vomiting |
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Constipation |
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Rash, redness, itching or peeling of your skin on your hands or feet |
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Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of INLYTA. For more information, ask your doctor or pharmacist.
