Inlyta
Generic name: axitinib [ axIT-i-nib ]
Drug classes: Multikinase inhibitors, VEGF/VEGFR inhibitors
What is Inlyta?
Inlyta is a prescription medicine that interferes with the growth of some cancer cells.
Inlyta is used to treat advanced kidney cancer (advanced renal cell carcinoma).
Inlyta is sometimes given after at least one other cancer treatment did not work or has stopped working.
It is not known if Inlyta is safe and effective in children.
Warnings
Do not use Inlyta if you are pregnant. It could harm the unborn baby. Use birth control to prevent pregnancy while you are receiving this medicine, whether you are a man or a woman. Inlyta use by either parent may cause birth defects or miscarriage.
Axitinib can increase your risk of serious bleeding. Stop using Inlyta and call your doctor at once if you have severe stomach pain, bloody or tarry stools, coughing up blood, or any heavy or unusual bleeding.
Some people taking this medicine have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.
Inlyta is usually taken once every 12 hours. It should be taken at evenly spaced intervals. Follow your doctor's instructions.
To be sure this medication is not causing harmful effects, your kidney, thyroid, and liver function will need to be tested. Your blood pressure will also need to be checked often. Visit your doctor regularly.
Before taking this medicine
You should not use Inlyta if you are allergic to axitinib.
To make sure Inlyta is safe for you, tell your doctor if you have:
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a perforation (a hole or tear) in your stomach or intestines;
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bleeding problems, or a wound that has not healed;
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a heart attack, heart failure, stroke, or blood clot;
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liver disease; or
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a thyroid disorder.
You may need to have a negative pregnancy test before starting this treatment.
Both men and women using this medicine should use effective birth control to prevent pregnancy. Axitinib can cause harm an unborn baby if the mother or father is using this medicine.
Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Inlyta.
This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because axitinib can harm an unborn baby.
It is not safe to breast-feed a baby while you are using this medicine. Also do not breast-feed for at least 2 weeks after your last dose.
How should I take Inlyta?
Take Inlyta exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Inlyta should be taken at evenly spaced intervals, usually once every 12 hours.
Take this medicine with a full glass of water. You may take this medicine with or without food.
Swallow the tablet whole and do not crush, chew, or break it.
If you vomit shortly after taking Inlyta, do not take another dose. Wait until your next scheduled dose time to take the medicine again.
Your blood pressure will need to be checked often. You may also need frequent medical tests.
If you need surgery, tell your surgeon you currently use Inlyta. You will need to stop using the medicine at least 24 hours before a planned surgery.
Store at room temperature away from moisture and heat.
Dosing information
Usual Adult Dose for Renal Cell Carcinoma:
Initial dose: 5 mg orally twice a day
Maintenance dose: Increase or decrease dose based on individual safety and tolerability
Dose range: 2 to 10 mg twice a day
Comments: Doses should be taken approximately 12 hours apart.
Use: For the treatment of advanced renal cell carcinoma after the failure of 1 prior systemic therapy.
What happens if I miss a dose?
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
Grapefruit may interact with axitinib and lead to unwanted side effects. Avoid the use of grapefruit products.
Inlyta side effects
Get emergency medical help if you have signs of an allergic reaction to Inlyta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some people taking Inlyta have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.
Also call your doctor at once if you have:
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chest pain or pressure, pain spreading to your jaw or shoulder, trouble breathing;
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sudden numbness or weakness, problems with vision or speech;
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headache, confusion, thinking problems, seizure (convulsions);
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a light-headed feeling, like you might pass out;
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easy bruising, unusual bleeding, purple or red spots under your skin;
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any bleeding that will not stop;
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liver problems - severe nausea or vomiting, right-sided upper stomach pain, loss of appetite, dark urine, clay- colored stools, jaundice (yellowing of the skin or eyes);
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heart problems - swelling, rapid weight gain, feeling short of breath;
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signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
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signs of a thyroid problem - sudden weight gain or loss, feeling very weak or tired, muscle pain, feeling hot or cold, hair loss, hoarse or deepened voice.
Common Inlyta side effects may include:
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liver problems;
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stomach pain;
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muscle and bone pain;
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abnormal blood tests;
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mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina;
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cough, shortness of breath;
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headache;
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rash, itching, redness, and peeling skin on your hands or feet;
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feeling weak or tired;
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increased blood pressure;
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decreased appetite, weight loss; or
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hoarse voice.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Inlyta?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Other drugs may interact with axitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Popular FAQ
Inlyta is not usually bad for the kidneys, in fact, research has found no difference with regards to kidney toxicity between patients with advanced renal cell carcinoma (RCC) and healthy volunteers regardless of baseline kidney function and recommend no adjustment to the starting dose of Inlyta for patients with pre-existing mild-to-severe renal impairment (kidney disease).
When Inlyta is used in combination with either avelumab or pembrolizumab, acute kidney injury (a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days) was reported in only 1.4% to 2.3% of patients respectively, and is considered an uncommon/rare side effect.
Inlyta in combination with avelumab or pembrolizumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Bavencio and Inlyta are used together because the combination is more effective than single therapy, reducing the overall risk of disease progression or death by about 31% compared to Sunitinib alone. Bavencio and Inlyta work in different ways: Bavencio is an immunotherapy treatment that boosts your immune system and Inlyta is a targeted treatment that prevents cancer cells from forming new blood vessels, slowing or stopping tumor growth.
In a clinical trial of 442 patients taking Bavenico with Inlyta compared to 444 patients taking only Sunitinib:
- The average progression-free survival (PFS) time (no tumor growth or spread) with B + I was 13.8 months compared to only 8.4 months with Sunitinib (a 5-month increase in PFS
- The size of the tumor was reduced in twice as many people taking B + I compared to those taking only Sunitinib
- 3.4% of patients (15 of 442) taking B + I saw their tumors disappear compared to 1.8% of patients (8 of 444) taking Sunitinib. This is called a complete response
- 48% of patients (212 of 442) taking B + I saw their tumors shrink compared to 24% of patients (106 of 444) taking Sunitinib. This is called a partial response and includes patients whose tumors shrank 30% or more and whose response to treatment lasted at least 4 weeks.
You may drink a small to moderate amount of alcohol with Inlyta if you wish, because there is no direct interaction between alcohol and Inlyta. However, alcohol can worsen some of the side effects of Inlyta, such as diarrhea, a sore mouth and throat, drowsiness, and liver toxicity, so it is best not consumed every night, or in large quantities.
Inlyta is considered a targeted treatment rather than a chemotherapy drug. Inlyta works by targeting specific receptors that exist on the surface of some cells, called receptor tyrosine kinases (RTKs), rather than just destroying rapidly growing and dividing cells like traditional chemotherapy agents do. RTKs help cells to communicate with each other and control several different biological functions, such as cell growth, motility, differentiation, and metabolism. Research has shown that activation of some of these receptors is associated with tumor growth, angiogenesis (the formation of new blood vessels from existing blood vessels), and metastatic progression of cancer. Inlyta inhibits multiple kinases including vascular endothelial growth factor receptors (VEGFR1, VEGFR2, and VEGFR3).
Inlyta belongs to the class of medicines known as multikinase inhibitors. It may also be called a VEGF/VEGFR inhibitor.
Inlyta is an oral medicine that is an angiogenesis inhibitor and VEGF/VEGFR inhibitor. It works by blocking proteins and signals to help slow down the growth of new blood vessels that fuel kidney tumor growth. Without new blood vessels, the cancer does not have a regular supply of oxygen and nutrients.
Inlyta and Keytruda are given as a combination therapy for first-line treatment of kidney cancer (advanced renal cell carcinoma) in adults. Inlyta is an oral medication given 2 times per day and Keytruda is an intravenous (IV) infusion given every 3 weeks or every 6 weeks. Continue reading
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Inlyta only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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