Inlyta (axitinib) is a targeted anticancer medication that’s used for treating advanced kidney cancer (renal cell carcinoma). Depending on your situation, it can be taken by itself or together with immunotherapy medications like Keytruda (pembrolizumab) and Bavencio (avelumab). Inlyta (axitinib) is taken by mouth twice a day. It can commonly cause side effects like diarrhea, tiredness, and high blood pressure.
Kidney cancer that has spread or cannot be removed by surgery
First treatment option, used together with Bavencio (avelumab) or Keytruda (pembrolizumab)
Second treatment option when a different therapy previously didn’t work, used by itself
Inlyta (axitinib) is a type of targeted anticancer therapy known as a tyrosine kinase inhibitor (TKI). More specifically, it’s considered a VEGFR inhibitor. This medication targets and blocks VEGFR proteins in cancer cells that are involved in providing blood supply to the tumor. By blocking these proteins, Inlyta (axitinib) prevents blood vessels from forming and supplying blood to the tumor. This helps to slow and stop cancer growth.
Source: DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Bleeding gums
bloody nose
blurred vision
clay colored stools
cloudy urine
confusion
coughing up blood
decreased urination
depressed mood
difficult or labored breathing
difficulty with swallowing
dizziness
dry skin and hair
fainting
feeling cold
headache
hoarseness or husky voice
incoherent speech
increased menstrual flow or vaginal bleeding
increased urination
itching skin or rash
lightheadedness
loss of appetite
metallic taste
muscle cramps, stiffness, or weakness
nervousness
nosebleeds
paralysis
pounding in the ears
rapid breathing
red or black, tarry stools
red or dark brown urine
redness, swelling, or pain of the skin
scaling of the skin on the hands and feet
slow or fast heartbeat
stomach pain or tenderness
sunken eyes
swelling of the feet or lower legs
thirst
tightness in the chest
tingling of the hands and feet
ulceration of the skin
unusual tiredness or weakness
vomiting
weight gain or loss
wrinkled skin
yellow eyes or skin
Less common
bleeding from the gums or nose
bleeding from the rectum
bloody, black or tarry stools
change in vision
chest pain or discomfort
extreme drowsiness
inability to speak
indigestion
numbness or tingling in the face, arms, hands, or legs
pain in the chest, groin, or legs
pain or discomfort in the arms, jaw, back, or neck
pain, redness, or swelling in the arm or leg
pale skin
ringing in the ears
seizures
sensitivity to heat
severe headaches of sudden onset
severe stomach pain, cramping, or burning
slurred speech
sores, ulcers, or white spots on the lips, tongue, or inside the mouth
sudden loss of coordination
sudden onset of slurred speech
sudden vision changes
sweating
temporary blindness
trouble sleeping
trouble speaking, thinking, or walking
troubled breathing with exertion
uncomfortable swelling around the anus
unusual bleeding or bruising
vomiting of material that looks like coffee grounds
weakness in the arm or leg on one side of the body
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Belching
change in taste
cracked lips
decreased appetite
difficulty with moving
joint pain or swelling
lack or loss of strength
loss of taste
muscle aches or pain
pain in the arms or legs
stomach discomfort or upset
swelling or inflammation of the mouth
upper stomach pain
voice changes
Less common
Burning sensation of the tongue
continuous ringing or buzzing or other unexplained noise in the ears
flushing or redness of the skin
hearing loss
thinning of the hair
unusually warm skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Can take with other anticancer medications in certain situations
Taken by mouth (not an injection)
Dosage can be adjusted up or down based on how well you tolerate the medication
Must take twice a day
Can cause serious bleeding and heart problems
Not safe to take while pregnant or breastfeeding
Take Inlyta (axitinib) tablets twice a day, about 12 hours apart, with or without food. Swallow the tablet whole with a full glass of water. Don’t crush, break, or chew it.
If you miss a dose of Inlyta (axitinib), take the next dose at your regularly scheduled time. Don’t double the dose to make it up.
Make sure to check your blood pressure regularly while you’re taking Inlyta (axitinib). This medication can raise your blood pressure. If it’s consistently higher than usual, you might need to take blood pressure medications to help manage your blood pressure.
Let your healthcare provider know if you’re planning to have surgery. Because Inlyta (axitinib) can slow wound healing and cause bleeding, you should stop taking the medication at least a few days before a planned surgery. You won’t be able to restart it until a couple weeks after surgery or until your surgical wounds fully heal. Your provider can give you specific instructions on when to stop and restart treatment.
Avoid eating grapefruit or drinking grapefruit juice while you’re taking Inlyta (axitinib). Grapefruit might raise the levels of the medication in your body, which can lead to more side effects.
Review your medication and supplement list with your provider before you start and while you’re taking Inlyta (axitinib) to make sure they can all be taken together safely. Inlyta (axitinib) can interact with other medications and supplements. For example, taking medications like St. John's wort or rifampin with Inlyta (axitinib) could cause the cancer medication to not work as well.
If you’re a woman who can have children, use reliable birth control during treatment and for at least 1 week after the last dose. Taking Inlyta (axitinib) can harm your unborn baby if it’s taken during pregnancy. If you become pregnant while using this medication, tell your provider right away.
If you’re a man with a partner who can get pregnant, make sure to use a condom during sex while you’re getting treated and until at least 1 week after the last dose. It’s possible that Inlyta (axitinib) can cause birth defects in your partner’s unborn baby if they become pregnant while you’re taking this cancer medication.
Based on studies done on animals, Inlyta (axitinib) might affect fertility, or your ability to have a baby. If this is a concern for you or your partner, speak with your provider.
Ask your provider or pharmacist about the best way to handle and throw away Inlyta (axitinib) safely. Anticancer medications can be very harmful to people who handle or come into contact with them.
Inlyta (axitinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Inlyta (axitinib) can commonly cause high blood pressure. It's usually mild, but can become more severe, leading to an emergency situation. Elevations in blood pressure most commonly start within the first month of treatment. For this reason, you should check your blood pressure regularly. If you develop high blood pressure while you’re taking Inlyta (axitinib), you might need to take blood pressure medication(s). If it’s severe, it’s possible that you’ll need to stop taking Inlyta (axitinib).
Although rare, blood clots in your veins or arteries can happen while you’re taking Inlyta (axitinib). Some blood clots can become fatal. Notify your provider right away and seek medical attention if you notice any signs or symptoms of a blood clot like shortness of breath, chest pain, swelling and pain in the legs, sudden numbness or weakness on one side of your body, or trouble speaking. If you develop a blood clot while you’re taking Inlyta (axitinib), your provider might recommend that you stop taking the medication altogether.
Inlyta (axitinib) can raise the risk of bleeding. In clinical trials, bleeding was rarely serious and fatal. These serious cases included blood in the urine, coughing up blood, stomach bleeding, and bleeding in the brain. Tell your provider as soon as possible if you have signs or symptoms of bleeding, like frequent nosebleeds, coughing or vomiting blood, blood in your urine or stool, abnormal vaginal bleeding, or abnormal bruising. Depending on how severe your bleed is, your provider might lower your dosage or recommend that you stop taking the medication completely.
Risk factors: High blood pressure | High cholesterol | Diabetes
Though uncommon, Inlyta (axitinib) can cause serious heart problems, including heart failure. In addition, studies showed that taking Inlyta (axitinib) with Bavencio (avelumab) can cause other severe and sometimes fatal heart problems, like heart attack, in addition to heart failure. Because of these risks, your provider might monitor your heart function before starting and during treatment.
Let your healthcare provider know right away if you have symptoms like chest pain, shortness of breath, swelling in lower legs or feet, racing heartbeat, feeling lightheaded, or tiredness. Your provider might lower your dose or instruct you to stop taking Inlyta (axitinib).
Though not common, some people who took Inlyta (axitinib) have developed tears in their gut and fistulas (an abnormal connection from one part of the body to another). These problems are serious and can sometimes even be life-threatening. Let your provider know if you have symptoms of gut injuries or fistulas, such as high fever, shivering, vomiting, a lot of stomach pain (especially if it doesn’t go away), pain in the anal area, or severe constipation.
Some people taking Inlyta (axitinib) developed thyroid gland problems, including both hyperthyroidism and hypothyroidism. Your healthcare provider should regularly check your thyroid function through lab tests while you're taking Inlyta (axitinib). Let your provider know if you have any symptoms of thyroid gland problems, like tiredness, feeling cold or hot, unexpected weight changes, and hair loss. If you develop thyroid gland problems, you might need to start thyroid medications to maintain your thyroid function.
Inlyta (axitinib) can make it more difficult for your wound to heal. Let your provider know if you’re planning to have a surgery or procedure. You shouldn’t take Inlyta (axitinib) at least 2 days before surgery. The medication shouldn’t be restarted until at least 2 weeks after the surgery and until your surgical wounds have properly healed.
In addition, if you get injured while you’re taking Inlyta (axitinib) and your wounds are healing very slowly, let your provider know. Your provider might ask you to temporarily stop the medication to wait for your injuries to heal before restarting at a lower dosage.
Very rarely, Inlyta (axitinib) can cause a neurological problem called reversible posterior leukoencephalopathy syndrome (RPLS). In clinical trials, this happened in less than 1% of people who took Inlyta (axitinib). RPLS can cause seizures, headache, severe tiredness, confusion, and changes in vision. This syndrome commonly goes away within a week when it's recognized and treated early. Let your provider know right away if you experience any symptoms of RLPS while you’re taking Inlyta (axitinib). You’ll need to stop treatment if you develop RPLS.
In clinical trials, 11% of people who took Inlyta (axitinib) had proteinuria (protein in the urine). Your healthcare provider will check your urine protein levels using a lab test called a urinalysis before you start this medication and regularly throughout treatment. If you develop protein in your urine while you’re taking Inlyta (axitinib), you might need to stop treatment temporarily and restart at a lower dosage.
Risk factors: Taking Inlyta (axitinib) with Keytruda (pembrolizumab) or Bavencio (avelumab)
Taking Inlyta (axitinib) can cause elevated liver enzymes in the blood. Some people who took the medication together with immunotherapy had serious liver damage. Because of this risk, your healthcare provider will lower your dose to prevent further liver damage if you already have liver problems. Inlyta (axitinib) hasn't been studied in people who have severe liver problems.
Your healthcare provider will perform to check your liver function regularly while you’re getting treated with Inlyta (axitinib). Let your provider know right away if you experience any symptoms of liver damage, like yellowing of the skin or eyes, pain on the right side of your stomach, dark urine, light-colored stools, loss of appetite, or severe nausea or vomiting. If you develop elevated liver enzymes or liver inflammation (hepatitis), you might need to stop taking Inlyta (axitinib).
Based on animal studies, it’s possible that Inlyta (axitinib) can cause harm to an unborn baby if it’s taken by mothers during pregnancy. If you’re a woman who can get pregnant, use birth control while you’re getting treated with Inlyta (axitinib) and for 1 week after the last dose. Men with partners who can have children should also use birth control (e.g., condom) while taking this medication and for 1 week after the last dose. Let your provider know right away if you or your partner becomes pregnant during treatment.
The typical starting dose is 5 mg by mouth twice daily (about 12 hours apart), with or without food.
Your provider will adjust your dose based on how well the medication is working to treat your cancer, the severity of any side effects, and whether you have liver problems.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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