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.
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.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
The following side effects were reported by people taking Inlyta (axitinib) by itself. Inlyta (axitinib) is often given along with other anticancer medications, so side effects might differ.
Contact your healthcare provider immediately if you experience any of the following.
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.
Yes, it’s possible that your Inlyta (axitinib) dose can change while you’re taking the medication. The typical starting dose is 5 mg by mouth twice daily. But your provider might adjust your dosage up or down depending on how well the medication is working for your cancer and whether you have side effects. If you experience side effects like high blood pressure or bleeding, your provider might need to lower your Inlyta (axitinib) dosage to 2 mg or 3 mg twice daily to manage these side effects. On the other hand, if you’re doing well with treatment after taking it for 2 weeks or more, it's possible that your provider will raise your Inlyta (axitinib) dosage up to 7 mg or 10 mg twice daily. Studies suggest that higher doses of Inlyta (axitinib) might work better to treat your kidney cancer.
If you get diarrhea during treatment with Inlyta (axitinib), make sure to stay well hydrated. This helps prevent dehydration. But avoid sugary sports drinks because they can make diarrhea worse. Also avoid foods that can irritate your stomach like spicy or greasy foods. It's best to try to eat bland foods like applesauce, rice, and toast. Your provider might recommend over-the-counter diarrhea medications, like loperamide (Imodium A-D), to help. If you have severe diarrhea, you might need to stop treatment temporarily or even permanently.
Hand-foot skin reaction is a reaction to Inlyta (axitinib) that causes reddening, swelling, and peeling of the skin on the palms of the hands or soles of the feet. Some ways to help prevent hand-foot skin reaction is limiting exposure of your hands and feet to hot water and avoiding too much rubbing or exercise to the hands and feet. You can also apply moisturizing creams. It’s important to follow these preventative measures because this skin reaction can be painful and come with tingling, numbness, and soreness of the hands and feet. If you experience a skin reaction while you’re taking Inlyta (axitinib), let your provider know so they can suggest ways to manage the reaction.
You should take Inlyta (axitinib) as instructed by your provider. How long you need treatment with Inlyta (axitinib) depends on several factors. These factors include how well the medication is working to treat your cancer, whether you have side effects from it, and how severe they are. If you have serious side effects like heart failure and extremely high blood pressure, you might need to stop taking Inlyta (axitinib). Don’t stop taking Inlyta (axitinib) without discussing with your provider first.
It isn’t recommended to breastfeed while you’re taking Inlyta (axitinib). We don’t know whether the medication can pass into human breast milk, but there’s a risk of serious harm to nursing infants if it does. Because of this risk, you shouldn’t breastfeed while you’re taking Inlyta (axitinib) and until 2 weeks after your last dose. Talk with your provider about other ways to feed your baby during treatment.
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.
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.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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.