Side Effect Tips
Tips to Help Manage Certain Side Effects
The tips in this section are based on published general guidelines for managing certain side effects that are common among patients with advanced kidney cancer (advanced RCC) or other cancers. You can find a list of possible serious side effects in the Important Safety Information. Not all side effects are manageable. Dose interruptions and/or reductions may be needed during treatment with INLYTA. Be sure to pay attention to all your side effects. They can be important signs that let you and your healthcare provider know what is happening in your body.
High blood pressure
INLYTA may cause your blood pressure to rise. In the clinical trial, hypertension occurred as early as 4 days into treatment. On average, this increase was seen within the first month of treatment.
Your healthcare provider should check your blood pressure regularly while you are being treated with INLYTA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with INLYTA. Tell your healthcare provider if you have high blood pressure or a history of heart disease.
Diarrhea is defined as 3 or more loose or watery stools/bowel movements in 1 day. If you have these symptoms, call your healthcare provider. It is important for you and your healthcare provider to try to manage diarrhea as soon as it begins.
If you experience diarrhea, your healthcare provider’s recommendations may include:
- Trying yogurt containing probiotics
- Eating small, frequent meals and foods containing soluble fiber
- Avoiding spicy foods, fatty foods, caffeine, and fruit
- Drinking fluids, such as water, diluted cranberry juice, or broth
Ask your healthcare provider if you can be treated with over-the-counter medications or prescriptions.
Tiredness or feeling weak
While you are taking INLYTA® (axitinib), you may feel tired or weak. Call your healthcare provider if you have these symptoms.
If tiredness or feeling weak is a recurring problem, your healthcare provider’s recommendations may include:
- Taking short naps and breaks instead of long ones
- Eating well and drinking plenty of fluids
- Staying as active as possible
- Trying to maintain normal work and social schedules
Ask your healthcare provider if there are over-the-counter or prescription medications that may help you manage your condition.
Decreased appetite or weight
During treatment, you may have less desire to eat. But maintaining good nutrition and a healthy weight are important to your overall health. Protein and calories are especially vital to someone with cancer.
If you have decreased appetite, you can discuss the following diet ideas with your healthcare provider:
- Eating several small meals a day, including nutritious snacks that are high in calories and protein
- Drinking fluids between meals rather than filling up with beverages during meals
- Flavoring foods with herbs, sugar, or sauces to maximize taste
- If taste changes cause you to eat less, try cold or frozen foods to minimize taste
- Consulting with a registered dietitian (RD) for more ideas
Ask your healthcare provider if there are over-the-counter or prescription medicines that may help you manage your condition.
Nausea or vomiting
It is best to call your healthcare provider at the first sign of nausea or vomiting. This is especially important if these symptoms keep you from taking your oral medications or keeping them down. Your healthcare provider may prescribe a medicine for these symptoms.
If you experience nausea or vomiting, your healthcare provider’s recommendations may include:
- Eating smaller, more frequent meals
- Avoiding fatty, fried, spicy, or highly sweet foods
- Eating bland foods at room temperature and drinking clear liquids
If you vomit, start with small amounts of water, broth, or other clear liquids when you are ready to eat again. If that stays down, then try soft foods. Some examples include gelatin, plain cornstarch pudding, yogurt, strained soup, or strained cooked cereal. Slowly work up to eating solid food. Make sure that you do not eat any food that you are allergic to.
Also called dysphonia (dis-FONE-ee-uh), this is when you have a weak, rough, or harsh voice.
If you have trouble speaking, your healthcare provider’s recommendations may include:
- Drinking plenty of water and avoiding irritants (eg, dust, smoke, alcohol, industrial chemicals)
- Writing things down to give your voice a break
- Remembering to avoid shouting or whispering
Skin conditions, such as rash, redness, itching, or peeling of the skin are other side effects that may occur. You may notice dryness, thickening, calluses, blisters, or cracking of the skin on the palms of your hands and soles of your feet. This is called hand-foot syndrome. Tell your healthcare provider if you start to develop skin problems. He or she may give you specific treatments, which may include lotions, moisturizers, or pain medicines.
To help manage the effects of hand-foot. syndrome, your healthcare provider’s recommendations may include:
- Wearing loose, cotton clothes
- Cleaning hands and feet with lukewarm water and gently patting dry
- Avoiding tight-fitting shoes and jewelry that rub or chafe the hands and feet
Some patients taking INLYTA experience constipation. This has the potential to become a serious side effect. Left untreated, constipation can cause a blockage in your intestines, leading to dehydration and even internal damage.
If you experience constipation, speak to your healthcare provider. He or she may recommend any of the following:
- Drinking more fluids
- Taking a stool softener
- Changing your dose of INLYTA
- Adding fiber to your diet
- Increasing physical activity
IMPORTANT SAFETY INFORMATION
Before taking INLYTA, tell your healthcare provider about all of your medical conditions, including if you:
- have high blood pressure
- have thyroid problems
- have liver problems
- have a history of blood clots in your veins or arteries (types of blood vessels), including stroke, heart attack, or change in vision
- have any bleeding problems
- have a history of heart problems, including heart failure
- have an unhealed wound
- plan to have surgery or have had a recent surgery. You should stop taking INLYTA for at least 2 days before planned surgery
For females, tell your healthcare provider if you:
- are pregnant or plan to become pregnant. Taking INLYTA during pregnancy can harm your unborn baby. You should not become pregnant during treatment with INLYTA.
- are able to become pregnant. You should have a pregnancy test before you start treatment with INLYTA. Use effective birth control during treatment and for 1 week after your last dose of INLYTA. Talk to your healthcare provider about birth control methods that you can use to prevent pregnancy during this time.
- are breastfeeding or plan to breastfeed. It is not known if INLYTA passes into your breast milk. Do not breastfeed during treatment and for 2 weeks after your last dose of INLYTA.
For males with female partners who are able to become pregnant:
- use effective birth control during treatment and for 1 week after your last dose of INLYTA.
- if your female partner becomes pregnant during your treatment with INLYTA, tell your healthcare provider right away.
INLYTA may cause fertility problems in males and females, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INLYTA and certain other medicines can affect each other causing serious side effects.
Talk with your healthcare provider before you start taking any new medicine. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Do not drink grapefruit juice or eat grapefruit. Grapefruit may increase the amount of INLYTA in your blood.
INLYTA may cause serious side effects, including:
- High blood pressure (hypertension). High blood pressure is common with INLYTA and may sometimes be severe. Your healthcare provider should check your blood pressure regularly during treatment with INLYTA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with INLYTA
Blood clots in your veins or arteries. INLYTA can cause blood clots which can be serious, and sometimes lead to death. Get emergency help and call your healthcare provider if you get any of the following symptoms:
- chest pain or pressure
- pain in your arms, back, neck or jaw
- shortness of breath
- numbness or weakness on one side of your body
- trouble talking
- vision changes
Bleeding. INLYTA can cause bleeding which can be serious, and sometimes lead to death. Call your healthcare provider right away or get medical help if you develop any of the following signs or symptoms:
unexpected bleeding or bleeding that lasts a long time, such as:
- unusual bleeding from the gums
- menstrual bleeding or vaginal bleeding that is heavier than normal
- bleeding that is severe or you cannot control
- pink or brown urine
- red or black stools (looks like tar)
- bruises that happen without a known cause or get larger
- cough up blood or blood clots
- vomit blood or your vomit looks like “coffee grounds”
- unexpected pain, swelling, or joint pain
- headaches, feeling dizzy or weak
Heart failure. Your healthcare provider should check you for signs or symptoms of heart failure regularly during treatment with INLYTA. Heart failure can be serious and can sometimes lead to death. Tell your healthcare provider if you have any of the following symptoms during your treatment with INLYTA:
- swelling of your stomach-area (abdomen), legs or ankles
- shortness of breath
- protruding neck veins
Tear in your stomach or intestinal wall (perforation). A tear in your stomach or intestinal wall can be serious and can sometimes lead to death. Get medical help right away if you get the following symptoms:
- severe stomach-area (abdominal) pain or stomach-area pain that does not go away
- vomit blood
- red or black stools
Thyroid gland problems. Your healthcare provider should do blood tests to check your thyroid gland function before and during your treatment with INLYTA. Tell your healthcare provider if you have any of the following symptoms during your treatment with INLYTA:
- tiredness that worsens or that does not go away
- feeling hot or cold
- your voice deepens
- weight gain or weight loss
- hair loss
- muscle cramps and aches
Risk of wound healing problems. Wounds may not heal properly during INLYTA treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with INLYTA.
- You should stop taking INLYTA at least 2 days before planned surgery
- Your healthcare provider should tell you when you may start taking INLYTA again after surgery
Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome (RPLS) can happen during treatment with INLYTA. Call your healthcare provider right away if you get:
- high blood pressure
- blindness or change in vision
- problems thinking
Protein in your urine. Your healthcare provider should check your urine for protein before and during your treatment with INLYTA. If you develop protein in your urine, your healthcare provider may decrease your dose of INLYTA or stop your treatment.
Liver problems. Your healthcare provider will do blood tests before and during your treatment with INLYTA. Your healthcare provider may delay or stop your treatment with INLYTA if you develop severe liver problems.
The most common side effects of INLYTA include:
- feeling tired or weak
- decreased appetite
- rash, redness, itching or peeling of your skin on your hands and feet
- decreased weight
These are not all of the possible side effects of INLYTA. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
INLYTA is a prescription medicine used to treat kidney cancer that has spread or cannot be removed by surgery (advanced renal cell carcinoma or RCC) when 1 prior drug treatment regimen for your RCC has not worked.
It is not known if INLYTA is safe and effective in children.
Please see full Prescribing Information and Patient Information, which includes a complete discussion of the risks of INLYTA.