Class: Biological Therapy

Generic Name: axitinib

Trade Name: Inlyta®

For which conditions is this drug approved? Inlyta is approved for the treatment of advanced renal cell carcinoma (kidney cancer) when prior treatment hasn’t worked.

What is the mechanism of action? Inlyta is a kinase inhibitor. These drugs work by blocking the action of enzymes called kinases, which are involved in many cell functions, including cell signaling, growth, and division. These enzymes may be too active or found at high levels in some types of cancer cells, and blocking them may help keep cancer cells from growing.

How is Inlyta typically given (administered)? Inlyta is given orally, as a tablet.

How are patients typically monitored? While you are taking Inlyta, your doctor will monitor your blood pressure, thyroid function, liver function, and check you for a condition called proteinuria in which your urine contains an abnormal amount of protein.

What are the common (occur in 30% or more of patients) side effects of treatment with Inlyta?

• Diarrhea
• High blood pressure
• Fatigue
• Decreased appetite
• Nausea
• Voice disorders

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Inlyta?

• Hand-foot syndrome (redness, swelling, and pain on the palms of the hands and/or the soles of the feet)
• Weight loss
• Vomiting
• Weakness and lack of energy and strength
• Constipation
• Hypothyroidism (thyroid glad does not make enough thyroid hormone)
• Cough
• Mucosal inflammation
• Joint pain
• Inflammation of mouth and lips (stomatitis)
• Dyspnea (difficult or labored respiration)
• Stomach pain
• Headache
• Pain in arms and legs
• Rash
• Proteinuria
• Change to sense of taste
• Dry skin
• Upper abdomen and chest discomfort due to gas

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Before you take Inlyta, tell your doctor if you have:
  • High blood pressure
  • Thyroid problems
  • Liver problems
  • History of blood clots in your veins or arteries (types of blood vessels), including stroke, heart attack, or change in vision
  • Bleeding problems
  • An unhealed wound
  • Any other medical conditions
• Tell your doctor if you plan to have surgery. You should stop taking Inlyta at least 24 hours before
planned surgery.
• Tell your doctor 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.
• Be especially sure to tell your doctor if you take:
  • Dexamethasone
  • John’s wort (hypericumperforatum)
  • Medicine for: asthma, tuberculosis, seizures, bacterial infections, fungal infections, depression, or HIV or AIDS
• Take Inlyta exactly as your doctor prescribes. Swallow the tablets whole with a glass of water, with or without food. Take Inlyta two times a day, approximately 12 hours apart.
• If you vomit or miss a dose of Inlyta, take your next dose at your regular time. Do not take two doses at the same time.
• If you take too much Inlyta, call your doctor or go to the nearest hospital emergency room right away.

Are there any special precautions patients should be aware of before starting treatment?

• Do not drink grapefruit juice or eat grapefruit while taking Inlyta. Grapefruit may increase the amount of the medicine in your blood.
• Tell your doctor if you are pregnant or plan to become pregnant. Inlyta can harm your unborn baby, so you should not become pregnant during treatment with Inlyta. If you become pregnant during treatment or think you may be pregnant, tell your healthcare provider right away.
• Women who are able to become pregnant should use effective birth control during treatment with Inlyta and for one month after the last dose.
• Men who are sexually active should use a condom during treatment with Inlyta.
• Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Inlyta will pass into your breast milk. You and your healthcare provider should decide if you will take Inlyta or breastfeed—you should not do both.

When should patients notify their physician? Tell your doctor if you have any side effect that bothers you or that does not go away, including:

• Tiredness that worsens or that does not go away
• Feeling hot or cold
• Deepening voice
• Weight gain or weight loss
• Hair loss
• Muscle cramps and aches

Tell your doctor if you have signs of problems with blood clots in your veins or arteries. Get emergency help is you experience 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
• Headache
• Vision changes

Tell your doctor if you have signs of bleeding. Get medical help right away if you experience:

• 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

Tell your doctor if you have signs of a tear in your stomach or intestinal wall (perforation). Get medical help right away if you get the following symptoms:

• Severe stomach (abdominal) pain or stomach pain that does not go away
• Vomit blood
• Red or black stools

Call your doctor right away if you have signs of a condition called reversible posterior leukoencephalopathy syndrome (RPLS). Signs of RPLS include:

• Headache
• Seizures
• Weakness
• Confusion
• High blood pressure
• Blindness or change in vision
• Problems thinking

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 09/16.

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