Advise patients that Inlyta may cause birth defects or fetal loss and that they should not become pregnant during treatment with Inlyta. Both male and female patients should be counseled to use effective birth control during treatment with Inlyta. Female patients should also be advised against breast-feeding while receiving Inlyta [see Warnings and Precautions (5.12) and Use in Specific Populations (8.3)].
Concomitant Medications
Advise patients to inform their doctor of all concomitant medications, vitamins, or dietary and herbal supplements.
FDA-Approved Patient Labeling
LAB- 0561-1.0
January 2012
PATIENT INFORMATION
Inlyta® (in-ly-ta)
(axitinib)
Tablets
Read this Patient Information before you start taking Inlyta and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is Inlyta?
Inlyta is a prescription medicine used to treat advanced kidney cancer (advanced renal cell carcinoma or RCC) when one prior drug treatment for this disease has not worked.
It is not known if Inlyta is safe or effective in children.
What should I tell my doctor before taking Inlyta?
Before you take Inlyta, tell your doctor 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 an unhealed wound
•plan to have surgery. You should stop taking Inlyta at least 24 hours before planned surgery.
•have any other medical conditions
For females, tell your doctor if you:
•are pregnant or plan to become pregnant. Taking Inlyta during pregnancy may cause the death of an unborn baby or birth defects. You should not become pregnant while taking Inlyta. Talk to your doctor if you are pregnant or plan to become pregnant.
•are able to become pregnant. You should use effective birth control during your treatment with Inlyta. Talk to your doctor about birth control methods to prevent pregnancy while you are taking Inlyta.
•are breastfeeding or plan to breastfeed. It is not known if Inlyta passes into your breast milk. You and your doctor should decide if you will take Inlyta or breastfeed. You should not do both.
For males:
•use effective birth control during your treatment with Inlyta. Talk to your doctor about birth control methods.
•if your female partner becomes pregnant while you are taking Inlyta, tell your doctor right away.
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.
Especially tell your doctor if you take:
•dexamethasone
•St. John's Wort (Hypericum perforatum)
•Medicine for:
◦asthma
◦tuberculosis
◦seizures
◦bacterial infections
◦fungal infections
◦depression
◦HIV or AIDS
Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. If you are taking any medicines for the conditions listed above, your doctor might need to prescribe a different medicine or your dose of Inlyta may need to be changed. Talk with |
