What are the possible side effects of GILOTRIF?

 GILOTRIF may cause serious side effects, including:

◦diarrhea. Diarrhea is common with GILOTRIF and may sometimes be severe. Severe diarrhea can cause loss of body fluid (dehydration) and kidney problems that can sometimes lead to death. During your treatment with GILOTRIF, your doctor should prescribe medicines to treat diarrhea. Take this medicine exactly as your doctor tells you to. Tell your doctor if you have diarrhea. Get medical attention right away if your diarrhea does not go away or becomes severe.
◦skin reactions. GILOTRIF can cause redness, rash, and acne. It is important to get treatment for skin reactions as soon as you notice them. Take medicines to help skin reactions exactly as your doctor tells you to. Get medical attention right away if you develop severe skin reactions such as peeling or blistering of the skin.
◦lung or breathing problems. Tell your doctor right away if you have any new or worsening lung problems, or any combination of the following symptoms:
◦trouble breathing or shortness of breath
◦cough
◦fever
◦liver problems. Tell your doctor right away if you have any symptoms of a liver problem which may include:
◦yellowing of your skin or the white part of your eyes (jaundice)
◦dark or brown (tea colored) urine
◦pain on the upper right side of your stomach area (abdomen)
◦bleeding or bruising more easily than normal
◦feeling very tired
   Your doctor will do blood tests to check your liver function during your treatment with GILOTRIF.

◦eye problems. Tell your doctor right away if you have symptoms of eye problems which may include:
◦eye pain, swelling, redness, or tearing
◦blurred vision
◦sensitivity to light
◦other changes in your vision
◦heart problems. Tell your doctor right away if you have symptoms of a heart problem which may include:
◦new or worsening shortness of breath while at rest or with activity
◦cough
◦tiredness
◦swelling of your ankles, feet, or legs
◦feeling that your heart is pounding or racing (palpitations)
◦sudden weight gain
The most common side effects of GILOTRIF include:

◦diarrhea
◦rash
◦mouth sores
◦nail infection
◦dry skin
◦acne
◦decreased appetite
◦itching
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of GILOTRIF. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store GILOTRIF?

◦Store GILOTRIF at room temperature between 68°F to 77°F (20°C to 25°C).
◦Keep GILOTRIF in the original container and keep the container tightly closed.
◦Keep GILOTRIF away from moisture and light.
◦Safely throw away (discard) any GILOTRIF that is out of date or no longer needed.
Keep GILOTRIF and all medicines out of the reach of children.

General information about GILOTRIF

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do no