What is GILOTRIF?
GILOTRIF is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC):
It is not known if GILOTRIF is safe and effective in children.
IMPORTANT SAFETY INFORMATION ABOUT GILOTRIF
Before you take GILOTRIF, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. GILOTRIF may affect the way other medicines work, and other medicines may affect the way GILOTRIF works.
What to avoid while taking GILOTRIF
Limit your time in the sun. GILOTRIF can make your skin sensitive to the sun. You could get or have worsening rash or acne. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin while you are taking GILOTRIF if you have to be in sunlight.
GILOTRIF may cause serious side effects, including:
Your doctor will do blood tests to check your liver function during your treatment with GILOTRIF.
The most common side effects of GILOTRIF include diarrhea, rash, mouth sores, nail inflammation, dry skin, acne, decreased appetite, nausea, vomiting, itching.
GILOTRIF may cause decreased fertility in females and males. Talk to your doctor if you have concerns about your fertility.
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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see the full Prescribing Information, including Patient Information.
GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations.
GILOTRIF is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.
Bullous and Exfoliative Skin Disorders
Interstitial Lung Disease
Adverse Reactions observed in clinical trials were as follows:
First-line treatment of EGFR mutation-positive, metastatic non-small cell lung cancer (NSCLC)
Previously Treated Metastatic Squamous NSCLC
Pancreatitis has been reported during post-marketing use of GILOTRIF. The frequency and causal relationship of pancreatitis to GILOTRIF has not been established.
Effect of P-glycoprotein (P-gp) Inhibitors and Inducers
Females and Males of Reproductive Potential
GF PROF ISI May 2016