Gilotrif Oral Tablet 20Mg Drug Medication Dosage Information
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GILOTRIF: Oral tablet (20mg)

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What is this Medicine?

AFATINIB (a FA ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat non-small cell lung cancer.

In-Depth Information

GILOTRIF 20mg Tablet

NDC: 005970141
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Non-small Cell Lung Cancer (NSCLC)

Storage Information
Store and dispense in original container
Protect from light
Avoid excessive humidity
Store at 77 degrees F; excursions permitted to 59-86 degrees F
GILOTRIF 20mg Tablet

Reported Side Effects for GILOTRIF 20mg Tablet

Liver Failure Incidence:
<0.2%*
Severity: SEVERE
Onset: DELAYED
Inflammation Of The Lip Incidence:
<12.0%*
Severity: MILD
Onset: DELAYED
Inflamed Pancreas Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Dry Skin Incidence:
<0.4%*
Severity: SEVERE
Onset: DELAYED
Low White Blood Cells Incidence:
<0.4%*
Severity: SEVERE
Onset: DELAYED
Acute Lung Injury Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Anemia Incidence:
<0.4%*
Severity: SEVERE
Onset: DELAYED
Constipation Incidence:
<2.6%*
Severity: MODERATE
Onset: DELAYED
Weight Loss Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Heart Failure Incidence:
<2.2%*
Severity: SEVERE
Onset: DELAYED
High Bilirubin Level Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Eye Inflammatoin Incidence:
<0.5%*
Severity: SEVERE
Onset: DELAYED
Blistery Rash Incidence:
>0.2%*
Severity: SEVERE
Onset: EARLY
Elevated Hepatic Enzymes Incidence:
0.2-3.5%*
Severity: SEVERE
Onset: DELAYED
Low White Blood Cell Counts Incidence:
0.4-1.0%*
Severity: SEVERE
Onset: DELAYED
Itching Incidence:
>0.4%*
Severity: SEVERE
Onset: RAPID
Vomiting Incidence:
1.0-4.0%*
Severity: SEVERE
Onset: EARLY
Bladder Infection Incidence:
>1.0%*
Severity: SEVERE
Onset: DELAYED
Lung Inflammation Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Low Potassium Levels Incidence:
1.0-8.0%*
Severity: SEVERE
Onset: DELAYED
Kidney Failure Incidence:
1.3-2.0%*
Severity: SEVERE
Onset: DELAYED
Hand And Foot Syndrome Incidence:
1.5-7.0%*
Severity: MODERATE
Onset: DELAYED
Tired Incidence:
>1.7%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
2.0-4.0%*
Severity: SEVERE
Onset: EARLY
Mouth Ulcers Incidence:
4.0-9.4%*
Severity: SEVERE
Onset: DELAYED
Drug-Induced Acne Incidence:
7.0-16.0%*
Severity: SEVERE
Onset: DELAYED
Conjunctivitis Incidence:
>11.0%*
Severity: MODERATE
Onset: DELAYED
Infection Incidence:
>11.0%*
Severity: SEVERE
Onset: DELAYED
Runny Nose Incidence:
>11.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
11.0-16.0%*
Severity: SEVERE
Onset: EARLY
Nose Bleed Incidence:
>17.0%*
Severity: MILD
Onset: DELAYED
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Daily Life Interactions for GILOTRIF 20mg Tablet

Elements of your daily lifestyle may have an effect on the medications you are taking. Drug interactions can result in unwanted side effects, reduce the effectiveness of your medicine or possibly increase the action of a particular medicine.

Moderate Lifestyle Interaction
Grapefruit juice and GILOTRIF 20mg Tablet(Afatinib)
Grapefruit juice and Afatinib(Afatinib)
Do not take these drugs together without talking to your health care professional. Taking these drugs together may result in increased levels of afatinib in your body and increased risk of afatinib side effects such as increased eye irritation and/or pain, shortness of breath or difficulty breathing, nausea, vomiting, rash, diarrhea, sores in mouth, or other unusual effects. An afatinib dose adjustment may be necessary when these agents are used together. Report any new or unusual side effects to your health care provider.
Pregnancy & Lactation Information
FIRST Trimester

Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

SECOND Trimester

Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

THIRD Trimester

Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

Lactation

Avoid - This drug is known to cause harm to infants when taken by nursing mothers.


Learning More About
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