Drugs Details

Drugs Info of Gilotrif
Drugs Details
  • Drugs Type  : FDA
  • Date : 27th Jan 2015 09:27 pm
  • Brand Name : Gilotrif
  • Generic Name : (afatinib) Tablets, for Oral Use
Descriptions

GILOTRIF tablets contain afatinib, a tyrosine kinase inhibitor which is a 4-anilinoquinazoline. Afatinib is presented as the dimaleate salt, with the chemical name 2-butenamide, N-[4-[(3-chloro-4-fluorophenyl)amino]7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-,(2E)-, (2Z)-2-butenedioate (1:2). Its structural formula is:

 

GILOTRIF™ (afatinib) Structural Formula Illustration

Afatinib dimaleate is a white to brownish yellow powder, water soluble and hygroscopic, with an empirical formula of C32H33ClFN5O11, and a molecular weight of 718.1 g/mol.

GILOTRIF tablets for oral administration are available in 40 mg, 30 mg, or 20 mg of afatinib (equivalent to 59.12 mg, 44.34 mg, or 29.56 mg afatinib dimaleate, respectively). The inactive ingredients of GILOTRIF are the following: Tablet Core: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate. Coating: hypromellose, polyethylene glycol, titanium dioxide, talc, polysorbate 80, FD&C Blue No. 2 (40 mg and 30 mg tablets only).


This monograph has been modified to include the generic and brand name in many instances.

Indications

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 [see Clinical Studies].

Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations [see Clinical Studies].

Dosage Administration

Patient Selection

Select patients for the first-line treatment of metastatic NSCLC with GILOTRIF based on the presence of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in tumor specimens [see INDICATIONS AND USAGE and Clinical Studies]. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dose

The recommended dose of GILOTRIF is 40 mg orally once daily until disease progression or no longer tolerated by the patient. Take GILOTRIF at least 1 hour before or 2 hours after a meal.

Do not take a missed dose within 12 hours of the next dose.

Dose Modification

Withhold GILOTRIF for any drug-related adverse reactions of:

  • NCI CTCAE* Grade 3 or higher
  • Diarrhea of Grade 2 or higher persisting for 2 or more consecutive days while taking anti-diarrheal medication [see WARNINGS AND PRECAUTIONS]
  • Cutaneous reactions of Grade 2 that are prolonged (lasting more than 7 days) or intolerable [see WARNINGS AND PRECAUTIONS]
  • Renal dysfunction of Grade 2 or higher

Resume treatment when the adverse reaction fully resolves, returns to baseline, or improves to Grade 1. Reinstitute GILOTRIF at a reduced dose, i.e., 10 mg per day less than the dose at which the adverse reaction occurred.

Permanently discontinue GILOTRIF for:

  • Life-threatening bullous, blistering, or exfoliative skin lesions [see WARNINGS AND PRECAUTIONS]
  • Confirmed interstitial lung disease (ILD) [see WARNINGS AND PRECAUTIONS]
  • Severe drug-induced hepatic impairment [see WARNINGS AND PRECAUTIONS]
  • Persistent ulcerative keratitis [see WARNINGS AND PRECAUTIONS]
  • Symptomatic left ventricular dysfunction
  • Severe or intolerable adverse reaction occurring at a dose of 20 mg per day

P-gp Inhibitors

For patients who require therapy with a P-glycoprotein (P-gp) inhibitor, reduce GILOTRIF daily dose by 10 mg if not tolerated. Resume the previous dose after discontinuation of the P-gp inhibitor as tolerated [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

P-gp Inducers

For patients who require chronic therapy with a P-gp inducer, increase GILOTRIF daily dose by 10 mg as tolerated. Resume the previous dose 2 to 3 days after discontinuation of the P-gp inducer [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

How Supplied

Dosage Forms And Strengths

GILOTRIF is available as:

40 mg tablets: light blue, film-coated, round, biconvex, bevel-edged tablets debossed with “T40” on one side and the Boehringer Ingelheim company symbol on the other side.

30 mg tablets: dark blue, film-coated, round, biconvex, bevel-edged tablets debossed with “T30” on one side and the Boehringer Ingelheim company symbol on the other side.

20 mg tablets: white to slightly yellowish, film-coated, round, biconvex, bevel-edged tablets debossed with “T20” on one side and the Boehringer Ingelheim company symbol on the other side.

Storage And Handling

GILOTRIF tablets are available as follows:

40 mg: light blue, film-coated, round, biconvex, bevel-edged tablets debossed with “T40” on one side and the Boehringer Ingelheim company symbol on the other side.

Unit of use bottles of 30 NDC: 0597-0138-30

30 mg: dark blue, film-coated, round, biconvex, bevel-edged tablets debossed with “T30” on one side and the Boehringer Ingelheim company symbol on the other side.

Unit of use bottles of 30 NDC: 0597-0137-30

20 mg: white to slightly yellowish, film-coated, round, biconvex, bevel-edged tablets debossed with “T20” on one side and the Boehringer Ingelheim company symbol on the other side.

Unit of use bottles of 30 NDC: 0597-0141-30

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense medication in the original container to protect from exposure to high humidity and light.

*National Cancer Institute Common Terminology Criteria for Adverse Events, v 3.0

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Revised: November 2013


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Diarrhea [see WARNINGS AND PRECAUTIONS]
  • Bullous and Exfoliative Skin Disorders [see WARNINGS AND PRECAUTIONS]
  • Interstitial Lung Disease [see WARNINGS AND PRECAUTIONS]
  • Hepatic Toxicity [see WARNINGS AND PRECAUTIONS]
  • Keratitis [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety evaluation of GILOTRIF is based on the data from more than 3800 patients, including 2135 NSCLC patients receiving GILOTRIF monotherapy at or above the recommended dose.

Controlled Study

The data in Tables 1 and 2 below reflect exposure of 229 EGFR-TKI naïve GILOTRIF-treated patients with EGFR mutation-positive, metastatic, non-squamous, NSCLC enrolled in a randomized, multicenter, open-label trial (Study 1). Patients received GILOTRIF 40 mg daily until documented disease progression or intolerance to the therapy. A total of 111 patients were treated with pemetrexed/cisplatin. Patients were treated with pemetrexed 500 mg/m² followed after 30 minutes by cisplatin 75 mg/m² every three weeks for a maximum of six treatment courses.

The median exposure was 11.0 months for patients treated with GILOTRIF and 3.4 months for patients treated with pemetrexed/cisplatin. The overall trial population had a median age of 61 years; 61% of patients in the GILOTRIF arm and 60% of patients in the pemetrexed/cisplatin arm were younger than 65 years. A total of 64% of patients on GILOTRIF and 67% of pemetrexed/cisplatin patients were female. More than two-thirds of patients were from Asia (GILOTRIF 70%; pemetrexed/cisplatin 72%).

Serious adverse reactions were reported in 29% of patients treated with GILOTRIF. The most frequent serious adverse reactions reported in patients treated with GILOTRIF were diarrhea (6.6%); vomiting (4.8%); and dyspnea, fatigue, and hypokalemia (1.7% each). Fatal adverse reactions in GILOTRIF-treated patients in Study 1 included pulmonary toxicity/ILD-like adverse reactions (1.3%), sepsis (0.43%), and pneumonia (0.43%).

Dose reductions due to adverse reactions were required in 57% of GILOTRIF-treated patients. The most frequent adverse reactions that led to dose reduction in the patients treated with GILOTRIF were diarrhea (20%), rash/acne (19%), paronychia (14%), and stomatitis (10%).

Discontinuation of therapy in GILOTRIF-treated patients for adverse reactions was 14.0%. The most frequent adverse reactions that led to discontinuation in GILOTRIF-treated patients were diarrhea (1.3%), ILD (0.9%), and paronychia (0.9%).

Clinical trials of GILOTRIF excluded patients with an abnormal left ventricular ejection fraction (LVEF), i.e., below the institutional lower limit of normal. In Study 1, all patients were evaluated for LVEF at screening and every 9 weeks thereafter in the GILOTRIF-treated group and as needed in the pemetrexed/cisplatin group. More GILOTRIF-treated patients (2.2%; n=5) experienced ventricular dysfunction (defined as diastolic dysfunction, left ventricular dysfunction, or ventricular dilation; all < Grade 3) compared to chemotherapy-treated patients (0.9%; n=1).

Table 1 : Adverse Reactions Reported in ≥ 10% of GILOTRIF-Treated Patients in Study 1

Adverse Reaction GILOTRIF
n=229
Pemetrexed/ Cisplatin
n=111
All Grades (%) Grade 3* (%) All Grades (%) Grade 3* (%)
Gastrointestinal disorders
  Diarrhea 96 15 23 2
  Stomatitis1 71 9 15 1
  Cheilitis 12 0 1 0
Skin and subcutaneous tissue disorders
  Rash/Dermatitis acneiform2 90 16 11 0
  Pruritus 21 0 1 0
  Dry skin 31 0 2 0
Infections and infestations
  Paronychia3 58 11 0 0
  Cystitis 13 1 5 0
Metabolism and nutrition disorders
  Decreased appetite 29 4 55 4
Respiratory, thoracic and mediastinal disorders
  Epistaxis 17 0 2 1
  Rhinorrhea 11 0 6 0
Investigations
  Weight decreased 17 1 14 1
General disorders and administration site conditions
  Pyrexia 12 0 6 0
Eye disorders  
  Conjunctivitis 11 0 3 0
*None of the adverse reactions in this table except stomatitis (one patient on GILOTRIF [0.4%]) were Grade 4 in severity.
1Includes stomatitis, aphthous stomatitis, mucosal inflammation, mouth ulceration, oral mucosa erosion, mucosal erosion, mucosal ulceration
2Includes group of rash preferred terms, acne, acne pustular, dermatitis acneiform
3Includes paronychia, nail infection, nail bed infection

Table 2 : Adverse Reactions of Laboratory Abnormalities from the Investigations SOC Reported in ≥ 5% of GILOTRIF-Treated Patients in Study 1

Adverse Reaction GILOTRIF
n=229
Pemetrexed/Cisplatin
n=111
All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Alanine aminotransferase increased 11 2 4 0
Hypokalemia1 11 4 5 4
Aspartate aminotransferase increased 8 2 2 1
1Includes hypokalemia, blood potassium decreased
SOC=system organ class

Read the Gilotrif (afatinib tablets, for oral use) Side Effects Center for a complete guide to possible side effects

Interactions

Effect Of P-glycoprotein (P-gp) Inhibitors And Inducers

Oral administration of a P-gp inhibitor (ritonavir at 200 mg twice daily) 1 hour before administration of GILOTRIF increased systemic exposure to afatinib by 48%. There was no change in afatinib exposure when ritonavir was administered simultaneously with or 6 hours after GILOTRIF. Concomitant taking of P-gp inhibitors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) with GILOTRIF can increase exposure to afatinib [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].

Co-administration with oral dose of a P-gp inducer (rifampicin at 600 mg once daily for 7 days) decreased exposure to afatinib by 34%. Concomitant taking of P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John's wort) with GILOTRIF can decrease exposure to afatinib [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Included as part of the PRECAUTIONS section.

OverDose

Overdose was reported in 2 healthy adolescents each of whom ingested 360 mg of GILOTRIF (as part of a mixed-drug ingestion) resulting in nausea, vomiting, asthenia, dizziness, headache, abdominal pain, and elevated amylase ( < 1.5 times upper limit of normal [ULN]). Both subjects recovered.

ContrainDications

None


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism Of Action

Afatinib covalently binds to the kinase domains of EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4) and irreversibly inhibits tyrosine kinase autophosphorylation, resulting in downregulation of ErbB signaling.

Afatinib demonstrated inhibition of autophosphorylation and in vitro proliferation of cell lines expressing wild-type EGFR or those expressing selected EGFR exon 19 deletion mutations or exon 21 L858R mutations, including some with a secondary T790M mutation, at afatinib concentrations achieved, at least transiently, in patients. In addition, afatinib inhibited in vitro proliferation of cell lines overexpressing HER2.

Treatment with afatinib resulted in inhibition of tumor growth in nude mice implanted with tumors either overexpressing wild type EGFR or HER2 or in an EGFR L858R/T790M double mutant model.

Pharmacodynamics

Cardiac Electrophysiology

The effect of multiple doses of GILOTRIF (50 mg once daily) on the QTc interval was evaluated in an open-label, single-arm study in patients with relapsed or refractory solid tumors. No large changes in the mean QTc interval (i.e., > 20 ms) were detected in the study.

Pharmacokinetics

Absorption And Distribution

Following oral administration of GILOTRIF tablets, time to peak afatinib plasma concentrations (Tmax) is 2 to 5 hours. Maximum concentration (Cmax) and area under the concentration-time curve from time zero to infinity (AUC0-∞) values increased slightly more than dose proportional in the range of 20 to 50 mg. The geometric mean relative bioavailability of 20 mg GILOTRIF tablets was 92% as compared to an oral solution. In vitro binding of afatinib to human plasma proteins is approximately 95%.

A high-fat meal decreased Cmax by 50% and AUC0-∞ by 39% relative to the fasted condition [see DOSAGE AND ADMINISTRATION].

Metabolism And Elimination

Covalent adducts to proteins are the major circulating metabolites of afatinib and enzymatic metabolism of afatinib is minimal.

In humans, excretion of afatinib is primarily via the feces (85%) with 4% recovered in the urine following a single oral dose of [14C]-labeled afatinib solution. The parent compound accounted for 88% of the recovered dose.

The elimination half-life of afatinib is 37 hours after repeat dosing in cancer patients. Steady-state plasma concentrations are achieved within 8 days of repeat dosing of GILOTRIF resulting in an accumulation of 2.8-fold for AUC and 2.1-fold for Cmax.

Specific Populations

Renal Impairment: The median trough afatinib plasma concentrations in patients with mild (CLcr 60-89 mL/min) and moderate (CLcr 30-59 mL/min) renal impairment were 27% and 85% higher than those in patients with normal renal function (CLcr ≥ 90 mL/min). GILOTRIF has not been studied in patients with severely impaired renal function (CLcr < 30 mL/min) [see Use In Specific Populations].

Hepatic Impairment: Afatinib is eliminated mainly by biliary/fecal excretion. Mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment had no influence on the afatinib exposure following a single dose of GILOTRIF. Subjects with severe (Child Pugh C) hepatic dysfunction have not been studied [see Use In Specific Populations].

Body Weight, Gender, Age, and Race: Based on the population pharmacokinetic analysis, weight, gender, age, and race do not have a clinically important effect on exposure of afatinib.

Drug Interactions

Effect of P-gp Inhibitors and Inducers on Afatinib: The effect of ritonavir dosing time relative to a single oral dose of GILOTRIF was evaluated in healthy subjects taking 40 mg of GILOTRIF alone as compared to those after ritonavir (200 mg twice daily for 3 days) co-administration at 6 hours after GILOTRIF administration. The relative bioavailability for AUC0-∞ and Cmax of afatinib was 119% and 104% when co-administered with ritonavir, and 111% and 105% when ritonavir was administered 6 hours after taking GILOTRIF. In another study, when ritonavir (200 mg twice daily for 3 days) was administered 1 hour before a 20 mg single dose of GILOTRIF, exposure to afatinib increased by 48% for AUC0-∞ and 39% for Cmax [see DRUG INTERACTIONS].

Pre-treatment with a potent inducer of P-gp, rifampicin (600 mg once daily for 7 days) decreased the plasma exposure to afatinib by 34% (AUC0-∞) and 22% (Cmax) [see DRUG INTERACTIONS].

P-glycoprotein (P-gp): Based on in vitro data, afatinib is a substrate and an inhibitor of P-gp.

Breast Cancer Resistance Protein (BCRP): Based on in vitro data, afatinib is a substrate and an inhibitor of the transporter BCRP.

Effect of CYP450 Enzyme Inducers and Inhibitors on Afatinib: In vitro data indicated that drug-drug interactions with GILOTRIF due to inhibition or induction of CYP450 enzymes by concomitant medications are unlikely. The metabolites formed by CYP450-dependent reactions were approximately 9% of the total metabolic turnover in sandwich-cultured human hepatocytes. In humans, enzyme-catalyzed metabolic reactions play a negligible role for the metabolism of afatinib. Approximately 2% of the afatinib dose was metabolized by FMO3; the CYP3A4-dependent N-demethylation was not detected.

Effect of Afatinib on CYP450 Enzymes: Afatinib is not an inhibitor or an inducer of CYP450 enzymes (CYP1A2, 2B6, 2C8, 2C9, 2C19, and 3A4) in cultured primary human hepatocytes. Therefore, afatinib is unlikely to affect the metabolism of other drugs that are substrates of CYP450 enzymes.

Clinical Studies

Non-small Cell Lung Cancer (NSCLC)

Study 1

The efficacy and safety of GILOTRIF in the first-line treatment of 345 patients with EGFR mutation-positive, metastatic (Stage IV and Stage IIIb with pleural and/or pericardial effusion as classified by the American Joint Commission on Cancer [AJCC, 6th edition]) NSCLC were established in a randomized, multicenter, open-label trial (Study 1). Patients were randomized (2:1) to receive GILOTRIF 40 mg orally once daily (n=230) or up to 6 cycles of pemetrexed/cisplatin (n=115). Randomization was stratified according to EGFR mutation status (exon 19 deletion vs exon 21 L858R vs other) and race (Asian vs non-Asian). The major efficacy outcome was progression-free survival (PFS) as assessed by an independent review committee (IRC). Other efficacy outcomes included objective response rate (ORR) and overall survival (OS). EGFR mutation status was prospectively determined for screening and enrollment of patients by a clinical trial assay (CTA). Tumor samples from 264 patients (178 randomized to GILOTRIF and 86 patients randomized to chemotherapy) were tested retrospectively by the companion diagnostic therascreen® EGFR RGQ PCR Kit, which is FDA-approved for selection of patients for GILOTRIF treatment.

Among the patients randomized, 65% were female, the median age was 61 years, the baseline ECOG performance status was 0 (39%) or 1 (61%), 26% were Caucasian and 72% were Asian. The majority of the patients had a tumor sample with an EGFR mutation categorized by the CTA as either exon 19 deletion (49%) or exon 21 L858R substitution (40%), while the remaining 11% had other mutations.

A statistically significant improvement in PFS as determined by the IRC was demonstrated for patients randomized to GILOTRIF compared with those randomized to chemotherapy. See Table 3 and Figure 1. There was no statistically significant difference for overall survival between the treatment arms at the interim analysis conducted at 84% of the planned events for the final analysis.

Table 3: Efficacy Results of Study 1

  GILOTRIF
(N=230)
Pemetrexed/Cisplatin
(N=115)
Progression-free Survival
Number of Deaths or Progressions, N (%) 152 (66.1%) 69 (60.0%)
  Median Progression-free Survival (months) 11.1 6.9
  95% CI (9.6, 13.6) (5.4, 8.2)
  HR (95% CI) 0.58 (0.43, 0.78)
  Stratified Log-Rank Test P-value* < 0.001
Overall Survival
Number of Deaths, N (%) 116 (50.4%) 59 (51.2%)
  Median Overall Survival (months) 28.1 28.2
  95% CI (24.6, 33.0) (20.7, 33.2)
  HR (95% CI) 0.91 (0.66, 1.25)
  Stratified Log-Rank Test P-value* 0.55
Objective Response Rate (CR + PR)
N (%) 116 (50.4%) 22 (19.1%)
Response Duration
Median (months) 12.5 6.7
*Stratified by EGFR mutation status and race. CR=complete response; PR=partial response

Figure 1 : Kaplan-Meier Curve for PFS by Independent Review by Treatment Group

View Enlarged Table

Subgroup analyses were conducted based on the stratification factor of EGFR mutation status (Del19, L858R, other) and mutation category (common [Del19, L858R] vs uncommon [other]). See Figure 2.

Figure 2 : Forest Plot of PFS and OS for Common (Del19, L858R) and Uncommon (other) EGFR Mutation Categories

View Enlarged Table

There were 26 GILOTRIF-treated patients in the “other” (uncommon) EGFR mutations subgroup with nine unique mutation patterns. None of these 26 patients achieved a complete response, while four achieved a partial response (see Table 4 below). No responses were seen in GILOTRIF-treated patients with the following mutations: T790M alone (n=2), deletion 19 and T790M (n=3), G719X and T790M (n=1), exon 20 insertion (n=6), and L861Q alone (n=3). There were 11 chemotherapy-treated patients in the “other” uncommon EGFR mutation subgroup; of these, four (36%) achieved a partial response.

Table 4 : Objective Tumor Responses in GILOTRIF-Treated Patients Based on Investigator Assessment in the “Other” (Uncommon) EGFR Mutation Subgroup

EGFR Mutations Number of GILOTRIF-Treated Patients Number of Patients with Partial Responses Duration of Response
L858R and T790M 5 1 6.9 months
L858R and S768I 2 1 12.4+ months
S768I 1 1 16.5+ months
G719X 3 1 9.6 months
+ Censored observation


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

GILOTRIF™
(JEE-loh-trif)
(afatinib) Tablets

Read this Patient Information before you start taking GILOTRIF and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

What is GILOTRIF?

GILOTRIF is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC),

  • that has certain types of abnormal epidermal growth factor receptor (EGFR) genes, and
  • who have not had previous treatment for cancer that has spread to other parts of the body

It is not known if GILOTRIF is safe and effective in children.

What should I tell my doctor before taking GILOTRIF?

Before you take GILOTRIF, tell your doctor if you:

  • have kidney or liver problems
  • have lung or breathing problems other than lung cancer
  • have a history of severe dry eye or any other eye problems. Tell your doctor if you wear contact lenses.
  • have heart problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. GILOTRIF can harm your unborn baby. You should not become pregnant while taking GILOTRIF.
    • Women who are able to become pregnant should use effective birth control during treatment with GILOTRIF and for at least 2 weeks after your last dose of GILOTRIF. Talk to your doctor about birth control methods that may be right for you.
    • Tell your doctor right away if you become pregnant while taking GILOTRIF.
  • are breastfeeding or plan to breastfeed. It is not known if GILOTRIF passes into your breast milk. You and your doctor should decide if you will take GILOTRIF or breastfeed. You should not do both.

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. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

How should I take GILOTRIF?

  • Take GILOTRIF exactly as your doctor tells you to take it.
  • Your doctor will tell you how many GILOTRIF tablets to take and when to take them. Do not change your dose or stop GILOTRIF unless your doctor tells you to.
  • Take GILOTRIF on an empty stomach at least 1 hour before a meal or 2 hours after a meal.
  • If you miss a dose of GILOTRIF, take it as soon as you remember. If it is within 12 hours of your next dose, skip the dose and just take your next dose at your regular time.
  • Do not take 2 doses of GILOTRIF at the same time.
  • If you take too much GILOTRIF, call your doctor or go to the nearest hospital emergency room right away.

What should I 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.

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
  • creased 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 not use GILOTRIF for a condition for which it was not prescribed. Do not give GILOTRIF to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information summarizes the most important information about GILOTRIF. If you would like more information about GILOTRIF, talk with your doctor. You can ask your doctor or pharmacist for information about GILOTRIF that is written for health professionals.

For more information, go to www.gilotrif.com or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or (TTY) 1-800-459-9906, or scan the code below to go to www.gilotrif.com.

 

GILOTRIF™ (afatinib) Figure  Illustration

What are the ingredients in GILOTRIF?

Active ingredient: afatinib

Inactive ingredients: Tablet Core: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate. Tablet Coating: hypromellose, polyethylene glycol, titanium dioxide, talc, polysorbate 80, FD&C Blue No. 2 (40 mg and 30 mg tablets only).

This Patient Information has been approved by the U.S. Food and Drug Administration.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

No Information Available!

Patient Detailed How Take

No Information Available!

Patient Detailed Avoid Taking

No Information Available!

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