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Starting Your Patients: A Step-by-Step Guide

NON-DISPENSING ACCOUNTS

GILOTRIF® (afatinib) Patient Services—Brought to you by Accredo®

Prescribing GILOTRIF for Non-dispensing Accounts

Get a GILOTRIF prescription form*

Or, contact Accredo® at 1-844-569-2836, or contact your sales consultant

Download Enrollment Form Opens in new tab
step 1

Complete and fax the form to Accredo® at 1-888-454-8488

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step 2

Once GILOTRIF prescription enrollment is complete, your patients will receive a welcome call, confirming enrollment and insurance benefits.

The first delivery often arrives within 4 days. Upon receiving the prescription and enrollment form, Accredo® will fill the prescription and call your patients to schedule their GILOTRIF delivery.

step 3

*Some states may require a separate prescription.

GILOTRIF PATIENT SERVICES

GILOTRIF® (afatinib) Patient Services include:

Co-pay Assistance Program

  • If you have commercial insurance, you will have the opportunity to enroll into the GILOTRIF co-pay program

  • If you are covered by any form of government-funded healthcare programs (Medicare, Medicaid, Tricare, VA, etc), you are not eligible for the program. Also, if you are paying cash, you will not be eligible

  • You may receive GILOTRIF for as little as $0 per month. There is no card to carry or worry about

  • Create an account for your pharmacy facility here

  • If you already have an account, login to enroll eligible patients for a co-pay card here

  • Please call 1-877-546-5349 for additional information

  • Please see full terms and conditions here

Bridge Program

  • Eligible patients experiencing more than a 5-day payer approval delay can receive a 15-day supply of GILOTRIF at no cost to the patient for the FDA-approved indications

GILOTRIF Dose Exchange™

  • Facilitates transition to a new dose at no cost to your patients*

  • Eliminates additional GILOTRIF co-pay in a given month for eligible patients

  • Eligible patients receive a new dose of GILOTRIF

    Convenient packaging to return unused tablets

    Call 1-844-569-2836 to learn more

*GILOTRIF Dose Exchange™ covers up to 2 dose modifications for patients serviced through Accredo® who have 9 or more tablets to exchange.

Your Patient's Roadmap once enrolled:

Patients will receive a welcome call, program overview, and GILOTRIF delivery schedule starting on Day 1. Nurses will continue to reach out to patients to provide support as needed.

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DAY 1
Initial Patient Counseling With Patient Care Advocate/Nurse
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DAY 5
Pharmacist Outreach
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DAY 10
Pharmacist Follow-up With Patient
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DAY 21
Nurse Follow-up With Patient
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DAY 45
Nurse Follow-up With Patient
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ONGOING SUPPORT
Nurse Follow-up As Needed

Patients can reach an Accredo® representative Monday–Friday from 8am to 8pm EST by calling 1-844-569-2836.

Communication with patients may vary based on individual patient need and availability.

Non-dispensing Accounts Guide

For Your Patients: GILOTRIF My Guide

  • This is a guide about taking GILOTRIF. My Guide walks through how GILOTRIF works and what patients can expect while taking GILOTRIF

DISPENSING ACCOUNTS

Are you from a Dispensing Account?

GILOTRIF Patient Support Kits

  • Approved Dispensing Pharmacies can place an order for a GILOTRIF Patient Support Kit for patients and providers by e-mailing BI-order2u@hibbertgroup.com (maximum 3 kits per month)

BI CARES PROGRAM

BOEHRINGER INGELHEIM CARES FOUNDATION PATIENT ASSISTANCE PROGRAM

For: Eligible patients who are uninsured or underinsured

The BI Cares Patient Assistance Program is a charitable program provided by the Boehringer Ingelheim Cares Foundation, an independent nonprofit organization. The program helps those in need obtain Boehringer Ingelheim medications including GILOTRIF free of charge. Patients prescribed Gilotrif who apply must meet program eligibility requirements including income and prescription coverage criteria in order to be enrolled. The program requires a completed application form signed by patient and healthcare provider and supporting documentation.

Visit the BI Cares Website Opens in new tab
Boehringer Ingelheim Cares Foundation logo
INDICATIONS AND USAGE

GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.

Limitations of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have resistant EGFR mutations.

GILOTRIF is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.

IMPORTANT SAFETY INFORMATION FOR GILOTRIF® (afatinib) TABLETS WARNINGS AND PRECAUTIONS
Diarrhea
  • GILOTRIF can cause diarrhea which may be severe and can result in dehydration with or without renal impairment. In clinical studies, some of these cases were fatal.
  • For patients who develop Grade 2 diarrhea lasting more than 48 hours or Grade 3 or greater diarrhea, withhold GILOTRIF until diarrhea resolves to Grade 1 or less, and then resume at a reduced dose.
  • Provide patients with an anti-diarrheal agent (e.g., loperamide) for self-administration at the onset of diarrhea and instruct patients to continue anti-diarrheal until loose stools cease for 12 hours.
Bullous and Exfoliative Skin Disorders
  • GILOTRIF can result in cutaneous reactions consisting of rash, erythema, and acneiform rash. In addition, palmar-plantar erythrodysesthesia syndrome was observed in clinical trials in patients taking GILOTRIF.
  • Discontinue GILOTRIF in patients who develop life-threatening bullous, blistering, or exfoliating skin lesions. For patients who develop Grade 2 cutaneous adverse reactions lasting more than 7 days, intolerable Grade 2, or Grade 3 cutaneous reactions, withhold GILOTRIF. When the adverse reaction resolves to Grade 1 or less, resume GILOTRIF with appropriate dose reduction.
  • Postmarketing cases of toxic epidermal necrolysis (TEN) and Stevens Johnson syndrome (SJS) have been reported in patients receiving GILOTRIF. Discontinue GILOTRIF if TEN or SJS is suspected.
Interstitial Lung Disease
  • Interstitial Lung Disease (ILD) or ILD-like adverse reactions (e.g., lung infiltration, pneumonitis, acute respiratory distress syndrome, or alveolitis allergic) occurred in patients receiving GILOTRIF in clinical trials. In some cases, ILD was fatal. The incidence of ILD appeared to be higher in Asian patients as compared to white patients.
  • Withhold GILOTRIF during evaluation of patients with suspected ILD, and discontinue GILOTRIF in patients with confirmed ILD.
Hepatic Toxicity
  • Hepatic toxicity as evidenced by liver function tests abnormalities has been observed in patients taking GILOTRIF. In 4257 patients who received GILOTRIF across clinical trials, 9.7% had liver test abnormalities, of which 0.2% were fatal.
  • Obtain periodic liver testing in patients during treatment with GILOTRIF. Withhold GILOTRIF in patients who develop worsening of liver function. Discontinue treatment in patients who develop severe hepatic impairment while taking GILOTRIF.
Gastrointestinal Perforation
  • Gastrointestinal (GI) perforation, including fatal cases, has occurred with GILOTRIF. GI perforation has been reported in 0.2% of patients treated with GILOTRIF among 3213 patients across 17 randomized controlled clinical trials.
  • Patients receiving concomitant corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anti-angiogenic agents, or patients with increasing age or who have an underlying history of GI ulceration, underlying diverticular disease, or bowel metastases may be at an increased risk of perforation.
  • Permanently discontinue GILOTRIF in patients who develop GI perforation.
Keratitis
  • Keratitis has been reported in patients taking GILOTRIF.
  • Withhold GILOTRIF during evaluation of patients with suspected keratitis. If diagnosis of ulcerative keratitis is confirmed, interrupt or discontinue GILOTRIF. If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered. GILOTRIF should be used with caution in patients with a history of keratitis, ulcerative keratitis, or severe dry eye. Contact lens use is also a risk factor for keratitis and ulceration.
Embryo-Fetal Toxicity
  • GILOTRIF can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
  • Advise females of reproductive potential to use effective contraception during treatment, and for at least 2 weeks after the last dose of GILOTRIF. Advise female patients to contact their healthcare provider with a known or suspected pregnancy.
ADVERSE REACTIONS
Adverse Reactions observed in clinical trials were as follows:
First-line treatment of EGFR mutation-positive, metastatic NSCLC
  • In GILOTRIF-treated patients (n=229) the most common adverse reactions (≥20% all grades & vs pemetrexed/cisplatin-treated patients (n=111)) were diarrhea (96% vs 23%), rash/acneiform dermatitis (90% vs 11%), stomatitis (71% vs 15%), paronychia (58% vs 0%), dry skin (31% vs 2%) and pruritus (21% vs 1%). Other clinically important adverse reactions observed in patients treated with GILOTRIF include: decreased appetite (29%), nausea (25%), and vomiting (23%).
  • 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 included pulmonary toxicity/ILD-like adverse reactions (1.3%), sepsis (0.43%), and pneumonia (0.43%).
  • More GILOTRIF-treated patients (2.2%) experienced ventricular dysfunction (defined as diastolic dysfunction, left ventricular dysfunction, or ventricular dilation; all < Grade 3) compared to chemotherapy-treated patients (0.9%).
Previously Treated, Metastatic Squamous NSCLC
  • In GILOTRIF-treated patients (n=392) the most common adverse reactions (≥20% all grades & vs erlotinib-treated patients (n=395)) were diarrhea (75% vs 41%), rash/acneiform dermatitis (70% vs 70%), stomatitis (30% vs 11%), decreased appetite (25% vs 26%), and nausea (21% vs 16%).
  • Serious adverse reactions were reported in 44% of patients treated with GILOTRIF. The most frequent serious adverse reactions reported in patients treated with GILOTRIF were pneumonia (6.6%), diarrhea (4.6%), and dehydration and dyspnea (3.1% each). Fatal adverse reactions in GILOTRIF-treated patients included ILD (0.5%), pneumonia (0.3%), respiratory failure (0.3%), acute renal failure (0.3%), and general physical health deterioration (0.3%).
DRUG INTERACTIONS
Effect of P-glycoprotein (P-gp) Inhibitors and Inducers
  • Concomitant use 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.
  • Concomitant use 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.
USE IN SPECIFIC POPULATIONS
Lactation
  • Because of the potential for serious adverse reactions in breastfed infants from GILOTRIF, advise women not to breastfeed during treatment with GILOTRIF and for 2 weeks after the final dose.
Females and Males of Reproductive Potential
  • GILOTRIF may reduce fertility in females and males of reproductive potential. It is not known if the effects on fertility are reversible.
Renal Impairment
  • Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m2) have a higher exposure to afatinib than patients with normal renal function. Administer GILOTRIF at a starting dose of 30 mg once daily in patients with severe renal impairment. GILOTRIF has not been studied in patients with eGFR <15 mL/min/1.73 m2 or who are on dialysis.
Hepatic Impairment
  • GILOTRIF has not been studied in patients with severe (Child Pugh C) hepatic impairment. Closely monitor patients with severe hepatic impairment and adjust GILOTRIF dose if not tolerated.

GF PROF ISI 10.21.19

Please see full Prescribing Information, including Patient Information.

  1. GlLOTRIF [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.
  2. Hochmair MJ, Morabito A, Hao D, et al. Sequential treatment with afatinib and osimertinib in patients with EGFR non-small-cell lung cancer: an observational study. Future Oncol. 2018;14(27):2861-2874.
  3. Hochmair MJ, Morabito A, Hao D, et al. Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: updated analysis of the observational GioTag study. Future Oncol. 2019;15(25):2905-2914.
  4. Halmos B, Tan E-H, Soo RA, et al. Impact of afatinib dose modification on safety and effectiveness in patients with EGFR mutation-positive advanced NSCLC: results from a global real-world study (ReaIGiDo). Lung Cancer: 2019;127:103-111.
  5. Yang JCH, Sequist LV, Zhou C, et al. Effect of dose adjustment on the safety and efficacy of afatinib for EGFR mutation-positive lung adenocarcinoma: post hoc analyses of the randomized LUX-Lung 3 and 6 trials. Ann Oncol. 2016;27(11):2103-2110.
  6. Data on file. Boehringer Ingelheim.
  7. Soria JC, Felip E, Cobo M, et al. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2015;16(8):897-907.
  8. Yang JC-H, Wu Y-L, Schuler M, et al. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015;16(2):141-151.
  9. Sequist LV, Yang JC-H, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013;31(27):3327-3334.
  10. Pignataro D, Tagliamento M, Reale ML, et al. Correlation between clinic pathological data and T790M detection in EGFR mutated NSCLC patients progressing on 1st/2nd generation TKIs. Poster presented at: International Association for the Study of Lung Cancer 2019 World Conference on Lung Cancer; September 7-10, 2019; Barcelona, Spain.
  11. Jenkins S, Yang JC-H, Janne PA, et al. EGFR mutation analysis for prospective patient selection in two phase II registration studies of osimertinib. J Thor Oncol. 2017;12(8):1247-1256.
  12. Lau SC, Chooback N, Ho C, Melosky B. Outcome differences between first- and second-generation EGFR inhibitors in advanced EGFR mutated NSCLC in a large population-based cohort. Clin Lung Cancer. 2019;20(5):e576-e583.
  13. Ke E-E, Zhou Q, Zhang Q-Y, et al. A higher proportion of the EGFR T790M mutation may contribute to the better survival of patients with exon 19 deletions compared with those with L858R. J Thor Oncol. 2017;12(9):1368-1375.
  14. Tagrisso [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  15. Schuler M, Wu YL, Hirsh V, et al. First-line afatinib versus chemotherapy in patients with non-small cell lung cancer and common epidermal growth factor receptor gene mutations and brain metastases. J Thorac Oncol. 2016;11(3):380-390.
  16. Kato T, Yoshioka H, Okamoto I, et al. Afatinib versus cisplatin plus pemetrexed in Japanese patients with advanced non-small cell lung cancer harboring activating EGFR mutations: subgroup analysis of LUX-Lung 3. Cancer Sci. 2015;106(9):1202-1211.
  17. Shen YC, Tseng GC, Tu CY, et al. Comparing the effects of afatinib with gefitinib or erlotinib in patients with advanced-stage lung adenocarcinoma harboring non-classical epidermal growth factor receptor mutations. Lung Cancer. 2017;110:56-62.
  18. Yang JC-H, Sequist LV, Geater SL, et al. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015;16(7):830-838.
  19. Kuiper JL, Hashemi SM, Thunnissen E, et al. Non-classic EGFR mutations in a cohort of Dutch EGFR-mutated NSCLC patients and outcomes following EGFR-TKI treatment. Br J Cancer. 2016;115(12):1504-1512.
  20. Beau-Feller M, Prim N, Ruppert AM, et al. Rare EGFR exon 18 and exon 20 mutations in non-small-cell lung cancer on 10 117 patients: a multicentre observational study by the French ERMETIC-IFCT network. Ann Oncol. 2014;25(1):126-131.
  21. Krawczyk P, Reszka K, Ramlau R, et al. Prevalence of rare EGFR gene mutations in nonsmaII-cell lung cancer: a multicenter study on 3856 Polish Caucasian patients. Ann Oncol. 2016;27(2)358-359.
  22. Heigener DF, Schumann C, Sebastian M, et al. Afatinib in non-small cell lung cancer harboring uncommon EGFR mutations pretreated with reversible EGFR inhibitors. Oncologist. 2015;20(10):1167-1174.
  23. Masood A, Kancha RK, Subramanian J. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors in non-small cell lung cancer harboring uncommon EGFR mutations: focus on afatinib. Semin Oncol. 2019;46(3):271-283.
  24. Genomic data commons data portal. National Cancer Institute GDC Data Portal website. https://portal.gdc.cancer.gov/ Accessed February 25, 2020.
  25. Yang S, Mao S, Li X, et al. Uncommon EGFR mutations associate with lower incidence of T790M mutation after EGFR-TKI treatment in patients with advanced NSCLC. Lung Cancer. 2020;139:133-139.
  26. Tarceva [prescribing information]. Northbrook, IL: OSI Pharmaceuticals, LLC, an affiliate of Astellas Pharma US, Inc.
  27. Iressa [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP.
  28. Paik PK, Pillai RN, Lathan CS, Velasco SA, Papadimitrakopoulou V. New treatment options in advanced squamous cell lung cancer. Am Soc Clin Oncol Educ Book. 2019;39:e198-e206
  29. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed June 23, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  30. Goss GD, Felip E, Cobo M, et al. Association of ERBB mutations with clinical outcomes of afatinib- or erlotinib-treated patients with lung squamous cell carcinoma: secondary analysis of the LUX-Lung 8 randomized clinical trial. JAMA Oncol. 2018;4(9):1189-1197.
  31. Engelman JA, Cantley LC. The role of the ErbB family members in non-small cell lung cancers sensitive to epidermal growth factor receptor kinase inhibitors. Clin Cancer Res. 2006;12(14 Pt 2) :4372s-4376s.
  32. Pillai RN, Behera M, Berry LD, et al. HER2 mutations in lung adenocarcinomas: a report from the Lung Cancer Mutation Consortium. Cancer. 2017;123(21):4099-4105.
  33. Solca F, Dahl G, Zoephel A, et al. Target binding properties and cellular activity of afatinib (BIBW 2992), an irreversible ErbB family blocker. J Pharmacol Exp Ther. 2012;343(2):342-350.
  34. Hirsh V. Next-generation covalent irreversible kinase inhibitors in NSCLC: focus on afatinib. BioDrugs. 2015;29(3):167-183.
  35. Hochmair MJ, Morabito A, Hao D, et al. Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: final analysis of the GioTag study. Future Oncol. 2020;16(34):2799-2808.
  36. Kim ES, Kish JK, Cseh A, Moehring B, Tang W, Terlizzi E, Subramanian J. Second-line afatinib or chemotherapy following immuno-chemotherapy for the treatment of metastatic, squamous cell carcinoma of the lung: real-world effectiveness and safety from a multi-site retrospective chart review in the USA. Clinical Lung Cancer (2021), doi: https://doi.org/10.1016/j.cllc.2021.02.006.
  37. Passaro A, Mok A, Peters S, Popat S, Ahn M-J, de Marinis F. Recent Advances on the Role of EGFR Tyrosine Kinase Inhibitors in the Management of NSCLC With Uncommon, Non Exon 20 Insertions, EGFR Mutations. J Thorac Oncol. 2021 May;16(5):764-773.
  38. Robichaux JP, Le X, Vijayan RSK, et al. Structure-based classification predicts drug response in EGFR-mutant NSCLC. Nature. 2021 Sep;597(7878):732-737.
  39. Girard N. Optimizing outcomes in EGFR mutation-positive NSCLC: which tyrosine kinase inhibitor and when? Future Oncol. 2018 May;14(11):1117-1132. doi: 10.2217/fon-2017-0636.

NCCN=National Comprehensive Cancer Network® (NCCN®).