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Patient Support Kit

Support for patients right from the start

Along with their first month of GILOTRIF, patients will receive:

Solutions Plus®, Patient Support Products
  • My Guide: Information about GILOTRIF
  • Nurse Support Opt-in Card: To enroll in the Nurse Support Program
  • Also includes supportive care products

Nurse & Pharmacy Support

WE PROVIDE NURSE SUPPORT FOR REAL-TIME PATIENT EDUCATION AND ASSISTANCE TO COMPLEMENT CARE

Solutions Plus®, Nurse Support

Oncology-trained nurses will call participating GILOTRIF patients* during critical time points of NSCLC treatment to assist with adherence

  • Patients will receive 5 outbound calls
  • Treatment-related adverse reactions education and tips for adherence are discussed
  • Language interpreter service available in 170 languages
Solutions Plus® Logo

Our oncology-trained nurses are also available to answer questions as needed.
Contact Solutions Plus® at 1-877-814-3915 8 am to 8 pm ET.

Healthcare professional portrayal.

SOLUTIONS PLUS® KEEPS YOUR PRACTICE INFORMED THROUGHOUT EACH PATIENTS PROGRAM PARTICIPATION

Solutions Plus®, Pharmacy Support
  • Dedicated GILOTRIF professionals are available for patients and physicians who have questions related to GILOTRIF
  • When a nurse speaks to a patient about treatment with GILOTRIF, your office receives a fax update
  • Physicians and healthcare practice professionals may connect directly with GILOTRIF-trained pharmacists
Accredo® Specialty Pharmacy Logo

Call 1-844-569-2837 from 8:30 am to 7 pm ET

Fax 1-888-454-8488

PATIENTS can reach Patient Care Advocates and GILOTRIF-trained nurses by calling the number below, or by
reaching out directly to Accredo®

Accredo® Specialty Pharmacy Logo

Call 1-844-569-2836 from 8 am to 8 pm ET

Healthcare professional portrayal.

* Patients are automatically enrolled in the Nurse Support Program when they enroll in Solutions Plus®.

  Patients not serviced through Accredo® are able to opt in to the Nurse Support Program if interested.

GILOTRIF Dose Exchange

ADJUSTMENTS

The GILOTRIF Dose Exchange™ program is designed to help facilitate dose adjustments and is offered to patients:

  • Serviced through our dedicated specialty pharmacy partner, Accredo®, or the GILOTRIF Dispense Network
  • For patients exchanging ≥9 tablets

The GILOTRIF Dose Exchange™ program offers the following:

  • Facilitation of the transition to new dose modifications
    • Eligible patients are sent their new dose promptly once their oncologist submits the new prescription
    • The program covers up to 2 dose modifications
    • Patients can easily return the unused drug using the prepaid envelope that is sent with the replacement dose
  • Elimination of additional co-pay in a given month
    • Insurers will not be billed, and patients will not be charged a co-pay for the replacement drugs

How the GILOTRIF Dose Exchange™ works

Patient serviced through Accredo® or the GILOTRIF Dispense Network is prescribed a new dosing strength of GILOTRIF tablets and ≥9 tablets remain in old dose

Oncologist provides new prescription to Solutions Plus® on the designated enrollment form

Solutions Plus® confirms GILOTRIF Dose Exchange™ eligibility

Accredo or a central pharmacy at Solutions Plus® sends new dose and prepaid return envelope to patient — health plan is not billed and patient is not charged a second co-pay for the new prescription

Patient returns tablets remaining from old dose using prepaid envelope provided by Solutions Plus®

GILOTRIF Logo

IMPORTANT SAFETY INFORMATION

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 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. Treatment should be discontinued in patients who develop severe hepatic impairment while taking GILOTRIF.
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, treatment with GILOTRIF should be interrupted or discontinued. 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 non-small cell lung cancer (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%).
Postmarketing Experience

Pancreatitis has been reported during post-marketing use of GILOTRIF. The frequency and causal relationship of pancreatitis to GILOTRIF has not been established.

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 nursing infants from GILOTRIF, lactating women should not 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.

INDICATIONS AND USAGE

  • GILOTRIF (afatinib) 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.

GF PROF ISI July 2016

References: 1. Gilotrif® (afatinib) tablets Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2. 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. 3. Sequist LV, Yang JC, 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. 4. Data on file. Boehringer Ingelheim. CTR. 5. Lee CK, Wu YL, Ding PN, et al. Impact of specific epidermal growth factor receptor (EGFR) mutations and clinical characteristics on outcomes after treatment with EGFR tyrosine kinase inhibitors versus chemotherapy in EGFR-mutant lung cancer: a meta-analysis. J Clin Oncol. 2015;33(17):1958-1965. 6. Soria J-C, 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;16:897-907. 7. Yang JC, 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 [published online September 6, 2016]. Ann Oncol. 2016. doi: 10.1093/annonc/mdw322. 8. Peters S, Zimmermann S, Adjei AA. Oral epidermal growth factor receptor tyrosine kinase inhibitors for the treatment of non-small cell lung cancer: comparative pharmacokinetics and drug-drug interactions. Cancer Treat Rev. 2014;40(8):917-926. 9. Sharma SV, Bell DW, Settleman J, Haber DA. Epidermal growth factor receptor mutations in lung cancer. Nat Rev Cancer. 2007;7(3):169-181. 10. Data on file. Boehringer Ingelheim. Other mutations PFS table. 11. Wu YL, Zhou C, Hu CP, et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014;15(2):213-222.

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