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Emend Detail Aid  Poster Work Sample Crystal Kaczkowski Watermarked
 

Emend Detail Aid Poster Work Sample Crystal Kaczkowski Watermarked

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Detail aid and poster written while working at Merck Frosst Canada.

Detail aid and poster written while working at Merck Frosst Canada.

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    Emend Detail Aid  Poster Work Sample Crystal Kaczkowski Watermarked Emend Detail Aid Poster Work Sample Crystal Kaczkowski Watermarked Document Transcript

    • DRAFT COPY Introducing EMEND™ (aprepitant) The First Neurokinin-1 (NK1) Receptor Antagonist For patients receiving highly emetogenic chemotherapy and women receiving anthracycline and cyclophosphamide-based chemotherapy e pl m sa g in rit iw sk w ko z ac K al st ry C From the Start. Combination therapy with EMEND ™ helps prevent CINV—from Cycle 1, Day 1. DRug INTERAcTIoNS INDIcATIoNS or back-up methods of contraception should be used during treatment with EMEND™ and for 1 month following the last Serious Drug Interactions EMEND™ (aprepitant), in combination with a 5-HT3 antagonist dose of EMEND™. class of antiemetics and dexamethasone, is indicated for the: • EMEND™ should be used with caution in patients receiving ADVERSE REAcTIoNS concomitant medicinal products that are primarily metabolized 1. prevention of acute and delayed nausea and vomiting due to through CYP3A4 and CYP2C9, including chemotherapy agents. highly emetogenic cancer chemotherapy Clinical Trial Adverse Experiences Inhibition of CYP3A4 by aprepitant could result The most common adverse experiences, regardless of causality, 2. prevention of nausea and vomiting in women due to treatment in elevated plasma concentrations of these concomitant occurring in patients receiving highly emetogenic chemotherapy with moderately emetogenic cancer chemotherapy consisting of medicinal products. Induction of CYP2C9 by aprepitant could who were treated with aprepitant in clinical studies (cycle 1) cyclophosphamide and anthracycline result in decreased plasma were: asthenia/ fatigue (17.8%), nausea (12.7%), hiccups concentrations of these concomitant medicinal products. coNTRAINDIcATIoNS (10.8%), diarrhea (10.3%), constipation (10.3%), anorexia (10.1%). The most common adverse experiences, regardless of • The effect of EMEND™ on the pharmacokinetics of orally EMEND™ is contraindicated in patients who are hypersensitive to causality, occurring in patients receiving moderately emetogenic any component of the formulation. EMEND™ should not be used administered CYP3A4 substrates is greater than the effect chemotherapy who were treated with aprepitant in clinical studies of EMEND™ on the pharmacokinetics of intravenously concurrently with pimozide, terfenadine, astemizole, or cisapride. (cycle 1) were: alopecia (24.0%), fatigue (21.9%), headache administered CYP3A4 substrates. Inhibition of cytochrome P450 isoenzyme 3A4 (CYP3A4) by (16.4%), constipation (12.3%), neutropenia (8.9%). aprepitant could result in elevated plasma concentrations of these • The efficacy of hormonal contraceptives during and for 28 days drugs, potentially causing serious or life-threatening reactions. after administration of EMEND™ may be reduced. Alternative Reference: 1. Data on file, Merck Frosst Canada Ltd.: EMEND™ — Product Monograph, 2007. CINV = chemotherapy-induced nausea and vomiting EMEND™ is a Trademark of Merck & Co., Inc. Used under license.
    • DRAFT COPY 5-HT3 receptor antagonists may not be enough How Many of Your Patients Treated With a 5-HT3 Receptor Antagonist Still Experience chemotherapy-induced Nausea and Vomiting? CINV Remains a Critical Problem Observed Incidence of Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy (Cycle 1) 33% Nausea Acute Day 1 12% Vomiting 60% Nausea Delayed Day 2–5 50% Vomiting 0 10 20 30 40 50 60 70 % of patients with nausea or vomiting (N=67) • Up to 60% of patients treated with antiemetics continued to experience nausea and vomiting Observed Incidence of Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy (Cycle 1) e pl m sa g in 37% rit Nausea iw sk Acute w ko Day 1 z ac K 13% al Vomiting st ry C 52% Nausea Delayed Day 2–5 28% Vomiting 0 10 20 30 40 50 60 70 % of patients with nausea or vomiting (N=231) • Up to 52% of patients treated with antiemetics continued to experience nausea and vomiting Study Design and Results In this multinational, prospective, observational study, physicians/nurses (N=13/11) estimated the frequency of acute (Day 1) and delayed (Days 2-5) nausea and vomiting after first administration of highly or moderately emetogenic chemotherapy and antiemetic treatment. Chemotherapy-naive patients older than 18 years (N=298) received either single-agent or combination therapy: highly emetogenic chemotherapy, such as cisplatin >50 mg/m2 or cyclophosphamide >1500 mg/m2, or moderately emetogenic chemotherapy, such as doxorubicin >20 mg/m2 or cyclophosphamide <1500 mg/m2. Patients recorded emetic episodes, nausea assessments, and antiemetic medications taken daily in a 6-day diary, which was then evaluated and matched against the medical predictions. Most patients (97%) received 5-HT3 antagonist; 78% also received a corticosteroid (mean 2.3 antiemetic agents per patient). The most common duration of 5-HT3 antagonist and corticosteroid therapy was 3 days. Reference: Grunberg SM, Deuson RR, Mavros P et al. Incidence of chemotherapy-induced nausea and vomiting after modern antiemetics. Cancer 2004;100:2261–2268. CINV = chemotherapy-induced nausea and vomiting EMEND™ is a Trademark of Merck & Co., Inc. Used under license.
    • DRAFT COPY Chemotherapy-induced nausea and vomiting 2 Key Pathways can Trigger Emetic Response1 central Pathway Activated by substance P Mediated by NK1 receptors in the emetic center of the brain Blocked by NK1 receptor antagonist — EMEND™ Peripheral Pathway Activated by serotonin e Mediated by 5-HT3 receptors pl m sa g in in the gut rit iw sk w ko z ac K al Blocked by 5-HT3 receptor st ry C antagonists — Zofran (ondansetron) ® — Kytril (granisetron) ® — Anzemet ® (dolasetron) Adapted from Grunberg et al2 and Hesketh et al.1 EMEND + 5-HT3 Receptor Antagonist ™ Target Both Pathways Reference: 1. Hesketh PJ, Van Belle S, Aapro M, et al. Differential involvement of neurotransmitters through the time course of cisplatin-induced emesis as revealed by therapy with specific receptor antagonists. Eur J Cancer. 2003;39:1074–1080. 2. Grunberg SM, Hesketh PJ. Control of chemotherapy-induced emesis. N Engl J Med. 1993;329:1790–1796. EMEND™ is a Trademark of Merck & Co., Inc. Used under license.
    • DRAFT COPY In many patients receiving cisplatin-based chemotherapy, EMEND™ From the Start Helped Significantly More Patients to Remain Free of Vomiting over 5 Days Time to First Emesis Day 1 Control regimen Zofran® (32 mg IV), dexamethasone 20 mg PO, and placebo Day 1 EMENDTM regimen EMENDTM 125 mg PO, Zofran® 32 mg IV, and dexamethasone 12 mg PO Day 1 100 90 Percentage of Patients With No Vomiting EMENDTM regimen (n=260) 80 70 p<0.001 60 e pl Control regimen (n=260) m sa g in rit 50 iw sk w ko Days 2–4 z ac Control regimen Dexamethasone 16 mg PO and K al st placebo Days 2–4 ry 40 C Acute Delayed EMENDTM regimen EMENDTM 80 mg PO Days 2 and 3; dexamethasone 8 mg PO Days 2–4 0–24 hours Day 1 Day 2 Day 3 Day 4 Day 5 Dose 1 Dose 2 Dose 3 Days Since Initiation of Chemotherapy Study Design and Results In a multicenter, randomized, double-blind, placebo-controlled clinical study, combination therapy with EMENDTM was compared with a 5-HT3 receptor antagonist regimen in 530 cisplatin-naive patients receiving a chemotherapy regimen that included cisplatin ≥70 mg/m2. Some patients also received additional chemotherapeutic agents. The primary clinical end point was “complete response” (overall, Days 1–5), defined as no vomiting and no rescue medication for nausea or vomiting. The percentage of patients achieving a complete response over 5 days were significantly improved with the EMEND™ regimen than the control regimen, respectively: overall phase 72.7% vs 52.3%; acute phase 89.2% vs 78.1%; delayed phase 75.4% vs 55.8%, p<0.001). The most common drug-related adverse experiences reported in patients treated with the aprepitant regimen and greater than control therapy were: hiccups, asthenia/fatigue and nausea occuring after day 5. Therapy Regimen *Combination therapy with EMENDTM=3 days EMENDTM (125 mg PO on Day 1 and 80 mg PO once daily on Days 2 and 3); plus 1 day ZOFRAN® (ondansetron) (32 mg IV on Day 1); plus 4 days dexamethasone (12 mg PO on Day 1 and 8 mg PO once daily on Days 2–4). **Control regimen=ZOFRAN® was administered at maximum dose of 32 mg IV on Day 1 and not followed by oral 5-HT3 therapy on Days 2-5. Reference: Hesketh PJ, Grunberg SM, Gralla RJ, et al; the Aprepitant Protocol 052 Study Group. The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin- the Aprepitant Protocol 052 Study Group. J Clin Oncol. 2003;21(22):4112-9. EMEND™ is a Trademark of Merck & Co., Inc. Used under license.