PRODUCT DISTRIBUTION GUIDE SELECT IMPORTANT SAFETY INFORMATION INDICATION. Infusion-Related Reactions

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Julie Gibbs
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1 PRODUCT DISTRIBUTION GUIDE INDICATION LARTRUVO is indicated, in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery. This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. The following information is presented for informational purposes only and is not intended to provide reimbursement or legal advice. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. Individual coding decisions should be based upon diagnosis and treatment of individual patients. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. Providers are encouraged to contact third-party payers for specific information on their coverage, coding, and payment policies. Please consult with your legal counsel or reimbursement specialist for any reimbursement or billing questions. For more information, please call Lilly PatientOne at SELECT IMPORTANT SAFETY INFORMATION Infusion-Related Reactions Infusion-related reactions (IRR) occurred in 70 (14%) of 485 patients who received at least one dose of LARTRUVO across clinical trials. For 68 of these 70 patients (97%), the first occurrence of IRR was in the first or second cycle. Grade 3 IRR occurred in 11 (2.3%) of 485 patients, with one (0.2%) fatality. Symptoms of IRR included flushing, shortness of breath, bronchospasm, or fever/chills, and in severe cases symptoms manifested as severe hypotension, anaphylactic shock, or cardiac arrest. Infusion-related reactions required permanent discontinuation in 2.3% of patients and interruption of infusion in 10% of patients. All 59 patients with Grade 1 or 2 IRR resumed LARTRUVO; 12 (20%) of these patients had a Grade 1 or 2 IRR with rechallenge. The incidence of IRR in the overall safety database (N = 485) was similar (18% versus 12%) between those who did (56%) and those who did not (44%) receive premedication. Monitor patients during and following LARTRUVO infusion for signs and symptoms of IRR in a setting with available resuscitation equipment. Immediately and permanently discontinue LARTRUVO for Grade 3 or 4 IRR.

2 LARTRUVO PRODUCT DISTRIBUTION Lilly has contracted with a network of specialty distributors and 1 specialty pharmacy to provide customers access to LARTRUVO.

LARTRUVO is supplied as 190 mg/19 ml and 500 mg/50 ml (10 mg/ml), single-dose vials.

2 2 LARTRUVO PRODUCT DISTRIBUTION Lilly has contracted with a network of specialty distributors and 1 specialty pharmacy to provide customers access to LARTRUVO. If purchasing LARTRUVO directly, you may use one of the 5 specialty distributors below. You also have the option of ordering from our authorized specialty pharmacy partner. LARTRUVO is supplied as 190 mg/19 ml and 500 mg/50 ml (10 mg/ml), single-dose vials. SPECIALTY DISTRIBUTOR NETWORK AmerisourceBergen Specialty Group Order Entry Code: Oncology Supply P: (800) F: (800) oncologysupply.com ASD Healthcare P: (800) F: (800) asdhealthcare.com Cardinal Health Specialty Pharmaceutical Distribution Order Entry Code: Oncology Clinics P: (877) F: (888) cardinalhealth.com/specialtyonline McKesson Specialty Health P: (800) F: (800) mscs.mckesson.com AUTHORIZED SPECIALTY PHARMACY Accredo P: (877) F: (800) accredo.com CuraScript Specialty Distribution Order Entry Code: P: (877) F: (800) curascriptsd.com McKesson Specialty Care Distribution Corporation Order Entry Code: Smith Medical Partners Order Entry Code: P: (800) F: (630) smpspecialty.com Hospitals P: (866) F: (888) cardinalhealth.com/specialtyonline McKesson Plasma and Biologics P: (877) F: (888) connect.mckesson.com NATIONAL DRUG CODE (NDC) Vial Size NDC 500 mg/50 ml * 190 mg/19 ml * Eli Lilly and Company is not responsible for the content on any of these websites. *FDA standard NDC has been zero-filled to ensure creation of an 11-digit code that meets HIPAA standards. The zero-fill location is indicated in bold. HIPAA=Health Insurance Portability and Accountability Act. For more information on purchasing, dispensing, or returning Lilly products, visit For inquiries about this matter, contact Lilly at LillyRx ( ).

3 LARTRUVO PRODUCT SPECIFICATIONS PACKAGING INFORMATION LARTRUVO Vial 500 mg/50 ml 190 mg/19 ml NDC 00002-8926-01 00002-7190-01 UPC 300028926017 3000227190013 Lilly Item Code VL8926001AM VL7190001AM

3 3 LARTRUVO PRODUCT SPECIFICATIONS PACKAGING INFORMATION LARTRUVO Vial 500 mg/50 ml 190 mg/19 ml NDC UPC Lilly Item Code VL AM VL AM WAC* $ $ Dosage Form Parenteral Parenteral Minimum Quantity Order 1 vial 1 vial Carton Quantity 1 vial 1 vial Carton Dimensions 2.40 x 1.89 x 3.35 in 1.8 x 1.7 x 2.7 in Carton Weight 3.8 oz 56.1 grams STORAGE AND HANDLING REQUIREMENTS DO NOT FREEZE OR SHAKE Store vials in a refrigerator at 2 C to 8 C (36 F to 46 F) until time of use Keep the vial in the outer carton in order to protect from light Store the diluted solution for up to 24 hours under refrigeration at 2 C to 8 C (36 F to 46 F) and for up to an additional 4 hours at room temperature (below 25 C [77 F]). Storage times include the duration of infusion Case Quantity 30 cartons/case 100 cartons/case Case Dimensions x 10.4 x 4.4 in 18.9 x 9.3 x 6.3 in Case Weight 7.7 lbs lbs Pallet Quantity 120 cases/pallet 60 cases/pallet Pallet Dimensions 48 x 42 x 49 in 48 x 42 x 44 in Pallet Weight ~992 lbs ~820 lbs * WAC is the listed price to the distribution channel not including prompt pay, service or administrative fees, stocking or distribution allowances, or any other discounts, rebates, or chargebacks provided by Lilly to any entity. Uses standard corrugated boxes (RSCs). UPC=Universal Product Code; WAC=wholesale acquisition cost. Vials are not actual size. See full Prescribing Information for further details on storage and physical stability. SELECT IMPORTANT SAFETY INFORMATION Embryo-Fetal Toxicity Based on animal data and its mechanism of action, LARTRUVO can cause fetal harm when administered to a pregnant woman. Animal knockout models link disruption of platelet-derived growth factor receptor alpha (PDGFR-α) signaling to adverse effects on embryo-fetal development. Administration of an anti-murine PDGFR-α antibody to pregnant mice during organogenesis caused malformations and skeletal variations. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LARTRUVO and for 3 months after the last dose.

4 4 VIAL SELECTION GUIDE Please utilize the table below to identify the most appropriate vial size(s) for your patient.* Patient weight range (kg) 500 mg 190 mg Dose range (mg) based on 15 mg/kg Number of vials needed* Number of vials needed* *Depending on the weight-based dose, the full amount in the vials may not be used.

5 5 IMPORTANT SAFETY INFORMATION FOR LARTRUVO WARNINGS AND PRECAUTIONS Infusion-Related Reactions Infusion-related reactions (IRR) occurred in 70 (14%) of 485 patients who received at least one dose of LARTRUVO across clinical trials. For 68 of these 70 patients (97%), the first occurrence of IRR was in the first or second cycle. Grade 3 IRR occurred in 11 (2.3%) of 485 patients, with one (0.2%) fatality. Symptoms of IRR included flushing, shortness of breath, bronchospasm, or fever/chills, and in severe cases symptoms manifested as severe hypotension, anaphylactic shock, or cardiac arrest. Infusion-related reactions required permanent discontinuation in 2.3% of patients and interruption of infusion in 10% of patients. All 59 patients with Grade 1 or 2 IRR resumed LARTRUVO; 12 (20%) of these patients had a Grade 1 or 2 IRR with rechallenge. The incidence of IRR in the overall safety database (N = 485) was similar (18% versus 12%) between those who did (56%) and those who did not (44%) receive premedication. Monitor patients during and following LARTRUVO infusion for signs and symptoms of IRR in a setting with available resuscitation equipment. Immediately and permanently discontinue LARTRUVO for Grade 3 or 4 IRR. Embryo-Fetal Toxicity Based on animal data and its mechanism of action, LARTRUVO can cause fetal harm when administered to a pregnant woman. Animal knockout models link disruption of platelet-derived growth factor receptor alpha (PDGFR-α) signaling to adverse effects on embryo-fetal development. Administration of an anti-murine PDGFR-α antibody to pregnant mice during organogenesis caused malformations and skeletal variations. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LARTRUVO and for 3 months after the last dose. MOST COMMON ADVERSE REACTIONS/LAB ABNORMALITIES The most commonly reported adverse reactions (all grades; grade 3-4) occurring in 20% of patients receiving LARTRUVO plus doxorubicin versus doxorubicin alone were nausea (73% vs 52%; 2% vs 3%), fatigue (69% vs 69%; 9% vs 3%), musculoskeletal pain (64% vs 25%; 8% vs 2%), mucositis (53% vs 35%; 3% vs 5%), alopecia (52% vs 40%; 0% vs 0%), vomiting (45% vs 19%; 0% vs 0%), diarrhea (34% vs 23%; 3% vs 0%) decreased appetite (31% vs 20%; 2% vs 0%), abdominal pain (23% vs 14%; 3% vs 0%), neuropathy (22% vs 11%; 0% vs 0%), and headache (20% vs 9%; 0% vs 0%). The most common laboratory abnormalities (all grades; grade 3-4) occurring in 20% of patients receiving LARTRUVO plus doxorubicin versus doxorubicin alone were lymphopenia (77% vs 73%; 44% vs 37%), neutropenia (65% vs 63%; 48% vs 38%) and thrombocytopenia (63% vs 44%; 6% vs 11%), hyperglycemia (52% vs 28%; 2% vs 3%), elevated aptt (33% vs 13%; 5% vs 0%), hypokalemia (21% vs 15%; 8% vs 3%), and hypophosphatemia (21% vs 7%; 5% vs 3%). USE IN SPECIFIC POPULATIONS Lactation: Because of the potential risk for serious adverse reactions in breastfeeding infants, advise women not to breastfeed during treatment with LARTRUVO and for at least 3 months following the last dose. Please see full Prescribing Information for LARTRUVO. OR HCP ISI 19OCT2016 PP-OR-US /2017 Lilly USA, LLC All rights reserved. LARTRUVO TM is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates. Follow Lilly on these social media platforms.

ADMINISTRATION GUIDE

DOSING AND ADMINISTRATION GUIDE INDICATION LARTRUVO is indicated, in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma (STS) with a histologic subtype for which