FDA label d0890ef4-afbb-4f18-9c21-e81492e4edf7

5 WARNINGS AND PRECAUTIONS Potential Sensitivity ( 5.1 ) Hypersensitivity Reactions ( 5.2 ) Transmission of Infectious Diseases ( 5.3 ) Donation of Blood, Organs, Tissues, or Cells ( 5.4 ) 5.1 Potential Sensitivity STRATAGRAFT contains glycerin. Avoid glycerin in patients with known sensitivity (irritant reaction) to glycerin. 5.2 Hypersensitivity Reactions Severe hypersensitivity reactions may occur [see Contraindications (4) ]. Monitor for both early and late symptoms and signs of hypersensitivity reaction following STRATAGRAFT application, and treat according to standard medical practice. 5.3 Transmission of Infectious Diseases STRATAGRAFT contains cells from human donors and may transmit infectious diseases or infectious agents, e.g., viruses, bacteria, or other pathogens, including the agent that causes transmissible spongiform encephalopathy (TSE, also known as Creutzfeldt-Jakob disease (CJD) or variant CJD). STRATAGRAFT is a xenotransplantation product because of a historic exposure of the keratinocyte cells to well-characterized mouse cells. The cell banks have been tested and found to be free of detectable adventitious agents and mouse cells are no longer used in the manufacture of STRATAGRAFT [see Description (11) ] . StrataGraft was established to be free of detectable pathogens using FDA-recommended characterization procedures and tests including molecular and analytical testing. Transmission of infectious diseases or agents by STRATAGRAFT has not been reported. 5.4 Donation of Blood, Organs, Tissues, or Cells Recipients of xenotransplantation products such as STRATAGRAFT are generally not eligible to donate whole blood or blood components, including source plasma and source leukocytes. However, individual blood collection establishments may request an exception. STRATAGRAFT recipients who otherwise meet donor requirements are eligible to donate human cells, tissues, or cellular or tissue-based products (HCT/Ps), human milk, ova, sperm, or organs for transplantation.

6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥2%) were itching (pruritus), blisters, hypertrophic scar and impaired healing. (Table 1). The most common (≥2%) adverse reactions were itching (pruritus), blisters, hypertrophic scar, and impaired healing. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Customer Care at 1-877-647-2239 or http://www.mallinckrodt.com/stratatech or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 data described in this section reflect exposure to STRATAGRAFT in four randomized, within-subject-controlled studies conducted in the United States, including two clinical studies in patients with deep partial-thickness thermal burns (Study 1 and Study 2) and two clinical studies in patients with full-thickness complex skin defects due to thermal burns or other causes. A total of 119 adult patients (101 patients with deep partial-thickness thermal burn, and 18 patients with full-thickness complex skin defects) received topical application of STRATAGRAFT. The patient population ranged in age from 19 to 79 years (mean age 43 years). Each patient received topical application of STRATAGRAFT at one wound site and either autografting (104 patients) or cadaver allografts (15 patients) as intrapatient comparators at another wound site. The most frequent adverse reactions (incidence ≥2%) observed in the 4 studies are summarized in Table 1. No patients discontinued study participation due to adverse reactions. Table 1: Adverse Reactions Reported at a Frequency of ≥2% Following Treatment with STRATAGRAFT (N=119) Adverse Reaction Patients n (%) If a patient had more than one incidence of an adverse reaction, the patient was counted only once. Pruritus (Itching) 13 (11) Blisters 5 (4) Hypertrophic Scar 3 (3) Impaired Healing 3 (3) Overall, the safety profile of STRATAGRAFT with regard to wound-related events, including erythema, swelling, local warmth and wound site infections, was similar to that of autografting in these studies. There were no reports of rejection of STRATAGRAFT in the clinical studies. The safety of STRATAGRAFT beyond 12 months was not evaluated in the clinical studies.

<table width="60%"><caption>Table 1: Adverse Reactions Reported at a Frequency of &#x2265;2% Following Treatment with STRATAGRAFT (N=119)</caption><col width="50%" align="left" valign="middle"/><col width="50%" align="center" valign="middle"/><thead><tr><th styleCode="Lrule Rrule" valign="top">Adverse Reaction</th><th styleCode="Rrule" valign="top">Patients n (%)<footnote>If a patient had more than one incidence of an adverse reaction, the patient was counted only once.</footnote></th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Pruritus (Itching)</td><td styleCode="Rrule">13 (11)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Blisters</td><td styleCode="Rrule">5 (4)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Hypertrophic Scar</td><td styleCode="Rrule">3 (3)</td></tr><tr><td styleCode="Lrule Rrule">Impaired Healing</td><td styleCode="Rrule">3 (3)</td></tr></tbody></table>