• Highlights
• Contents
• Indications and Usage
• Dosage and Administration
• Dosage Forms and Strengths
• Contraindications

• Warnings and Precautions
• Adverse Reactions
• Drug Interactions
• Use in Specific Populations
• Description

• Clinical Pharmacology
• Nonclinical Toxicology
• Clinical Studies
• References
• How Supplied/
  Storage and Handling

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with RECOTHROM. It is also not known whether RECOTHROM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RECOTHROM should be given to a pregnant woman only if clearly needed.

8.4 Pediatric Use

Of the 72 patients undergoing burn wound excision and grafting treated with RECOTHROM applied with the spray applicator in the open-label, single group, Phase 2 study, 4 were pediatric patients. All were age 12 to 16 years. The safety and effectiveness of RECOTHROM in all pediatric age groups have not been fully established.

8.5 Geriatric Use

Of the total number of patients in Phase 2 and Phase 3 clinical studies of RECOTHROM with absorbable gelatin sponge, 38% were 65 years old and over, while 16% were 75 years old and over.
No substantive differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.