CAVERJECT® IMPULSE Use in Specific Populations

(alprostadil)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

CAVERJECT IMPULSE is not indicated for use in females.

8.2 Lactation

CAVERJECT IMPULSE is not indicated for use in females.

8.4 Pediatric Use

CAVERJECT IMPULSE is not indicated for use in pediatric patients [see Warnings and Precautions (5.8)].

8.5 Geriatric Use

A total of 341 subjects included in clinical studies were 65 and older. No overall differences in safety and effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between elderly and younger patients.

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Use in Specific Populations

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

CAVERJECT IMPULSE is not indicated for use in females.

8.2 Lactation

CAVERJECT IMPULSE is not indicated for use in females.

8.4 Pediatric Use

CAVERJECT IMPULSE is not indicated for use in pediatric patients [see Warnings and Precautions (5.8)].

8.5 Geriatric Use

A total of 341 subjects included in clinical studies were 65 and older. No overall differences in safety and effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between elderly and younger patients.

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