Skytrofa Auto-Injector User Manual

Ascendis Pharma Customer Support
1-844-44ASCENDIS
(1-844-442-7236)
Device expiration
Keep Track of Your Injections
This is your
Instructions for Use
• For quick overview of steps, read your Quick Reference Guide
• For training video, go to www.skytrofa.com
This Instructions for Use has been approved by
the U.S. Food and Drug Administration.
Approved: Month, Year
2021-07-16 13500500
Distributed by:
Ascendis Pharma, Inc.
Palo Alto, CA 94301
USA
Phillips-Medisize A/S
Gimsinglundvej 20
DK-7600 Struer
Denmark
Instructions
for Use
Instructions
for Use
Quick
Reference Guide
Training
Video
Single-patient use

Skytrofa Auto-Injector Specifications

General

Drug Class	Growth Hormone
Manufacturer	Ascendis Pharma
Delivery Method	Subcutaneous injection
Device Type	Auto-injector
Brand Name	Skytrofa
Active Ingredient	Lonapegsomatropin
Route of Administration	Subcutaneous
Generic Name	Lonapegsomatropin
Indication	Treatment of growth hormone deficiency
Dosage Form	Injectable solution
Dose Adjustment	Yes, dose is individualized based on patient response.
Storage	Refrigerate at 2°C to 8°C (36°F to 46°F)
Shelf Life	24 months