The SKYTROFA Auto‑Injector
The award-winning SKYTROFA Auto-Injector was designed with patients in mind and is the only once-weekly treatment for pGHD with a permanent needle guard that keeps the needle hidden during injections.
Not an actual patient
The SKYTROFA Auto-Injector is reusable, rechargeable, and ready-to-use.
Its innovative design helps reduce waste with no disposable pens or batteries. A full charge powers up to 4 weeks of use (based on one injection per week) and the device is built to last up to 4 years or 210 injections, whichever comes first.
* Store SKYTROFA in the original package to protect from light. Do not freeze. SKYTROFA can be stored at room temperature (not to exceed 86°F [30°C]) for up to 6 months. Alternatively, SKYTROFA can be stored under refrigeration at 36°F to 46°F (2°C to 8°C) until the expiration date. If refrigerated, keep at room temperature for 15 minutes before use. Do not use SKYTROFA beyond the expiration date or 6 months after the date it was first removed from refrigeration (whichever is earlier).
Prep, inject, and go with innovative features of the SKYTROFA Auto-Injector
No refrigeration, no preservatives
SKYTROFA cartridges do not need to be refrigerated for up to 6 months.* Each single-dose cartridge contains only the active ingredient (lonapegsomatropin-tcgd), diluent, and sterile water.
Pre-measured doses means no dialing
The SKYTROFA Auto-Injector delivers a single use injection with no dose dialing—delivering the full dose—while automated cues guide you through each step.
Thin needle size—keeping your child's comfort in mind
Every SKYTROFA injection uses a pre-filled cartridge with a thin, 31-gauge needle featuring a permanent guard that conceals the needle during injections.
* Store SKYTROFA in the original package to protect from light. Do not freeze. SKYTROFA can be stored at room temperature (not to exceed 86°F [30°C]) for up to 6 months. Alternatively, SKYTROFA can be stored under refrigeration at 36°F to 46°F (2°C to 8°C) until the expiration date. If refrigerated, keep at room temperature for 15 minutes before use. Do not use SKYTROFA beyond the expiration date or 6 months after the date it was first removed from refrigeration (whichever is earlier).
The SKYTROFA Auto-Injector: Ease of Use Assessment
In a clinical study* of 115 patients, patients and caregivers assessed the ease of use of the SKYTROFA Auto-Injector.
Not an actual patient
94% of patients and caregivers reported† that SKYTROFA could be administered using the auto-injector without difficulty or making a mistake.
Limitations: The auto-injector was available to US patients only. The questionnaire used in this analysis has not been validated, and the findings represent early results that have not been assessed over long-term use. Data should be interpreted with caution; no conclusions can be drawn.
* A long-term extension trial in children with GHD who completed the SKYTROFA pivotal trial and follow-up trials (N = 298); mean treatment duration was 3.5 years (max 5 years).
† Patients at select US sites switched from administering SKYTROFA with a vial and syringe to the auto-injector (n = 160) once it became available. Patient-reported outcomes for the SKYTROFA Auto-Injector based on the device usability questionnaire were available for 115 patients who completed the questionnaire after 13 weeks of auto-injector use. The device questionnaire is an 8-item survey in which patients or caregivers rate their level of agreement with statements regarding the ease of use of the auto-injector, as well as any associated pain or skin reactions.
“SKYTROFA has fit well into our family’s lifestyle. As a family that likes to travel, not needing to refrigerate‡ SKYTROFA provides us with more flexibility when we’re on the go.”
–Montara, Caregiver Ambassador
Individual results may vary.
‡ Store SKYTROFA in the original package to protect from light. Do not freeze. SKYTROFA can be stored at room temperature (not to exceed 86°F [30°C]) for up to 6 months. Alternatively, SKYTROFA can be stored under refrigeration at 36°F to 46°F (2°C to 8°C) until the expiration date. If refrigerated, keep at room temperature for 15 minutes before use. Do not use SKYTROFA beyond the expiration date or 6 months after the date it was first removed from refrigeration (whichever is earlier).
How to use the SKYTROFA Auto-Injector
For detailed instructions, see the Instructions for Use.
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Patients who require 2 cartridges per week will need to repeat the steps shown.
It is important to be trained by an HCP on how to use your auto-injector prior to first use.
Download the Gen 1 Quick Reference Guide
Use this step-by-step guide as a reference after you’ve completed your
SKYTROFA Auto-Injector training.
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Patients who require 2 cartridges per week will need to repeat the steps shown.
It is important to be trained by an HCP on how to use your auto-injector prior to first use.
Download the Gen 2 Quick Reference Guide
Use this step-by-step guide as a reference after you’ve completed your
SKYTROFA Auto-Injector training.
Not an actual patient
Get a text when it's time to inject
With fewer injection days than daily treatments, SKYTROFA may fit well into your families routine.
Weekly text reminders can help you and your child stay on track—even on the busiest days.
The SKYTROFA Auto-Injector—recognized for its patient-centric product design
Usability
Selected for its patient-centric design in the Health Product category.
Innovation
Recognized for technical innovation in advancing the field of bio/pharmaceutical manufacturing.
Industrial Design
Awarded for outstanding, high‑quality product design.
Not an actual patient
In the case of a missed dose
- Administer SKYTROFA as soon as possible and not more than 2 days after the missed dose. If more than 2 days have passed from their scheduled day, skip that dose and administer the next dose on their regular injection day.
- To avoid missed doses, SKYTROFA can be taken 2 days before or 2 days after their scheduled dosing day. You should always go back to their regular injection day after taking a missed dose.
- Ensure there are at least 5 days between doses.
IMPORTANT SAFETY INFORMATION & USES
SKYTROFA is a prescription medicine used for:
- the replacement of growth hormone in children 1 year old or older who weigh at least 26 pounds (11.5 kilograms) with growth hormone deficiency (GHD)
- the replacement of growth hormone in adults with growth hormone deficiency (GHD)
Do not take SKYTROFA if:
- you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing problems
- you are allergic to somatropin or any of the ingredients in SKYTROFA
- you are a child with closed bone growth plates
- you have cancer or other tumors
- you have certain types of eye problems caused by diabetes
- you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (briefly stopping breathing during sleep)
Tell your healthcare provider if you are pregnant or plan to become pregnant, about all of your medical conditions, and about all the medicines you take. SKYTROFA may affect how other medicines work, and other medicines may affect how SKYTROFA works.
What are the possible side effects of SKYTROFA?
SKYTROFA may cause serious side effects, including:
- serious allergic reactions. Get medical help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing
- high risk of death in people who have critical illnesses caused by heart or stomach surgery, trauma, or serious breathing problems
- increased risk of growth of an existing tumor or cancer, or increased risk of a previous tumor or cancer returning in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your healthcare provider will need to monitor for the growth or return of a tumor or cancer. Contact your healthcare provider if you start to have sudden changes in behavior, headaches, vision problems, or changes in moles, birthmarks, or skin color
- new or worsening high blood sugar or diabetes. Your blood sugar may need to be monitored during treatment with SKYTROFA
- increase in pressure in the skull. Contact your healthcare provider if headaches, eye problems, nausea, or vomiting occur
- too much fluid in the body (fluid retention). Contact your healthcare provider if you notice swelling in the hands and feet, pain in the joints or muscles, or nerve problems that cause pain, burning or tingling in the hands, arms, legs, and feet
- decrease in a hormone called cortisol. Your healthcare provider will do blood tests to check your cortisol levels
- decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well SKYTROFA works. Your healthcare provider will do blood tests to check your thyroid hormone levels
- hip and knee pain or a limp in children (slipped capital femoral epiphysis). This may lead to a serious condition where bone tissue dies due to a lack of blood supply (osteonecrosis). Get medical help right away for children who develop a limp or have hip or knee pain
- worsening of curvature of the spine in children (scoliosis)
- severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your healthcare provider about any new abdominal pain
- loss of fat and tissue weakness in the area of skin you or your child inject. Talk to your healthcare provider about rotating the areas where SKYTROFA is injected
- high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea
- increase in phosphate, alkaline phosphatase, and parathyroid hormone levels in your blood. Your healthcare provider will do blood tests to check this
The most common side effects of SKYTROFA in children include: viral infection, fever, cough, nausea and vomiting, bleeding, diarrhea, stomach area pain, joint pain and arthritis
The most common side effects of SKYTROFA in adults include: swelling due to fluid build-up and low thyroid hormone
These are not all of the possible side effects of SKYTROFA. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. You may also report side effects to Ascendis Pharma at 1-844-442-7236.
Please click here for SKYTROFA full Prescribing Information.
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