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The SKYTROFA Auto-Injector was designed with these built-in safeguards:

Needle guard hides needle from patients view¹
Auditory and visual cues help guide patients through each step¹
Automated injection ensures the full dose is delivered with no split doses^1,5

Gen 1 Gen 2

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Gen 1 Gen 2

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* SKYTROFA cartridges can be refrigerated at 36°F to 46°F (2°C to 8°C) in the outer carton to protect from light until the expiration date. Once removed from the refrigerator, cartridges may be stored at room temperature up to 86°F (30°C) for up to 6 months.⁵

Watch: How to use the SKYTROFA Auto-Injector

See how to properly use SKYTROFA and the innovative SKYTROFA Auto-Injector in action. For detailed instructions, download and read the Instructions for Use Instructions for Use.

Patients who require 2 cartridges per week will need to repeat the steps shown.

Gen 1 Gen 2

Triple-award-winning device recognized for its innovative, patient-centric product design^2-4

Usability

Selected for its patient-centric design in the Health Product category²

Innovation

Recognized for technical innovation in advancing the field of bio/pharmaceutical manufacturing³

Industrial Design

Awarded for outstanding, high‑quality product design⁴

SKYTROFA Auto-Injector: Patient Reported Outcomes

Ease of use of the device was assessed

In the enliGHten trial,

94% of patients and caregivers (n = 115)

reported^† that SKYTROFA could be administered using the auto-injector without difficulty or making a mistake⁶

†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 auto-injector based on the device usability questionnaire‡ were available for 115 patients who completed the questionnaire after 13 weeks of auto-injector use.⁶ ‡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.^6,9

enliGHten: An open-label extension study of pediatric patients with GHD who had previously participated in phase 3 SKYTROFA trials, heiGHt (n = 158) or fliGHt(n = 140) (N = 298). The mean age at baseline of the enliGHten trial was 10.3 years. At the start of enliGHten trial, patients either received SKYTROFA 0.24 mg/kg/week or the most recent dose they received in the earlier study. Long-term safety was the primary endpoint.^6,7

Study limitations: The auto-injector was available to US patients only. Questionnaire results have not been validated, and at week 13 do not represent long-term use. Data should be interpreted with caution; no conclusions can be drawn.

Injection training materials were well understood

In a comprehension study (N = 135), following a review of injection training materials and performing a simulated injection⁸:

≥95% across all groups

(HCPs, caregivers, children) were successful with their injections⁸

98% of participants

reported that they could use the device safely on their own or with caregiver supervision⁸

Study limitations: The study had a small sample size, which included non-GHD patients. It was conducted in a controlled environment, with an assessment at only one time point, which does not represent long-term use. Data should be interpreted with caution; no conclusions can be drawn.

Participants had reviewed materials supplied with the auto-injector, including cartridges, packaging, IFU, QRG, a training video, and the auto-injector Help Line. They were then assessed on their performance of a simulated injection and charging of the auto-injector, as well as their comprehension of the IFU, followed by a debriefing discussion with the investigator. The participants included patients with pediatric GHD and proxy conditions including diabetes (n = 60), caregivers (n = 60), and HCPs (n = 15). Pediatric patient ages ranged from 6 to 17 years.⁸

For detailed instructions on using the SKYTROFA
Auto-Injector, download and read the Instructions for Use.

Download Gen 1 Download Gen 2

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

SKYTROFA^® (lonapegsomatropin-tcgd) injection is a human growth hormone (GH) indicated for the:

Treatment of pediatric patients aged 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous GH
Replacement of endogenous GH in adults with growth hormone deficiency (GHD)

CONTRAINDICATIONS

SKYTROFA is contraindicated in patients with:

Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to risk of increased mortality with use of somatropin
Hypersensitivity to somatropin or any of the excipients in SKYTROFA
Pediatric patients with closed epiphyses
Active malignancy
Active proliferative or severe non-proliferative diabetic retinopathy
Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death

WARNINGS AND PRECAUTIONS

Increased Mortality in Patients with Acute Critical Illness: Increased mortality has been reported after treatment with somatropin in patients with acute critical illness due to complications following open-heart surgery, abdominal surgery, multiple accidental trauma, and in patients with acute respiratory failure
Severe Hypersensitivity: Serious systemic hypersensitivity reactions including anaphylaxis and angioedema have been reported with post-marketing use of somatropin products, including SKYTROFA. Inform patients and/or caregivers that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs
Increased Risk of Neoplasms: There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy. Any preexisting malignancy should be inactive, and its treatment complete prior to instituting SKYTROFA. In childhood cancer survivors treated with radiation to the brain/head for their first neoplasm who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Children with certain rare genetic causes of short stature have an increased risk of developing malignancies and should be carefully monitored for development of neoplasms. Monitor patients with a history of GHD secondary to an intracranial neoplasm for progression/recurrence of the tumor. Monitor patients carefully for development of neoplasms and/or increased growth/potential malignant changes of preexisting nevi. Advise patients/caregivers to report changes in the appearance of preexisting nevi
Glucose Intolerance and Diabetes Mellitus: Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. Previously undiagnosed impaired glucose tolerance and overt type 2 diabetes mellitus may be unmasked. Monitor glucose levels in all patients, especially those with risk factors for type 2 diabetes mellitus, such as obesity or a family history of type 2 diabetes mellitus. When initiating SKYTROFA, monitor patients with preexisting type 1 or type 2 diabetes mellitus or impaired glucose tolerance closely, and adjust the doses of antihyperglycemic drugs as needed
Intracranial Hypertension: Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with somatropin. Symptoms usually occurred within 8 weeks of the initiation of somatropin and resolved rapidly after cessation of therapy/reduction of the dose. Perform fundoscopic examination prior to initiation of treatment and periodically thereafter. If papilledema is observed, stop the treatment. If somatropin-induced IH is confirmed, restart SKYTROFA treatment at a lower dose after IH-associated signs and symptoms have resolved
Fluid Retention: May occur during somatropin therapy. Clinical manifestations of fluid retention (eg, edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent
Hypoadrenalism: Patients receiving somatropin therapy who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance/stress doses following initiation of SKYTROFA therapy. Monitor patients with known hypoadrenalism for reduced serum cortisol levels and/or need for glucocorticoid dose increases
Hypothyroidism: Undiagnosed/untreated hypothyroidism may prevent an optimal response to SKYTROFA. Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of SKYTROFA
Slipped Capital Femoral Epiphysis in Pediatric Patients: Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth and may lead to osteonecrosis. Evaluate pediatric patients receiving SKYTROFA with the onset of a limp or complaints of persistent hip or knee pain for slipped capital femoral epiphysis and osteonecrosis, and manage accordingly
Progression of Preexisting Scoliosis in Pediatric Patients: Monitor patients with a history of scoliosis for disease progression
Pancreatitis: Cases of pancreatitis have been reported in pediatric patients receiving somatropin. The risk may be greater in pediatric patients than in adults. Consider pancreatitis in patients with persistent severe abdominal pain
Lipoatrophy: Lipoatrophy may result when somatropin is administered at the same site over a long period of time. Rotate injection sites to reduce this risk
Sudden Death in Pediatric Patients With Prader-Willi Syndrome: There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than female patients. SKYTROFA is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome
Laboratory Tests: Serum levels of alkaline phosphatase and phosphate may increase after SKYTROFA therapy. Serum levels of parathyroid hormone may increase after somatropin treatment. If a patient is found to have abnormal laboratory tests, monitor as appropriate

ADVERSE REACTIONS

Pediatric patients with GHD: the most common adverse reactions (≥ 5%) in patients treated with SKYTROFA and more frequently than in those treated with daily somatropin were viral infection, pyrexia, cough, nausea and vomiting, hemorrhage, diarrhea, abdominal pain, and arthralgia and arthritis
Adult patients with GHD: the most common adverse reaction (≥ 5%) in patients treated with SKYTROFA and more frequently than in those treated with placebo were edema and central (secondary) hypothyroidism

DRUG INTERACTIONS

Glucocorticoids: Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of SKYTROFA
Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment: Adjust glucocorticoid dosing in pediatric patients to avoid both hypoadrenalism and an inhibitory effect on growth
Cytochrome P450-Metabolized Drugs: SKYTROFA may alter the clearance. Monitor carefully if used with SKYTROFA
Oral Estrogen: Patients receiving oral estrogen replacement may require higher SKYTROFA dosages
Insulin and/or Other Antihyperglycemic Agents: Dose adjustment of insulin and/or antihyperglycemic agent may be required for patients with diabetes mellitus

You are encouraged to report side effects to FDA at (800) FDA-1088 or 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.

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

SKYTROFA^® (lonapegsomatropin-tcgd) injection is a human growth hormone (GH) indicated for the:

Treatment of pediatric patients aged 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous GH
Replacement of endogenous GH in adults with growth hormone deficiency (GHD)

CONTRAINDICATIONS

SKYTROFA is contraindicated in patients with:

Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to risk of increased mortality with use of somatropin
Hypersensitivity to somatropin or any of the excipients in SKYTROFA

GHD = growth hormone deficiency; IFU = Instructions for Use; QRG = Quick Reference Guide.

References: 1. SKYTROFA. Instructions for use. Ascendis Pharma Endocrinology, Inc.; 2025. 2. CPHI Online. Pharmapack Awards 2022. June 19, 2025. Accessed October 6, 2025. https://www.cphionline.com/pharmapack-awards-2022-winnersrevealed-news117523.html 3. PDA, Inc. PDA announces 2022 Drug Delivery Innovation Awards winners. October 19, 2022. Accessed October 6, 2025. https://www.pda.org/pda-letterportal/home/full-article/ pda-announces-2022-drug-delivery-innovation-awards-winners 4. Red Dot Award. Your success in the Red Dot Award: Product Design 2023. March 2023. 5. SKYTROFA. Prescribing information. Ascendis Pharma Endocrinology, Inc.; 2025. 6. Maniatis AK, Casella SJ, Nadgir UM, et al. Safety and efficacy of lonapegsomatropin in children with growth hormone deficiency: enliGHten trial 2-year results. J Clin Endocrinol Metab. 2022;107(7):e2680-e2689. doi:10.1210/clinem/dgac217 7. Maniatis AK, Thornton PS, Nadgir UM, et al. Children with growth hormone deficiency treated with lonapegsomatropin demonstrated sustained height improvements for up to 6 years—enliGHten trial final results. Horm Res Paediatr. [Published online March 6, 2025]. doi:10.1159/000545064 8. Lau M, Fabricius PE, Jensen J, Madsen NB, Egesborg H. Patient-centric design of the lonapegsomatropin auto-injector for pediatric growth hormone deficiency. Poster presented at: 25th European Congress of Endocrinology; May 13-16, 2023; Istanbul, Turkey. 9. Ascendis Pharma Endocrinology, Inc. Data on Fie; 2023