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SKYTROFA®: The Freedom of Once Weekly
SKYTROFA®: The Freedom of Once Weekly
More than 10,000 patients have been prescribed SKYTROFA1*
*Numbers are based on Ascendis Signature Access Program® (A·S·A·P) prescribing data as of May 1, 2024.1
In pediatric GHD treatment…
SKYTROFA is the ONLY GH that offers your patients:
Predictable release of unmodified somatropin over the course of one week2-5†
A preservative-free formulation2,4,5‡
Auto-Injector designed to deliver the full dose and minimize the potential for wasted medication2
Room temperature storage for up to 6 months2,4,5§
SKYTROFA demonstrated higher mean annualized height velocity (AHV) compared with a daily somatropin at week 52 in a clinical trial2,3
A treatment difference of 0.9 cm/year (95% CI: 0.2 to 1.5) at 52 weeks compared with daily somatropin (11.2 cm/year with SKYTROFA compared with 10.3 cm/year with daily somatropin)2,3II
†SKYTROFA is a prodrug that releases active somatropin with the same molecular weight and amino acid sequence as endogenous GH. SOGROYA® (somapacitan-beco) is an hGH analog with a single substitution in the amino acid backbone (L101C) to which an albumin-binding moiety has been attached. NGENLA® (somatrogon) is a recombinant hGH with 3 CTPs from the beta chain of hCG attached.2-5‡SKYTROFA does not contain preservatives. SOGROYA and NGENLA contain the preservatives phenol and metacresol, respectively.2,4,5§SKYTROFA can be stored at room temperature for up to 6 months. SKYTROFA cartridges can be stored at 36°F to 46°F (2°C to 8°C) in the outer carton to protect from light until the expiration date. SOGROYA can be stored at room temperature for a total of 3 days. NGENLA should be refrigerated.2,4,5IIIn the phase 3 heiGHt trial comparing once-weekly SKYTROFA with a daily somatropin in 161 treatment-naïve children with GHD. The primary endpoint was mean AHV at week 52.2,3
Expanded coverage
Your local team is available to provide details on our expanded coverage across payors
SKYTROFA® is a human growth hormone
(GH) indicated for the treatment of pediatric patients aged ≥ 1
years weighing ≥ 11.5 kg with growth failure due to inadequate
secretion of endogenous GH.
IMPORTANT SAFETY INFORMATION 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 pharmacologic doses of
somatropin
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Ascendis Pharma Medical Information or call 1-844-442-7236.
INDICATION
SKYTROFA® is a human growth hormone
(GH) indicated for the treatment of pediatric patients aged ≥ 1
years weighing ≥ 11.5 kg with growth failure due to inadequate
secretion of endogenous GH.
IMPORTANT SAFETY
INFORMATION 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 pharmacologic doses of somatropin
Hypersensitivity to somatropin or
any of the excipients in SKYTROFA. Systemic hypersensitivity
reactions have been reported with post-marketing use of
somatropin products
Closed epiphyses
Active malignancy
Active proliferative or severe non-proliferative diabetic retinopathy
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 due
to complications following open heart surgery, abdominal surgery
or multiple accidental trauma, or those with acute respiratory
failure has been reported after treatment with pharmacologic
doses of somatropin. The safety of continuing SKYTROFA treatment
in patients receiving replacement doses for approved indications
who concurrently develop these illnesses has not been
established
Serious systemic hypersensitivity reactions including
anaphylaxis and angioedema have been reported with
post-marketing use of somatropin products. Inform patients and
caregivers that such reactions are possible and that prompt
medical attention should be sought if an allergic reaction
occurs. Do not use SKYTROFA in patients with known
hypersensitivity to SKYTROFA or any of its excipients
Patients with active malignancy have an increased risk of
progression with somatropin treatment. Any preexisting
malignancy should be inactive and treatment complete before
instituting therapy with SKYTROFA. In childhood cancer survivors
treated with radiation to the brain/head for their first
neoplasm who developed subsequent GHD treated with somatropin,
an increased risk for a second neoplasm has been reported.
Monitor patients with a history of GHD secondary to an
intracranial neoplasm routinely for progression/recurrence of
the tumor. Monitor patients carefully for development of
neoplasms and/or increased growth/potential malignant changes of
preexisting nevi
Treatment with somatropin may decrease insulin sensitivity, and
new onset type 2 diabetes mellitus has been reported. Previously
undiagnosed impaired glucose tolerance and overt diabetes
mellitus may be unmasked. Patients with type 1 and 2 diabetes
mellitus or impaired glucose tolerance should be monitored
closely, and antihyperglycemic drugs may require adjustment
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 resolved
rapidly after cessation of therapy/reduction of the dose.
Perform fundoscopic examination routinely before initiating
treatment with SKYTROFA to exclude preexisting papilledema, and
periodically thereafter. If papilledema is observed, stop the
treatment. If somatropin-induced IH is diagnosed, restart
treatment at a lower dose after IH-associated signs and symptoms
have resolved
Fluid retention during somatropin therapy may occur. Clinical
manifestations of fluid retention (eg, edema, arthralgia,
myalgia, nerve compression syndromes including carpal tunnel
syndrome/paresthesia) are usually transient and dose dependent
Patients receiving somatropin therapy may be at risk for reduced
serum cortisol levels and/or unmasking of central
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
Undiagnosed or untreated hypothyroidism may prevent response to
SKYTROFA. Central hypothyroidism may first become evident or
worsen with treatment. Perform periodic thyroid function tests
and initiate/properly adjust thyroid hormone replacement therapy
when indicated
Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Evaluate pediatric patients with the onset of a limp or complaints of persistent hip or knee pain, as slipped capital femoral epiphysis has been reported during lonapegsomatropin treatment. Patients and caregivers should be made aware that osteonecrosis is considered a potential risk for human growth hormone products
Monitor patients for progression of preexisting scoliosis
Cases of pancreatitis have been reported in pediatric patients
receiving somatropin. Consider pancreatitis in patients with
persistent severe abdominal pain
Lipoatrophy may result when somatropin is administered at the
same site over a long period of time. Rotate injection sites to
reduce this risk
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 females.
SKYTROFA is not indicated for the treatment of pediatric
patients who have growth failure due to genetically confirmed
Prader-Willi syndrome
Serum levels of inorganic phosphorus, alkaline phosphatase, and
parathyroid hormone may increase after somatropin treatment.
Monitor abnormal laboratory tests as appropriate
ADVERSE REACTIONS
The most common adverse reactions (≥ 5%) in patients treated with
SKYTROFA were: viral infection (15%), pyrexia (15%), cough (11%),
nausea and vomiting (11%), hemorrhage (7%), diarrhea (6%), abdominal
pain (6%), and arthralgia and arthritis (6%).
DRUG INTERACTIONS
Glucocorticoids: SKYTROFA may
reduce serum cortisol concentrations, which may require an
increase in the dose of glucocorticoids
Cytochrome P450-metabolized
drugs: Somatropin may increase cytochrome P450
(CYP450)-mediated antipyrine clearance. Carefully monitor
patients using drugs metabolized by CYP450 liver enzymes in
combination with SKYTROFA
Oral estrogen: May reduce the
response to SKYTROFA. Higher doses of SKYTROFA may be required
Insulin and/or other hypoglycemic
agents: SKYTROFA may decrease insulin sensitivity.
Patients with diabetes mellitus may require adjustment of
insulin or hypoglycemic agents
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 full Prescribing Information for SKYTROFA.
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heiGHt was a 52-week, randomized, open-label,
active-controlled, parallel-group phase 3 study of 161
treatment-naïve, prepubertal (Tanner stage I) pediatric
patients with GHD aged 3 years and older. Patients were
randomized in a 2:1 ratio to receive either
SKYTROFA® 0.24 mg/kg/week (n = 105) or daily
somatropin using Genotropin® 0.24 mg/kg/week (n = 56). The primary endpoint
was AHV at 52 weeks.1,2https://doi.org/10.1210/clinem/dgab529
fliGHt was a multicenter, phase 3, open-label, 26-week trial investigating the safety, tolerability, and efficacy of SKYTROFA administered once weekly in children with GHD. The trial included 3 treatment-naïve and 143 treatment-experienced patients previously treated with daily hGH for ≤ 130 weeks. Previous daily GH treatments included HumatroPen®, Genotropin Pen®, Saizen one.click®, Omnitrope® Pen, Genotropin GoQuick®, Genotropin MiniQuick®, Norditropin FlexPro®, and Nutropin AQ® NuSpin®. The mean daily somatropin dose was 0.29 mg/kg/week upon entering the trial. Safety and tolerability were the primary endpoints. Patients aged 6 months to 3 years could be treatment naïve and were included only in the safety and tolerability analyses.3https://doi.org/10.1159/000524003
SKYTROFA was studied in
an open-label extension study of pediatric patients
with GHD who had previously participated in phase 3 SKYTROFA
trials. The study enrolled a total of 298 patients: 103
patients on SKYTROFA and 55 patients on daily somatropin
from the heiGHt trial, and 140 patients on SKYTROFA from the
fliGHt trial. The mean age at baseline of the enliGHten trial was 9.5 years for
SKYTROFA-treated patients from the heiGHt trial, 9.5 years
for daily somatropin-treated patients from the heiGHt trial,
and 11.1 years for patients from the fliGHt trial. Long-term
safety was the primary endpoint.4https://doi.org/10.1210/clinem/dgac217
Once-weekly SKYTROFA® was
studied in a multicenter, phase 3, open-label, 26-week trial
investigating the safety, tolerability, and efficacy of
SKYTROFA administered once weekly in children with pediatric
GHD. The trial included 3 treatment-naïve and 143
treatment-experienced patients previously treated with daily
hGH for ≤ 130 weeks. The mean daily somatropin dose was
0.29 mg/kg/week upon entering the trial. Safety and
tolerability were the primary endpoints.1
heiGHt was a 52-week, randomized, open-label, active-controlled, parallel-group phase 3 study of 161 treatment-naïve, prepubertal (Tanner stage I) pediatric patients with GHD aged 3 years and older. Patients were randomized in a 2:1 ratio to receive either SKYTROFA® 0.24 mg/kg/week (n = 105) or daily somatropin using Genotropin® 0.24 mg/kg/week (n = 56). The primary endpoint was AHV at 52 weeks.1,2
Diagnosis of GHD (defined as peak GH ≤ 10 ng/mL confirmed via 2 different GH stimulation tests)
Treatment-naïve males and females (aged 3 to 12 or 3 to 11 years, respectively)
Tanner stage I
Height SDS ≤ -2.0
IGF-1 SDS ≤ -1.0
BMI within ± 2.0 SD of the mean
Bone age ≥ 6 months behind chronological age as determined by a blinded radiologist
Patients were excluded based on the following2
Prior exposure to GH or IGF-1 therapies
History of malignant disease (clinically cured tumors permitted)
Contemporaneous malnourishment, idiopathic short stature, small for gestational age, or other non-GHD-related cause of short stature
Prior diagnosis of or receiving treatment for other major medical conditions in which the disease and/or treatment might affect longitudinal growth
Patient baseline demographics2*
SKYTROFA® 0.24 mg hGH/kg/week
Daily somatropin† 0.24 mg hGH/kg/week
Total
(n = 105)
(n = 56)
(N = 161)
Male, n (%)
86 (82)
46 (82)
132 (82)
White, n (%)
100 (95.2)
52 (92.9)
152 (94.4)
Chronological age (year)
8.5 ± 2.7
8.5 ± 2.8
8.5 ± 2.7
Bone age (year)
5.8 ± 2.6
6.0 ± 2.7
5.9 ± 2.6
Bone age/chronological age (ratio)
0.69 ± 0.16
0.70 ± 0.14
0.69 ± 0.15
Weight (kg)
21.0 ± 6.5
21.2 ± 6.7
21.1 ± 6.6
BMI (kg/m2)
16.1 ± 1.8
16.5 ± 2.2
16.2 ± 1.9
Height (cm)
112.9 ± 14.1
112.2 ± 15.3
112.7 ± 14.5
Height (SDS)
–2.89 ± 0.85
–3.00 ± 0.90
2.93 ± 0.87
Historical growth rate (cm/year)‡
3.9 ± 2.0
3.9 ± 1.7
3.9 ± 1.9
IGF-1 SDS
–2.08 ± 0.88
–1.96 ± 0.98
2.04 ± 0.92
*Plus-minus values are means ± SD.†Genotropin®.‡Historical growth rates based on best available medical records (SKYTROFA [n = 94] and daily somatropin† [n = 54]).
fliGHt was a multicenter, phase 3, open-label, 26-week trial investigating the safety, tolerability, and efficacy of SKYTROFA® administered once weekly in children with GHD. The trial included 3 treatment-naïve and 143 treatment-experienced patients previously treated with daily hGH for ≤ 130 weeks. Previous daily GH treatments included HumatroPen®, Genotropin Pen®, Saizen one.click®, Omnitrope® Pen, Genotropin GoQuick®, Genotropin MiniQuick®, Norditropin FlexPro®, and Nutropin AQ® NuSpin®. The mean daily somatropin dose was 0.29 mg/kg/week upon entering the trial. Safety and tolerability were the primary endpoints.1 Patients aged 6 months to 3 years could be treatment naïve and were included only in the safety and tolerability analyses.
Investigator-determined pediatric GHD with supporting biochemical and auxological criteria
Treatment-experienced patients aged 6 months to 17 years
Tanner stage < V
Open epiphyses
Treated with commercially available daily hGH therapy ≥ 0.20 mg/kg/week for 13 to 130 weeks
Patients were excluded based on the following1:
Body weight < 5.5 kg or > 80 kg
History of malignant disease
Major medical conditions or clinically significant abnormality likely to affect growth or the evaluation of growth
Poorly controlled diabetes mellitus or diabetic complications
A broad range of patients enrolled in the 26-week clinical trial1
Baseline demographics and clinical characteristics
Total enrolled
Previously treated
N = 146
n = 143
Male, n (%)
110 (75.3)
109 (76.2)
White, n (%)
124 (84.9)
121 (84.6)
Hispanic or Latino, n (%)
10 (6.8)
10 (7.0)
Mean chronological age (year)
10.6
10.8
BMI SDS, mean (SD)
–0.3 (1.1)
–0.24 (1.06)
Height SDS, mean (SD)
–1.42 (0.84)
–1.40 (0.83)
Tanner stage, n (%)
I
95 (65.1)
92 (64.3)
II
14 (9.6)
14 (9.8)
III
30 (20.5)
30 (21.0)
IV
7 (4.8)
7 (4.9)
IGF‑1 SDS, mean (SD)
0.85 (1.29)
0.91 (1.25)
Daily somatropin dose at trial enrollment (mg hGH/kg/week)
n/a
0.29 (0.05)
Daily somatropin dose duration since treatment initiation (years)
n/a
1.14 (0.73)
enliGHten was an open-label extension study of pediatric patients with GHD who had previously participated in phase 3 SKYTROFA® trials. The study enrolled a total of 298 patients: 103 patients on SKYTROFA and 55 patients on daily somatropin from the heiGHt trial, and 140 patients on SKYTROFA from the fliGHt trial. The mean age at baseline of the enliGHten trial was 9.5 years for SKYTROFA-treated patients from the heiGHt trial, 9.5 years for daily somatropin-treated patients from the heiGHt trial, and 11.1 years for patients from the fliGHt trial. Treatment completion status was evaluated throughout the study, and the results were stratified accordingly. Long-term safety was the primary endpoint.2
*Baseline indicates last nonmissing measurement before the first dose of lonapegsomatropin-tcgd.2†Patients completed SKYTROFA® treatment (mean treatment duration 3.2 years) because the physician deemed that treatment for pediatric GHD was no longer necessary.2