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Established Safety Profile

The safety profile of SKYTROFA^® has been established in pediatric patients aged 1 year and older who weigh at least 11.5 kg¹

Boy playing with drum kit.

Some patients taking SKYTROFA experienced mild injection-site reactions²
Low immunogenicity, with no neutralizing antibodies detected^1,2
- Only 6.3% (19 of 304) of patients showed detectable binding antibodies at any time¹

AEs reported in ≥ 5% of SKYTROFA-treated pediatric patients and more frequently than in daily somatropin-treated pediatric patients (52 weeks of treatment)¹

AEs	SKYTROFA (n = 105)	Daily Somatropin (n = 56)
	n (%)	n (%)
Viral infection	16 (15%)	6 (11%)
Pyrexia	16 (15%)	5 (9%)
Cough	11 (11%)	4 (7%)
Nausea and vomiting	11 (11%)	4 (7%)
Hemorrhage*	7 (7%)	1 (2%)
Diarrhea	6 (6%)	3 (5%)
Abdominal pain	6 (6%)	2 (4%)
Arthralgia and arthritis^†	6 (6%)	1 (2%)

* The etiology of hemorrhage in the SKYTROFA treatment group included epistaxis (n = 3), contusion (n = 2), petechiae (n = 1), and eye hemorrhage (n = 1).¹

^† The etiology of arthralgia and arthritis in the SKYTROFA treatment group included arthralgia (n = 5) and reactive arthritis (n = 1).¹

Efficacy And Safety Guide Brochure

Efficacy and Safety Guide
Learn more about the clinical differentiation of SKYTROFA.

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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

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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
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.