Skytrofa

Skytrofa is an FDA-registered drug product whose active ingredient is LONAPEGSOMATROPIN-TCGD. It is labelled by Ascendis Pharma Endocrinology, Inc. taken by subcutaneous and marketed as a human prescription drug product. Identifiers on file: NDC 73362-003, application BLA761177, label effective 20260723. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing LONAPEGSOMATROPIN-TCGD are most often described in connection with: growth hormone, pediatric patients, weigh least, failure due, inadequate secretion, replacement endogenous, deficiency ghd, usage skytrofa. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH). Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD). SKYTROFA is a human growth hormone indicated for: Pediatric Patients: Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH) ( 1 ). Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD) ( 1 ).

2 DOSAGE AND ADMINISTRATION SKYTROFA should be administered subcutaneously once weekly into the abdomen, buttock, or thigh with regular rotation of the injection sites ( 2.7 ). Pediatric Patients: Recommended dose is 0.24 mg/kg body weight once weekly ( 2.2 ). Adults: Recommended starting dose is based on age and concomitant use of oral estrogen. Titrate monthly until the desired clinical response and/or weekly average IGF-1 concentration are achieved ( 2.3 ). See Full Prescribing Information for instructions on preparation and administration of drug ( 2.5 , 2.6 , 2.7 ). 2.1 General Dosing Information For subcutaneous injection, once weekly. Therapy with SKYTROFA should be supervised by a healthcare provider who is experienced in the diagnosis and management of patients with growth hormone deficiency (GHD). Perform fundoscopic examination before initiating treatment with SKYTROFA to exclude preexisting papilledema. If papilledema is identified, evaluate the etiology and treat the underlying cause before initiating treatment with SKYTROFA [see Warnings and Precautions (5.5) ] . 2.2 Recommended Dosage for Pediatric Patients The recommended dose of SKYTROFA for treatment-naïve patients and patients switching from another growth hormone product is 0.24 mg/kg body weight, given once weekly. Individualize and titrate the dosage of SKYTROFA based on response. When changing from daily somatropin therapy to once-weekly SKYTROFA, wait at least 8 hours between the final dose of daily somatropin and the first dose of SKYTROFA. When changing from another once-weekly growth hormone therapy to once-weekly SKYTROFA, wait at least 7 days between the final dose of the previous growth hormone therapy and the first dose of SKYTROFA. Assess compliance and evaluate other causes of poor growth, such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human growth hormone if patients experience failure to increase height velocity, particularly during the first year of treatment. Patients who were treated with SKYTROFA for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuing SKYTROFA. 2.3 Recommended Dosage for Adults The recommended starting dose of SKYTROFA in adults with GHD is based on age and concomitant use of oral estrogen [see Dosage Forms and Strengths (3) ] . For treatment-naïve patients or for patients switching from another growth hormone product, start SKYTROFA as described below: 1.4 mg once weekly for adults 30 to 60 years old, with no oral estrogen intake 2.1 mg once weekly for adults under 30 years old, or adults of any age intaking oral estrogen 0.7 mg once weekly for adults over 60 years old, with no oral estrogen intake When changing from daily somatropin therapy to once-weekly SKYTROFA, wait at least 8 hours between the final dose of daily somatropin and the first dose of SKYTROFA. When changing from another once-weekly growth hormone therapy to once-weekly SKYTROFA, wait at least 7 days between the final dose of the previous growth hormone therapy and the first dose of SKYTROFA. Increase the dose monthly to a higher strength cartridge based on the clinical response and/or IGF-1 concentration. Draw IGF-1 serum sample 4 to 5 days after the prior dose. Decrease the dose to a lower strength cartridge as needed based on adverse reactions or a weekly average IGF-1 concentration above the age- and sex-specific normal range. The maximum recommended dose is 6.3 mg once weekly. 2.4 Missed Doses Administer a missed dose as soon as possible and not more than 2 days after the missed dose. To avoid missed doses, SKYTROFA can be taken 2 days before or 2 days after the scheduled dosing day. Resume once-weekly dosing for the next dose at the previously scheduled dosing day. If more than 2 days have passed from the scheduled day, skip the dose and administer the next dose on the regularly scheduled day. At least 5 days should elapse between doses. 2.5 Administration Instructions for Pediatric Patients SKYTROFA is available in 9 cartridges (dosage strengths in somatropin equivalents) for pediatric patients. Selection of the appropriate cartridge (mg) is based on the prescribed dose (mg/kg) and the patient's body weight (kg) [see Dosage Forms and Strengths (3) ] . If prescribing a dose of 0.24 mg/kg/week and the patient's weight is 11.5 to 100 kg, follow the recommended dosing in Table 1. If prescribing a dose other than 0.24 mg/kg/week, calculate the total weekly dose (in mg) and select the appropriate cartridge as follows: Total weekly dose (mg) = prescribed weekly dose (mg/kg) × patient's body weight (kg). Round the total weekly dose (mg) to the closest cartridge dose while also considering treatment goals and clinical response. Table 1: Recommended Dosing for Pediatric Patients Prescribed Doses of 0.24 mg/kg/week Weight (kg) Dose (mg) 11.5 – 13.9 3 14 – 16.4 3.6 16.5 – 19.9 4.3 20 – 23.9 5.2 24 – 28.9 6.3 29 – 34.9 7.6 35 – 41.9 9.1 42 – 50.9 11 51 – 60.4 13.3 60.5 – 69.9 15.2 (using two cartridges of 7.6 mg each) 70 – 84.9 18.2 (using two cartridges of 9.1 mg each) 85 – 100 22 (using two cartridges of 11 mg each) 2.6 Administration Instructions for Adults SKYTROFA is available in 14 cartridges (dosage strengths in somatropin equivalents) for adults. Selection of the appropriate cartridge (mg) is based on the prescribed dose (mg/week) [see Dosage Forms and Strengths (3) ] . 2.7 Preparation and Administration The SKYTROFA cartridge has been designed for use only with the SKYTROFA Auto-Injector. If refrigerated, the SKYTROFA cartridge must be kept at room temperature for 15 minutes before use. The SKYTROFA Auto-Injector provides a fully automated reconstitution of the lyophilized drug product which is followed by a manual mixing step controlled by the device. When the injection needle is inserted into the skin, the device automatically delivers the drug product. The built-in electronics and software assist the user during the entire preparation and injection sequence and provide confirmation that the full dose has been delivered. The mixed solution should be clear and colorless to opalescent. The solution may contain air bubbles and this is acceptable. DO NOT inject if the solution is cloudy or contains particulate matter. Use SKYTROFA cartridges within 4 hours after reconstitution. Discard reconstituted SKYTROFA cartridges after 4 hours when stored at room temperature up to 86°F (30°C). Inject SKYTROFA subcutaneously into the abdomen, buttock, or thigh. Rotate injection sites between and within regions to reduce the risk of lipoatrophy [see Warnings and Precautions (5.12) ] . Refer to the Instructions for Use for complete administration instructions with illustrations. The instructions can also be found on www.Skytrofa.com/IFU. Patients and/or caregivers who will administer SKYTROFA should receive appropriate training and instruction on the proper use of SKYTROFA from their healthcare provider.

4 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 the risk of increased mortality with use of pharmacologic doses of somatropin [see Warnings and Precautions (5.1) ] . Hypersensitivity to somatropin or any of the excipients in SKYTROFA. Severe systemic hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported [see Warnings and Precautions (5.2) ]. Pediatric patients with closed epiphyses. Active malignancy due to the risk of malignancy progression [see Warnings and Precautions (5.3) ]. Active proliferative or severe non-proliferative diabetic retinopathy because treatment with somatropin may worsen this condition. 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 [see Warnings and Precautions (5.13) ]. Acute critical illness ( 4 ) Hypersensitivity to somatropin or any of the excipients in SKYTROFA ( 4 ) Children with closed epiphyses ( 4 ) Active malignancy ( 4 ) Active proliferative or severe non-proliferative diabetic retinopathy ( 4 ) Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment due to risk of sudden death ( 4 )

6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in the labeling: Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1) ] Severe hypersensitivity [see Warnings and Precautions (5.2) ] Increased risk of neoplasms [see Warnings and Precautions (5.3) ] Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4) ] Intracranial hypertension [see Warnings and Precautions (5.5) ] Fluid retention [see Warnings and Precautions (5.6) ] Hypoadrenalism [see Warnings and Precautions (5.7) ] Hypothyroidism [see Warnings and Precautions (5.8) ] Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions (5.9) ] Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions (5.10) ] Pancreatitis [see Warnings and Precautions (5.11) ] Lipoatrophy [see Warnings and Precautions (5.12) ] Sudden death in pediatric patients with Prader-Willi syndrome [see Warnings and Precautions (5.13) ] Pediatric Patients: Most common adverse reactions (≥ 5%): viral infection, pyrexia, cough, nausea and vomiting, hemorrhage, diarrhea, abdominal pain, and arthralgia and arthritis ( 6.1 ). Adults: Most common adverse reaction (≥ 5%): edema peripheral ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Ascendis Pharma Endocrinology, Inc., at 1-844-442-7236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Pediatric Patients with Growth Hormone Deficiency SKYTROFA was studied in a 52-week, open-label, active-controlled trial in 161 treatment-naïve, prepubertal pediatric patients with growth hormone deficiency (GHD) [see Clinical Studies (14.1) ] . The subjects ranged in age from 3.2 to 13.1 years with a mean of 8.5 years. One hundred thirty-two (82%) of the subjects were male and 29 (18%) were female. One subject was Asian, 3 were Black or African American, 152 were Caucasian, and 5 were categorized as "other." Table 2 shows common adverse reactions that occurred in ≥ 5% of patients treated with SKYTROFA in this trial. Table 2: Adverse Reactions Occurring in ≥ 5% SKYTROFA-Treated Pediatric Patients and More Frequently Than in Daily Somatropin-Treated Pediatric Patients (52 Weeks of Treatment) Adverse reactions Daily Somatropin (N = 56) n (%) SKYTROFA (N = 105) n (%) Adverse reactions that are medically related were grouped to a single preferred term. Infection, viral 6 (11%) 16 (15%) Pyrexia 5 (9%) 16 (15%) Cough 4 (7%) 11 (11%) Nausea and vomiting 4 (7%) 11 (11%) Hemorrhage Hemorrhage in the SKYTROFA treatment group included epistaxis (3), contusion (2), petechiae (1) and eye hemorrhage (1). 1 (2%) 7 (7%) Diarrhea 3 (5%) 6 (6%) Abdominal pain 2 (4%) 6 (6%) Arthralgia and arthritis Arthralgia and arthritis in the SKYTROFA treatment group included arthralgia (5) and reactive arthritis (1). 1 (2%) 6 (6%) Laboratory Tests More SKYTROFA-treated patients shifted from normal baseline levels to elevated phosphate and alkaline phosphatase levels at the end of the trial compared to the daily somatropin group (44.2% vs. 30.2% and 19.2% vs. 9.4%, respectively); these laboratory changes occurred intermittently [see Warnings and Precautions (5.14) ] . Adults with Growth Hormone Deficiency SKYTROFA was studied in a 38-week parallel-arm, placebo-controlled (double-blind) and active-controlled (open label) trial in 259 adults with growth hormone deficiency (GHD) [see Clinical Studies (14.2) ] . The mean (range) age at enrollment was 43 (23 to 81) years old, with 119 (46%) females (55 on oral estrogen) and 140 (54%) males. One subject was American Indian or Alaska Native, one was Black or African American, 28 were Asian, and 218 were Caucasian. Table 3 shows adverse reactions that occurred in ≥ 5% of adults treated with SKYTROFA and more frequently than in placebo-treated adults in this trial. Table 3: Adverse Reactions Occurring in ≥ 5% of SKYTROFA-Treated Adults and More Frequently Than in Placebo-treated Adults (38 Weeks of Treatment) Adverse reactions Placebo (N = 84) n (%) SKYTROFA (N = 89) n (%) Adverse reactions that are medically related were grouped to a single preferred term. Edema Edema in the SKYTROFA treatment group included edema peripheral (6) and peripheral swelling (1). 1 (1%) 7 (8%) Central (secondary) hypothyroidism Central (secondary) hypothyroidism in the SKYTROFA treatment group included thyroxine free decreased (3), central hypothyroidism (2), thyroxine decreased (1), blood thyroid stimulating hormone decreased (1), tri-iodothyronine free decreased (1). Preexisting central hypothyroidism in 5 of 6 SKYTROFA-treated patients. 1 (1%) 6 (7%) Laboratory Tests More SKYTROFA-treated patients shifted from normal or low baseline levels to elevated alkaline phosphatase levels at the end of the trial compared to the placebo group (14% vs. 6%); these laboratory changes were noted with increased frequency as the trial progressed [see Warnings and Precautions (5.14) ] . 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of somatropin products or SKYTROFA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Severe systemic hypersensitivity reactions, including anaphylactic reactions and angioedema Musculoskeletal and connective tissue disorders – osteonecrosis in pediatric patients

What is Skytrofa used for?
1 INDICATIONS AND USAGE SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH). Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD). SKYTROFA is a human growth hormone …

Who makes Skytrofa?
Ascendis Pharma Endocrinology, Inc. is the labeler of record for Skytrofa.

What form does Skytrofa come in?
administered by subcutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Skytrofa prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Skytrofa been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.