Skytrofa 5.2 mg/1
Lonapegsomatropin-tcgd · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Ascendis Pharma Endocrinology, Inc.
Skytrofa is a injection, powder, lyophilized, for solution containing lonapegsomatropin-tcgd at 5.2 mg/1, taken subcutaneous. Manufactured by Ascendis Pharma Endocrinology, Inc..
Key Facts
- Brand Name
- Skytrofa
- Generic Name
- Lonapegsomatropin-tcgd
- NDC Code (Product)
73362-006- Manufacturer
- Ascendis Pharma Endocrinology, Inc.
- Strength
- 5.2 mg/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761177
- Drug Class
- Recombinant Human Growth Hormone [EPC]
- Marketing Start
- 08/25/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 ).
Dosage & Administration
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 patient…
Contraindications
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 ) A…
Drug Interactions
7 DRUG INTERACTIONS Table 4 includes a list of drugs with clinically important drug interactions when administered concomitantly with SKYTROFA and instructions for preventing or managing them. Table 4: Clinically Important Drug Interactions with SKYTROFA Replacement Glucocorticoid Treatment Clinical Impact: Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. Somatropin inhibits 11βHSD-1. Consequently, individuals with untreated growth hormone deficiency (GHD) have relative increases in 11βHSD-1 and serum cortisol. Initiation of SKYTROFA may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. Intervention: Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of SKYTROFA [see Warnings and Precautions (5.7) ] Examples Cortisone acetate and prednisone may be affected more than others because conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1. Pharmacologic Glucocorticoid Therapy and Suprap…
Adverse Reactions
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 ar…
Frequently Asked Questions
What is Skytrofa used for?
Skytrofa contains Lonapegsomatropin-tcgd. It is a injection, powder, lyophilized, for solution taken subcutaneous. Consult your doctor for specific uses.
Is Skytrofa a controlled substance?
Skytrofa is not classified as a controlled substance by the DEA.
What is the generic name for Skytrofa?
The generic name for Skytrofa is Lonapegsomatropin-tcgd. There are no other listed brand versions of Lonapegsomatropin-tcgd.
What is the NDC code for Skytrofa 5.2 mg/1?
The NDC (National Drug Code) for Skytrofa 5.2 mg/1 is 73362-006, listed by Ascendis Pharma Endocrinology, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)