Prescription medicine
Lonapegsomatropin Brand names: Skytrofa
Lonapegsomatropin (Skytrofa) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the lonapegsomatropin FDA label on DailyMed (effective July 23, 2026); every lonapegsomatropin label on DailyMed.
Highlights of the record
FDA label of July 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSKYTROFA (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).
Forms and strengths
- 0.7 mg
- 1.4 mg
- 1.8 mg
- 2.1 mg
- 2.5 mg
- 3 mg
- 3.6 mg
- 4.3 mg
- 5.2 mg
- 6.3 mg
- 7.6 mg
- 9.1 mg
Injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 612 through July 30, 2026
What is lonapegsomatropin used for?
From the label: indications and usageSKYTROFA (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 ).
FDA pharmacologic class: Recombinant Human Growth Hormone.
Source: FDA drug label (Skytrofa), Ascendis Pharma Endocrinology, Inc., effective July 23, 2026 (SPL set 9229f871-bc61-4ddc-8122-d126d40e36ac), via openFDA; the full label on DailyMed
Is there a generic for lonapegsomatropin (Skytrofa)?
No generic lonapegsomatropin is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the lonapegsomatropin label say about other medicines?
The lonapegsomatropin label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cortisone | drug interactions | 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. … Intervention: Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of SKYTROFA [see ] |
| Prednisone | drug interactions | 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. … 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 … |
| Somatropin | contraindications | … 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) ]. |
Source: FDA drug label (Skytrofa), Ascendis Pharma Endocrinology, Inc., effective July 23, 2026 (SPL set 9229f871-bc61-4ddc-8122-d126d40e36ac), via openFDA; the full label on DailyMed
What do FAERS reports show for lonapegsomatropin?
The FDA Adverse Event Reporting System holds 612 reports that list lonapegsomatropin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 15 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other recombinant human growth hormones
- the pharmacologic class, with prices and generics
- Lonapegsomatropin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other