Eftansomatropin alfa
Also known as: hGH-Fc fusion protein, MOD-4023, Ngenla, somatropin Fc fusion
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Summary
Eftansomatropin alfa (also known as TransCon hGH or lonapegsomatropin in some contexts; brand name Skytrofa is a different prodrug, whereas eftansomatropin alfa is marketed as Ngenla) is a long-acting recombinant human growth hormone Fc fusion protein developed by OPKO Health / Pfizer. It requires once-weekly subcutaneous administration instead of daily injections, improving patient convenience. It is approved for pediatric growth hormone deficiency (pGHD).
Mechanism of Action
Eftansomatropin alfa is a recombinant fusion protein consisting of human growth hormone (hGH) linked to an immunoglobulin Fc fragment (IgG4-Fc), which extends its half-life. It acts as a GH receptor agonist, binding to and activating growth hormone receptors to stimulate IGF-1 production, promote linear growth, and regulate metabolism.
Routes of Administration
Goals & Uses
- Adult growth hormone deficiency (investigational)EndocrinologyLow
- IGF-1 normalizationBiomarker / Surrogate EndpointHigh
- Improved treatment adherence via once-weekly dosingPatient Convenience / AdherenceHigh
- Treatment of pediatric growth hormone deficiency (pGHD)Endocrinology / GrowthHigh
Contraindications
- Active malignancyOncologyHighUse caution or avoid depending on agent and context
- Acute critical illnessCritical CareHigh
- Closed epiphyses (for growth promotion indication)Pediatric / SkeletalModerate
- Diabetic retinopathyOphthalmologyModerate
- Prader-Willi syndrome with severe obesity or respiratory impairmentGenetic SyndromeHigh
- Hypersensitivity to somatropin or excipientsAllergy / ImmunologyHigh
Adverse Effects
- Injection site reactionsLocalCommon
- HeadacheNeurologicCommonPain in the head or upper neck
- Fluid retention / edemaFluid / ElectrolyteUncommon
- Intracranial hypertensionNeurologicalRare
- HypothyroidismEndocrineUncommon
- Elevated IGF-1 levelsEndocrine / LaboratoryCommon
Drug Interactions
- GlucocorticoidsModerate
- Insulin / Oral antidiabeticsModerate
- Thyroid hormone replacementModerate
- CYP450 substrates (e.g., cyclosporine, sex hormones)Low
Population Constraints
- Patients with prior or active malignancyOncologyAbsolute
- PregnancyReproductive SafetyRelative
- AdultsAdult PopulationRelative
- Patients with diabetes mellitusMetabolicRelative
- Children under 3 years of agePediatricRelative
Regulatory Status
- European UnionApprovedApproved: Pediatric growth hormone deficiency (pGHD)EMA approved; marketed as Ngenla in the European Union.
- United StatesApprovedApproved: Pediatric growth hormone deficiency (pGHD) in patients 3 years and olderFDA approved June 2023; marketed as Ngenla by Pfizer/OPKO Health.
- United KingdomApprovedApproved: Pediatric growth hormone deficiency (pGHD)MHRA approved following EMA decision; available as Ngenla.
Approved by the FDA in June 2023 for pediatric patients 3 years and older with growth hormone deficiency. Also approved by the EMA. Developed by OPKO Health in partnership with Pfizer; marketed under the brand name Ngenla.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Eftansomatropin alfa?
Eftansomatropin alfa (also known as TransCon hGH or lonapegsomatropin in some contexts; brand name Skytrofa is a different prodrug, whereas eftansomatropin alfa is marketed as Ngenla) is a long-acting recombinant human growth hormone Fc fusion protein developed by OPKO Health / Pfizer. It requires once-weekly subcutaneous administration instead of daily injections, improving patient convenience. It is approved for pediatric growth hormone deficiency (pGHD).
What is Eftansomatropin alfa used for?
Eftansomatropin alfa is educationally associated with: Adult growth hormone deficiency (investigational), IGF-1 normalization, Improved treatment adherence via once-weekly dosing, Treatment of pediatric growth hormone deficiency (pGHD). Educational only — not medical advice.
How is Eftansomatropin alfa administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Eftansomatropin alfa?
Reported adverse effects include: Injection site reactions, Headache, Fluid retention / edema, Intracranial hypertension, Hypothyroidism, Elevated IGF-1 levels. This list is not exhaustive — consult a qualified clinician.
Who should avoid Eftansomatropin alfa?
Recorded contraindications: Active malignancy, Acute critical illness, Closed epiphyses (for growth promotion indication), Diabetic retinopathy, Prader-Willi syndrome with severe obesity or respiratory impairment, Hypersensitivity to somatropin or excipients. Consult a qualified clinician before use.