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Skytrofa (lonapegsomatropin-tcgd)
lonapegsomatropin
Adult Dosing .
Dosage forms: INJ (cartridge): 0.7 mg per injection, 1.4 mg per injection, 1.8 mg per injection, 2.1 mg per injection, 2.5 mg per injection, 3 mg per injection, 3.6 mg per injection, 4.3 mg per injection, 5.2 mg per injection, 6.3 mg per injection, 7.6 mg per injection, 9.1 mg per injection, 11 mg per injection, 13.3 mg per injection
Special Note
- [drug name clarification]
- Info: nonproprietary name = lonapegsomatropin-tcgd
growth hormone deficiency
- [<30 yo or w/ concurrent PO estrogen use]
- Dose: individualize dose SC qwk; Start: 2.1 mg SC qwk, may incr. dose qmo; Max: 6.3 mg/wk; Info: adjust dose based on IGF-1 levels and sx; cartridges for use w/ Skytrofa auto-injector only
- [30-60 yo w/o concurrent PO estrogen use]
- Dose: individualize dose SC qwk; Start: 1.4 mg SC qwk, may incr. dose qmo; Max: 6.3 mg/wk; Info: adjust dose based on IGF-1 levels and sx; cartridges for use w/ Skytrofa auto-injector only
- [>60 yo w/o concurrent PO estrogen use]
- Dose: individualize dose SC qwk; Start: 0.7 mg SC qwk, may incr. dose qmo; Max: 6.3 mg/wk; Info: adjust dose based on IGF-1 levels and sx; cartridges for use w/ Skytrofa auto-injector only
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ (cartridge): 3 mg per injection, 3.6 mg per injection, 4.3 mg per injection, 5.2 mg per injection, 6.3 mg per injection, 7.6 mg per injection, 9.1 mg per injection, 11 mg per injection, 13.3 mg per injection
Special Note
- [drug name clarification]
- Info: nonproprietary name = lonapegsomatropin-tcgd
growth hormone deficiency
- [1 yo and older, >11.5 kg]
- Dose: 0.24 mg/kg/dose SC qwk; Info: round dose to nearest cartridge size; adjust dose based on tx response; cartridges for use w/ Skytrofa auto-injector only; D/C when pt reaches satisfactory ht, epiphyses close, or no response
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- malignancy, active
- epiphysis, closed (peds patients)
- diabetic retinopathy
- illness, acute critical
- papilledema
- obesity, severe (peds patients w/ Prader-Willi syndrome)
- respiratory impairment, severe (peds patients w/ Prader-Willi syndrome)
- upper airway obstruction (peds patients w/ Prader-Willi syndrome)
- sleep apnea (peds patients w/ Prader-Willi syndrome)
- respiratory infection (peds patients w/ Prader-Willi syndrome)
- caution: elderly patients
- caution: intracranial neoplasm hx
- caution: malignancy risk
- caution: hypopituitarism
- caution: hypopituitarism risk
- caution: hypoadrenalism
- caution: hypothyroidism
- caution: diabetes mellitus
- caution: diabetes mellitus risk
- caution: scoliosis
Drug Interactions .
Overview
somatropin
growth hormone agonist
- 11-beta-hydroxysteroid dehydrogenase type 1 inhibitor
- affects growth hormone diagnostic test results
- hyperglycemic effects
- hyperphosphatemia
- pseudotumor cerebri
- caution advised w/ drugs metabolized by CYP450 liver enzymes; somatropin may increase CYP450 metabolic function, alter levels of concomitant drugs, incr. risk of adverse effects or decr. efficacy
- lonapegsomatropin is a prodrug of somatropin; similar interactions anticipated
Avoid/Use Alternative
- erdafitinib
- macimorelin
- tretinoin
Monitor/Modify Tx
- acarbose
- acitretin
- alogliptin
- betamethasone
- bexagliflozin
- bromocriptine
- canagliflozin
- ciprofloxacin
- colesevelam
- cortisone
- cyclosporine
- cysteamine
- danazol
- dapagliflozin
- deflazacort
- delafloxacin
- demeclocycline
- dexamethasone
- doxycycline
- dulaglutide
- empagliflozin
- eravacycline
- ertugliflozin
- estetrol (contraceptive)
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- exenatide
- fludrocortisone
- futibatinib
- glimepiride
- glipizide
- glyburide
- goserelin
- histrelin
- insulin
- isotretinoin
- leuprolide
- levofloxacin
- linagliptin
- liraglutide
- lithium
- lixisenatide
- mecasermin
- metformin
- methylprednisolone
- miglitol
- minocycline
- moxifloxacin
- nafarelin
- nateglinide
- ofloxacin
- omadacycline
- palovarotene
- pioglitazone
- pramlintide
- prednisolone
- prednisone
- repaglinide
- rosiglitazone
- sarecycline
- saxagliptin
- semaglutide
- sitagliptin
- somapacitan
- somatrogon
- tetracycline
- tigecycline
- tirzepatide
- triamcinolone
- triptorelin
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- anaphylaxis
- angioedema
- secondary neoplasm
- diabetes mellitus
- hypothyroidism unmasked
- hypoadrenalism unmasked
- intracranial HTN
- pancreatitis
- scoliosis progression (peds patients)
- slipped capital femoral epiphysis (peds patients)
- osteonecrosis (peds patients)
- sudden death (Prader-Willi peds patients)
Common Reactions
- hyperphosphatemia
- alk phos elevated
- viral infection
- fever
- cough
- nausea
- vomiting
- central hypothyroidism (adult patients)
- diarrhea
- abdominal pain
- arthralgia
- epistaxis
- fluid retention
- injection site rxn
- injection site lipoatrophy
- cortisol decr.
Safety/Monitoring .
Monitoring Parameters
glucose, esp. if diabetes or diabetes risk; TFTs; cortisol if hypoadrenalism; funduscopic exam at baseline, then periodically; dermatologic exams
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available, though no known risk of fetal harm based on limited human data w/ somatropin; no known risk of teratogenicity based on animal data at up to 30x MRHD
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available, though risk of infant harm not expected based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: kidney primarily, liver; CYP450: unknown; Info: prodrug converted to somatropin
Excretion: bile (0.1% unchanged); Half-life: 25h; Info: drug effects longer than half-life due to slow induction and IGF-1 clearance
Subclass: Growth Hormones/Agonists
Mechanism of Action
stimulates multiple growth, anabolic, and anti-catabolic effects
Formulary .
No Formulary Selected
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