Peringatan Keamanan

Subcutaneous doses of somatrogon higher than 0.66 mg/kg per week have not been studied. Based on existing clinical data of other growth hormone products, short-term overdosage from somatrogon could lead initially to hypoglycemia and subsequently to hyperglycemia. Long-term overdosage could result in signs and symptoms of gigantism or acromegaly consistent with the effects of excess growth hormone. Overdose with somatrogon should be treated with general supportive measures.L39362

Somatrogon

DB14960

biotech approved

Deskripsi

Somatrogon is a long-acting recombinant human growth hormone. Growth hormone is a peptide hormone secreted by the pituitary gland that plays a crucial role in promoting longitudinal growth during childhood and adolescence and regulating metabolic function in adulthood.A241515 Recombinant growth hormone therapy for growth hormone deficiency and other conditions has been available since 1985, with daily administration being the standard treatment for many years. More recently, longer-acting forms of growth hormone were developed to improve patient adherence and thus, improve the therapeutic efficacy of treatment.A241485 Somatrogon was produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. It is a chimeric product generated by fusing three copies of the C-terminal peptide (CTP), or 28 carboxy-terminal residues, from the beta chain of human chorionic gonadotropin (hCG) to the N-terminus and C-terminus of human growth hormone.A241515,L39362 The glycosylation and the presence of CTPs in the protein sequence prolongs the half-life of somatrogon and allows its once-weekly dosing.L39362

In October 2021, Health Canada approved somatrogon under the market name NGENLA as the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone caused by growth hormone deficiency, marking Canada as the first country to approve this drug.L39060 In June 2023, the FDA approved the use of somatrogon also for the treatment of pediatric growth hormone deficiency.L47153,L47158 Somatrogon is available as a once-weekly subcutaneous injection.L39080,L47153

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: ObatTargetGenEnzim(Panah → menunjukkan arah efek / relasi)TransporterCarrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) Following subcutaneous administration of 0.66 mg/kg/wk in pediatric patients with growth hormone deficiency, the half-life was 28.3 hours. Somatrogon was detected in the circulation for about 6 days after the last dose.[L39362]
Volume Distribusi Following subcutaneous administration of 0.66 mg/kg/wk in pediatric patients with growth hormone deficiency, the apparent central volume of distribution (Vc) was 0.812 L/kg and the apparent peripheral volume of distribution (Vt) was 0.169 L/kg. Somatrogon does not accumulate after once-weekly administration.[L39362]
Klirens (Clearance) Following subcutaneous administration of 0.66 mg/kg/wk in pediatric patients with growth hormone deficiency, the clearance was 0.0336 L/h/kg.[L39362]

Absorpsi

Following subcutaneous administration of 0.66 mg/kg/wk in pediatric patients with growth hormone deficiency, Cmax of somatrogon was 690 ng/mL. Tmax was 8 hours and the AUC was 21800 ng x h/mL. Over the dose range of 0.25-0.66 mg/kg/week, somatrogon exposure increased in a dose-proportional manner.L39362

Metabolisme

Somatrogon is expected to undergo protein catabolism, with subsequent reclamation of the amino acids and return to the systemic circulation.L39362

Rute Eliminasi

There is no information available.

Interaksi Obat

975 Data
Cortisone acetate The serum concentration of the active metabolites of Cortisone acetate can be reduced when Cortisone acetate is used in combination with Somatrogon resulting in a loss in efficacy.
Macimorelin The therapeutic efficacy of Macimorelin can be decreased when used in combination with Somatrogon.
Antipyrine The metabolism of Antipyrine can be increased when combined with Somatrogon.
Fluvoxamine The metabolism of Fluvoxamine can be increased when combined with Somatrogon.
Bortezomib The metabolism of Bortezomib can be increased when combined with Somatrogon.
Betaxolol The metabolism of Betaxolol can be increased when combined with Somatrogon.
Caffeine The metabolism of Caffeine can be increased when combined with Somatrogon.
Anagrelide The metabolism of Anagrelide can be increased when combined with Somatrogon.
Carmustine The metabolism of Carmustine can be increased when combined with Somatrogon.
Ropinirole The metabolism of Ropinirole can be increased when combined with Somatrogon.
Theophylline The metabolism of Theophylline can be increased when combined with Somatrogon.
Disopyramide The therapeutic efficacy of Disopyramide can be decreased when used in combination with Somatrogon.
Lidocaine The metabolism of Lidocaine can be increased when combined with Somatrogon.
Conjugated estrogens The therapeutic efficacy of Somatrogon can be decreased when used in combination with Conjugated estrogens.
Ropivacaine The metabolism of Ropivacaine can be increased when combined with Somatrogon.
Penciclovir The metabolism of Penciclovir can be increased when combined with Somatrogon.
Zolmitriptan The metabolism of Zolmitriptan can be increased when combined with Somatrogon.
Acetaminophen The metabolism of Acetaminophen can be increased when combined with Somatrogon.
Amitriptyline The metabolism of Amitriptyline can be increased when combined with Somatrogon.
Olanzapine The metabolism of Olanzapine can be increased when combined with Somatrogon.
Chlorzoxazone The metabolism of Chlorzoxazone can be increased when combined with Somatrogon.
Clozapine The metabolism of Clozapine can be increased when combined with Somatrogon.
Grepafloxacin The metabolism of Grepafloxacin can be increased when combined with Somatrogon.
Mirtazapine The metabolism of Mirtazapine can be increased when combined with Somatrogon.
Mexiletine The metabolism of Mexiletine can be increased when combined with Somatrogon.
Tacrine The metabolism of Tacrine can be increased when combined with Somatrogon.
Triamterene The metabolism of Triamterene can be increased when combined with Somatrogon.
Sorafenib The metabolism of Sorafenib can be increased when combined with Somatrogon.
Promazine The metabolism of Promazine can be increased when combined with Somatrogon.
Zolpidem The metabolism of Zolpidem can be increased when combined with Somatrogon.
Entecavir The metabolism of Entecavir can be increased when combined with Somatrogon.
Imipramine The metabolism of Imipramine can be increased when combined with Somatrogon.
Nabumetone The metabolism of Nabumetone can be increased when combined with Somatrogon.
Quinine The therapeutic efficacy of Quinine can be decreased when used in combination with Somatrogon.
Fluoxetine The metabolism of Fluoxetine can be increased when combined with Somatrogon.
Chlorpromazine The metabolism of Chlorpromazine can be increased when combined with Somatrogon.
Flutamide The metabolism of Flutamide can be increased when combined with Somatrogon.
Haloperidol The metabolism of Haloperidol can be increased when combined with Somatrogon.
Albendazole The metabolism of Albendazole can be increased when combined with Somatrogon.
Erlotinib The metabolism of Erlotinib can be increased when combined with Somatrogon.
Mephenytoin The metabolism of Mephenytoin can be increased when combined with Somatrogon.
Rofecoxib The metabolism of Rofecoxib can be increased when combined with Somatrogon.
Fluorouracil The metabolism of Fluorouracil can be increased when combined with Somatrogon.
Cinnarizine The metabolism of Cinnarizine can be increased when combined with Somatrogon.
Propranolol The metabolism of Propranolol can be increased when combined with Somatrogon.
Fenfluramine The metabolism of Fenfluramine can be increased when combined with Somatrogon.
Clonidine The metabolism of Clonidine can be increased when combined with Somatrogon.
Diclofenac The metabolism of Diclofenac can be increased when combined with Somatrogon.
Imatinib The metabolism of Imatinib can be increased when combined with Somatrogon.
Efavirenz The metabolism of Efavirenz can be increased when combined with Somatrogon.
Guanabenz The metabolism of Guanabenz can be increased when combined with Somatrogon.
Pemetrexed The metabolism of Pemetrexed can be increased when combined with Somatrogon.
Estrone The metabolism of Estrone can be increased when combined with Somatrogon.
Verapamil The metabolism of Verapamil can be increased when combined with Somatrogon.
Tamoxifen The metabolism of Tamoxifen can be increased when combined with Somatrogon.
Warfarin The metabolism of Warfarin can be increased when combined with Somatrogon.
Tizanidine The metabolism of Tizanidine can be increased when combined with Somatrogon.
Paroxetine The metabolism of Paroxetine can be increased when combined with Somatrogon.
Thiabendazole The metabolism of Thiabendazole can be increased when combined with Somatrogon.
Riluzole The metabolism of Riluzole can be increased when combined with Somatrogon.
Zileuton The metabolism of Zileuton can be increased when combined with Somatrogon.
Clopidogrel The metabolism of Clopidogrel can be increased when combined with Somatrogon.
Etoposide The metabolism of Etoposide can be increased when combined with Somatrogon.
Estradiol The therapeutic efficacy of Somatrogon can be decreased when used in combination with Estradiol.
Mefenamic acid The metabolism of Mefenamic acid can be increased when combined with Somatrogon.
Acyclovir The metabolism of Acyclovir can be increased when combined with Somatrogon.
Naproxen The metabolism of Naproxen can be increased when combined with Somatrogon.
Pentoxifylline The metabolism of Pentoxifylline can be increased when combined with Somatrogon.
Trifluoperazine The metabolism of Trifluoperazine can be increased when combined with Somatrogon.
Perphenazine The metabolism of Perphenazine can be increased when combined with Somatrogon.
Dacarbazine The metabolism of Dacarbazine can be increased when combined with Somatrogon.
Terbinafine The metabolism of Terbinafine can be increased when combined with Somatrogon.
Ranitidine The metabolism of Ranitidine can be increased when combined with Somatrogon.
Ethanol The metabolism of Ethanol can be increased when combined with Somatrogon.
Ondansetron The metabolism of Ondansetron can be increased when combined with Somatrogon.
Cyclobenzaprine The metabolism of Cyclobenzaprine can be increased when combined with Somatrogon.
Maprotiline The metabolism of Maprotiline can be increased when combined with Somatrogon.
Alosetron The metabolism of Alosetron can be increased when combined with Somatrogon.
Azelastine The metabolism of Azelastine can be increased when combined with Somatrogon.
Ethinylestradiol The therapeutic efficacy of Somatrogon can be decreased when used in combination with Ethinylestradiol.
Lomefloxacin The metabolism of Lomefloxacin can be increased when combined with Somatrogon.
Ramelteon The metabolism of Ramelteon can be increased when combined with Somatrogon.
Azathioprine The metabolism of Azathioprine can be increased when combined with Somatrogon.
Frovatriptan The metabolism of Frovatriptan can be increased when combined with Somatrogon.
Levobupivacaine The metabolism of Levobupivacaine can be increased when combined with Somatrogon.
Cinacalcet The metabolism of Cinacalcet can be increased when combined with Somatrogon.
Selegiline The metabolism of Selegiline can be increased when combined with Somatrogon.
Tocainide The metabolism of Tocainide can be increased when combined with Somatrogon.
Praziquantel The metabolism of Praziquantel can be increased when combined with Somatrogon.
Melatonin The metabolism of Melatonin can be increased when combined with Somatrogon.
Benzocaine The metabolism of Benzocaine can be increased when combined with Somatrogon.
Primaquine The metabolism of Primaquine can be increased when combined with Somatrogon.
Hesperetin The metabolism of Hesperetin can be increased when combined with Somatrogon.
Leflunomide The metabolism of Leflunomide can be increased when combined with Somatrogon.
Pimozide The metabolism of Pimozide can be increased when combined with Somatrogon.
Nifedipine The metabolism of Nifedipine can be increased when combined with Somatrogon.
Carvedilol The metabolism of Carvedilol can be increased when combined with Somatrogon.
Doxepin The metabolism of Doxepin can be increased when combined with Somatrogon.
Cilostazol The metabolism of Cilostazol can be increased when combined with Somatrogon.
Propafenone The metabolism of Propafenone can be increased when combined with Somatrogon.

Target Protein

Growth hormone receptor GHR

Referensi & Sumber

Artikel (PubMed)
  • PMID: 31939485
    Lal RA, Hoffman AR: Perspectives on long-acting growth hormone therapy in children and adults. Arch Endocrinol Metab. 2019 Nov-Dec;63(6):601-607. doi: 10.20945/2359-3997000000190.
  • PMID: 20020365
    Bidlingmaier M, Strasburger CJ: Growth hormone. Handb Exp Pharmacol. 2010;(195):187-200. doi: 10.1007/978-3-540-79088-4_8.
  • PMID: 26421979
    Carter-Su C, Schwartz J, Argetsinger LS: Growth hormone signaling pathways. Growth Horm IGF Res. 2016 Jun;28:11-5. doi: 10.1016/j.ghir.2015.09.002. Epub 2015 Sep 10.

Contoh Produk & Brand

Produk: 6 • International brands: 1
Produk
  • Ngenla
    Injection, solution • 24 mg/1.2ml • Subcutaneous • EU • Approved
  • Ngenla
    Injection, solution • 60 mg/1.2ml • Subcutaneous • EU • Approved
  • Ngenla
    Solution • 20 mg / mL • Subcutaneous • Canada • Approved
  • Ngenla
    Solution • 50 mg / mL • Subcutaneous • Canada • Approved
  • Ngenla
    Injection, solution • 24 mg/1.2mL • Subcutaneous • US • Approved
  • Ngenla
    Injection, solution • 60 mg/1.2mL • Subcutaneous • US • Approved
International Brands
  • Ngenla — Pfizer, Inc.

Sekuens Gen/Protein (FASTA)

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