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| Primary information |
|---|
| ID | 15732 |
| Therapeutic ID | Th1622 |
| Protein Name | Somapacitan |
| Sequence | >Th1622_Somapacitan
FPTIPLSRLFDNAMLRAHRLHQLAFDTYQEFEEAYIPKEQKYSFLQNPQTSLCFSESIPTPSNREETQQKSNLELLRISLLLIQSWLEPVQFLRSVFANSCVYGASDSNVYDLLKDLEEGIQTLMGRLEDGSPRTGQIFKQTYSKFDTNSHNDDALLKNYGLLYCFRKDMDKVETFLRIVQCRSVEGSCGF
|
| Molecular Weight | NA |
| Chemical Formula | C1038H1609N273O319S9 |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | The elimination half life of somapacitan is 2-3 days.[L15661] |
| Description | Somapacitan, also known as NNC0195-0092,[A219136] is a growth hormone analog indicated to treat adults with growth hormone deficiency.[A219126,L15661] This human growth hormone analog differs by the creation of an albumin binding site, and prolonging the effect so that it requires weekly dosing rather than daily.[A219146] Somapacitan was granted FDA approval on 28 August 2020.[L15666] |
| Indication/Disease | Somapacitan is indicated as a replacement for growth hormone in adult patients with growth hormone deficiency.[L15661] |
| Pharmacodynamics | Somapacitan stimulates the growth hormone receptor.[L15661] Somapacitan has a long duration of action as it is given once weekly.[L15661] It has a moderately wide therapeutic window as an acute overdose may cause hypoglycemia followed by hyperglycemia.[L15661] Patients should be counselled regarding the risk of increased mortality in patients with critical illness, risk of neoplasms, glucose intolerance in diabetes mellitus, intracranial hypertension, hypersensitivity, fluid retention, hypoadrenalism, hypothyroidism, pancreatitis, lipohypertrophy, and lipoatrophy.[L15661] |
| Mechanism of Action | Somapacitan binds to the growth hormone receptor and induces intracellular signalling to up-regulate insulin-like growth factor I (IGF-1).[A219096,L15661] IGF-1 causes growth in bones and muscle tissue.[A219096] Growth hormones more directly cause the fusion of myoblasts and myotubes to cause muscle fibre growth, activate neural stem cells, and induce chondrocyte proliferation.[A219096] |
| Toxicity | Patients experiencing an acute overdose of somapacitan may present with fluid retention.[L15661] Chronic overdose may resemble gigantism or acromegaly.[L15661] Treat patients with symptomatic and supportive measures to minimize the permanent effects.[A219141] |
| Metabolism | Studies in humans and rats show that somapacitan is metabolized through cleavage of the albumin-binding moiety and linker sidechain before further non-specific mechanisms.[A219096,L15661] |
| Absorption | A 0.02mg/kg single dose of somapacitan reaches a Cmax of 14.4 ng/mL, with a Tmax of 11.1 hours, and an AUC of 475 ng |
| The approximate volume of distribution of somapacitan is 14.6 L.[L15661] |
| Clearance | The apparent maximum rate of saturable elimination is estimated to be 0.268 ± 0.03 mg/h.[A219126] |
| Categories | Amino Acids, Peptides, and Proteins |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | Growth hormone receptor |
| Brand Name | Sogroya |
| Company | Novo Nordisk |
| Brand Description | Novo Nordisk |
| Prescribed For | Subcutaneous |
| Chemical Name | 10 mg/1.5ml |
| Formulation | SOGROYA is contraindicated in patients with:Acute critical illness after open-heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure because of the risk of increased mortality with use of pharmacologic doses of SOGROYA [see WARNINGS AND PRECAUTIONS].Active malignancy [see WARNINGS AND PRECAUTIONS].Hypersensitivity to SOGROYA or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with other growth hormone products [see WARNINGS AND PRECAUTIONS].Active proliferative or severe non-proliferative diabetic retinopathy. |
| Physical Appearance | back pain, joint pain, indigestion/heartburn, sleep disorder, dizziness, tonsillitis, swelling of extremities, vomiting, adrenal insufficiency, high blood pressure (hypertension), increased blood creatine phosphokinase, weight gain, and anemia |
| Route of Administration | Sogroya is a prescription medicine that contains human growth hormone, the same growth hormone made by the human body. Sogroya is given by injection under the skin (subcutaneous) and is used to treat adults who do not make enough growth hormone. It is not known if Sogroya is safe and effective in children.... |
| Recommended Dosage | SOGROYA is indicated for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (GHD). |
| Contraindication | (2S)-5-[2-[2-[2-[[(2S)-1-amino-6-[[2-[(2R)-2-amino-2-carboxyethyl]sulfanylacetyl]amino]-1-oxohexan-2-yl]amino]-2-oxoethoxy]ethoxy]ethylamino]-2-[[(4S)-4-carboxy-4-[[2-[2-[2-[4-[16-(2H-tetrazol-5-yl)hexadecanoylsulfamoyl]butanoylamino]ethoxy]ethoxy]acetyl]amino]butanoyl]amino]-5-oxopentanoic acid |
| Side Effects | NA |
| Useful Link 1 | Link |
| Useful Link 2 | Link |
| Remarks | NA |