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10584 details
Primary information
ID10584
Therapeutic IDTh1120
Protein NameTeriparatide
Sequence>Th1120_Teriparatide SVSEIQLMHNLGKHLNSMERVEWLRKKLQDVHNF
Molecular Weight4117.715
Chemical FormulaC181H291N55O51S2
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeNA
DescriptionRecombinant, human parathyroid hormone (PTH). It is a potent anabolic agent used to treat osteoporosis. It is manufactured and marketed by Eli Lilly and Company.
Indication/DiseaseFor the treatment of osteoporosis in men and postmenopausal women who are at high risk for having a fracture. Also used to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.
PharmacodynamicsClinical trials indicate that teriparatide increases predominantly trabecular bone in the lumbar spine and femoral neck; it has less significant effects at cortical sites. The combination of teriparatide with antiresorptive agents is not more effective than teriparatide monotherapy. The most common adverse effects associated with teriparatide include injection-site pain, nausea, headaches, leg cramps, and dizziness. After a maximum of two years of teriparatide therapy, the drug should be discontinued and antiresorptive therapy begun to maintain bone mineral density.
Mechanism of ActionTeriparatide is the portion of human parathyroid hormone (PTH),amino acid sequence 1 through 34 of the complete molecule which contains amino acid sequence 1 to 84. Endogenous PTH is the primary regulator of calcium and phosphate metabolism in bone and kidney. Daily injections of teriparatide stimulate new bone formation leading to increased bone mineral density.
ToxicityEffects of overexposure may include headaches, dizziness, dizziness, decreased blood pressured, decreased fetal survival, leg cramps, changes in clinical chemistry including increased in blood levels of calcium, decreased serum phosphorous, and increased urinary calcium and phosphorus.
MetabolismHepatic
AbsorptionBioavailability is 95% following subcutaneous injection.
0.12 L/kg
Clearance* 62 L/hr [Women] * 94 L/hr [Men]
CategoriesBone Density Conservation Agents
Patents NumberUS6977077
Date of Issue20-12-2005
Date of Expiry19-08-2019
Drug InteractionNA
TargetParathyroid hormone/parathyroid hormone-related peptide receptor
Brand NameForteo
CompanyEli Lilly and Company
Brand DescriptionEli Lilly and Company
Prescribed ForTreatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture, Increase of Bone Mass in Men with Primary or Hypogonadal Osteoporosis at High Risk for Fracture, Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis at High Risk for Fracture.
Chemical NameNA
FormulationEach prefilled delivery device is filled with 2.7 mL to deliver 2.4 mL. Each mL contains 250 mcg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetic acid, 0.1 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3 mg Metacresol, and Water for Injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4. Each cartridge, pre-assembled into a delivery device, delivers 20 mcg of teriparatide per dose each day for up to 28 days.
Physical Appearance Sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable delivery device (pen) for subcutaneous injection
Route of AdministrationSubcutaneous
Recommended DosageTreatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture. The recommended dose is 20 mcg subcutaneously once a day. Increase of Bone Mass in Men with Primary or Hypogonadal Osteoporosis at High Risk for Fracture. he recommended dose is 20 mcg subcutaneously once a day.
ContraindicationHypersensitivity to teriparatide or to any of its excipients. Reactions have included angioedema and anaphylaxis
Side EffectsNA
Useful Link 1Link
Useful Link 2NA
RemarksNA