Teriparatide Recombinant Human

Teriparatide Recombinant Human Uses, Dosage, Side Effects, Food Interaction and all others data.

Endogenous 84-amino acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption. The biological actions of PTH and teriparatide are mediated through binding to specific high-affinity cell-surface receptors. Teriparatide Recombinant Human and the 34 N-terminal amino acids of PTH bind to these receptors with the same affinity and have the same physiological actions on bone and kidney. Teriparatide Recombinant Human is not expected to accumulate in bone or other tissues. The skeletal effects of teriparatide depend upon the pattern of systemic exposure. Once-daily administration of teriparatide stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity. In monkey studies, teriparatide improved trabecular microarchitecture and increased bone mass and strength by stimulating new bone formation in both cancellous and cortical bone. In humans, the anabolic effects of teriparatide manifest as an increase in skeletal mass, an increase in markers of bone formation and resorption, and an increase in bone strength. By contrast, continuous excess of endogenous PTH, as occurs in hyperparathyroidism, may be detrimental to the skeleton because bone resorption may be stimulated more than bone formation.

Clinical 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.

Teriparatide Recombinant Human
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Teriparatide Recombinant Human
Availability	Prescription only
Generic	Teriparatide
Teriparatide Other Names	PTH (1-34), PTH 1-34, Teriparatida, Teriparatide, Teriparatide recombinant human
Related Drugs	Prolia, hydrochlorothiazide, alendronate, calcitonin, Fosamax, Tymlos
Type
Formula	C₁₈₁H₂₉₁N₅₅O₅₁S₂
Weight	4117.715 Da
Groups	Approved, Investigational
Therapeutic Class	Thyroid drugs & hormone
Manufacturer
Available Country
Last Updated:	September 19, 2023 at 7:00 am

Uses

Teriparatide Recombinant Human is a parathyroid hormone analog, (PTH 1-34), used for:

Treatment 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 osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.

Pediatric Use: The safety and efficacy of Teriparatide Recombinant Human have not been established in any pediatric population.
Hepatic Impairment: No studies have been performed in patients with hepatic impairment.

Teriparatide Recombinant Human is also used to associated treatment for these conditions: Osteoporosis, Osteoporosis caused by glucocorticoid, Primary Osteoporosis

How Teriparatide Recombinant Human works

Teriparatide Recombinant Human 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 stimulates new bone formation leading to increased bone mineral density.

Dosage

Teriparatide Recombinant Human dosage

Treatment 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: The recommended dose is 20 mcg subcutaneously once a day.
Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis at High Risk for Fracture: The recommended dose is 20 mcg subcutaneously once a day.

Teriparatide Recombinant Human should be administered as a subcutaneous injection into the thigh or abdominal wall. There are no data available on the safety or efficacy of intravenous or intramuscular injection of Teriparatide Recombinant Human.
Teriparatide Recombinant Human should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Teriparatide Recombinant Human is a clear and colorless liquid. Do not use if solid particles appear or if the solution is cloudy or colored.
Patients and caregivers who administer Teriparatide Recombinant Human should receive appropriate training and instruction on the proper use of the Teriparatide Recombinant Human delivery device from a qualified health professional

Side Effects

Most common adverse reactions include: arthralgia, pain, and nausea.

Toxicity

Effects 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.

Precaution

Patients with Paget’s disease of bone, pediatric and young adult patients with open epiphyses, and patients with prior external beam or implant radiation involving the skeleton: Should not be treated with Teriparatide Recombinant Human
Treatment duration: Use of Teriparatide Recombinant Human for more than 2 years during a patient’s lifetime is not recommended.
Patients with bone metastases, history of skeletal malignancies, metabolic bone diseases other than osteoporosis, or hypercalcemic disorders: Should not be treated with Teriparatide Recombinant Human
Laboratory alterations: Teriparatide Recombinant Human may increase serum calcium, urinary calcium, and serum uric acid
Urolithiasis: Use with caution in patients with active or recent urolithiasis because of risk of exacerbation
Orthostatic hypotension: Transient orthostatic hypotension may occur with initial doses of Teriparatide Recombinant Human.

Interaction

Digoxin: A single Teriparatide Recombinant Human dose did not alter the effect of digoxin on the systolic time interval (from electrocardiographic Q-wave onset to aortic valve closure, a measure of digoxin’s calcium-mediated cardiac effect). However, because Teriparatide Recombinant Human may transiently increase serum calcium, Teriparatide Recombinant Human should be used with caution in patients taking digoxin

Hydrochlorothiazide: The coadministration of hydrochlorothiazide 25 mg with teriparatide did not affect the serum calcium response to teriparatide 40 mcg. The effect of coadministration of a higher dose of hydrochlorothiazide with teriparatide on serum calcium levels has not been studied

Furosemide: Coadministration of intravenous furosemide (20 to 100 mg) with teriparatide 40 mcg in healthy people and patients with mild, moderate, or severe renal impairment (CrCl 13 to 72 mL/min) resulted in small increases in the serum calcium (2%) and 24-hour urine calcium (37%) responses to teriparatide that did not appear to be clinically important

Food Interaction

Take with or without food.

Teriparatide Recombinant Human Disease Interaction

Major: hyperparathyroidism, malignancy, metabolic bone disorderModerate: orthostatic hypotension, renal impairment, urolithiasis

Volume of Distribution

0.12 L/kg

Elimination Route

Bioavailability is 95% following subcutaneous injection.

Clearance

62 L/hr [Women]
94 L/hr [Men]

Elimination Route

Peripheral metabolism of PTH is believed to occur by non-specific enzymatic mechanisms in the liver followed by excretion via the kidneys. The 24-hour urine excretion of calcium was reduced by a clinically unimportant amount (15%).

Pregnancy & Breastfeeding use

There are no available data on Teriparatide Recombinant Human use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider discontinuing Teriparatide Recombinant Human when pregnancy is recognized. It is not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on the breastfed infant.

Contraindication

Do not use Teriparatide Recombinant Human in patients with hypersensitivity to teriparatide or to any of its excipients. Reactions have included angioedema and anaphylaxis.

Storage Condition

The Teriparatide Recombinant Human delivery device should be stored under refrigeration at 2 to 8°C at all times. Do not freeze. Do not use Teriparatide Recombinant Human if it has been frozen.