Parathyroid Hormone Dosage
Applies to the following strength(s): 25 mcg/dose ; 50 mcg/dose ; 75 mcg/dose ; 100 mcg/dose
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Hypocalcemia
50 mcg subcutaneously once a day
-The injection should be given in the thigh (alternate thigh every day).
Use: An adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.
Renal Dose Adjustments
Mild renal impairment: No adjustment recommended
Moderate to severe renal impairment: Data not available
Liver Dose Adjustments
Mild to moderate hepatic impairment: No adjustment recommended
Severe hepatic impairment: Data not available
-The dose should be individualized based on total serum calcium (albumin corrected) and 24 hour urinary calcium excretion.
-The recommended dose is the minimum to prevent both hypocalcemia and hypercalciuria. This dose should maintain total serum calcium (albumin corrected) within the lower half of the normal range (i.e., between 8 and 9 mg/dL) without the need for active forms of vitamin D and with calcium supplementation sufficient to meet the patient daily requirements.
-Doses of active forms of vitamin D and calcium supplements will need to be adjusted when using this drug.
Initiating this drug:
1) Initiate at 50 mcg subcutaneously once a day
2) In patients using active forms of vitamin D, the dose of active vitamin D should be decreased by 50% if serum calcium is above 7.5 mg/dL.
3) In patients using calcium supplements, the dose should be maintained.
4) Serum calcium concentration should be measured within 3 to 7 days.
5) The dose of active vitamin D or calcium supplement or both should be adjusted based on serum calcium value and clinical assessment (i.e., signs of hypocalcemia or hypercalcemia).
6) Repeat steps 4 and 5 until target serum calcium levels are within the lower half of the normal range, active vitamin D has been discontinued, and calcium supplementation is sufficient to meet daily requirements.
Suggested adjustments to active vitamin D and calcium supplement based on serum calcium levels:
-Serum calcium above the Upper Limit of Normal (ULN) (10.6 mg/dL): Decrease or discontinue (discontinue in patients receiving the lowest available dose) vitamin D and decrease calcium.
-Serum calcium greater than 9mg/dL and below the ULN (10.6 mg/dL): Decrease or discontinue (discontinue in patients receiving the lowest available dose) vitamin D and no change/or decrease calcium if vitamin D has been discontinued.
-Serum calcium less than or equal to 9 mg/dL and above 8 mg/dL: No change to vitamin D and no change to calcium.
-Serum calcium lower than 8 mg/dL: Increase vitamin D and increase calcium.
-The dose may be increased in increments of 25 mcg every four weeks up to a maximum daily dose of 100 mcg if serum calcium cannot be maintained above 8 mg/dL without an active form of vitamin D and/or oral calcium supplementation.
-The dose may be decreased to as low as 25 mcg per day if total serum calcium is repeatedly above 9 mg/dL after the active form of vitamin D has been discontinued and calcium supplement has been decreased to a dose sufficient to meet daily requirements.
-After a dose change the clinical response and serum calcium should be monitored. The active vitamin D and calcium doses should be adjusted per steps 4 through 6 above if indicated.
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for parathyroid hormone. It includes elements to assure safe use, and an implementation system. For additional information: www.fda.gov/REMS.
US BOXED WARNINGS:
-In animal studies, parathyroid hormone caused an increase in the incidence of osteosarcoma. The occurrence of osteosarcoma was dependent on parathyroid hormone dose and treatment duration. This effect was observed at parathyroid hormone exposure levels ranging from 3 to 71 times the exposure levels in humans. These data could not exclude a risk to humans.
-Because of a potential risk of osteosarcoma, use this drug only in patients who cannot be well controlled on calcium and active forms of vitamin D alone and for whom the potential benefits outweigh this potential risk.
-Avoid use of this drug in patients who are at increased baseline risk for osteosarcoma such as patients with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, patients with hereditary disorders predisposing to osteosarcoma or patients with a prior history of external beam or implant radiation therapy involving the skeleton.
-Because of the risk of osteosarcoma, this drug is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NATPARA REMS Program.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Refer to the manufacturer product information.
-Refer to the manufacturer product information.
-Refer to the manufacturer product information or local protocol.
More about parathyroid hormone
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- Drug class: parathyroid hormone and analogs
Other brands: Natpara