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Natpara Generic Name & Formulations
Legal Class
Rx
General Description
Parathyroid hormone (recombinant) 25mcg, 50mcg, 75mcg, 100mcg; lyophilized pwd for SC inj after reconstitution.
Pharmacological Class
Hormone.
How Supplied
Multi-dose cartridges (dual-chamber)—2
Manufacturer
Generic Availability
NO
Natpara Indications
Indications
Adjunct to calcium and vitamin D to control hypocalcemia in hypoparathyroidism.
Limitations of Use
Use only for patients uncontrolled on calcium supplements and active vitamin D alone. Not studied in hypoparathyroidism caused by calcium-sensing receptor mutations or in acute post-surgical hypoparathyroidism.
Natpara Dosage and Administration
Adult
Individualize based on total serum calcium (albumin-corrected) and 24hr urinary calcium excretion. Give as SC inj in the thigh (alternate thigh daily). Initially 50mcg once daily; may increase in increments of 25mcg every 4 weeks up to max 100mcg daily, if serum calcium is not maintained >8mg/dL. May decrease to 25mcg daily if serum calcium repeatedly >9mg/dL. If currently receiving active vitamin D: decrease vitamin D dose by 50% if serum calcium >7.5mg/dL. Maintenance: use lowest dose to achieve total serum calcium within the lower half of the normal range (approx. 8–9mg/dL). See full labeling.
Children
<18yrs: not established.
Natpara Contraindications
Not Applicable
Natpara Boxed Warnings
Boxed Warning
Potential risk of osteosarcoma.
Natpara Warnings/Precautions
Warnings/Precautions
Confirm sufficient 25-hydroxyvitamin D stores and serum calcium >7.5mg/dL prior to initiation. Avoid in those with increased risk of osteosarcoma (eg, Paget's disease of bone, unexplained elevations of alkaline phosphatase, pediatric and young adults with open epiphyses, hereditary disorders predisposing to osteosarcoma, history of external beam or implant radiation therapy involving the skeleton). Measure calcium concentration every 3–7 days after starting therapy and when adjusting Natpara, active vitamin D, or calcium supplement doses; consider holding and/or reducing dose if severe hypercalcemia occurs. Monitor for severe hypocalcemia when Natpara interruption or discontinuation; resume treatment with or increase dose of vitamin D and/or calcium supplements if occurs. Renal impairment. Elderly. Pregnancy. Nursing mothers: monitor infants.
REMS
Natpara Pharmacokinetics
See Literature
Natpara Interactions
Interactions
Concomitant alendronate: not recommended. Concomitant digoxin: monitor serum calcium, digoxin levels, and for digitalis toxicity; adjustments may be needed for both drugs.
Natpara Adverse Reactions
Adverse Reactions
Paresthesia, hypocalcemia, headache, hypercalcemia, nausea, hypoaesthesia, diarrhea, vomiting, arthralgia, hypercalciuria, pain in extremity; hypersensitivity reactions (discontinue if occur), possibly osteosarcoma.
Natpara Clinical Trials
See Literature
Natpara Note
Not Applicable
Natpara Patient Counseling
See Literature
