Chronic hypoparathyroidism is a rare endocrine disease resulting from an inappropriately low circulating parathyroid hormone (PTH) concentration.1
NATPAR is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.2
- Bollerslev J, Rejnmark L, Marcocci C, et al. European Society of Endocrinology Clinical Guideline: Treatment of chronic hypoparathyroidism in adults. Eur J Endocrinol 2015;173(2):G1–20.
- NATPAR (parathyroid hormone for injection), EMA Summary of Product Characteristics. Shire Pharmaceuticals.
NATPAR® (parathyroid hormone (rDNA)
Detailed Safety Statement
Please consult the NATPAR Summary Product Characteristics (SmPC) before prescribing.
NATPAR treatment should be supervised by a physician or other qualified healthcare professional experienced in the management of patients with hypoparathyroidism.
NATPAR is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, who are receiving or who have previously received radiation therapy to the skeleton, with skeletal malignancies or bone metastases, who are at increased baseline risk for osteosarcoma, with unexplained elevations of bone-specific alkaline phosphatase, with pseudohypoparathyroidism.
Warnings and Precautions
Monitoring of patients during treatment Pre-dose and in some cases post-dose serum calcium levels must be monitored during treatment with NATPAR.
Hypercalcaemia This was reported in clinical trials with NATPAR. Hypercalcaemia commonly occurred during the titration period, during which doses of oral calcium, active vitamin D, and NATPAR were being adjusted. Hypercalcaemia may be minimized by following the recommended dosing, the monitoring information and asking patients about any symptoms of hypercalcaemia. If severe hypercalcaemia develops, hydration and temporarily stopping NATPAR, calcium and active vitamin D should be considered until serum calcium returns to the normal range. Then consider resuming NATPAR, calcium and active vitamin D at lower doses.
Hypocalcaemia A common clinical manifestation of hypoparathyroidism, was reported in clinical trials with NATPAR. Most of the hypocalcaemic events occurring in the clinical trials were mild to moderate severity. The risk for serious hypocalcaemia was greatest after the withdrawal of NATPAR. Temporary or permanent discontinuation of NATPAR must be accompanied by monitoring of serum calcium levels and increase of exogenous calcium and/or vitamin D sources as necessary. Hypocalcaemia may be minimized by following the recommended dosing, the monitoring information, and asking patients about any symptoms of hypocalcaemia.
Concomitant use with cardiac glycosides Hypercalcaemia of any cause may predispose to digitalis toxicity, monitor serum calcium and cardiac glycoside levels and patients for signs and symptoms of digitalis toxicity.
Severe renal or hepatic disease NATPAR should be used with caution in patients with severe renal or hepatic disease because they have not been evaluated in clinical trials.
Use in young adults NATPAR should be used with caution in young adult patients with open epiphyses.
Tachyphylaxis The calcium-raising effect of NATPAR may diminish over time in some patients. The response of serum calcium concentration to administration of NATPAR should be monitored at intervals to detect this and the diagnosis of tachyphylaxis considered.
The most commonly observed adverse events with NATPAR treatment were hypercalcaemia, hypocalcaemia, headache, diarrhoea, vomiting, paraesthesia, hypoaesthesia and hypercalciuria.
|Hypercalcaemia, hypocalcaemia, headache, hypoaesthesia, paraesthesia, diarrhoea, nausea, vomiting, arthralgia, and muscle spasms.|
(≥1/100 to <1/10):
|Hypomagnesaemia, tetany, anxiety, insomnia, somnolence, palpitations, hypertension, cough, abdominal pain upper, muscle twitching, musculoskeletal pain, myalgia, neck pain, pain in extremity, hypercalciuria, pollakiuria, asthenia, chest pain, fatigue, injection site reactions, thirst, anti-PTH antibody positive, blood 25-hydroxycholecalciferol decreased, vitamin D decreased.|
Source: NATPAR European Abbreviated Prescribing Information.
Date of preparation: May 2017
|Body weight (kg)||Volume to be injected (mL)|