SubcutaneousHypoparathyroidismAdult: As adjunct to Ca and vitamin D supplementation for the management of hypocalcaemia: Initially, 50 mcg once daily via SC inj into the thigh (alternating thighs daily). Upon treatment initiation, reduce the dose of active vitamin D by 50% if baseline serum Ca is >7.5 mg/dL; maintain Ca supplement dose. Parathyroid hormone dose may be increased by 25 mcg increments every 4 weeks if total serum Ca cannot be maintained >8 mg/dL without an active vitamin D and/or oral Ca supplementation. Max: 100 mcg daily. Dose may be decreased to as low as 25 mcg once daily if total serum Ca is repeatedly >9 mg/dL after active vitamin D has been discontinued and Ca supplement has been reduced to a dose adequate to meet daily needs. Recommended maintenance dose is the lowest dose required to reach a total serum Ca (albumin-corrected) concentration within the lower half of the normal range (approx 8-9 mg/dL) without requiring active vitamin D and with adequate Ca supplementation to meet daily needs. Active vitamin D and Ca supplements may require dosage adjustments during treatment depending on serum Ca and clinical assessment. Refer to detailed product guidelines for further dosing instructions or adjustments.
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Refer to detailed product guidelines for the instructions on reconstitution of the medication cartridge using the provided mixing device.
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Hypersensitivity. Skeletal malignancies or bone metastases, pseudohypoparathyroidism, increased risk for osteosarcoma (e.g. Paget's disease of bone, hereditary disorders predisposing to osteosarcoma, unexplained elevations of alkaline phosphatase, current or previous radiation therapy to the skeleton, children or young adults with open epiphyses).
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Patient with active or recent urolithiasis. Severe renal and hepatic impairment. Elderly. Pregnancy and lactation.
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Significant: Severe hypercalcaemia; severe hypocalcaemia including cases that resulted in seizures (particularly when dose is withheld, missed, or abruptly discontinued); increased risk of osteosarcoma; hypersensitivity reactions (e.g. anaphylaxis, dyspnoea, angioedema, urticaria, rash).
Cardiac disorders: Palpitations.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, upper abdominal pain.
General disorders and administration site conditions: Asthenia, chest pain, fatigue, inj site reactions, thirst.
Investigations: Decreased blood 25-hydroxycholecalciferol concentrations; anti-PTH antibody positive.
Metabolism and nutrition disorders: Hypomagnesaemia, tetany.
Musculoskeletal and connective tissue disorders: Arthralgia, muscle spasms or twitching, musculoskeletal pain, myalgia, neck pain, pain in the extremity.
Nervous system disorders: Headache, hypoaesthesia, paraesthesia, somnolence.
Psychiatric disorders: Anxiety, insomnia.
Renal and urinary disorders: Hypercalciuria, pollakiuria.
Respiratory, thoracic and mediastinal disorders: Cough, URTI, sinusitis.
Vascular disorders: Hypertension.
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Before treatment initiation, verify 25-hydroxyvitamin D stores are sufficient and serum Ca level is >7.5 mg/dL. Monitor total serum Ca (albumin-corrected) within 3-7 days after initiation or during dosage adjustments until maintenance dose is achieved and periodically thereafter. Obtain urinary Ca excretion after reaching the maintenance dose. Assess for signs and symptoms of hypocalcaemia and hypercalcaemia.
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May reduce Ca-sparing effect with alendronic acid, which may affect the normalisation of serum Ca. Concomitant use with cardiac glycosides (e.g. digoxin, digitoxin) may increase the risk of digitalis toxicity if hypercalcaemia develops.
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Description:
Mechanism of Action: Parathyroid hormone is a biosynthetic preparation that is structurally similar to the 84 amino acid sequence of the endogenous human parathyroid hormone. It elevates serum Ca concentrations by increasing renal tubular Ca reabsorption and increases intestinal Ca absorption by converting 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D. Parathyroid hormone also enhances bone turnover, thus releasing Ca into the circulation.
Onset: Peak effect: 10-12 hours.
Duration: >24 hours.
Pharmacokinetics:
Absorption: Bioavailability: 53%. Time to peak plasma concentration: 5-30 minutes (initial).
Metabolism: Primarily metabolised in the liver; cleaved by cathepsins.
Excretion: Via urine. Elimination half-life: Approx 3 hours.
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Before reconstitution, store the medication cartridge between 2-8°C. Do not freeze. Once reconstituted, store between 2-8°C for up to 14 days, or store below 25°C for up to 3 days during the 14-day use period. Protect from heat and light. Do not freeze or shake.
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H05AA03 - parathyroid hormone ; Belongs to the class of parathyroid hormones and analogues. Used in the management of calcium homeostasis.
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Anon. Parathyroid Hormone. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 03/10/2023. Anon. Parathyroid Hormone. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 31/07/2023. Buckingham R (ed). Parathyroid Hormone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 31/07/2023. Joint Formulary Committee. Parathyroid Hormone. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 31/07/2023. Natpar 100 micrograms/dose Powder and Solvent for Solution for Injection (Takeda Pharmaceuticals International AG Ireland Branch). MHRA. https://products.mhra.gov.uk. Accessed 31/07/2023. Natpar Powder and Solvent for Solution for Injection (Takeda Pharmaceuticals International AG Ireland Branch). European Medicines Agency [online]. Accessed 03/10/2023. Natpara Injection, Powder, Lyophilized, for Solution (Takeda Pharmaceuticals America, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 31/07/2023. Parathyroid Hormone. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 31/07/2023.
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