Medically reviewed by Drugs.com. Last updated on Sep 26, 2020.
(par a THYE roid HOR mone)
- Recombinant Human Parathyroid Hormone (1-84)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Natpara: 25 mcg (1 ea); 50 mcg (1 ea); 75 mcg (1 ea); 100 mcg (1 ea) [contains metacresol]
Brand Names: U.S.
- Parathyroid Hormone Analog
Exogenous parathyroid hormone; parathyroid hormone raises serum calcium concentrations by increasing renal tubular calcium reabsorption, increasing intestinal calcium absorption, and by increasing bone turnover, which releases calcium into the circulation.
Vdss: 5.35 L
Primarily hepatic; cleavage by cathepsins
Renal (primarily by glomerular filtration)
Onset of Action
Peak effect: 10 to 12 hours
Time to Peak
5 to 30 minutes
Duration of Action
Special Populations: Renal Function Impairment
Mean Cmax in subjects with mild (CrCl 60 to 90 mL/minute) and moderate (CrCl 30 to 60 mL/minute) renal impairment was ~22% higher than that observed in subjects with normal renal function. AUC0-last and baseline-corrected AUC0-last was ~3.9% and ~2.5%, respectively, higher than that observed for subjects with normal renal function. No studies were conducted in patients with severe renal impairment or in patients on dialysis.
Special Populations: Hepatic Function Impairment
Mean Cmax and baseline-corrected Cmax values were 18% to 20% greater in the moderately impaired subjects than in those with normal function.
Use: Labeled Indications
Hypoparathyroidism: Adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism
Limitations of use: Because of the potential risk of osteosarcoma, recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone; has not been studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations or in patients with acute postsurgical hypoparathyroidism
Hypersensitivity to parathyroid hormone or any component of the formulation.
Hypoparathyroidism: SubQ: Note: Prior to initiation of therapy, confirm that the serum calcium concentration is >7.5 mg/dL and the 25-hydroxyvitamin D stores are sufficient (correct if insufficient)
Initial: 50 mcg once daily.
Dosage adjustment: Note: Active forms of vitamin D and calcium supplementation may require adjustment during parathyroid hormone therapy based on albumin-corrected serum calcium concentrations; consult parathyroid hormone product labeling for more information.
Serum calcium (albumin-corrected) cannot be maintained >8 mg/dL without an active form of vitamin D and/or calcium supplementation: Increase the parathyroid hormone dose in increments of 25 mcg/day every 4 weeks; maximum daily dose: 100 mcg/day
Serum calcium (albumin-corrected) repeatedly >9 mg/dL after discontinuation of active forms of vitamin D and calcium supplementation decreased to a dose sufficient to meet daily needs: May decrease the parathyroid hormone dose to a minimum of 25 mcg/day
Maintenance: Use the lowest dose required to prevent both hypocalcemia and hypercalciuria while maintaining albumin-corrected serum calcium concentrations at the lower half of the normal range (ie, between 8 and 9 mg/dL) without the need for active forms of vitamin D and with calcium supplementation sufficient to meet the patient’s daily requirements.
Discontinuation or interruption of therapy: An abrupt interruption or discontinuation may result in severe hypocalcemia; resume treatment with or increase the dose of an active form of vitamin D and calcium supplementation (if indicated).
Missed dose: Administer parathyroid hormone as soon as reasonably feasible; additional calcium should be administered in the event of hypocalcemia.
Refer to adult dosing; use with caution.
Reconstitute medication cartridge with provided mixing device. The mixing device can be used to reconstitute up to six medication cartridges.
SubQ: Administer subcutaneously into the thigh (alternate thighs each day) using the provided Q-Cliq pen. Follow instructions provided with the medication cartridges and the Q-Cliq pen to prepare the injection device for use. One Q-Cliq pen may be used for up to 2 years, with changing the reconstituted cartridge every 2 weeks. Patients and caregivers who will administer parathyroid hormone should receive appropriate training and instruction by a trained health care professional prior to first use.
Prior to reconstitution, the dual-chamber medication cartridge should be stored in the package provided at 2°C to 8°C (36°F to 46°F). After reconstitution, the medication cartridge should be stored in the Q-Cliq pen at 2°C to 8°C (36°F to 46°F) for up to 14 days. Store away from heat and light. Discard reconstituted medication cartridges after 14 days. Do not freeze or shake or use if it has been frozen or shaken. The mixing device and empty Q-Cliq pen can be stored at room temperature.
Alendronate: May diminish the therapeutic effect of Parathyroid Hormone. More specifically, Alendronate may interfere with normalization of blood calcium concentrations. Avoid combination
Cardiac Glycosides: Parathyroid Hormone may enhance the adverse/toxic effect of Cardiac Glycosides. More specifically, Parathyroid Hormone-related hypercalcemia may predispose to digitalis toxicity. Monitor therapy
Central nervous system: Paresthesia (31%), headache (25%), hypoesthesia (14%)
Endocrine & metabolic: Hypocalcemia (27%), hypercalcemia (19%)
Gastrointestinal: Diarrhea (12%), vomiting (12%)
Genitourinary: Hypercalciuria (11%)
Immunologic: Antibody development (9% to 16%)
Neuromuscular & skeletal: Arthralgia (11%)
1% to 10%:
Cardiovascular: Hypertension (6%)
Central nervous system: Peripheral pain (10%), facial hypoesthesia (6%)
Endocrine & metabolic: Inhibited conversion of vitamin D3 to 25-hydroxy-D3 (6%)
Gastrointestinal: Upper abdominal pain (7%)
Neuromuscular & skeletal: Neck pain (6%)
Respiratory: Upper respiratory tract infection (8%), sinusitis (7%)
<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, hypersensitivity reaction, seizure
ALERT: U.S. Boxed WarningPotential risk of osteosarcoma:
In male and female rats, parathyroid hormone caused an increase in the incidence of osteosarcoma (a malignant bone tumor). 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 receiving a 100 mcg dose of Natpara. These data could not exclude a risk to humans.
Because of a potential risk of osteosarcoma, use Natpara only in patients who cannot be well-controlled on calcium and active forms of vitamin D alone and for whom the potential benefits are considered to outweigh this potential risk.
Avoid use of Natpara in patients who are at increased baseline risk for osteosarcoma such as patients with Paget 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, Natpara is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Natpara REMS Program.
Concerns related to adverse effects:
• Hypercalcemia: Severe hypercalcemia has been reported; the risk is highest during initiation of therapy and dose escalation. Monitor serum calcium concentrations and patients for signs and symptoms of hypercalcemia. Treat hypercalcemia as needed and consider temporary discontinuation or a reduction in dose if severe hypercalcemia occurs.
• Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, dyspnea, angioedema, urticaria, and rash, have been reported with parathyroid hormone therapy. Discontinue therapy if signs of severe hypersensitivity occur.
• Hypocalcemia: Severe hypocalcemia has been reported, including cases that have resulted in seizures, and can occur at any time during therapy; the risk is highest when a dose is missed or when parathyroid hormone therapy is withheld or abruptly discontinued. Monitor serum calcium concentrations and patients for signs and symptoms of hypocalcemia. In patients who must have therapy interrupted or discontinued, resume treatment with or increase the dose of an active form of vitamin D and/or calcium supplements to prevent severe hypocalcemia.
• Osteosarcoma: [US Boxed Warning]: In animal studies, parathyroid hormone has been associated with an increase in osteosarcoma; risk was dependent on both dose and duration. Avoid use in patients with an increased risk of osteosarcoma (including Paget disease, prior external beam or implant radiation therapy involving the skeleton, unexplained elevation of alkaline phosphatase, patients with open epiphyses, patients with hereditary disorders predisposing to osteosarcoma). Treatment should only be used in patients who cannot be well controlled on calcium supplements and active forms of vitamin D alone. Parathyroid hormone is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NATPARA REMS Program.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Total serum calcium (albumin-corrected) prior to therapy initiation, within 3 to 7 days following initiation or dosage adjustments until maintenance dose has been achieved, and periodically thereafter; urinary calcium excretion (after maintenance dose is achieved); signs and symptoms of hypo- and hypercalcemia
Pregnancy Risk Factor
Adverse events were observed in animal reproduction studies.
What is this drug used for?
• It is used to control low blood calcium levels in people who have low blood parathyroid hormone levels.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Joint pain
• Painful extremities
• Common cold symptoms
• Neck pain
• Abdominal pain
• Tingling, tickling, or burning of skin
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• High calcium like weakness, confusion, feeling tired, headache, nausea and vomiting, constipation, or bone pain
• Skin growths
• Persistent pain
• Severe dizziness
• Severe headache
• Passing out
• Vision changes
• Fast heartbeat
• Low calcium like muscle cramps or spasms, numbness and tingling, or seizures
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about parathyroid hormone
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- 6 Reviews
- Drug class: parathyroid hormone and analogs
- FDA Alerts (1)
Other brands: Natpara