Parathyroid Hormone
Generic Name: parathyroid hormone
Brand Names:
Natpara (parathyroid Hormone)
11 DESCRIPTION The active ingredient in NATPARA, parathyroid hormone, is produced by recombinant DNA technology using a modified strain of Escherichia coli . Parathyroid hormone has 84 amino acids and a molecular weight of 9425 daltons; the amino acid sequence for parathyroid hormone is shown below in Figure 1.
Overview
11 DESCRIPTION The active ingredient in NATPARA, parathyroid hormone, is produced by recombinant DNA technology using a modified strain of Escherichia coli . Parathyroid hormone has 84 amino acids and a molecular weight of 9425 daltons; the amino acid sequence for parathyroid hormone is shown below in Figure 1.
Uses
1 INDICATIONS AND USAGE NATPARA is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Limitations of Use Because of the potential risk of osteosarcoma, NATPARA is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone [see Warnings and Precautions (5.1) ] . NATPARA was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations. NATPARA was not studied in patients with acute post-surgical hypoparathyroidism. NATPARA is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.
Dosage
2 DOSAGE AND ADMINISTRATION The dose of NATPARA should be individualized to achieve a serum calcium level in the lower half of the normal range. ( 2.1 ) Confirm vitamin D stores are sufficient and serum calcium is above 7.5 mg/dL before starting NATPARA. ( 2.2 ) The starting dose of NATPARA is 50 mcg injected once daily in the thigh. When starting NATPARA, decrease dose of active vitamin D by 50%, if serum calcium is above 7.5 mg/dL. ( 2.3 ) Monitor serum calcium levels every 3 to 7 days after starting or adjusting NATPARA dose and when adjusting either active vitamin D or calcium supplements dose while using NATPARA.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail in other sections of the label: Osteosarcoma [see Boxed Warning , Warnings and Precautions (5.1) ] Hypercalcemia [see Warnings and Precautions (5.3) ] Hypocalcemia [see Warnings and Precautions (5.4) ] Hypersensitivity [see Contraindications (4) , Warnings and Precautions (5.6) ] The most common adverse reactions associated with NATPARA and occurring in greater than 10% of individuals were: paresthesia, hypocalcemia, headache, hypercalcemia, nausea, hypoesthesia, diarrhea, vomiting, arthralgia, hypercalciuria and pain in extremity ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS Digoxin: Monitor serum calcium more frequently when using NATPARA in patients receiving digoxin. ( 5.5 , 7.2 ) 7.1 Alendronate Co-administration of alendronate and NATPARA leads to reduction in the calcium-sparing effect, which can interfere with the normalization of serum calcium. Concomitant use of NATPARA with alendronate is not recommended. 7.2 Digoxin NATPARA causes transient increase in calcium and therefore, concomitant use of NATPARA and cardiac glycosides (e.g., digoxin) may predispose patients to digitalis toxicity if hypercalcemia develops. Digoxin efficacy is reduced if hypocalcemia is present. In patients using NATPARA concomitantly with digoxin, carefully monitor serum calcium and digoxin levels, and patients for signs and symptoms of digoxin toxicity.
Warnings
WARNING: POTENTIAL 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. 5 WARNINGS AND PRECAUTIONS Potential Risk of Osteosarcoma: Prescribe NATPARA only to patients who cannot be well-controlled on calcium and active vitamin D. Avoid use of NATPARA in patients who are at increased risk for osteosarcoma. ( 5.1 ) Severe Hypercalcemia : Monitor serum calcium when starting or adjusting NATPARA dose and when making changes to co-administered drugs known to raise serum calcium. ( 2.4 , 5.3 , 6.1 ) Severe Hypocalcemia: Can occur with interruption or discontinuation of NATPARA treatment. Monitor serum calcium and replace calcium and vitamin D. ( 2.4 , 5.4 , 6.1 ) Digoxin Toxicity: Hypercalcemia increases the risk of digoxin toxicity. 4 CONTRAINDICATIONS NATPARA is contraindicated in patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions (e.g., anaphylaxis, angioedema, and urticaria) have occurred with NATPARA [see Warnings and Precautions (5.6) , Adverse Reactions (6.3) ] . Hypersensitivity to any component of this product. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available data with NATPARA Injection use in pregnant women are insufficient to inform a drug associated risk of birth defects, miscarriage or adverse maternal or fetal outcomes. There are disease associated risks to the mother and the fetus related to hypocalcemia in pregnancy. (see Clinical Considerations ).
Storage
16.2 Storage and Handling Prior to reconstitution, the dual-chamber NATPARA medication cartridge should be stored in the package provided at refrigerated temperature, 36 to 46°F (2 to 8°C). After reconstitution, the medication cartridge should be stored in the Q-Cliq pen under refrigeration at 36 to 46°F (2 to 8°C). The reconstituted product can be used for up to 14 days under these conditions.
Frequently Asked Questions
What is Parathyroid Hormone used for?▼
1 INDICATIONS AND USAGE NATPARA is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Limitations of Use Because of the potential risk of osteosarcoma, NATPARA is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone [see Warnings and Precautions (5.1) ] . NATPARA was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations. NATPARA was not studied in patients with acute post-surgical hypoparathyroidism. NATPARA is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.
What are the side effects of Parathyroid Hormone?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail in other sections of the label: Osteosarcoma [see Boxed Warning , Warnings and Precautions (5.1) ] Hypercalcemia [see Warnings and Precautions (5.3) ] Hypocalcemia [see Warnings and Precautions (5.4) ] Hypersensitivity [see Contraindications (4) , Warnings and Precautions (5.6) ] The most common adverse reactions associated with NATPARA and occurring in greater than 10% of individuals were: paresthesia, hypocalcemia, headache, hypercalcemia, nausea, hypoesthesia, diarrhea, vomiting, arthralgia, hypercalciuria and pain in extremity ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Parathyroid Hormone during pregnancy?▼
8.1 Pregnancy Risk Summary Available data with NATPARA Injection use in pregnant women are insufficient to inform a drug associated risk of birth defects, miscarriage or adverse maternal or fetal outcomes. There are disease associated risks to the mother and the fetus related to hypocalcemia in pregnancy. (see Clinical Considerations ).
What are the important warnings for Parathyroid Hormone?▼
WARNING: POTENTIAL 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. 5 WARNINGS AND PRECAUTIONS Potential Risk of Osteosarcoma: Prescribe NATPARA only to patients who cannot be well-controlled on calcium and active vitamin D. Avoid use of NATPARA in patients who are at increased risk for osteosarcoma. ( 5.1 ) Severe Hypercalcemia : Monitor serum calcium when starting or adjusting NATPARA dose and when making changes to co-administered drugs known to raise serum calcium. ( 2.4 , 5.3 , 6.1 ) Severe Hypocalcemia: Can occur with interruption or discontinuation of NATPARA treatment. Monitor serum calcium and replace calcium and vitamin D. ( 2.4 , 5.4 , 6.1 ) Digoxin Toxicity: Hypercalcemia increases the risk of digoxin toxicity. 4 CONTRAINDICATIONS NATPARA is contraindicated in patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions (e.g., anaphylaxis, angioedema, and urticaria) have occurred with NATPARA [see Warnings and Precautions (5.6) , Adverse Reactions (6.3) ] . Hypersensitivity to any component of this product. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.