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  • Natpara
    / Neopharm


    Active Ingredient
    Parathyroid Hormone 25, 50, 75, 100 mcg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Cartridge (solution for injection)

    2 X 25 mcg

    not in the basket chart 25016

    Cartridge (solution for injection)

    2 X 50 mcg

    not in the basket chart 25022

    Cartridge (solution for injection)

    2 X 75 mcg

    not in the basket chart 25115

    Cartridge (solution for injection)

    2 X 100 mcg

    not in the basket chart 24998

    Related information


    Dosage

    The dose of NATPARA should be individualized based on total serum calcium (albumin-corrected) and 24-hour urinary calcium excretion. The recommended NATPARA dose is the minimum dose required to prevent both hypocalcemia and hypercalciuria. This dose will generally be the dose that maintains total serum calcium (albumin-corrected) within the lower half of the normal range (i.e., between 8 and 9 mg/dL) without the need for active forms of vitamin D and with calcium supplementation sufficient and individualized to meet the patient’s daily requirements.
    Doses of active forms of vitamin D and calcium supplements will need to be adjusted when using NATPARA.
    Before initiating NATPARA and during therapy with NATPARA:
    – Confirm 25-hydroxyvitamin D stores are sufficient. If insufficient, replace to sufficient levels per standard of care.
    – Confirm serum calcium is above 7.5 mg/dL before starting NATPARA.
    – The goal of NATPARA treatment is to achieve serum calcium within the lower half of the normal range.
    Initiating NATPARA:
    1. Initiate NATPARA 50 mcg once daily as a subcutaneous injection in the thigh (alternate thigh every day).
    2. In patients using active forms of vitamin D, decrease the dose of active vitamin D by 50%, if serum calcium is above 7.5 mg/dL.
    3. In patients using calcium supplements, maintain calcium supplement dose.
    4. Measure serum calcium concentration within 3 to 7 days.
    5. Adjust dose of active vitamin D or calcium supplement or both based on serum calcium value and clinical assessment (i.e., signs and symptoms of hypocalcemia or hypercalcemia). Suggested adjustments to active vitamin D and calcium supplement based on serum calcium levels are provided in table 1 at the attached doctor’s leaflet.
    6. Repeat steps 4 and 5 until target serum calcium levels are within the lower half of the normal range, active vitamin D has been discontinued and calcium supplementation is sufficient to meet daily requirements.
    Dose Adjustments: The dose of NATPARA may be increased in increments of 25 mcg every four weeks up to a maximum daily dose of 100 mcg if serum calcium cannot be maintained above 8 mg/dL without an active form of vitamin D and/or oral calcium supplementation.
    The dose of NATPARA may be decreased to as low as 25 mcg per day if total serum calcium is repeatedly above 9 mg/dL after the active form of vitamin D has been discontinued and calcium supplement has been decreased to a dose sufficient to meet daily requirements.
    After a NATPARA dose change monitor clinical response as well as serum calcium. Adjust active vitamin D and calcium supplements per steps 4-6 above if indicated.
    Maintenance Dose: The maintenance dose should be the lowest dose that achieves a total serum calcium (albumin-corrected) within the lower half of the normal total serum calcium range (i.e., approximately 8 and 9 mg/dL), without the need for active forms of vitamin D and with calcium supplementation sufficient to meet daily requirements. Monitor serum calcium and 24-hour urinary calcium per standard of care once a maintenance dose is achieved.
    Dose Interruption or Discontinuation: Abrupt interruption or discontinuation of NATPARA can result in severe hypocalcemia. Resume treatment with, or increase the dose of, an active form of vitamin D and calcium supplements if indicated in patients interrupting or discontinuing NATPARA, monitor for signs and symptoms of hypocalcemia and serum calcium levels.
    In the case of a missed dose, the next NATPARA dose should be administered as soon as reasonably feasible and additional exogenous calcium should be taken in the event of hypocalcemia.
    For Reconstitution and Administration Instructions please see prescribing information.


    Indications

    NATPARA is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in adult 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.
    – 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.


    Contra-Indications

    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.


    Special Precautions

    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 observed to be 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 for 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 wellcontrolled on calcium supplements and active forms of vitamin D alone and for whom the potential benefits are considered to outweigh this potential risk.
    To further mitigate the potential risk of osteosarcoma avoid use of NATPARA in patients who are at increased risk for osteosarcoma, such as patients with Paget’s 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. Instruct patients to promptly report clinical symptoms (e.g., persistent localized pain) and signs (e.g., soft tissue mass tender to palpation) that could be consistent with osteosarcoma.
    Hypercalcemia: The marketing of Natpara is subject to a risk management plan (RMP) including a ‘Patient safety information card’. The ‘Patient safety information card’, emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment.
    Severe hypercalcemia has been reported with NATPARA. In the pivotal trial, 3 patients randomized to NATPARA required administration of IV fluids to correct hypercalcemia during treatment with NATPARA. The risk is highest when starting or increasing the dose of NATPARA but can occur at any time. Monitor serum calcium and patients for signs and symptoms of hypercalcemia. Treat
    hypercalcemia per standard practice and consider holding and/or lowering the dose of NATPARA if severe hypercalcemia occurs.
    Hypocalcemia: Severe hypocalcemia has been reported in patients taking NATPARA, including cases of hypocalcemia that resulted in seizures. The risk is highest when NATPARA is withheld, missed or abruptly discontinued, but can occur at any time. Monitor serum calcium and patients for signs and symptoms of hypocalcemia. Resume treatment with, or increase the dose of, an active form of vitamin D or calcium supplements or both if indicated in patients interrupting or discontinuing NATPARA to prevent severe hypocalcemia.
    Risk of Digoxin Toxicity with Concomitant Use of Digitalis Compounds: The inotropic effects of digoxin are affected by serum calcium levels. Hypercalcemia of any cause may predispose to digoxin toxicity. In patients using NATPARA concomitantly with digitalis compounds, monitor serum calcium and digoxin levels and patients for signs and symptoms of digitalis toxicity.
    Adjustment of digoxin and/or NATPARA may be needed. No drug-drug interaction study has been conducted with digoxin and NATPARA.
    Hypersensitivity: There have been reports of hypersensitivity reactions in patients taking NATPARA. Reactions included anaphylaxis, dyspnea, angioedema, urticaria, and rash. If signs or symptoms of a serious hypersensitivity reaction occur, discontinue treatment with NATPARA, treat hypersensitivity reaction according to the standard of care, and monitor until signs and symptoms resolve. Monitor for hypocalcemia if NATPARA is discontinued.


    Side Effects

    Common Adverse Reactions associated with NATPARA use in Subjects
    with Hypoparathyroidism: Paraesthesia, Hypocalcemia, Headache, Hypercalcemia, Nausea, Hypoaesthesia, Diarrhea, Vomiting, Arthralgia, Hypercalciuria, Pain in extremity, Upper respiratory tract infection, Abdominal pain upper, Sinusitis, Blood 25-hydroxycholecalciferol decreased, Hypertension, Hypoaesthesia facial, Neck pain.
    See prescribing information for full details.


    Drug interactions

    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.
    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. Adjustment of digoxin and/or NATPARA may be needed. No drug-drug interaction study has been conducted with digoxin and NATPARA.


    Pregnancy and Lactation

    Pregnancy: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. NATPARA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
    Lactation: It is unknown whether NATPARA is excreted in human milk. For nursing mothers, consideration should be made whether discontinuing nursing or NATPARA is warranted, taking into account the importance of the drug to the mother.
    See prescribing information for full details.


    Overdose

    Accidental overdose in studies in hypoparathyroidism occurred in 1 subject who received a 150 mcg dose and experienced mild palpitations. Serum calcium 24 hours later was 10.3 mg/dL. In the event of overdose, the patient should be carefully monitored for hypercalcemia by a medical professional.


    Important notes

    Storage: Prior to reconstitution, the dual-chamber NATPARA medication cartridge should be stored in the package provided at refrigerated temperature, 2 to 8°C. After reconstitution, the medication cartridge should be stored in the Q-Cliq pen under refrigeration at 2 to 8°C. The reconstituted product can be used for up to 14 days under these conditions. Store away from heat and light. Avoid exposure to elevated temperatures.
    Discard reconstituted NATPARA medication cartridges after 14 days.
    Do not freeze or shake. Do not use NATPARA if it has been frozen or shaken.
    The mixing device and empty Q-Cliq pen can be stored at room temperature.
    Safely discard needles.


    Manufacturer
    NPS Pharmaceuticals, Inc., USA
    Licence holder
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