CAMBRIDGE, Massachusetts, March 31, 2021 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. announced today that we do not expect the NATPARA® (parathyroid hormone) for Injection to return to the US commercial market before March 31, 2022.
While we have made progress on the original issue that led to the US recall, which was the issue of rubber particulates originating from the rubber septum of the NATPARA cartridge, we have not yet reached a resolution. We continue to face complex challenges in bringing NATPARA back to the broader patient community in the US. At this time we do not expect a return to the US market before the end of the first quarter of 2022.
Patients who are currently enrolled in the NATPARA Special Use Program (SUP) continue to have access to therapy.
The NATPARA SUP came into effect in September 2019, in agreement with FDA, following the US recall of NATPARA early that month. The goal of the SUP is to offer patients previously prescribed NATPARA who are at extreme risk of life-threatening complications an option to continue NATPARA therapy.
We will continue to keep the US hypoparathyroidism community informed of relevant updates as we progress.
NATPARA (parathyroid hormone) for Injection is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.
In male and female rats, parathyroid hormone caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration. A risk to humans could not be excluded.
Because of the potential risk of osteosarcoma, prescribe NATPARA only to patients who cannot be well-controlled on calcium and active forms of vitamin D and for whom the potential benefits are considered to outweigh the potential risk.
Avoid use of NATPARA in patients who are at increased baseline risk for osteosarcoma (including those 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 history of prior external beam or implant radiation therapy involving the skeleton).
NATPARA is available only through a restricted program called the NATPARA REMS Program.
For more information about the NATPARA REMS program, call 1-855-NATPARA or go to www.NATPARAREMS.com.
NATPARA is contraindicated in patients with a known hypersensitivity to any component of NATPARA. Hypersensitivity reactions (e.g., anaphylaxis, angioedema, and urticaria) have occurred with NATPARA.
Hypercalcemia: Severe hypercalcemia has been reported 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 that resulted in seizures. The risk is highest with interruption or discontinuation of NATPARA treatment but can occur at any time. Monitor serum calcium and patients for signs and symptoms of hypocalcemia, and replace calcium and vitamin D if indicated in patients interrupting or discontinuing NATPARA to prevent severe hypocalcemia.
Digoxin Toxicity: Hypercalcemia increases the risk of digoxin toxicity. In patients using NATPARA concomitantly with digoxin, monitor serum calcium more frequently and increase monitoring when initiating or adjusting NATPARA dose.
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.
The most common adverse reactions associated with NATPARA and occurring in greater than 10% of individuals were: paresthesia, hypocalcemia, headache, hypercalcemia, nausea, hypoaesthesia, diarrhea, vomiting, arthralgia, hypercalciuria and pain in extremity.
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.
There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The safety and efficacy in pediatric patients have not been established
Please see Full Prescribing Information, including Boxed Warning for potential risk of osteosarcoma.
Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit https://www.takeda.com.
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