Takeda Announces NATPARA® Special Use Program in the US

September 24, 2019 Cambridge, MA

Takeda has worked with the FDA to develop a Special Use Program for NATPARA.  The program is intended to support patients previously prescribed NATPARA who are facing life-threatening complications as a result of discontinuation of NATPARA.  Through this program, healthcare providers will be able to request NATPARA for these extraordinary, life-threatening cases.  It is anticipated that an extremely small number of patients prescribed NATPARA will qualify for this very limited program.   Additional information for healthcare providers about the Special Use Program can be found here.  Patients who have questions about their eligibility under the Special Use Program or about their individual treatment plans should consult with their healthcare providers.

We realize that while this program is an important first step, it will only help a very small number of patients.  We recognize that many more patients are in need of NATPARA to control their hypoparathyroidism.  Takeda continues to work with the FDA on both short- and long-term solutions to bring NATPARA back to the broader patient community, which remains our highest priority. 

We are committed to the hypoparathyroidism community and resupplying NATPARA to patients. We will continue to work urgently on this issue and keep patients and healthcare providers informed of our progress as more information becomes available.

 

 

About NATPARA® (parathyroid hormone) for Injection in the US

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.

 

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
  • NATPARA was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor
  • NATPARA was not studied in patients with acute post-surgical hypoparathyr

 

IMPORTANT SAFETY INFORMATION

WARNING: POTENTIAL RISK OF OSTEOSARCOMA

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.

 

Contraindications:

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.

Warnings and Precautions:

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.

Adverse Reactions:

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.

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.

Use in Specific Populations:

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.

 

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About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. 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 and regions.
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