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Takeda, in alignment with the U.S. Food and Drug Administration (FDA), will close the U.S. Special Use Program (SUP) for NATPARA® (parathyroid hormone) for Injection at the end of 2025. TAKEDA WILL CEASE SHIPMENTS OF NATPARA BY DECEMBER 31, 2025 AND NATPARA WILL NO LONGER BE AVAILABLE TO SUP PATIENTS. Learn How This May Affect You
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NATPARA is a prescription parathyroid hormone used with calcium and vitamin D to control low blood calcium (hypocalcemia) in people with low parathyroid hormone blood levels (hypoparathyroidism). It is only for people who do not respond well to treatment with calcium and active forms of vitamin D alone, because it may increase the possible risk of bone cancer (osteosarcoma).

NATPARA was not studied in people with hypoparathyroidism caused by calcium-sensing receptor mutations. It was not studied in people who get sudden hypoparathyroidism after surgery. It is not known if NATPARA is safe and effective for children 18 years of age and younger. NATPARA should not be used in children and young adults whose bones are still growing.

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NATPARA is a prescription parathyroid hormone used with calcium and vitamin D to control low blood calcium (hypocalcemia) in people with low parathyroid hormone blood levels (hypoparathyroidism). It is only for people who do not respond well to treatment with calcium and active forms of vitamin D alone, because it may increase the possible risk of bone cancer (osteosarcoma).

NATPARA was not studied in people with hypoparathyroidism caused by calcium-sensing receptor mutations. It was not studied in people who get sudden hypoparathyroidism after surgery. It is not known if NATPARA is safe and effective for children 18 years of age and younger. NATPARA should not be used in children and young adults whose bones are still growing.

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IMPORTANT INFORMATION REGARDING THE CLOSURE OF THE NATPARA® (PARATHYROID HORMONE) U.S. SPECIAL USE PROGRAM

The purpose of this letter is to inform you that Takeda, in alignment with the U.S. Food and Drug Administration (FDA), will close the U.S. Special Use Program for NATPARA® (parathyroid hormone) for Injection on December 31, 2025. This means that no NATPARA shipments will be sent after December 31, 2025. This decision follows the previously communicated global manufacturing discontinuation of NATPARA in December 2024 and aligns with our current estimate for NATPARA inventory depletion in the U.S.

We understand that you may have questions and are here to support you during this time. Our priority remains to maintain treatment continuity for patients currently receiving NATPARA under the U.S. Special Use Program until the program ends. We are informing you of the program end now to give you approximately six months to develop a longer-term treatment plan with your healthcare team.

The U.S. NATPARA Special Use Program, a first-of-its-kind access program intended to support patients previously prescribed NATPARA who may face life-threatening complications as a result of discontinued treatment, has been in place since September 2019. The primary reason the FDA supported Takeda’s efforts to make the recalled product available in the U.S. through the Special Use Program was the unavailability at that time of an alternate approved parathyroid hormone for the treatment of patients with hypoparathyroidism. With the availability of a new treatment option for hypoparathyroidism in the U.S., our goal is to now support you as you develop a treatment plan with your healthcare teams to transition to alternate therapy by the end of this calendar year.

Transitioning To Alternate Treatment
If you have not already done so, we encourage you to start the conversation as soon as possible with your healthcare team to allow sufficient time for you to develop an appropriate alternate treatment plan. It is imperative that you speak to your healthcare team before stopping NATPARA.

While you remain in the U.S. NATPARA Special Use Program, it is important to adhere to the previously agreed upon administration guidelines. Each NATPARA cartridge dispensed to you under the U.S. NATPARA Special Use Program is intended for single use. This product is approved for your personal use only. Per the U.S. NATPARA Special Use Program requirements, please remember to return all used and unused NATPARA cartridges to Takeda.

Takeda Support
We remain steadfastly committed to supporting you throughout this transition. Our NATPARA Special Use Program support team is here to help you. If you have any questions about the program, please contact your NATPARA Special Use Program manager at 1-866-888-0660, Monday through Friday 8:30 AM – 8:00 PM ET.

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Important Safety Information

What is the most important information I should know about NATPARA?

Warning: Possible bone cancer (osteosarcoma).

  • During animal drug testing, NATPARA caused some rats to develop a bone cancer called osteosarcoma.
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Important Safety Information

What is the most important information I should know about NATPARA?

Warning: Possible bone cancer (osteosarcoma).

  • During animal drug testing, NATPARA caused some rats to develop a bone cancer called osteosarcoma. It is not known if people who take NATPARA will have a higher chance of getting osteosarcoma. Tell your doctor right away if you have pain in any areas of your body that does not go away, or any new or unusual lumps or swelling under your skin that is tender to touch.
  • NATPARA is only available through the NATPARA Risk Evaluation and Mitigation Strategy (REMS) Program. The purpose of the NATPARA REMS program is to inform patients about the potential risk of osteosarcoma associated with the use of NATPARA. For more information about this REMS program, call 1-855-NATPARA (628-7272) or go to www.NATPARAREMS.com.

NATPARA may cause other serious side effects, including:

High blood calcium (hypercalcemia)

  • NATPARA can cause some people to have a higher blood calcium level than normal.
    • Your doctor should check your blood calcium before you start and during your treatment with NATPARA.
    • Tell your doctor if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs that you have too much calcium in your blood.

Low blood calcium (hypocalcemia)

  • People who stop using or miss a dose of NATPARA may have an increased risk of severe low blood calcium levels.
  • Tell your doctor if you have tingling of your lips, tongue, fingers and feet, twitching of face muscles, cramping of feet and hands, seizures, depression, or have problems thinking or remembering.

Tell your doctor right away if you have any of these signs and symptoms of high or low blood calcium levels.

Who should not use NATPARA?

  • Do not use NATPARA if you are allergic to parathyroid hormone or any of the ingredients in NATPARA.

What should I tell my healthcare provider before using NATPARA?

  • Before you start using NATPARA, tell your doctor about all of your medical conditions. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of NATPARA?

  • NATPARA may cause serious side effects like allergic (hypersensitivity) reaction, including anaphylaxis. Tell your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction:
    • swelling of your face, lips, mouth, or tongue
    • breathing problems
    • fainting, dizziness, feeling lightheaded (low blood pressure)
    • fast heartbeat
    • itching
    • rash
    • hives
  • The most common side effects of NATPARA include: tingling, tickling, or burning feeling of the skin, low or high blood calcium, headache, nausea, reduced sense of touch or sensation, diarrhea, vomiting, pain in joints, too much calcium in urine, and pain in limbs.

These are not all the possible side effects of NATPARA. For more information, talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Prescribing Information, Medication Guide, and Instructions for Use.