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Managing hypoparathyroidism

NATPARA works by treating low blood calcium in hypoparathyroidism

NATPARA is the first and only FDA-approved prescription parathyroid hormone that is taken along with calcium and vitamin D to control hypocalcemia in adults with hypoparathyroidism.

PTH balances the level of calcium and vitamin D in the body in 3 major organs by:

Activating vitamin D to help the body get calcium from food

Activating vitamin D to help the body get calcium from food

Increasing the amount of calcium the kidneys reabsorb

Increasing the amount of calcium the kidneys reabsorb

Releasing calcium from the bones into the bloodstream

Releasing calcium from the bones into the bloodstream

NATPARA helps to control your blood calcium level

NATPARA helps raise low blood calcium levels caused by hypoparathyroidism. It works by:

  • Helping your intestines absorb calcium by activating vitamin D
  • Increasing the amount of calcium your kidneys reabsorb
  • Releasing calcium from your bones

NATPARA may cause 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.

NATPARA helped reduce the need for oral calcium supplements and reduced or removed the need for active vitamin D

In a 24-week clinical study in 124 adults with hypoparathyroidism:

  • To prove the efficacy of NATPARA, by the end of the study patients had to have their:
    • Dose of active vitamin D reduced by at least 50%
    • Dose of calcium reduced by at least 50%
    • Blood calcium level in a certain target range (between 7.5 mg/dL and 10.6 mg/dL)

of patients who received NATPARA reduced their active vitamin D and oral calcium use by at least half while maintaining calcium levels in the blood within a target range compared with 3% in the placebo groupa,b

of patients who received NATPARA were able to stop all use of active vitamin D and to reduce their oral calcium to no more than 500 mg per day compared with 3% in the placebo groupa,b

of patients who received NATPARA reduced their oral calcium use by at least half compared with 8% in the placebo groupa,b

At the end of the clinical study, there were no differences in the percentage of patients with serum calcium levels between 7.5 mg/dL and 10.6 mg/dL in the NATPARA (86.9%) and placebo (87.5%) groups.

Of the 124 adult patients, 84 were taking NATPARA and 40 were taking placebo.

NATPARA may cause serious side effects, including:

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.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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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.