Natpara

What is Natpara?

Natpara is a parathyroid hormone used as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.

What are the uses of this medicine?

This medicine is used to treat:

• NATPARA is a prescription parathyroid hormone (PTH) used with calcium and vitamin D to control low blood calcium (hypocalcemia) in people with low PTH blood levels (hypoparathyroidism).

Limitations of Use

• NATPARA 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.
• NATPARA was not studied in people who get sudden hypoparathyroidism after surgery.

How does this medicine work?

• NATPARA is a parathyroid hormone.
• Parathyroid hormone raises serum calcium by increasing renal tubular calcium reabsorption, increasing intestinal calcium absorption (i.e., by converting 25-OH vitamin D to 1,25-OH2 vitamin D) and by increasing bone turnover which releases calcium into the circulation.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• with a known hypersensitivity to any component of this product.

What drug interactions can this medicine cause?

• Concomitant use of NATPARA with alendronate is not recommended.
• 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.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

• The recommended NATPARA dose is the minimum dose required to prevent both hypocalcemia and hypercalciuria.
• 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.

Recommended Dosage:

• The starting dose of NATPARA is 50 mcg injected once daily in the thigh.
• When starting NATPARA, decrease dose of active vitamin D by 50%, if serum calcium is above 7.5 mg/dL.
• Monitor serum calcium levels every 3 to 7 days after starting or adjusting NATPARA dose and when adjusting either active vitamin D or calcium supplements dose while using NATPARA.

Administration

• Use NATPARA exactly as your doctor tells you to.
• NATPARA is given with the Q-CliqTM pen injector. Before you use NATPARA for the first time, a healthcare provider will show you how to use the Q-Cliq pen the right way and how to properly mix NATPARA using the mixing device.
• Do not stop taking or change your dose of NATPARA unless your doctor tells you to. Your calcium level could become dangerously low.
• Give NATPARA 1 time each day in your thigh just under your skin (subcutaneous).
• After you mix NATPARA, each medicine cartridge can be used for 14 injections (14 doses). After you use the 14 doses throw away the cartridge.
• Do not throw away the Q-Cliq pen. It can be re-used for up to 2 years, by changing the mixed NATPARA medicine cartridges every 2 weeks (14 days).
• Look at NATPARA for any discoloration or particles in the medicine. It should be colorless. It is normal to see small particles in the liquid.
• Do not transfer the medicine from the NATPARA medicine cartridge to a syringe. This can cause you to use the wrong dose of NATPARA.
• Your doctor should check your blood calcium level when you start and while you are using NATPARA. After you start NATPARA, your doctor may change your doses of calcium and active vitamin D.
• If you miss a day or forget to give your daily NATPARA injection, give your injection as soon as you remember and call your doctor right away. You may need to take more calcium. Take your next dose of NATPARA the next day as prescribed.
• If you use more than your daily dose of NATPARA, call your doctor right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• NATPARA is supplied as a multiple-dose, dual-chamber glass cartridge containing a sterile lyophilized powder and a sterile diluent for reconstitution in four dosage strengths.
• For injection: 25 mcg, 50 mcg, 75 mcg, or 100 mcg

This medicine is available in fallowing brand namesː

• NATPARA

What side effects can this medication cause?

The most common side effects of this medicine include:

• tingling,tickling, or a burning feeling of your skin (paresthesia)
• headache
• nausea

NATPARA may cause serious side effects, including:

• possible bone cancer (osteosarcoma)
• high blood calcium (hypercalcemia)
• low blood calcium (hypocalcemia)
• Allergic (hypersensitivity) reaction, including anaphylaxis

What special precautions should I follow?

• Because of a potential risk of osteosarcoma, use NATPARA only in patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone and for whom the potential benefits are considered to outweigh this potential risk.
• Because of the potential risk of osteosarcoma associated with NATPARA therapy, NATPARA is available only through a restricted REMS program called the NATPARA REMS Program.
• Severe hypercalcemia has been reported with NATPARA. Monitor serum calcium when starting or adjusting NATPARA dose and when making changes to co-administered drugs known to raise serum calcium.
• Severe hypocalcemia has been reported in patients taking NATPARA, including cases of hypocalcemia that resulted in seizures. Can occur with interruption or discontinuation of NATPARA treatment. Monitor serum calcium and replace calcium and vitamin D.
• 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 reactions (anaphylaxis, dyspnea, angioedema, urticaria, rash) have been reported. If signs or symptoms of a serious hypersensitivity reaction occur, discontinue treatment with NATPARA and treat patient according to the standard of care.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• mild palpitations
• hypercalcemia

Management for overdosage:

• In the event of overdose, the patient should be carefully monitored for hypercalcemia by a medical professional.

Can this medicine be used in pregnancy?

• Available data with NATPARA Injection use in pregnant women are insufficient to inform a drug associated risk of birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and efficacy in patients less than 18 years of age has not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: recombinant human parathyroid hormone
• Inactive ingredients: sodium chloride, mannitol, citric acid monohydrate, m-cresol in sterile water

Who manufactures and distributes this medicine?

• Manufactured for: Shire-NPS Pharmaceuticals, Inc., 300 Shire Way, Lexington

NATPARA® is a registered trademark of Shire-NPS Pharmaceuticals, Inc., a Takeda company.

What should I know about storage and disposal of this medication?

• Unmixed NATPARA medicine cartridges: Refrigerate NATPARA between 36°F to 46°F (2°C to 8°C). Do not freeze.
• Mixed NATPARA medicine cartridges:
• Refrigerate between 36°F to 46°F (2°C to 8°C). Do not freeze.
• You can use the Q-Cliq pen for up to 14 days after mixing the medicine cartridge.
• Throw away the mixed NATPARA medicine cartridges 14 days after mixing the medicine cartridge.
• Store NATPARA away from heat and light.
• Do not freeze or shake NATPARA. Do not use NATPARA if it was frozen or shaken.
• Keep NATPARA and all medicines out of the reach of children.

• Dailymed label info on Natpara
• FDA Natpara

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