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What you need to know about using NATPARA

NATPARA is available as an injection (shot). You will need to inject NATPARA once a day directly under the skin of the thigh. Be sure to inject a different thigh (alternate thigh) every day. A Nurse Educator will teach you how to properly prepare, administer and store your NATPARA when you start on therapy.

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NATPARA (parathyroid hormone) for Injection dosing options and considerations before starting

NATPARA offers dosing options to help your doctor find the dose that is best for you

The starting dose for NATPARA is 50 mcg once a day as a subcutaneous injection in the thigh (alternate thigh every day). Your doctor will adjust the doses of NATPARA, calcium, and vitamin D you take based on what you need. If necessary, your doctor will increase the dose of NATPARA.

A majority of patients in the NATPARA clinical study required a maximum dose of 100 mcg. The goal of treatment is to have you take the lowest dose of NATPARA that will achieve a calcium level within the lower half of the normal range without the need for active forms of vitamin D and with enough calcium to meet your body’s daily needs.

With 4 dosage strengths of NATPARA, your doctor can find the dose that is right for you

Use NATPARA exactly as your doctor tells you to. Do not stop taking or change your dose of NATPARA unless your doctor tells you to. Your calcium level could become dangerously low.

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.

Before starting NATPARA, talk to your doctor and review the Medication Guide and Instructions for Use.

Before you start using NATPARA, tell your doctor about all your medical conditions, including if you:

  • Have Paget’s disease or other bone disease
  • Have or have had cancer in your bones
  • Have or have had radiation therapy
  • Have or have had too much calcium in your blood
  • Have or have had high blood levels of certain electrolytes (for example, alkaline phosphatase)
  • Are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. It is not known if NATPARA will harm your unborn baby or if NATPARA passes into your breast milk. You and your doctor should decide if you will use NATPARA or breastfeed. You should not do both

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

NATPARA and other medicines may affect each other, causing side effects. Especially tell your doctor if you are taking medicines that contain digoxin, alendronate, calcium supplements, or food products that contain calcium or active vitamin D.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist each time you get a new medicine.

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 in your face, lips, mouth, or tongue; breathing problems; fainting, dizziness, feeling lightheaded (low blood pressure); fast heartbeat; itching; rash; or, hives.

Common side effects

The most common side effects associated with NATPARA were:

Paresthesia (tingling, tickling, or burning feeling of the skin), hypocalcemia (low blood calcium), headache, hypercalcemia (high blood calcium), nausea, hypoaesthesia (reduced sense of touch or sensation), diarrhea, vomiting, arthralgia (pain in joints), hypercalciuria (too much calcium in urine), and pain in extremity.

These are not all the possible side effects of NATPARA. For more information, ask your doctor. Call your doctor for medical advice about side effects.

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. You can also call Shire at 1-866-888-0660.

These are not all the possible side effects of NATPARA. For more information, ask your doctor. Call your doctor for medical advice about side effects. 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.

You can also call Shire at 1-866-888-0660.

Regular monitoring is key to successful treatment

Your doctor will need to monitor how NATPARA is working

Keeping track of hypoparathyroidism is critical to good management. You can work together with your doctor by telling him or her about any symptoms you may be experiencing. Your doctor will take blood tests to ensure your calcium levels are within a target range.

Your doctor will need to monitor how NATPARA is working. It is important to have routine blood tests and a yearly or twice yearly 24-hour urine collection test once the maintenance dose is achieved, so that your doctor can measure your level of calcium and see how well you are responding to NATPARA.

Routine blood tests to measure the levels of calcium

Yearly or twice yearly 24-hour urine collection to check calcium levels

Check with your doctor to get your routine tests

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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.