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What is Teriparatide Injection?

Teriparatide Injection is a medication designed to assist in building new bone, and is comprised of protein similar to one naturally produced by the body. It has also been shown to help increase bone strength.^‡

^‡Only proven in postmenopausal women with osteoporosis.

Taking Teriparatide Injection

Inject Teriparatide Injection one time each day in your thigh or abdomen (lower stomach area).^§ Talk to a healthcare provider about how to rotate injection sites. It is not effective as an oral medication.

^§You should not take Teriparatide Injection for a period in excess of 2 years during your lifetime.

This multi-dose pen device uses a needle significantly smaller than a typical flu shot needle, and contains enough medication to last 28 days. It is set to give a 20-mcg dose of medicine each day.^|

^|Needles sold separately.

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Indications & Important Safety Information

Warning: Potential Risk of Osteosarcoma

Indications

Teriparatide Injection is a prescription medicine used in both men and postmenopausal women with osteoporosis who are at high risk for having bone fractures—defined as those who have had a fracture related to osteoporosis, who are at high risk for fracture, or who cannot use other osteoporosis treatments. It is also used for treating osteoporosis associated with glucocorticoid medicines, such as prednisone, in patients who are at high risk for fracture.

Important Safety Information

WARNING: POTENTIAL RISK OF OSTEOSARCOMA

During drug testing, Teriparatide Injection caused some rats to develop a serious, but rare, bone cancer called osteosarcoma. It is not known if people who take Teriparatide Injection are at a higher risk of contracting osteosarcoma. Before taking, advise your healthcare provider if you have Paget’s disease of bone, are a child or young adult whose bones are still growing, or have undergone radiation therapy.

Do not use Teriparatide Injection if you are allergic to any of its ingredients. Serious allergic reactions may occur.

Before taking Teriparatide Injection, inform your healthcare provider if you have a bone disease other than osteoporosis, have cancer in your bones, have trouble injecting yourself, are a child or young adult whose bones are still growing, have or have had kidney stones, have had radiation therapy, have been diagnosed with too much calcium in your blood, are pregnant or thinking about becoming pregnant, are breastfeeding or plan to breastfeed, or have any other medical conditions. Tell your healthcare provider about all the medicines you take, especially medicines that contain digoxin.

Teriparatide can cause serious side effects, including a decrease in blood pressure upon changing positions. Dizziness, accelerated heartbeat, or a feeling of faintness may occur, usually within four hours of taking Teriparatide Injection, and typically subside within a few hours. You should not use Teriparatide Injection for more than two years during your lifetime.

Other side effects include nausea, vomiting, constipation, low energy, joint aches, pain, leg cramps, or muscle weakness, which may be signs of too much calcium in your blood.

Injection site reactions can include pain, swelling and bruising.

If symptoms persist, stop taking Teriparatide Injection and call your healthcare provider.

Visit www.fda.gov/medwatch or call 800.FDA.1088 to report any additional negative side effects to the FDA.

For additional safety information, please see the Medication Guide and Prescribing Information, including the full User Manual which accompanies the delivery device.

Indications

Teriparatide Injection is a prescription medicine used in both men and postmenopausal women with osteoporosis who are at high risk for having bone fractures—defined as those who have had a fracture related to osteoporosis, who are at high risk for fracture, or who cannot use other osteoporosis treatments. It is also used for treating osteoporosis associated with glucocorticoid medicines, such as prednisone, in patients who are at high risk for fracture.

WARNING: POTENTIAL RISK OF OSTEOSARCOMA

In male and female rats, Teriparatide Injection caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration. The effect was observed at systemic exposures to Teriparatide Injection ranging from 3 to 60 times the exposure in humans given a 20-mcg dose. Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe Teriparatide Injection only for patients for whom the potential benefits are considered to outweigh the potential risk. Teriparatide Injection should not be prescribed for 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, or prior external beam or implant radiation therapy involving the skeleton).

Contraindications

Hypersensitivity to Teriparatide Injection or to any of its excipients. Reactions have included angioedema and anaphylaxis.

Warnings and Precautions

Teriparatide Injection should not be prescribed for patients at increased baseline risk of osteosarcoma. These patients include: Paget’s disease of bone, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy.

The safety and efficacy of Teriparatide Injection has not been evaluated beyond two years of treatment, and use for more than two years during a patient’s lifetime is not recommended.

Patients with the following should not be treated with Teriparatide Injection: bone metastases or a history of skeletal malignancies, metabolic bone diseases other than osteoporosis, or hypercalcemic disorders.

Use with caution in patients with active or recent urolithiasis because of risk of exacerbation. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered.

Teriparatide Injection should be administered so that patients can sit or lie down if symptoms of orthostatic hypotension occur. In short-term clinical studies, transient orthostatic hypotension was observed in 5% of patients.

Patients receiving digoxin should use Teriparatide Injection with caution, as it may transiently increase serum calcium and hypercalcemia may predispose patients to digitalis toxicity.

Adverse Reactions

The most common adverse reactions in clinical trials include: arthralgia (10.1% vs. 8.4% placebo), pain (21.3% vs. 20.5% placebo), and nausea (8.5% vs. 6.7% placebo). Other adverse reactions include: dizziness, leg cramps, joint aches, and injection site reactions.

Pregnancy and Lactation

There is no available data on Teriparatide Injection use in pregnant women. Consider discontinuing when pregnancy is recognized.

It is not known whether Teriparatide Injection is excreted in human milk, affects human milk production, or has effects on the breastfed infant. Breastfeeding is not recommended.

For additional safety information, please see the Prescribing Information and full User Manual that accompanies the delivery device.