Forteo (teriparatide)

• Teriparatide (Forteo) is a prescription medicine used to treat osteoporosis, a bone disease that over time causes bones to become fragile and more likely to break. Teriparatide is similar to human parathyroid hormone (PTH) and is made using recombinant DNA (rDNA) technology. PTH is naturally produced by the body and is the key regulator of calcium and phosphate metabolism in the bone and kidney. Calcium and phosphate are the main minerals necessary for bone health. PTH also increases the absorption of calcium in the intestines. Teriparatide binds to the same receptors as natural PTH and mimics the favorable effects of PTH on bone health. Beneficial effects of teriparatide in osteoporosis treatment include reduced bone turnover, formation of new bone, and increased bone mineral density and bone strength.
• Teriparatide was first approved by the FDA in 2002.

What brand names are available for teriparatide?

Forteo

Is teriparatide available as a generic drug?

No

Do I need a prescription for teriparatide?

Yes

Forteo is a prescription medicine that is used to treat:

• Postmenopausal women with osteoporosis who are at high risk for bone fractures
• Men with primary or hypogonadal osteoporosis at high risk for fractures
• Men and women with osteoporosis due to the use of steroid medicines who are at high risk for fractures.

The most common side effects of Forteo are

• nausea,
• joint aches, and
• pain.

Forteo can cause some serious side effects including a drop in blood pressure when getting up from a sitting or lying position (orthostatic hypotension) and increased calcium in the blood.

In animal studies some rats developed osteosarcoma, a type of bone cancer. Osteosarcoma is a rare but serious form of cancer rarely reported in patients taking Forteo. To investigate if Forteo increases the risk of osteosarcoma, a voluntary patient registry has been developed. Patients can get more information about this registry by calling 1-866-382-6813 or visiting www.forteoregistry.rti.org.

Possible serious side effects or adverse events:

• Patients with Paget's disease of bone, pediatric and young adult patients with open epiphyses (ends of long bones that are still growing), and patients with prior external beam or implant radiation involving the skeleton should not receive Forteo.
• Forteo should not be used for more than 2 years in a patient's lifetime and should not be given to patients with bone cancer, history of skeletal cancer, metabolic bone diseases other than osteoporosis, or hypercalcemic disorders.
• Forteo may increase blood levels of calcium and uric acid. It may also increase calcium levels in urine.

• The recommended dose for all FDA approved indications is 20 mcg subcutaneously once a day. F
• Forteo should be administered subcutaneously in either the thigh or stomach area.
• Forteo pens are preset to deliver 20 mcg of medicine with each injection.
• The safety and effectiveness of Forteo injection has not been studied beyond 2 years of treatment.

:

• Forteo injection should be used cautiously in patients taking digoxin (Lanoxin), a medication used to treat irregular heart rhythms. Forteo increases calcium in the blood and high levels of calcium may increase the risk for digoxin associated side effects.
• Forteo injection should be used cautiously with other medicines that may increase calcium in the blood.

What preparations of teriparatide-injection are available?

Prefilled multi-dose pen containing 600 mcg/2.4ml. Each dose is 20 mcg.

How should I keep teriparatide-injection stored?

• Forteo injection should be stored in the refrigerator between 2 C to 8 C (36 F to 4 F).
• Pens should be removed from the refrigerator only when ready to use and returned to the refrigerator right after use. Forteo injection should not be stored in the freezer.