Forteo (Teriparatide (rDNA origin) Injection) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 7, 2012

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Osteoporosis is a condition characterized by a decrease in the density of bone, decreasing its strength and resulting in fragile bones. Osteoporosis literally leads to abnormally porous bone that is compressible, like a sponge. This disorder of the skeleton weakens the bone and results in frequent fractures (breaks) in the bones. Osteopenia is a condition of bone that is slightly less dense than normal bone but not to the degree of bone in osteoporosis.

Normal bone is composed of protein, collagen, and calcium, all of which give bone its strength. Bones that are affected by osteoporosis can break (fracture) with relatively minor injury that normally would not cause a bone to fracture. The fracture can be either in the form of cracking (as in a hip fracture) or collapsing (as in a compression fracture of the vertebrae of the spine). The spine, hips, ribs, and wrists are common areas of bone fractures from osteoporosis although osteoporosis-...

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FORTEO (teriparatide rdna origin injection)
(teriparatide [rDNA origin]) Injection for Subcutaneous use

WARNING

POTENTIAL RISK OF OSTEOSARCOMA

In male and female rats, teriparatide 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 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 FORTEO (teriparatide rdna origin injection) ® only for patients for whom the potential benefits are considered to outweigh the potential risk. FORTEO (teriparatide rdna origin 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) [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and Nonclinical Toxicology].

DRUG DESCRIPTION

FORTEO (teriparatide rdna origin injection) (teriparatide [rDNA origin] injection) contains recombinant human parathyroid hormone (1-34), and is also called rhPTH (1-34). It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone.

Teriparatide has a molecular weight of 4117.8 daltons and its amino acid sequence is shown below:

FORTEO (teriparatide [rDNA origin]) amino acid sequence Illustration

Teriparatide (rDNA origin) is manufactured using a strain of Escherichia coli modified by recombinant DNA technology. FORTEO (teriparatide rdna origin injection) is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable delivery device (pen) for subcutaneous injection. Each prefilled delivery device is filled with either 3.3 mL to deliver 3 mL or 2.7 mL to deliver 2.4 mL. Each mL contains 250 mcg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetic acid, 0.1 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3 mg Metacresol, and Water for Injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4.

Each cartridge, pre-assembled into a delivery device, delivers 20 mcg of teriparatide per dose each day for up to 28 days.

What are the possible side effects of teriparatide (Forteo)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using teriparatide and call your doctor at once if you have any of these serious side effects: