FORTEO® (teriparatide [rDNA origin] injection)
is indicated:
- For the treatment of postmenopausal women with osteoporosis
at high risk for fracture
- To increase bone mass in men with primary or hypogonadal
osteoporosis at high risk for fracture
- For the treatment of men and women with osteoporosis
associated with sustained, systemic glucocorticoid therapy at high risk for fracture
FORTEO® (teriparatide [rDNA origin] injection)
is indicated:
- For the treatment of postmenopausal women with osteoporosis
at high risk for fracture
FORTEO® (teriparatide [rDNA origin] injection)
is indicated:
- To increase bone mass in men with primary or hypogonadal
osteoporosis at high risk for fracture
FORTEO® (teriparatide [rDNA origin] injection)
is indicated:
- For the treatment of men and women with osteoporosis
associated with sustained, systemic glucocorticoid therapy at high risk for fracture
Important Safety Information
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 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 or to any of its excipients. Reactions have included
angioedema and anaphylaxis.
WARNINGS AND PRECAUTIONS
The following categories of patients have increased baseline risk of osteosarcoma
and therefore should not be treated with FORTEO: Paget's disease of bone, pediatric
populations and young adults with open epiphyses, or prior external beam or implant
radiation therapy.
Patients should be encouraged to enroll in the voluntary FORTEO Patient Registry,
which is designed to collect information about any potential risk of osteosarcoma
in patients who have taken FORTEO. Enrollment information can be obtained by calling
1-866-382-6813, or by visiting .
Osteosarcoma occurs in about 4 out of every million older adults each year. Cases
of bone tumor and osteosarcoma have been reported rarely in people taking FORTEO
in the post-marketing period. The causality to FORTEO use is unclear.
Use of FORTEO for more than 2 years during a patient's lifetime is not recommended.
Patients with the following conditions also should not receive FORTEO: bone metastases
or a history of skeletal malignancies, metabolic bone diseases other than osteoporosis,
or hypercalcemic disorders.
FORTEO may increase serum calcium, urinary calcium, and serum uric acid.
Use with caution in patients with active or recent urolithiasis because of risk
of exacerbation. If active urolithiasis or pre-existing hypercalciuria are suspected,
measurement of urinary calcium excretion should be considered.
Transient orthostatic hypotension may occur with initial doses of FORTEO. In short-term
clinical pharmacology studies, transient episodes of symptomatic orthostatic hypotension
were observed in 5% of patients. FORTEO should be administered initially under circumstances
where the patient can sit or lie down if symptoms of orthostatic hypotension occur.
Patients receiving digoxin should use FORTEO with caution because FORTEO may transiently
increase serum calcium and hypercalcemia may predispose patients to digitalis toxicity.
FORTEO should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus. Based on animal studies, FORTEO may cause fetal harm.
It is not known whether teriparatide is excreted in human milk. Breastfeeding mothers
should discontinue nursing or FORTEO, taking into account the importance of treatment
to the mother.
ADVERSE REACTIONS
The most common adverse reactions in clinical trials include: arthralgia (10.1 FORTEO
vs. 8.4 placebo), pain (21.3 FORTEO vs. 20.5 placebo), and nausea (8.5 FORTEO vs.
6.7 placebo). Other adverse reactions include: dizziness, leg cramps, joint aches,
and injection site reactions.
INSTRUCTIONS FOR FORTEO USE
FORTEO is provided as a fixed-dose, prefilled delivery device that can be used for
up to 28 days, including the first injection. The delivery device contains 28 daily
doses of 20 mcg each. Do not transfer the contents of the delivery device into a
syringe. The FORTEO Delivery Device should be stored under refrigeration at 36°
to 46° F (2° to 8° C) at all times. Do not use FORTEO if it has been frozen.
Please see full Prescribing Information, including Medication Guide, for other important safety information.