What is this medication?
Parathyroid Hormone Analog
FORTEO/OSNUVO (Teriparatide) is a parathyroid hormone analog, (PTH 1-34), indicated for treatment of postmenopausal women with osteoporosis at high risk for fracture. Treatment in men with primary or hypogonadal osteoporosis with low bone mass, and treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.
In rats, teriparatide caused an increase in the incidence of osteosarcoma, a malignant bone tumor. Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe FORTEO only for patients for whom potential benefits outweigh potential risk. FORTEO should not be prescribed for patients at increased baseline risk for osteosarcoma (e.g., 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).
What is a biosimilar biologic drug?
Manufacturers have found cost-efficient ways to recreate the molecules used in the original or “reference” biologic drug. Biosimilars are highly “similar” to a reference biological drug despite differing in their chemical composition.
The FDA approval of biosimilar drugs is based on a totality of evidence which is used by regulators in the approval of reference and biological drugs. The FDA uses the same approach in evaluating biosimilars to confirm that there are no clinically meaningful differences in safety and efficacy between the reference biologic drug and the biosimilar. The rigorous standard for authorization means that you can have confidence knowing that the quality, safety, and efficacy of a biosimilar is the same as any other biologic drug.
FORTEO is a biologic
OSNUVO is a biosimilar to FORTEO (Teriparatide)
How does this medication work?
FORTEO/OSNUVO (Teriparatide) works similarly to teriparatide by promoting bone formation and reducing bone resorption which results in increased bone mineral density, bone mass and strength.
How should I take this medication?
SQ: Inject 20 mcg subcutaneously once daily.
Note: Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate; however, use caution to avoid hypercalcemia. Assess serum calcium prior to initiation; avoid use in patients with pre-existing hypercalcemia or hypercalcemic disorder.
How to Take: Initial administration should occur under circumstances in which the patient may sit or lie down, in the event of orthostasis. Inject into the thigh or abdominal wall. May administer dose immediately following removal from the refrigerator.
What should I watch for while using this medication?
Before starting FORTEO/OSNUVO (Teriparatide), make sure your physician is aware of any allergies or medications you currently take. Teriparatide may cause orthostatic hypotension and there have been animal studies that have shown an increase in osteosarcoma and subsequently should not be used in patients with Paget disease, prior radiation, unexplained elevation of alkaline phosphatase, prior external beam or implant radiation therapy involving the skeleton, or in patients with open epiphyses. Furthermore, Teriparatide should not use in patients with bone metastases, a history of skeletal metastases, hyperparathyroidism, or preexisting hypercalcemia.
What size needle does this medication use?
32-gauge x 4mm
31-gauge x 5mm
31-gauge x 8mm
Note: Forteo does not come with a needle. You must attach a new needle (recommended sizes listed above) in order to administer medication.
What if I miss a dose?
If you miss a dose of medication, try to take it as soon as possible. However, if it is almost time for your next dose, take only that scheduled dose. Do not take double or extra doses. Teriparatide should be taken once a day only.
How should I store this medication?
Store in the refrigerator at 2° to 8°C (36° to 46°F) at all times except when administering the product. Minimize leaving Teriparatide out of the refrigerator; deliver the dose immediately following removal from the refrigerator. Recap the prefilled pen when not in use to protect the cartridge from physical damage and light. Do not freeze.
What are the possible side effects of using this medication?
Hypercalcemia, orthostatic hypotension, angina pectoris, syncope, dizziness, headache, insomnia, anxiety, depression, vertigo, hyperuricemia, nausea, gastritis, dyspepsia, vomiting, antibody development, Herpes zoster, joint and leg pain, rhinitis, pharyngitis, dyspepsia, pneumonia.
Note this is not a complete list of side effects for FORTEO/OSNUVO (Teriparatide), only common ones.