Terrosa

/ Dexcel

The recommended dose is 20 mcg given subcutaneously once a day.
Instruct patients to take supplemental calcium and vitamin D if daily dietary intake is inadequate

This medical product is indicated:
* For the treatment of postmenopausal women with osteoporosis at high risk for fracture, (defined herein as having a history of osteoporotic fracture, or multiple risk factors for fracture), or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Teriparatide, reduces the risk of vertebral and non-vertebral fractures.
* To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, or who have failed or are intolerant to other available osteoporosis therapy.
* For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture, or who have failed or are intolerant to other available osteoporosis therapy.

Hypersensitivity to teriparatide or to any of the excipients. Hypersensitivity reactions have included angioedema and anaphylaxis.

Osteosarcoma
Osteosarcoma has been reported in patients treated with teriparatide in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of teriparatide use.
Avoid teriparatide use in patients with (these patients are at increased baseline risk of osteosarcoma):
* Open epiphyses (pediatric and young adult patients). (Teriparatide is not approved in pediatric patients).
* Metabolic bone diseases other than osteoporosis, including Paget’s disease of the bone.
* Bone metastases or a history of skeletal malignancies.
* Prior external beam or implant radiation therapy involving the skeleton.
* Hereditary disorders predisposing to osteosarcoma.
Hypercalcemia and Cutaneous Calcification
Hypercalcemia
Teriparatide has not been studied in patients with pre-existing hypercalcemia. Teriparatide may cause hypercalcemia and may exacerbate hypercalcemia in patients with pre-existing hypercalcemia. Avoid teriparatide in patients known to have an underlying hypercalcemic disorder, such as primary hyperparathyroidism.
Risk of Cutaneous Calcification Including Calciphylaxis
Serious reports of calciphylaxis and worsening of previously stable cutaneous calcification have been reported in the postmarketing setting in patients taking teriparatide. Risk factors for development of calciphylaxis include underlying autoimmune disease, kidney failure and concomitant warfarin or systemic corticosteroid use. Discontinue teriparatide in patients who develop calciphylaxis or worsening of previously stable cutaneous calcification.
Risk of Urolithiasis
In clinical trials, the frequency of urolithiasis was similar in patients treated with teriparatide and patients treated with placebo. However, teriparatide has not been studied in patients with active urolithiasis. If teriparatide-treated patients have pre-existing hypercalciuria or suspected/known active urolithiasis, consider measuring urinary calcium excretion. Consider the risks and benefits of use in patients with active or recent urolithiasis because of the potential to exacerbate this condition.
Orthostatic Hypotension
Teriparatide should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur. In short-term clinical pharmacology studies of teriparatide in healthy volunteers, transient episodes of symptomatic orthostatic hypotension were observed in 5% of volunteers. Typically, these events began within 4 hours of dosing and resolved (without treatment) within a few minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the first several doses, it was relieved by placing the person in a reclining position, and it did not preclude continued treatment.
Risk of Digoxin Toxicity
Hypercalcemia may predispose patients to digitalis toxicity because teriparatide transiently increases serum calcium. Consider the potential onset of signs and symptoms of digitalis toxicity when teriparatide is used in patients receiving digoxin
See prescribing information for full details.

Most common: Pain, Nausea, Arthralgia.
See prescribing information for full details.

Digoxin
Sporadic case reports have suggested that hypercalcemia may predispose patients to digitalis toxicity. Teriparatide may transiently increase serum calcium. Consider the potential onset of signs and symptoms of digitalis toxicity when teriparatide is used in patients receiving digoxin.

Pregnancy:
There are no available data on teriparatide use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Consider discontinuing Terrosa when pregnancy is recognized.
In animal reproduction studies, teriparatide increased skeletal deviations and variations in mouse offspring at subcutaneous doses equivalent to more than 60 times the recommended 20 mcg human daily dose (based on body surface area, mcg/m2), and produced mild growth retardation and reduced motor activity in rat offspring at subcutaneous doses equivalent to more than 120 times the human dose. The background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk in the US general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
Lactation:
It is not known whether teriparatide is excreted in human milk, affects human milk production or has effects on the breastfed infant. Avoid Terrosa use in women who are breastfeeding.

In postmarketing spontaneous reports, there have been cases of medication errors in which the entire contents (up to 800 mcg) (40 times the recommended dose) of the teriparatide delivery device (pen) have been administered as a single dose. Transient events reported have included nausea, weakness/lethargy and hypotension. No fatalities associated with overdose have been reported. Additional signs, symptoms and complications of teriparatide overdosage may include a delayed hypercalcemic effect, vomiting, dizziness, and headache.
Overdose Management -There is no specific antidote for a teriparatide overdosage. Treatment of suspected overdosage should include discontinuation of Terrosa, monitoring of serum calcium and phosphorus, and implementation of appropriate supportive measures, such as hydration.

Storage and Handling
Store in a refrigerator (2-8°C). Do not freeze. Keep the cartridge in the outer carton in order to protect from light.
After insertion of the cartridge into the pen, the combined pen and cartridge should be returned to the refrigerator immediately after use.
Do not store the injection device with the needle attached. Do not remove the cartridge from the pen during the 28 days of use.
Once opened, the product may be stored for a maximum of 28 days within its shelf life at 2-8°C.
The expiry date of the product is indicated on the packaging materials.
See prescribing information for full details.