MEGAPTH Special Precautions

General: Teriparatide has not been studied in patients with active urolithiasis in reported clinical trials.
Teriparatide should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition. In reported short term clinical studies with teriparatide injection, isolated episodes of transient orthostatic hypotension were observed. Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the first several doses, was relieved by placing subjects in a reclining position, and did not preclude continued treatment.
In a reported study of 15 healthy people administered digoxin daily to steady state, a single dose of teriparatide did not alter the effect of digoxin on the systolic time interval from electrocardiographic Q-wave onset to aortic valve closure, a measure of digoxin's calcium mediated cardiac effect).
However, sporadic case reports have suggested that hypercalcemia may predispose patients to digitalis toxicity. Because teriparatide transiently increases serum calcium, Teriparatide should be used with caution in patients taking digitalis. In normocalcaemic patients, slight and transient elevations of serum calcium concentrations reach a maximum between 4 and 6 hours and return to baseline by 16 to 24 hours after each dose of Teriparatide.
Routine calcium monitoring during therapy is not required.
Therefore, if any blood samples are taken from a patient, this should be done at least 16 hours after the most recent Teriparatide injection.
Teriparatide may cause small increases in urinary calcium excretion.
Limited information is available to evaluate safety in patients with hepatic, renal and cardiac disease.
No clinically important adverse renal effects were observed in reported clinical studies.
Assessments included creatinine clearance; measurements of blood urea nitrogen (BUN), creatinine, and electrolytes in serum; urine specific gravity and pH; and examination of urine sediment. Longterm evaluation of patients with severe renal insufficiency, patients undergoing acute or chronic dialysis, or patients who have functioning renal transplants has not been reported. Caution should be exercised in patients with moderate renal impairment.
Teriparatide therapy was associated with increased incidence of elevated uric acid, with the incidence being highest in patients with moderately impaired renal function and in those receiving teriparatide 40 mcg/day. Even so, adverse event data did not suggest an increased incidence of gout or arthralgia or of nephrolithiasis in teriparatide treated patients with normal, mild or moderate renal impairment.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. However, transient, orthostatic hypotension or dizziness was observed in some patients. These patients should refrain from driving or the use of machines until symptoms have subsided.
Use in Pregnancy: Reported studies in rabbits have shown reproductive toxicity. The potential risk for humans is unknown. Given the indication, Teriparatide should not be used during pregnancy.