Prescribing guidelines in special population

 

Geriatrics: No differences in Teriparatide pharmacokinetics were detected with respect to age (range 31 to 85 yrs). Dosage adjustments based on the age are not required.

 

Pediatrics: Pharmacokinetic data in pediatric population is not available.

 

Gender:  Although systemic exposure to Teriparatide was approximately 20-30% lower in men than among women, the recommended dosage for both the genders is 20mcg/day.

 

Race: the populations included in the pharmacokinetic analyses were 98.5% Caucasian. The influence of race has not been determined.

 

Renal insufficiency: No pharmacokinetic differenced were identified in 11 patients with mild or moderate renal insufficiency (creatinine clearance 20-72 ml/min).

 

Heart Failure: No clinically relevant pharmacokinetic, blood pressure, or pulse rate differences were identified in 13 patients with stable New York heart association class I to III heart failure after the administrations of two 20 mcg doses of Teriparatide.

 

Hepatic Insufficiency: Non-specific proteolytic enzymes in the liver cleave PTH (1-34) and PTH (1-84) into fragments that are cleared from the circulation mainly by the kidney.