Forsteo® (teriparatid): Farmakokinetik och dosering vid nedsatt njurfunktion

Pharmacokinetics of Teriparatide in Renal Impairment

There is limited data describing the use of teriparatide in patients with renal impairment.

Mild or Moderate Renal Impairment

The pharmacokinetics of teriparatide in 11 patients with mild or moderate renal impairment (CrCl 30 to 72 mL/min) did not differ significantly from normal subjects when administered a single dose of teriparatide.¹

Severe Renal Impairment

Relative to normal subjects, 5 patients with severe renal impairment (CrCl <30 mL/min) receiving a single dose of teriparatide experienced a

• 73% increase in the AUC, and

• 77% increase in half-life (from 1-hour to 2 hours).¹

Contraindications relevant for Patients with Renal Impairment

Fractures across the stages of CKD could be due to osteoporosis, some form of renal osteodystrophy defined by specific quantitative histomorphometry or CKD-MBD. CKD-MBD is a systemic disease that links disorders of mineral and bone metabolism due to CKD to either one or all of the following: abnormalities of calcium, phosphorus, parathyroid hormone or vitamin D metabolism; abnormalities in bone turnover, mineralization, volume, linear growth or strength; or vascular or other soft-tissue calcification. Osteoporosis, as defined by The National Institutes of Health, may coexist with renal osteodystrophy or CKD-MBD.²

The Forsteo contraindications include³

• severe renal impairment, and

• pre-existing hypercalcaemia.

• Patients with metabolic bone diseases (including hyperparathyroidism and Paget’s disease of the bone) other than primary osteoporosis or glucocorticoid-induced osteoporosis

Therefore a critical consideration of contraindication is recommended before considering teriparatide in a patient with renal impairment. For full list of contraindication please refer to the SmPC.

Dosing of Teriparatide in Patients with Renal Impairment

When the individual clinical decision was made to start a treatment with teriparatide in a patient with renal impairment, the recommended dose is the same dose that is recommended for patients with normal renal function, i. e. 20 mcg teriparatide once daily. The summary of product information does not recommend other doses of teriparatide for treatment of patients with renal impairment.³

References

1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2. Miller PD. Chronic kidney disease and osteoporosis: evaluation and management. Bonekey Rep. 2014;542(3):1-7. http://dx.doi.org/10.1038/bonekey.2014.37

3. Forsteo [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

AUC = area under the curve

CKD = chronic kidney disease

CKD-MBD = chronic kidney disease-mineral and bone disorder

CrCl = creatinine clearance