Indications of Uniplar 1 mcg

Chronic Kidney Disease Stages 3 and 4: Uniplar 1 mcg capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.Chronic Kidney Disease Stage 5 ... Read moreChronic Kidney Disease Stages 3 and 4: Uniplar 1 mcg capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.Chronic Kidney Disease Stage 5: Uniplar 1 mcg capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).

Theropeutic Class

Thyroid drugs and hormone

Pharmacology

Uniplar 1 mcg is a synthetic, biologically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Preclinical andin vitro studies have demonstrated that Uniplar 1 mcg's biological actions are mediated through binding of the VDR, which results in the selective activation of vitamin D responsive pathways. Vitamin D and Uniplar 1 mcg have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion.

Dosage and Administration of Uniplar 1 mcg

Usual Adult Dose for Secondary Hyperparathyroidism: Initial dose:Stage 3 or 4 Chronic Kidney Disease (CKD): Initial dosing is based on baseline intact parathyroid hormone (iPTH): 500 pg/mL or less: 1 mcg orally daily OR 2 mcg orally 3 times a week Over 500 pg/mL: 2 mcg orally daily OR 4 mcg orally 3 times a week Stage 5 Chronic Kidney Disease (CKD): Starting dose (micrograms) = baseline iPTH level (pg/mL)/80 Starting dose is given orally 3 times a week; only start if baseline serum calcium has been adjusted to 9.5 mg/dL or lower. Usual Pediatric Dose for Secondary Hyperparathyroidism: Safety and efficacy have not been established in pediatric patients. The following is dosing used in a very small pediatric trial. No data are available on children under 5 years old.Initial dose, children 5 to 18 years: 0.04 mcg/kg three times per week if baseline intact parathyroid hormone (iPTH) is less than 500 pg/mL 0.08 mcg/kg three times per week if baseline iPTH is 500 pg/mL or higher. Injected as a bolus dose through a hemodialysis vascular access port at any time during dialysisMaximum frequency: Every other day

Dosage of Uniplar 1 mcg

The initial dose of this capsule for CKD stage 3 and 4 patients is based on baseline intact parathyroid hormone (iPTH) levels. Baseline intact parathyroid hormone (iPTH) Level: andlt;500 pg/ml Daily Dose: 1 mcg Daily Dose: 2 mcg Baseline intact parathyroid hormone (iPTH) Level: andgt;500 pg/ml Daily Dose: 2 mcg Daily Dose: 4 mcg

Interaction of Uniplar 1 mcg

Strong CYP3A inhibitors (e.g. ketoconazole) will increase the exposure of Uniplar 1 mcg. Use with caution. Cholestyramine, Mineral Oil: Intestinal absorption of Uniplar 1 mcg may be reduced if administered simultaneously with cholestyramine or mineral oil. Take Uniplar 1 mcg capsules at least 1 hour before or 4 to 6 hours after taking cholestyramine or mineral oil.

Contraindications

Uniplar 1 mcg capsules should not be given to patients with evidence of hypercalcemia or vitamin D toxicity.

Side Effects of Uniplar 1 mcg

The most common adverse reactions (andgt;5percent and more frequent than placebo) include diarrhea, nasopharyngitis, dizziness, vomiting, hypertension, hypersensitivity, nausea, and edema.

Pregnancy and Lactation

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: C Lactation: Not known if distributed into breast milk, use caution

Precautions and Warnings

Hypercalcemia: Excessive administration of Uniplar 1 mcg capsules can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease. Preion-based doses of vitamin D and its derivatives should be withheld during Uniplar 1 mcg treatment.Digitalis toxicity: Potentiated by hypercalcemia of any cause. Use caution when Uniplar 1 mcg capsules are prescribed concomitantly with digitalis compounds.Laboratory tests: Monitor serum calcium, serum phosphorus, and serum or plasma iPTH during initial dosing or following any dose adjustment. Uniplar 1 mcg capsules may increase serum creatinine and therefore decrease the estimated GFR (eGFR).Aluminum overload and toxicity: Avoid excessive use of aluminum-containing compounds.

Storage Conditions

keep in a dry place away from light and heat. Keep out of the reach of children.

Drug Classes

Thyroid drugs and hormone

Mode Of Action

Uniplar 1 mcg is a synthetic, biologically active vitamin D2 analog of calcitriol. Preclinical and in vitro studies have demonstrated that Uniplar 1 mcg's biological actions are mediated through binding of the VDR, which results in the selective activation of vitamin D responsive pathways. Vitamin D and Uniplar 1 mcg have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion.

Pregnancy

Limited data with Uniplar 1 mcg capsules in pregnant women are insufficient to inform a drug- associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with chronic kidney disease in pregnancy. In animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered Uniplar 1 mcg intravenously during the period of organogenesis at doses 2 and 0.5 times, respectively, the maximum recommended human dose (MRHD). Adverse reproductive outcomes were observed at doses that caused maternal toxicity. There is no information available on the presence of Uniplar 1 mcg in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production.

Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.