Monograph Details
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Urogenital System
> Miscellaneous urogenital disorders
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HECTOROL |
| Manufacturer |
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Genzyme Corporation |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Vit. D analogue. |
| Generic Name |
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Doxercalciferol 0.5micrograms, 2.5micrograms; caps. |
| Also |
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• HECTOROL INJ
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| Indications |
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Secondary hyperparathyroidism in patients with chronic kidney disease (CKD) on dialysis. Predialysis patients with Stage 3 or 4 CKD (oral form only). |
| Children |
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Not recommended. |
| Adults |
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Dialysis: initially 10micrograms three times weekly at dialysis; adjust to maintain intact parathyroid hormone (iPTH) between 150–300picograms/mL; max 20micrograms three times weekly. Predialysis: initially 1microgram once daily; adjust by 0.5microgram at 2-week intervals to target iPTH levels; max 3.5micrograms/day. |
| Contraindications |
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Hypercalcemia. Vit.D toxicity. Concurrent other forms of Vit.D. |
| Precautions |
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Maintain appropriate calcium, phosphate, fluid intake. Keep serum calcium times phosphate product (Ca × P) <55 in CKD patients or <70 in patients with elevated iPTH. Monitor iPTH, serum calcium, phosphorus (dialysis: at baseline and weekly during titration, then periodically; predialysis: every 2 weeks for 3 months during titration, then monthly for 3 months, then every 3 months). Adjust phosphate binder dose to maintain PTH suppression and serum calcium and phosphate levels. Hepatic impairment. Pregnancy (Cat.B). Nursing mothers: not recommended. |
| Interactions |
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Hypermagnesemia with magnesium-containing antacids. Absorption reduced by mineral oil. May be antagonized by hepatic enzyme inducers (eg, phenobarbital). |
| Adverse Reactions |
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Headache, malaise, GI upset, constipation, arthralgia, edema, dizziness, sleep disorder, dyspnea; Vit.D toxicity (eg, hypercalcemia, hypercalciuria, hyperphosphatemia, adynamic bone diseases, arrhythmias, seizures); see literature. |
| How Supplied |
Caps—50
Inj (2mL)—1 |
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