Alfacalcidol is used in adult patients with chronic renal failure for:

• Treatment of hypocalcemia
• Management of secondary hyperparathyroidism
• Renal osteodystrophy

Alfacalcidol enhances the absorption of calcium and phosphorus from the intestine and promotes calcium reabsorption from bone and possibly from the kidneys. Most patients experience improvement in bone pain and muscle weakness within 2 weeks to 3 months of treatment. It rapidly corrects calcium malabsorption. During oral therapy, levels of alkaline phosphatase and parathyroid hormone (PTH) usually begin to decrease within 3 months, although normalization of plasma calcium may take longer. This delay does not necessarily indicate treatment failure but may reflect ongoing bone mineralization. In patients receiving intermittent intravenous therapy, PTH levels may decline more quickly, often within 3 months.

An initial dose of 0.25 mcg/day is recommended for the first 2 months, unless hypercalcemia develops. If hypercalcemia occurs then the dose should be reduced to 0.25 mcg on alternate days. If serum calcium is below the desired range, the dose may be adjusted in increments of 0.25 mcg/day every 2 months.

Maintenance Doses: Most patients will be maintained on a dose of 0.5 mcg/day. However, doses up to 1 mcg/day may be necessary to maintain serum calcium within the desired range. Serum calcium and phosphate levels should be monitored at monthly intervals or as is considered necessary if hypercalcemia develops. If hypercalcemia develops at any time during treatment then the dose of alfacalcidol should be reduced by 50% and all calcium supplements stopped until calcium levels return to normal.

Pediatrics: The safety and efficacy of Alfacalcidol in children has not been established.

Thiazide diuretics may increase the likelihood of hypercalcemia when used with Alfacalcidol. Certain antiepileptic drugs (such as carbamazepine, phenobarbital, phenytoin, and primidone) can increase the body’s requirement for vitamin D. Additionally, medications like rifampicin, isoniazid, and corticosteroids may reduce the effectiveness of vitamin D.

Alfacalcidol should not be used in:

• Patients with known hypersensitivity to Alfacalcidol or any of its components, including inactive ingredients or container materials
• Patients with biochemical evidence of hypercalcemia, hyperphosphatemia, or vitamin D toxicity

Possible side effects include:

• Increased blood urea nitrogen (BUN), albumin in urine, high cholesterol, elevated liver enzymes (AST, ALT), loss of appetite, weight loss, excessive thirst, high body temperature, dry mouth, metallic taste
• Cardiac rhythm disturbances and high blood pressure
• Eye-related issues such as conjunctivitis, corneal calcification, and light sensitivity
• Runny nose
• Psychological symptoms such as confusion or psychosis
• Headache, drowsiness, and dizziness
• Gastrointestinal problems including diarrhea, vomiting, constipation, nausea, and pancreatitis
• Itching
• Muscle and bone pain, abnormal calcification
• Increased urination, especially at night
• Reduced libido
• Fatigue and weakness

Alfacalcidol should be avoided during pregnancy unless absolutely necessary, as elevated calcium levels may lead to congenital abnormalities in the fetus. Adequate safety data in pregnant women is not available. Animal studies have shown reproductive toxicity, including reduced pregnancy rates, smaller litter sizes, and lower birth weights. Since Alfacalcidol may pass into breast milk, breastfeeding is not recommended during treatment.

Special caution is required in patients who are pregnant, breastfeeding, have renal impairment, infants, or elderly individuals. Serum calcium levels should be regularly monitored, especially in patients with kidney disease. Use cautiously in patients with hypercalciuria or a history of kidney stones. Avoid use in patients who are hypersensitive to formulations containing propylene glycol.

Vitamin D analogs used in bone formation.

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.