ALFOST CAPSULES 0.25MCG [SIN16483P]

Product Info

ALFOST CAPSULES 0.25MCG

[SIN16483P]

INDICATIONS
Alfacalcidol Capsules is indicated in all conditions where there is a disturbance of calcium metabolism due to reduced endogenous production 1.25‐dihydroxyvitamin D3. The main indications are:

1. Renal osteodystrophy

2. As an adjunct to the management of tertiary hyperparathyroidism

3. Postoperative or idiopathic hypoparathyroidism

4. Neonatal hypocalcaemia or rickets

5. Nutritional and malabsorptive rickets and osteomalacia

6. (D-dependent) rickets and osteomalacia

7. Vitamin D-resistant rickets and osteomalacia

8. Pseudohypoparathyroidism

9. Malabsorption of calcium, osteoporosis

DOSE AND ADMINISTRATION

Posology
Initial dose for all indications:
Adults and children over 20 kg bodyweight: 1 microgram/day
Elderly: There is no specific clinical experience in the treatment of elderly patients. Special attention is not deemed necessary.
Reduced renal function: See section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Alfacalcidol Capsules capsules must be swallowed whole.

Reduced liver function: With severe liver insufficiency the hydroxylation of 1α‐hydroxy vitamin D3 to 1.25 dihydroxy vitamin D3 may be reduced, and the intestinal absorption may be reduced because of decreased enterohepatic circulation. A higher dosage may be necessary.
Neonates and premature infants: 0.05 – 0.1 microgram/kg/day
Children under 20 kg bodyweight: 0.05 microgram/kg/day

The dose of Alfacalcidol Capsules should be adjusted thereafter to avoid hypercalcaemia according to the biochemical response. Indices of response include plasma levels of calcium (ideally corrected for protein binding), alkaline phosphatase, parathyroid hormone, as well as radiographic and histological investigations.

Plasma levels should initially be measured at weekly intervals. The daily dose of Alfacalcidol Capsules may be increased by increments of 0.25 – 0.5 microgram. When the dose is stabilised, measurements may be taken every 2 – 4 weeks.
Most adult patients respond to doses between 1 and 3 micrograms per day. When there is biochemical or radiographic evidence of bone healing, (and in hypoparathyroid patients when normal plasma calcium levels have been attained), the dose generally decreases. Maintenance doses are generally in the range of 0.25 to 1 microgram per day. If hypercalcaemia occurs, Alfacalcidol Capsules should be stopped until plasma calcium returns to normal (approximately 1 week) then restarted at half the previous dose.

1. Renal bone disease:
   Patients with relatively high initial plasma calcium levels may have autonomous hyperparathyroidism, often unresponsive to Alfacalcidol Capsules. Other therapeutic measures may be indicated. Before and during treatment with Alfacalcidol Capsules, phosphate binding agents should be considered to prevent hyperphosphataemia. It is particularly important to make frequent plasma calcium measurements in patients with chronic renal failure because prolonged hypercalcaemia may aggravate the decline of renal function.

2. Hyperparathyroidism:
   In patients with primary or tertiary hyperparathyroidism about to undergo parathyroidectomy, pre-operative treatment with Alfacalcidol Capsules for 2–3 weeks alleviates bone pain and myopathy without aggravating pre-operative hypercalcaemia. In order to decrease post-operative hypocalcaemia, Alfacalcidol Capsules should be continued until plasma alkaline phosphatase levels fall to normal or hypercalcaemia occurs.

3. Hypoparathyroidism:
   In contrast to the response to parent vitamin D, low plasma calcium levels are restored to normal relatively quickly with Alfacalcidol Capsules. Severe hypocalcaemia is corrected more rapidly with higher doses of Alfacalcidol Capsules (e.g. 3–5 micrograms) together with calcium supplements.

4. Neonatal hypocalcaemia:
   Although the normal starting dose of Alfacalcidol Capsules is 0.05–0.1 microgram/kg/day (followed by careful titration) in severe cases doses of up to 2 microgram/kg/day may be required. Whilst ionised serum calcium levels may provide a guide to response, measurement of plasma alkaline phosphatase activity may be more useful. Levels of alkaline phosphatase approximately 7.5 times above the adult range indicates active disease. A dose of 0.1 microgram/kg/day of Alfacalcidol Capsules has proven effective as prophylaxis against early neonatal hypocalcaemia in premature infants.

5. Nutritional and malabsorptive rickets and osteomalacia:
   Nutritional rickets and osteomalacia can be cured rapidly with Alfacalcidol Capsules. Malabsorptive osteomalacia (responding to large doses of IM or IV parent vitamin D) will respond to small doses of Alfacalcidol Capsules.

6. (D-dependent) rickets and osteomalacia:
   Although large doses of parent vitamin D would be required, effective doses of Alfacalcidol Capsules are similar to those required to heal nutritional vitamin D deficiency rickets and osteomalacia.

7. Vitamin D-resistant rickets and osteomalacia:
   Neither large doses of parent vitamin D nor phosphate supplements are entirely satisfactory. Treatment with Alfacalcidol Capsules at normal dosage rapidly relieves myopathy when present and increases calcium and phosphate retention. Phosphate supplements may also be required in some patients.

Route of Administration
Oral use

CONTRAINDICATIONS:

Hypersensitivity to the active substance or to any of the excipients.
Hypercalcaemia, metastatic calcification.