UN-ALFA

Renal osteodystrophy: o curative treatment of renal osteodystrophy radiologically obvious and/or with elevated alkaline and hypocalcaemia phosphatases (< 95 mg/l) in renal insufficiency with creatinine clearance < 30 ml/min and in hemodialysis; o preventive treatment of renal osteodystrophy only in children with renal insufficiency but not adults.

• Pseudo-carential rachitis.

• Rachitis and osteomacias by vitamino-resistant hypophosphataemia in combination with an Oral 4 supplement.

• Hypoparathyroidism and pseudo-hypoparathyroidisms.

• Prevention of postparathyroidectomy hypocalcaemia in cases of primary or tertiary hyperparathyroidism.

Special warnings

Self-nominated hyperparathyroidism (primary or tertiary) and osteomalacia by aluminium poisoning are not justiciable to treatment with alfacalcidol.

Combination with certain medicines should be avoided.

Precautions for use

The conduct of treatment requires regular (weekly) monitoring of serum calcium and phosphoraemia in order to control the phosphocalcium product.

It is also appropriate to dose creatinine, magnesium, serum alkaline phosphatases and in the absence of renal failure, in a monthly manner.

Monitoring will be more frequent: o during the period of useful dose setting; o and at the time when treatment effectiveness results in a decrease in alkaline phosphatases, or a net radiological improvement: doses required for the treatment of bone disorders should be reduced.

In all cases, it is appropriate to avoid the appearance of a medicinal product that is not sufficiently strong to cause a disease (hypercalcaemia, hypercytic acid, hyperphosphoremia, etc).

Pharmacotherapeutic group

Vitamin A and D and combinations of both included, ATC code: A11CC03.

Alfacalcidol normalizes intestinal absorption of calcium and phosphorus.

It raises both serum calcium and phosphoremia.

It lowers high levels of parathyroid hormone only if hyperphosphoremia is prevented by increased doses of aluminum hydroxide.

Its action continues even when renal 1-alpha-hydroxylation is disturbed.

The pharmacological action is rapidly and proportionally manifested to the dose.

The following adverse reactions are classified by organ system and frequency order.

The frequency classification uses the following convention: very common (≥ 1/10), common (≥ 1/100; < 1/10), uncommon (≥ 1/1,000; < 1/100), rare (≥ 1/10,000; < 1/1,000), very rare (< 1/10,000), and unknown frequency (cannot be estimated from available data).

Metabolism and nutrition disorders.

• - Not known: hypercalcaemia (associated with hypercalciuria), hyperphosphoremia.

• In renal insufficiency: the major risk of alfacalcidol is hypercalcaemia and hyperphosphoremia resulting in calcifications of soft tissues (corned, conjunctivities, skin, vessel, kidneys) that can cause functional and vital prognosis.

• In hypoparathyroidal and hypophosphatemic non-renal-resistant vitamino: the risk is, here, that of hypercalcaemia and hypercalciuria.

It is possible to prevent any adverse drug drug, which is suspected to cause serious adverse reactions and adverse reactions to the drug.