SEFAL ® - Alfacalcidol

SEFAL ® is a drug based on Alfacalcidol

THERAPEUTIC GROUP: Vitamin D

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications SEFAL ® - Alfacalcidol

SEFAL ® is indicated in the treatment of bone diseases such as rickets, osteomalacia and osteoporosis associated with vitamin D deficiency due to renal failure.

Mechanism of action SEFAL ® - Alfacalcidol

Alfacalcidol, also called 1 alpha-hydroxycholecalciferol, is a biologically active synthetic product derived from vitamin D, which has the same effects as the common activated vitamin D (1, 25-OH-D3) without requiring the intervention of the kidney.

The possibility of skipping renal metabolism allows the use of this drug in patients with reduced hydroxylating capacity linked to limiting renal or extra-renal diseases.

Furthermore, the advantageous pharmacokinetic properties of SEFAL ® characterized by a much shorter half-life, make it possible to significantly reduce the side effects of vitamin D overdose and the relative risk of hypercalcemia, thus making the treatment safer and more easily manageable.

Studies carried out and clinical efficacy

1. ALFACALCIDOLO AND ALENDRONATO COMPARISON

Study demonstrating the greater efficacy of bisphosphonates in the treatment of patients at high risk of bone fractures. In light of these data, it should be considered that Alfacalcidol alone cannot produce particularly important results.

2. ALFACALCIDOLO AND CALCIUM-ALCAL SYNDROME

Case report demonstrating how the daily administration of alfacalcidol may be responsible for calcium-alkali syndrome and therefore accompanied by generalized weakness and numbness.

3. INEFFICACY OF ALFACALCIDOLO

An interesting case report demonstrating that if oral alfacalcidol is not effective, the intramuscular administration of ergo calciferol may be effective in improving the patient's health.

Method of use and dosage

SEFAL ®

Soft capsules of 0.25 -1 mcg of alfacalcidol:

treatment should start with the administration of 1 mcg of alfacalcidol per day and continue with the minimum dosage necessary to ensure the desired therapeutic effect.

In any case, the entire therapeutic procedure should be supervised by your doctor.

Dosages of SEFAL ® vary significantly in pediatric age.

Warnings SEFAL ® - Alfacalcidol

All treatment with SEFAL ® should be accompanied by periodic monitoring of calcium concentrations and various electrolytes in order to avoid the appearance of hypercalcemia and associated complications.

The monitoring of these values is also important in order to optimize the therapeutic efficacy of the drug through a modulation of the dosages used .

PREGNANCY AND BREASTFEEDING

The use of SEFAL ® is contraindicated during pregnancy and lactation due to the absence of clinical trials able to demonstrate the safety of alfacalcidol on the health of the fetus.

Interactions

The simultaneous use of anticonvulsants and antiepileptics could increase the need for vitamin D, therefore requiring a further adjustment of the dosage of SEFAL ®.

Attention should also be paid to the simultaneous use of drugs capable of modulating the metabolism of calcium, phosphorus and magnesium in order to avoid the appearance of electrolyte imbalances.

Contraindications SEFAL ® - Alfacalcidol

SEFAL ® is contraindicated in case of hypercalcaemia or hypersensitivity to the active substance or to one of its excipients.

Undesirable effects - Side effects

The administration of SEFAL ® is generally safe and free of clinically significant side effects if performed according to the appropriate medical indications.

Higher dosages or protracted for a long time could instead cause the appearance of nausea, diarrhea, anorexia, weight loss, polyuria, sweating, headache, thirst, dizziness, hypercalcaemia, hypercalciuria and hyperfostatemia with the relative complications.

However, the low half-life of the drug facilitates the restoration of optimal health conditions in a short time after the treatment is suspended.