Product image of Hidroferol Hebdomadaire (Calcifediol Monohydrate) supplied by GNH India

Hidroferol Hebdomadaire

Active Ingredient:
Calcifediol Monohydrate
Origin:
EU

Hidroferol Hebdomadaire (Calcifediol Monohydrate)

Hidroferol Hebdomadaire is a weekly oral product that contains the vitamin D analog calcifediol monohydrate. The formulation is supplied without a specified strength, and it is marketed in the European Union. As a source of 25‑hydroxyvitamin D3, it is intended to raise circulating vitamin D levels when taken as directed. The product belongs to the vitamin D supplementation class and is generally administered by mouth.

Manufacturer / TM Owner

Faes Farma S.A.

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Indications & Clinical Uses

Hidroferol Hebdomadaire is used in clinical practice to address conditions related to insufficient vitamin D status.

  • Treatment of documented vitamin D deficiency in adults.
  • Prevention of osteomalacia in individuals at risk.
  • Adjunct therapy for osteoporosis management to support bone health.
  • Support for patients with malabsorption syndromes that impair vitamin D synthesis.
  • Seasonal prophylaxis of low vitamin D levels in populations with limited sun exposure.

How It Works

  • Calcifediol monohydrate is the 25‑hydroxy form of vitamin D3. After oral absorption, it bypasses hepatic 25‑hydroxylation and directly increases serum 25‑hydroxyvitamin D concentrations. The elevated metabolite binds to the vitamin D receptor (VDR) in target tissues, regulating gene transcription that enhances intestinal calcium and phosphate absorption, modulates bone remodeling, and influences immune function. The VDR‑mediated transcription also up‑regulates calbindin and other calcium‑transport proteins, facilitating efficient mineral uptake.

Side Effects

Adverse reactions to Hidroferol Hebdomadaire are generally mild, but rare serious events have been reported.

Common

  • Transient hypercalcemia symptoms such as mild nausea or constipation.
  • Headache or dizziness.
  • Mild fatigue.
  • Skin rash or mild pruritus.

Serious

  • Persistent hypercalcemia leading to kidney stones or calcification of soft tissues.
  • Severe allergic reactions including anaphylaxis.
  • Acute pancreatitis associated with markedly elevated calcium levels.
  • Hepatic dysfunction manifested by elevated liver enzymes.

Precautions & Warnings

Before initiating Hidroferol Hebdomadaire, certain safety considerations should be reviewed.

  • Assess baseline serum 25‑hydroxyvitamin D, calcium, and phosphate levels.
  • Use caution in patients with a history of hypercalcemia, renal stones, or granulomatous diseases.
  • Adjust dose or avoid use in severe renal impairment (eGFR <30 mL/min/1.73 m²).
  • Monitor calcium and renal function periodically during therapy.
  • Pregnant or breastfeeding women should consult a healthcare professional before use.
  • Concomitant use with high‑dose vitamin D supplements may increase risk of toxicity.

Avoid Interactions

Hidroferol Hebdomadaire may interact with other medicines that affect calcium balance or vitamin D metabolism.

Avoid

  • High‑dose vitamin D or calcium supplements that could cause hypercalcemia.
  • Thiazide diuretics, which reduce urinary calcium excretion.
  • Medications that increase vitamin D activation such as anticonvulsants (e.g., phenobarbital, phenytoin).
  • Sarcoidosis or other granulomatous disorders where endogenous vitamin D production is elevated.

Use with caution

  • Bisphosphonates, as combined therapy may affect bone turnover monitoring.
  • Corticosteroids, which can impair vitamin D metabolism and require dose adjustment.
  • Loop diuretics, which increase calcium loss and may counteract the drug’s effect.
  • Antiretroviral agents (e.g., efavirenz) that may lower vitamin D levels.

Frequently Asked Questions

The product contains calcifediol monohydrate, the 25‑hydroxy form of vitamin D3.

It is formulated for weekly oral administration, but the exact schedule should follow a healthcare professional’s recommendation.

Adults with documented vitamin D deficiency, individuals at risk for osteomalacia, or patients needing additional vitamin D support for bone health may be considered.

Pregnant or breastfeeding women should discuss use with their physician, as safety has not been fully established.

Baseline serum 25‑hydroxyvitamin D, calcium, phosphate, and renal function tests are typically advised.

Concurrent high‑dose calcium supplements may increase the risk of hypercalcemia and should be used only under medical supervision.

Mild nausea, constipation, headache, dizziness, fatigue, and occasional skin rash are among the most frequently reported effects.

Signs of persistent hypercalcemia such as severe abdominal pain, kidney stones, or an allergic reaction like swelling and difficulty breathing should prompt urgent care.

Calcifediol is already 25‑hydroxylated, bypassing the liver step required for cholecalciferol, leading to a more rapid increase in circulating 25‑hydroxyvitamin D levels.

Anticonvulsants such as phenobarbital and phenytoin can increase vitamin D metabolism, potentially lowering its efficacy.

Periodic assessment of serum calcium, phosphate, and 25‑hydroxyvitamin D levels is recommended to ensure therapeutic response and avoid toxicity.

Contact a healthcare provider for guidance; generally, the missed dose should not be doubled without professional advice.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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