Product image of Kalcifediol Faes (Calcifediol Monohydrate) supplied by GNH India

Kalcifediol Faes

Active Ingredient:
Calcifediol Monohydrate
Origin:
EU

Kalcifediol Faes (Calcifediol Monohydrate)

Calcifediol Monohydrate, the active ingredient in Kalcifediol Faes, is a vitamin D analog presented as an oral dosage form for oral use. It is used to correct vitamin D deficiency, manage secondary hyperparathyroidism, and support bone health in adults and children.

GNH India supplies Kalcifediol Faes as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable logistics for global distribution. Its network covers major markets across Europe, Asia and the Americas, ensuring timely access to essential vitamin D therapy.

Manufacturer / TM Owner

Faes Farma S.A.

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Indications & Clinical Uses

Calcifediol is indicated for conditions related to vitamin D metabolism and bone health.

  • Vitamin D deficiency: restores adequate serum 25‑hydroxyvitamin D levels to support calcium absorption.
  • Secondary hyperparathyroidism: reduces elevated parathyroid hormone concentrations associated with chronic kidney disease.
  • Bone health maintenance: contributes to normal bone remodeling and mineralization in adults at risk of osteopenia.

How It Works

  • Calcifediol Monohydrate is absorbed from the gastrointestinal tract and undergoes hepatic 25‑hydroxylation to form 25‑hydroxyvitamin D, the main circulating form of vitamin D. This metabolite is subsequently converted by renal 1α‑hydroxylase to the active hormone 1,25‑dihydroxyvitamin D, which binds to the vitamin D receptor (VDR) in target tissues, regulating transcription of genes involved in calcium and phosphate homeostasis and bone mineralization.

Side Effects

Calcifediol may be associated with a range of adverse reactions, most of which are mild and reversible.

Common Side Effects

  • Hypercalcemia: elevated blood calcium levels causing fatigue or nausea.
  • Hyperphosphatemia: increased serum phosphate, occasionally leading to muscle cramps.
  • Gastrointestinal discomfort: mild abdominal pain, constipation or diarrhea.
  • Headache: transient mild headache episodes.

Serious or Rare Side Effects

  • Nephrolithiasis: kidney stone formation due to calcium precipitation.
  • Hypercalciuria: excessive urinary calcium excretion, potentially damaging kidneys.
  • Allergic reactions: rash, pruritus or angioedema in sensitive individuals.
  • Severe hypercalcemia: confusion, arrhythmia or cardiac arrest in extreme cases.

Precautions & Warnings

When using Calcifediol, certain precautions should be observed to minimize risk and ensure optimal therapy.

  • Assess baseline: measure serum calcium, phosphate and 25‑hydroxyvitamin D before initiating therapy.
  • Monitor levels: repeat laboratory tests periodically to detect hypercalcemia or hyperphosphatemia.
  • Renal impairment: adjust use in patients with severe kidney disease due to altered conversion to active form.
  • Drug interactions: review concomitant medications that affect calcium metabolism.
  • Pregnancy and lactation: use only if clearly needed and prescribed by a healthcare professional.
  • Store at ambient temperature: keep below 25 °C, in the original container, protected from moisture and direct sunlight.

Avoid Interactions

Calcifediol can interact with several medicines, influencing its efficacy or safety.

Major Interactions (Avoid)

  • Thiazide diuretics: may increase risk of hypercalcemia.
  • Calcium supplements: can exacerbate hypercalcemia when combined.
  • Vitamin D analogues (e.g., calcitriol): additive effect on calcium levels.

Moderate Interactions (Monitor Closely)

  • Anticonvulsants (phenytoin, phenobarbital): may enhance metabolism and lower vitamin D levels.
  • Glucocorticoids: can reduce calcium absorption and counteract benefits.
  • Bisphosphonates: concurrent use may require monitoring of bone turnover markers.

Frequently Asked Questions

Kalcifediol Faes is used to treat vitamin D deficiency, manage secondary hyperparathyroidism, and support overall bone health. By providing the 25‑hydroxyvitamin D precursor, it helps restore normal calcium and phosphate balance in patients who need additional vitamin D support.

Calcifediol is absorbed and converted in the liver to 25‑hydroxyvitamin D, the main circulating form of vitamin D. This metabolite is later activated by the kidneys to 1,25‑dihydroxyvitamin D, which binds to the vitamin D receptor and regulates genes that control calcium and phosphate absorption, bone remodeling, and mineralization.

The appropriate dose of Kalcifediol Faes is determined by a qualified healthcare professional based on the individual’s serum vitamin D level, underlying condition, age, and renal function. Prescribers tailor the regimen to achieve target 25‑hydroxyvitamin D concentrations while avoiding excess calcium.

Calcifediol should be used during pregnancy or lactation only if clearly indicated and prescribed by a physician. Limited data are available, so the benefits must outweigh any potential risks. Women who are pregnant or nursing should discuss their specific situation with a healthcare provider before starting therapy.

To order Kalcifediol Faes, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.

Unlike cholecalciferol (vitamin D3), calcifediol is already 25‑hydroxylated, allowing faster and more predictable increases in serum 25‑hydroxyvitamin D. This can be advantageous in patients with liver impairment or those needing rapid correction, while still providing the same downstream activation to the active hormone as other vitamin D analogues.

Store Kalcifediol Faes at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed to maintain stability throughout its shelf life.

Kalcifediol Faes is taken orally, usually as a tablet or capsule, with or without food as directed by the prescriber. Patients should follow the healthcare professional’s instructions regarding timing and whether the dose should be taken with meals to optimize absorption.

The most serious risks include severe hypercalcemia, which can cause confusion, cardiac arrhythmias, or renal failure, and nephrolithiasis (kidney stones). Patients should report symptoms such as persistent nausea, vomiting, excessive thirst, or unexplained fatigue to their clinician promptly.

Kalcifediol Faes should be avoided in individuals with known hypersensitivity to calcifediol or any excipients, in patients with untreated hypercalcemia, and in those with severe renal impairment where conversion to the active form is compromised, unless a physician specifically advises otherwise.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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