What is Calfos used for?

Treatment of vitamin D deficiency in adults. Prevention of vitamin D deficiency in adults with identified risks. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency.

What pharmaceutical form is Calfos available in?

Calfos: Kapsułki miękkie 0,266 mg

What are the side effects of Calfos?

Adverse reactions to Domnisol are generally uncommon (≥ 1/1 000 to <1/100) but sometimes they are moderately significant. The most significant adverse effects are related to excessive intake of vitamin D, i.e., they are often associated with overdose or prolonged treatment, especially when associated with high doses of calcium. The doses of vitamin D analogues required for hypervitaminosis vary considerably from one subject to another. The most common adverse reactions are due

Who should NOT take Calfos?

- Hypersensitivity to the active ingredient or to any of the excipients listed in section 6.1. - Hypercalcemia (serum calcium > 10.5 mg/dl) or hypercalciuria - Calcium lithiasis - Hypervitaminosis D

Does Calfos interact with other medications?

- Phenytoin, phenobarbital, primidone and other enzyme inducers: enzyme inducers may reduce plasma concentrations of calcifediol monohydrate and inhibit its effects by inducing its hepatic metabolism. For this reason, it is generally recommended to monitor plasma 25-OH-D levels when calcifediol monohydrate is administered with antiepileptics that are CYP3A4 inducers in order to consider supplementation. - Cardiac glycosides: Calcifediol monohydrate can cause hypercalcemia, whic

Can Calfos be used during pregnancy?

Pregnancy High doses of vitamin D should not be administrated during pregnancy. Animal reproduction studies have shown toxicity for reproduction when it is administered at higher doses than the therapeutic usual doses (see section 5.3). There is no or limited data from the use of calcifediol monohydrate in pregnant women. Domnisol is not recommended during pregnancy; during first and second trimesters when it should not be used. If the mother baseline condition requires treatme

What precautions should be taken with Calfos?

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

What ATC class does Calfos belong to?

Calfos: ATC A11CC06. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Calfos

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pharmacotherapeutic group: Vitamin D and analogues, ATC code: A11CC06 Mechanism of action Vitamin D has two main forms: D2 (ergocalciferol) and D3 (cholecalciferol).‍‍‍‍‍‍‍‍‍‍‍‍‍ Vitamin D3 is mainly synthesized in the skin by exposure to sunlight (ultraviolet radiation) and is also obtained from the diet. Vitamin D must undergo a two-step metabolic process to be active; the first step occurs in the microsomal fraction of the liver where Vitamin D is hydroxylated at position 25 leading to 25-hydroxycholecalciferol (calcifediol monohydrate or calcidiol); the second step takes place mainly in the kidney where 1,25-dihydroxycholecalciferol or calcitriol is formed due to the activity of enzyme 1-alpha-hydroxylase; conversion to 1,25-dihydroxycholecalciferol is regulated mainly by its own concentration, by parathyroid hormone (PTH) and by the fibroblastic growth factor 23 (FGF23). Calcitriol is transported from the kidney to target tissues (intestine, bone and possibly kidney and parathyroid gland) where it binds to the calcitriol receptors and activates the responsive pathways that result in increased intestinal absorption of calcium and phosphorus and reduced parathyroid hormone synthesis. Pharmacodynamic effects Vitamin D increases absorption of calcium and phosphorus in the intestine and improves normal bone formation and mineralization and acts on three levels: Intestine: Vitamin D enhances absorption of calcium and phosphorus in the small intestine. Bone: calcitriol enhances bone formation by increasing levels of calcium and phosphate and stimulates action of osteoblasts. Kidney: calcitriol enhances tubular reabsorption of calcium. Parathyroid glands: vitamin D inhibits the secretion of parathyroid hormone. Immune system: modulates innate and adaptative immune response. Clinical efficacy and safety The efficacy and safety of Domnisol 266 micrograms soft capsules were evaluated in a randomized, double-blind study in post-menopausal women with vitamin D deficiency. 303 subjects were randomized and 298 conformed the intention to treat population. Patients were treated with calcifediol monohydrate 266 micrograms/month or cholecalciferol at recommended therapeutic guidelines dose (25000 IU/month). After 1 month, 13.5 % of patients treated with calcifediol achieved 25(OH)D levels greater than 30 ng/mL (75 nmol/l) and 59.1% achieved levels greater than 20 ng/mL (50 nmol/l). After 4 months 35% of patients treated with calcifediol monohydrate achieved 25(OH)D levels greater than 30 ng/mL (75 nmol/l) and 81% achieved levels greater than 20 ng/mL (50 nmol/l). The mean (SD) increase in 25(OH)D concentrations with respect to baseline levels was 9.7 (6.7) ng/mL (24.3 (16.8) nmol/l) after 1 month and 14.9 (8.1) ng/mL (37.3 (20.3) nmol/l) after 4 months of treatment. Highest 25(OH)D levels with calcifediol were achieved after 4 months of treatment and remained stable for 12 months in the long term, indicating a non-accumulative effect. Calcifediol monohydrate was safe and well tolerated.

Calfos

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