What is Egostar? ¹

Egostar is a prescription-only Vitamin D treatment with each film-coated tablet containing 560 micrograms (22 400 IU) of cholecalciferol (vitamin D3).

What is Egostar indicated for? ¹

Egostar is indicated for use in adults for;

• Prevention of vitamin D deficiency in patients with an identified risk.
• Initial treatment of clinically relevant vitamin D deficiency.
• As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency.

How should Egostar be taken? ¹

• Egostar tablets should be swallowed whole with water, and ideally with food.
• Treatment duration is based upon the indication, the severity of the disease and the patient's response to treatment.
• Dose should be established on an individual basis depending on the extent of the necessary vitamin D supplementation.
• The patient's dietary habits should be carefully evaluated and artificially added vitamin D content of certain food types should be taken into consideration.

Medical supervision is necessary as dose requirements may vary dependent on patient response

What is the correct dose of Egostar? ¹

Dose should be established on an individual basis depending on the extent of the necessary vitamin D supplementation. The following dosing information is taken from the Summary of Product Characteristics.

Prevention of Vitamin D deficiency: One tablet (22 400 IU) once every 28 days.

Initial treatment of Vitamin D deficiency: One tablet (22 400 IU) once a week for four weeks. After four weeks, lower doses may be considered, dependent upon desirable serum levels of 25 hydroxycolecalciferol (25(OH)D), the severity of the disease and/or the patient´s response to treatment.

As an adjunct to specific therapy for osteoporosis: One tablet (22 400 IU) once every 28 days.

Medical supervision is necessary as dose requirements may vary dependent on patient response

What is the national guidance for Ireland on Vitamin D supplementation?

New advice on Vitamin D supplementation was issued in April 2023.⁶

In 2023 the Food Safety Authority of Ireland, at the request of the Department of Health, produced a report titled, "Vitamin D: Scientific Recommendations for 5 to 65 Year Olds Living in Ireland" ⁷. Some of the key conclusions from the report are listed here;

• Vitamin D plays key physiological roles in the musculoskeletal system, the functioning of the immune system, and the process of cell division
• Vitamin D deficiency leads to impaired mineralisation of bone due to an inefficient absorption of dietary calcium and phosphorus, which manifests as rickets in children and osteomalacia in adults.
• In addition, although causation has not been proven, several studies suggest associations between vitamin D deficiency and non-skeletal health conditions, such as cardiovascular diseases; diabetes; inflammatory disorders; some infectious diseases (including COVID-19) and immune disorders; certain cancers; and higher mortality rates.
• Serum 25-hydroxyvitamin D (25(OH)D) concentrations below 30 nanomoles per litre (nmol/L), is representative of an increased risk of vitamin D deficiency, as it relates to bone health
• Vitamin D is obtained from the diet (via natural foods, fortified foods, and food supplements) and unprotected skin exposure to sunlight (during the months of April through October in Ireland).
• Dietary vitamin D requirement for maintaining serum 25(OH)D at or above 30 nmol/L is 15 μg daily for adults (aged 18–65 years) of all ethnicities.
• Mean daily intakes of vitamin D in adults in Ireland who did not consume vitamin D-containing supplements were only around 2–3 μg per day (μg/d).
• A cross-sectional study of adults aged 18–50 years showed that the prevalence of serum 25(OH)D levels below 30 nmol/L among adults from a dark-skinned ethnic minority group (e.g. Irish Asian) is much higher (70%) than that in the Caucasian population (12%).

Based on the above conclusions, The Food Safety Authority of Ireland advises the following.

For healthy adults (aged 18–65 years) who get sunlight exposure during summer:

• For those of fair-skinned ethnicity, a daily vitamin D supplement containing 15 µg (600 IU) taken during the extended winter months (end of October to March) is expected to meet their requirements.
• For those of darker-skinned ethnicity, a daily vitamin D supplement containing 15 µg (600 IU) taken throughout the full year is expected to meet their requirements.

People who are currently taking a vitamin D supplement that has been prescribed by a doctor or a nurse and that contains more than 15 microgram (15μg) should consult their doctor or nurse.

What is the relevance of a vitamin D treatment being gelatine free?

Gelatine is made by processing animal bones, cartilage, and skin. Producers may use the bodies of cows or fish, for example. The process extracts the collagen, a fibrous protein that connects muscles, bones, and skin, and turns it into gelatin, a flavorless, colorless, jelly-like substance.⁸

Gelatin comes from processed animal tissue.

Products containing gelatin are unsuitable for vegetarians or for anyone following kosher or halal diets (if the gelatin is derived from non-kosher or non-halal animals). Some religions prohibit the consumption of certain animal products or specific animals, and others opposed to animal products or concerned about animal welfare may avoid gelatin. In a recent report by Board Bia, The Irish Food Board, concluded that 4.3% of adults in Ireland were vegetarian. ⁵

Egostar is gelatin-free.^9,10

Who might benefit from Egostar?

Egostar is indicated for use in adults for;

• Prevention of vitamin D deficiency in patients with an identified risk.
• Initial treatment of clinically relevant vitamin D deficiency.
• As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency.

Vitamin D deficiency can result from several causes. ⁴

1. Decreased dietary intake and/or absorption

   Certain malabsorption syndromes such as celiac disease, short bowel syndrome, gastric bypass, inflammatory bowel disease, chronic pancreatic insufficiency, and cystic fibrosis may lead to vitamin D deficiency. Lower vitamin D intake orally is more prevalent in the elderly population.

2. Decreased sun exposure

   Twenty minutes of sunshine daily with over 40% of skin exposed is required to prevent vitamin D deficiency. Cutaneous synthesis of vitamin D declines with aging. Dark-skinned people have less cutaneous vitamin D synthesis. Decreased exposure to the sun, as seen in individuals who are institutionalized or have prolonged hospitalizations, can also lead to vitamin D deficiency. Effective sun exposure is decreased in individuals who use sunscreens consistently.

3. Decreased endogenous synthesis

   Individuals with chronic liver disease such as cirrhosis can have defective 25-hydroxylation, leading to deficiency of active vitamin D. Defects in 1-alpha 25-hydroxylation can be seen in hyperparathyroidism, renal failure, and 1-alpha hydroxylase deficiency.

4. Increased hepatic catabolism

   Medications such as phenobarbital, carbamazepine, dexamethasone, nifedipine, spironolactone, clotrimazole, and rifampin induce hepatic p450 enzymes, which activate the degradation of vitamin D.

5. End organ resistance

   End-organ resistance to vitamin D can be seen in hereditary vitamin D-resistant rickets.

   Certain populations are at high risk of vitamin D deficiency, and may require higher doses and monitoring of serum 25(OH)D:¹

   • Institutionalised or hospitalised individuals
   • Dark skinned individuals
   • Individuals with limited effective sun exposure due to protective clothing or consistent use of sun screens
   • Obese individuals
   • Patients being evaluated for osteoporosis
   • People using certain concomitant medications (e.g., anticonvulsant medications, glucocorticoids)
   • Patients with malabsorption, including inflammatory bowel disease and coeliac disease
   • Those recently treated for vitamin D deficiency, and requiring maintenance therapy.

Who should not take Egostar? ¹

Egostar is not to be used in children.

Egostar is not recommended in women who are pregnant or breast feeding.

Egostar has the following contraindications;

• Hypersensitivity to the active substance or any of the excipients listed in section 6.1. of the Egostar SmPC
• Hypervitaminosis D
• Nephrolithiasis
• Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria.
• Severe renal impairment

The following special warnings and precautions exist for using Egostar;

• Egostar should not be administered to patients with hypercalcaemia
• This medicinal product should be used with caution in patients with impairment of renal function (or calculi) and the effect on calcium and phosphate levels should be monitored
• Caution is required in patients receiving treatment for cardiovascular disease (e.g. digitalis)
• Caution is required in patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active form. These patients should be monitored with regard to the calcium content in serum and urine
• Allowances should be made for vitamin D supplements from other sources
• The need for additional calcium supplementation should be considered for individual patients. Calcium supplements should be given under close medical supervision
• Medical supervision is required whilst on treatment to prevent hypercalcaemia
• It is advised that patients receiving pharmacological doses of vitamin D should have their plasma-calcium concentration monitored at regular intervals, especially initially or if symptoms suggest toxicity