Vitamin D3 (Cholecalciferol)

Pharmacologic Category

Vitamin D Analog

Dosing: Adult

Note: 1 mcg = 40 units

Hypoparathyroidism (off-label use): Note: Active vitamin D preparations (ie, alfacalcidol, calcitriol) in conjunction with calcium supplementation are recommended therapy. Addition of cholecalciferol (or ergocalciferol) may be considered for supplemental therapy (Endocrine Society [Brandi 2016]).

Osteoporosis, prevention (off-label use): Adults ≥50 years of age: Oral: 800 to 1,000 units/day is recommended, through dietary sources and/or supplementation if needed (NOF [Cosman 2014]).

Vitamin D insufficiency/deficiency treatment (off-label use): Note: Repletion strategies may vary depending on desired target serum 25(OH)D levels as well as the clinical status of the patient. The optimal serum 25(OH)D level is controversial; the Institute of Medicine recommends a 25(OH)D level >20 ng/mL as sufficient in nearly all persons (IOM 2011), whereas others have suggested targeting a level of ~30 ng/mL to minimize the risk of fractures, particularly in patients with osteoporosis (AACE [Camacho 2016]; NOF [Cosman 2014]). However, some data suggest levels >40 ng/mL (median level in one trial: ~48 ng/mL) are associated with increased risk of falls in postmenopausal women (Sanders 2010; Smith 2017).

Therefore, some experts recommend a range of 20 to 40 ng/mL as a reasonable target in most patients (Dawson-Hughes 2018). In patients with normal absorption, for every 100 units/day of cholecalciferol, the serum 25(OH)D level is expected to increase by ~0.7 to 1 ng/mL after a few weeks (ASPEN [McKeever 2017]; Dawson-Hughes 2018). The dose-response declines as the 25(OH)D concentration increases above 40 ng/mL (100 nmol/L) (Dawson-Hughes 2018). The following recommendations are based primarily on expert opinion and clinical experience:

Initial dosing (according to baseline serum 25(OH)D level):

Serum 25(OH)D 20 to 30 ng/mL: Initial: Supplementation dosing: Oral: 600 to 800 units once daily; a repeat serum 25(OH)D level is not required (Dawson-Hughes 2018) or 1,000 to 2,000 units once daily; may consider a repeat serum 25(OH)D level in ~3 months to determine if the target level has been achieved (Khan 2010).

Serum 25(OH)D 10 to <20 ng/mL: Initial:

Supplementation dosing: Oral: 800 to 1,000 units once daily (Dawson-Hughes 2018) or 2,000 units once daily (Khan 2010); a repeat serum 25(OH)D level should be drawn after ~3 months. If target serum 25(OH)D level has not been achieved, may increase to 2,000 units once daily or administer therapeutic dosing of 50,000 units once weekly for 6 to 8 weeks (Dawson-Hughes 2018).

OR

Therapeutic dosing (ie, high-dose cholecalciferol): Oral: 50,000 units once weekly (or 5,000 to 7,000 units once daily) for ~8 weeks, followed by decreased maintenance dosing as needed to maintain target serum 25(OH)D level (AACE [Camacho 2016]; NOF [Cosman 2014]).

Serum 25(OH)D <10 ng/mL or in patients with deficiency symptoms: Initial: Therapeutic dosing (ie, high-dose cholecalciferol): Oral: 50,000 units once weekly (or 5,000 to 7,000 units once daily) for 6 to 8 weeks to achieve target serum 25(OH)D level; a repeat serum 25(OH)D level should be drawn after ~3 months to assure target serum 25(OH)D level has been met (AACE [Camacho 2016]; Dawson-Hughes 2018; NOF [Cosman 2014]).

Maintenance dosing: Maintenance dosing is highly patient specific and dependent on target 25(OH)D level, and may range from: 600 to 800 units/day (Dawson-Hughes 2018) to 1,000 to 2,000 units/day (AACE [Camacho 2016]; NOF [Cosman 2014]).

Special populations (obese patients, patients on medications known to affect vitamin D metabolism, patients with malabsorption syndromes or gastrectomy): Higher doses or longer durations may be necessary for adequate repletion (AACE [Camacho 2016]; Dawson-Hughes 2018).

Vitamin D deficiency/insufficiency in patients with chronic kidney disease (off-label use): Oral:

Note: In patients without severe and progressive hyperparathyroidism, including chronic kidney disease stages G3 to G5 and dialysis or transplant patients, KDIGO guidelines recommend correcting vitamin D deficiency and insufficiency with treatment strategies recommended for the general population using cholecalciferol (or ergocalciferol) while avoiding hypercalcemia and ensuring phosphate levels are in the normal range. An individualized monitoring approach to direct treatment is also recommended (KDIGO 2009; KDIGO 2017). In patients in whom serum parathyroid hormone levels are progressively rising and remain persistently elevated despite correction of modifiable factors (eg, hyperphosphatemia, vitamin D deficiency), calcitriol or vitamin D analogs are suggested instead of cholecalciferol (or ergocalciferol) (KDOQI commentary [Uhlig 2010]).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

Vitamin D deficiency, prevention (eg, Rickets prevention): (AAP [Folsom 2017]; AAP [Wagner 2008]; Munns 2016): Oral:

Breast-fed infants (fully or partially): Oral: 400 units/day beginning in the first few days of life. Continue supplementation until infant is weaned to ≥1,000 mL/day or 1 qt/day of vitamin D-fortified formula or whole milk (after 12 months of age)

Formula-fed infants ingesting <1,000 mL of vitamin D-fortified formula: Oral: 400 units/day

Children and Adolescents without adequate intake: Oral: 400 to 600 units/day. Note: Children with increased risk of vitamin D deficiency (chronic fat malabsorption, maintained on chronic antiseizure medications) may require higher doses; use laboratory testing [25(OH)D, PTH, bone mineral status] to evaluate

Vitamin D deficiency, treatment: Oral: Note: Treatment should also include calcium and phosphorus supplementation; some patients with chronic fat malabsorption, obesity, or who are maintained on chronic antiseizure medications, glucocorticoids, HIV medications, or antifungals may require higher doses of cholecalciferol (AAP [Golden 2014]); monitor vitamin D status closely.

Infants: Oral: 2,000 units daily for 6 weeks to achieve a serum 25(OH)D level >20 ng/mL; followed by a maintenance dose of 400 to 1,000 units daily. Note: For patients at high risk of fractures a serum 25(OH)D level >30 ng/mL has been suggested (AAP [Golden 2014]).

Children and Adolescents: Oral: 2,000 units daily for 6 to 8 weeks to achieve serum 25(OH)D level >20 ng/mL; followed by a maintenance dose of 600 to 1,000 units daily. Note: For patients at high risk of fractures a serum 25(OH)D level >30 ng/mL has been suggested (AAP [Golden 2014]).

Vitamin D deficiency in cystic fibrosis, prevention and treatment: Oral:

CF guidelines (Tangricha [CF Foundation] 2012):

Recommended initial daily intake to maintain serum 25(OH)D level ≥30 ng/mL:

Infants: Oral: 400 to 500 units/day

Children ≤10 years: Oral: 800 to 1,000 units/day

Children >10 years and Adolescents: Oral: 800 to 2,000 units/day

Dosing adjustment for serum 25(OH)D level between 20 to 30 ng/mL and patient adherence established (Step 1 increase):

Infants: Oral: 800 to 1,000 units/day

Children ≤10 years: Oral: 1,600 to 3,000 units/day

Children >10 years and Adolescents: Oral: 1,600 to 6,000 units/day

Dosing adjustment for serum 25(OH)D level <20 ng/mL or persistently between 20 to 30 ng/mL and patient adherence established (Step 2 increase):

Infants: Increase up to a maximum 2,000 units/day

Children ≤10 years: Increase to a maximum of 4,000 units/day

Children >10 years and Adolescents: Increase to a maximum of 10,000 units/day

Alternate dosing (Hall 2010):

Initial dose: Serum 25(OH)D level ≤30 ng/mL

Infants: Oral: 8,000 units/week

Children and Adolescents: Oral: 800 units/day

Medium-dose regimen: Serum 25(OH)D level remains ≤30 ng/mL and patient compliance established

Infants and Children <5 years: Oral: 12,000 units/week for 12 weeks

Children ≥5 years and Adolescents: Oral: 50,000 units/week for 12 weeks

High-dose regimen: Repeat 25(OH)D level remains ≤30 ng/mL and patient compliance established

Infants and Children <5 years: Oral: 12,000 units twice weekly for 12 weeks

Children ≥5 years and Adolescents: Oral: 50,000 units twice weekly for 12 weeks

Vitamin D insufficiency or deficiency associated with CKD (stages 2 to 5, 5D), treatment; serum 25 hydroxyvitamin D [25(OH)D] level ≤30 ng/mL (KDOQI Guidelines 2009): Oral:

Serum 25(OH)D level 16 to 30 ng/mL: Infants, Children, and Adolescents: 2,000 units/day for 3 months or 50,000 units every month for 3 months

Serum 25(OH)D level 5 to 15 ng/mL: Infants, Children, and Adolescents: 4,000 units/day for 12 weeks or 50,000 units every other week for 12 weeks

Serum 25(OH)D level <5 ng/mL: Infants, Children, and Adolescents: 8,000 units/day for 4 weeks then 4,000 units/day for 2 months for total therapy of 3 months or 50,000 units/week for 4 weeks followed by 50,000 units 2 times/month for a total therapy of 3 months

Maintenance dose [once repletion accomplished; serum 25(OH)D level >30 ng/mL]: Infants, Children, and Adolescents: 200 to 1,000 units/day

Nutritional rickets, treatment: Limited data available (Munns 2016): Administer in combination with calcium supplementation:

Daily therapy (preferred):

Infants: Oral: 2,000 units daily for ≥3 months, followed by maintenance dose of 400 units daily

Children: Oral: 3,000 to 6,000 units daily for ≥3 months, followed by maintenance dose of 600 units daily

Adolescents: Oral: 6,000 units daily for ≥3 months, followed by maintenance dose of 600 units daily

Single-dose therapy:

Infants ≥3 months: Oral: 50,000 units once, or in divided doses over several days; after 3 months, initiate maintenance dose of 400 units daily

Children: Oral: 150,000 units once, or in divided doses over several days; after 3 months, initiate maintenance dose of 600 units daily

Adolescents: Oral: 300,000 units once, or in divided doses over several days; after 3 months, initiate maintenance dose of 600 units daily

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, cholecalciferol is not renally eliminated to a significant extent and dosage adjustment is not necessary.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Use: Labeled Indications

Dietary supplement: As a vitamin D dietary supplement

Use: Off-Label: Adult

HypoparathyroidismLevel of Evidence [G]

Since parathyroid hormone (PTH) is required for the conversion of vitamin D (ergocalciferol or cholecalciferol) to the active metabolite of vitamin D (1,25-dihydroxyvitamin D), alternative vitamin D preparations not dependent on this conversion (eg, alfacalcidol, calcitriol) are recommended for routine use. Based on the Endocrine Society guidelines for the Management of Hypoparathyroidism, active vitamin D preparations (ie, alfacalcidol, calcitriol) in conjunction with calcium supplementation is the standard therapy for hypoparathyroidism. Addition of native vitamin D (eg, cholecalciferol or ergocalciferol) may be considered for supplemental therapy.

Osteoporosis, preventionLevel of Evidence [G]

Based on the National Osteoporosis Foundation (NOF) Clinician’s Guide to Prevention and Treatment of Osteoporosis, adequate intake of vitamin D (through dietary sources and/or supplementation with cholecalciferol [or ergocalciferol] if needed) is effective and recommended for the prevention of osteoporosis.

Vitamin D insufficiency/deficiencyLevel of Evidence [G]

Based on the National Osteoporosis Foundation (NOF) Clinician’s Guide to Prevention and Treatment of Osteoporosis, supplemental cholecalciferol (or ergocalciferol) may be used for the prevention or treatment of vitamin D deficiency to achieve desired serum 25(OH)D levels.

Vitamin D insufficiency/deficiency in patients with chronic kidney disease, treatmentLevel of Evidence [G]

Based on the KDIGO Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD), vitamin D insufficiency/deficiency in patients without severe and progressive hyperparathyroidism, including CKD stages G3 to G5 and dialysis or transplant patients, should be corrected using treatment strategies recommended for the general population, which includes repletion with cholecalciferol (or ergocalciferol) Ref. In patients in whom serum parathyroid hormone levels are progressively rising and remain persistently elevated despite correction of modifiable factors, calcitriol or vitamin D analogs are suggested instead of instead of cholecalciferol (or ergocalciferol) Ref.

Level of Evidence Definitions

Level of Evidence Scale

Class and Related Monographs

Vitamin D

Clinical Practice Guidelines

Chronic Kidney Disease:

KDIGO Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD), 2009

KDIGO Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD), 2017

Cystic Fibrosis:

Cystic Fibrosis Foundation, Screening, Diagnosis, Management and Treatment of Vitamin D Deficiency in Cystic Fibrosis, 2012

Hypoparathyroidism:

Endocrine Society, “Management of Hypoparathyroidism: Summary Statement and Guidelines,” 2016

Nutrition:

American Academy of Pediatrics, Optimizing Bone Health in Children and Adolescents, 2014

Lawson Wilkins Pediatric Endocrine Society, Vitamin D Deficiency in Children and Its Management: Review of Current Knowledge and Recommendations, 2008

Osteoporosis:

American Association of Clinical Endocrinologists and American College of Endocrinology, “Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis,” 2016

American College of Physicians, “Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update from the American College of Physicians,” 2017

American College of Rheumatology, “Guideline for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis,” 2017

Endocrine Society, “Osteoporosis in Men: An Endocrine Society Clinical Practice Guideline,” 2012

Endocrine Society, “Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Clinical Practice Guideline,” 2019

National Osteoporosis Foundation, Clinician’s Guide to Prevention and Treatment of Osteoporosis, 2014

Administration: Oral

Wafers: Chew or crush before swallowing; do not swallow wafer whole; administer with the largest meal of the day.

Administration: Pediatric

Oral: May be administered without regard to meals; for oral liquid, administer with an accurate measuring device; do not use a household teaspoon (overdosage may occur).

Dietary Considerations

Vitamin D is found in egg yolks, fatty fish, fortified milk, fortified cereal, and infant formulas; it is also produced by exposure to sunlight (IOM 2011).

Dietary Reference Intake for Vitamin D (IOM 2011):

0 to 12 months: Adequate intake: 10 mcg/day (400 units/day)

1 to 70 years: RDA: 15 mcg/day (600 units/day)

>70 years: RDA: 20 mcg/day (800 units/day)

Pregnancy/Lactating: RDA: 15 mcg/day (600 units/day)

Storage/Stability

Store at 15°C to 30°C (59°F to 86°F); do not freeze. Protect from light.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat or prevent vitamin D deficiency.

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• High calcium like weakness, confusion, fatigue, headache, nausea and vomiting, constipation, or bone pain.

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound-alike/look-alike issues:

Administration issues:

Contraindications

OTC labeling: Replesta products only: When used for self-medication, do not use if you have hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D, Williams syndrome, or are pregnant.

Documentation of allergenic cross-reactivity for vitamin D is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Warnings/Precautions

Concerns related to adverse effects:

• Vitamin D toxicity: May occur with excessive doses; symptoms may include nausea, vomiting, loss of appetite, constipation, dehydration, fatigue, irritability, confusion, weakness and/or weight loss. Effects of vitamin D can last ≥2 months after therapy is discontinued.

Disease related concerns:

• Hyperphosphatemia: Normal serum phosphorous concentrations must be maintained in patients treated for hyperphosphatemia to prevent metastatic calcification.

• Obesity: Adults with a BMI >30 kg/m2 are at high risk for vitamin D deficiency due to storage of vitamin D in adipose tissue. Doses higher than the RDA may be required, but must be carefully monitored to avoid toxicity.

• Renal impairment: Metabolism of vitamin D may be altered in patients with chronic kidney disease. Supplementation with cholecalciferol may be needed; close monitoring is required (KDIGO 2009).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP 1997; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer's labeling.

Geriatric Considerations

Vitamin D, folate, and B12 (cyanocobalamin) have decreased absorption with age (clinical significance unknown); studies in ill geriatrics demonstrated that low serum concentrations of vitamin D result in greater bone loss. Calorie requirements decrease with age and therefore, nutrient density must be increased to ensure adequate nutrient intake, including vitamins and minerals. The use of a daily supplement with a multiple vitamin with minerals is recommended because elderly consume less vitamin D, absorption may be decreased, and many have decreased sun exposure. This is a recommendation of particular need to those with high risk for osteoporosis.

Vitamin D supplementation has been shown to increase muscle function and strength, as well as improve balance. Patients at risk for falls should have vitamin D serum concentrations measured and be evaluated for supplementation.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP, 1997; Shehab, 2009).

Pregnancy Considerations

The cholecalciferol metabolite, 25(OH)D, crosses the placenta; maternal serum concentrations correlate with fetal concentrations at birth (Misra 2008; Wagner 2008).

Adequate maternal vitamin D is required for fetal growth and development (Misra 2008). Vitamin D deficiency in a pregnant woman may lead to a vitamin D deficiency in the neonate (Misra 2008; Wagner 2008). Serum 25(OH)D concentrations should be measured in pregnant women considered to be at increased risk of deficiency (ACOG 2011). The amount of vitamin D contained in prenatal vitamins may not be adequate to treat a deficiency during pregnancy; although larger doses may be needed, current guidelines recommend a total of 1,000 to 2,000 units/day until more safety data is available (ACOG 2011). In women not at risk for deficiency, doses larger than the RDA should be avoided during pregnancy (ACOG 2011; IOM 2011).

Breast-Feeding Considerations

Cholecalciferol is present in breast milk (Oberhelman 2013).

Following administration of vitamin D as cholecalciferol, concentrations of cholecalciferol and 25(OH)D increase in the maternal serum and may correlate with breast milk concentrations (Oberhelman 2013).

Vitamin D is present in breast milk following normal maternal exposure via sunlight and diet (Wagner 2008). Vitamin D in breast milk is primarily vitamin D3 (cholecalciferol) and 25(OH)D3 (við Streym 2016). The amount of endogenous vitamin D in breast milk is insufficient to provide an exclusively breastfed child the recommended intake of vitamin D (Misra 2008). In addition, premature infants, infants born to vitamin D deficient mothers, dark-skinned children, children living at high latitudes, and exclusively breastfed infants and children may be at increased risk for vitamin D deficiency. Therefore, vitamin D supplementation is recommended in all infants who are partially or exclusively breast fed (IOM 2011; Misra 2008; Wagner 2008).

Maternal vitamin D requirements are the same for breastfeeding and nonbreastfeeding females (IOM 2011). Although administration of cholecalciferol in doses larger than the maternal RDA may increase 25(OH)D in breast milk, the actual maternal dose needed to provide the infant with an adequate amount of vitamin D is still under study (Wagner 2008)

Briggs' Drugs in Pregnancy & Lactation

• Cholecalciferol

Adverse Reactions

No adverse reactions listed in the manufacturer's labeling.

Allergy and Idiosyncratic Reactions

• Vitamin D Analog Allergy

Toxicology

• Vitamin D

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Aluminum Hydroxide: Vitamin D Analogs may increase the serum concentration of Aluminum Hydroxide. Specifically, the absorption of aluminum may be increased, leading to increased serum aluminum concentrations. Risk X: Avoid combination

Bile Acid Sequestrants: May decrease the serum concentration of Vitamin D Analogs. More specifically, bile acid sequestrants may impair absorption of Vitamin D Analogs. Management: Avoid concomitant administration of vitamin D analogs and bile acid sequestrants (eg, cholestyramine). Separate administration of these agents by several hours to minimize the potential risk of interaction. Monitor plasma calcium concentrations. Risk D: Consider therapy modification

Calcium Salts: May enhance the adverse/toxic effect of Vitamin D Analogs. Risk C: Monitor therapy

Cardiac Glycosides: Vitamin D Analogs may enhance the arrhythmogenic effect of Cardiac Glycosides. Risk C: Monitor therapy

Danazol: May enhance the hypercalcemic effect of Vitamin D Analogs. Risk C: Monitor therapy

Erdafitinib: Serum Phosphate Level-Altering Agents may diminish the therapeutic effect of Erdafitinib. Management: Avoid coadministration of serum phosphate level-altering agents with erdafitinib before initial dose increase period based on serum phosphate levels (Days 14 to 21). Risk D: Consider therapy modification

Mineral Oil: May decrease the serum concentration of Vitamin D Analogs. More specifically, mineral oil may interfere with the absorption of Vitamin D Analogs. Management: Avoid concomitant, oral administration of mineral oil and vitamin D analogs. Consider separating the administration of these agents by several hours to minimize the risk of interaction. Monitor plasma calcium concentrations. Risk D: Consider therapy modification

Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Vitamin D Analogs. Risk X: Avoid combination

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Vitamin D Analogs. Risk X: Avoid combination

Orlistat: May decrease the serum concentration of Vitamin D Analogs. More specifically, orlistat may impair absorption of Vitamin D Analogs. Management: Monitor clinical response (including serum calcium) to oral vitamin D analogs closely if used with orlistat. If this combination must be used, consider giving the vitamin D analog at least 2 hrs before or after orlistat. Risk D: Consider therapy modification

Sucralfate: Vitamin D Analogs may increase the serum concentration of Sucralfate. Specifically, the absorption of aluminum from sucralfate may be increased, leading to an increase in the serum aluminum concentration. Risk X: Avoid combination

Thiazide and Thiazide-Like Diuretics: May enhance the hypercalcemic effect of Vitamin D Analogs. Risk C: Monitor therapy

Vitamin D Analogs: May enhance the adverse/toxic effect of other Vitamin D Analogs. Risk X: Avoid combination

Monitoring Parameters

Signs and symptoms of vitamin D toxicity (eg hypercalcemia, hypercalcuria, confusion, psychosis, tremor, calcification of soft tissues, nausea, weakness) (ASPEN [McKeever 2017]).

Adults:

Serum 25(OH)D: For patients being treated for vitamin D deficiency, measure ~3 months after initiation or dosage adjustment. In healthy patients initiating supplementation dosing, routine monitoring is not required (Dawson-Hughes 2018).

Additional monitoring of calcium, phosphorous, parathyroid hormone (PTH), alkaline phosphatase may be required depending on severity of 25(OH)D deficiency and/or concomitant clinical conditions (eg, chronic kidney disease, hypoparathyroidism) (Dawson-Hughes 2018; Endocrine Society [Brandi 2016]; KDIGO 2017).

Infants, Children, and Adolescents:

Vitamin D deficiency: Monitor serum calcium, phosphorus and alkaline phosphatase (ALP) one month after starting therapy; serum calcium, phosphorous, magnesium, ALP, 25(OH)D, and PTH as well as x-ray (may also consider urine calcium/creatinine ratio) after 3 months; 25(OH)D yearly (Misra 2008).

Increased risk of vitamin D deficiency (chronic fat malabsorption, chronic antiseizure medication use): Serum 25(OH)D, PTH, and bone mineral status (baseline). If vitamin D supplement is required, repeat 25(OH)D levels at 3-month intervals until normal. PTH and bone mineral status should be monitored every 6 months until normal. (Wagner 2008).

CKD: Measure serum 25(OH)D levels after 3 months of treatment. Measure corrected total calcium and phosphorous after 1 month and then at least every 3 months (KDOQI 2009).

Reference Range

Vitamin D deficiency: There is no clear consensus on a reference range for total serum 25(OH)D concentrations or the validity of this level as it relates clinically to bone health. In addition, there is significant variability in the reporting of serum 25 (OH)D levels as a result of different assay types in use. However, the following ranges have been suggested:

Adults:

<12 ng/mL (30 nmol/L): At risk for deficiency (IOM 2011).

12 to 20 ng/mL (30 to 50 nmol/L): Potentially at risk for inadequacy (IOM 2011).

≥20 ng/mL (50 nmol/L): Sufficient levels in practically all persons (IOM 2011).

>40 ng/mL (100 nmol/L): Increased risk of falls have been reported in elderly females with levels >40 ng/mL (Smith 2017) or ~48 ng/mL (120 nmol/L) (Sanders 2010).

>50 ng/mL (125 nmol/L): There are insufficient data to determine the safe upper limit of serum 25(OH)D. Serum 25(OH)D levels above approximately 50 ng/mL (125 nmol/L) should be avoided (IOM 2011).

Osteoporosis patients: Recommended level to reach and maintain may vary by guideline/organization: ≥20 ng/mL (50 nmol/L) is considered adequate according to some experts (ES [Eastell 2019]); others suggest a goal of ~30 ng/mL (75 nmol/L) (NOF [Cosman 2014]).

Children (Misra 2008):

<15 ng/mL (37.5 nmol/L): At risk for deficiency.

15 to 20 ng/mL (37.5 to 50 nmol/L): Potentially at risk for inadequacy.

≥20 ng/mL (50 nmol/L): Sufficient levels in practically all children.

>100 ng/mL (250 nmol/L): Concern for risk of toxicity.

Advanced Practitioners Physical Assessment/Monitoring

Obtain serum 25(OH)D, calcium, phosphorus, parathyroid hormone, and alkaline phosphatase as clinically needed. Assess for signs of vitamin D toxicity.

Nursing Physical Assessment/Monitoring

Check ordered labs and report any abnormalities. Monitor for and educate patient to report any signs of vitamin D toxicity (eg, confusion, psychosis, tremor, nausea, weakness, tissue calcification).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

D3-50: 1.25 MG (50000 UT) [dairy free, egg free, fish derivative free, gluten free, kosher certified, no artificial color(s), nut free, soy free, sugar free, wheat free, yeast free]

Decara: 1.25 MG (50000 UT) [contains fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow), soybean oil]

Decara: 250 MCG (10000 UT) [contains fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake, gelatin (bovine)]

Decara: 625 MCG (25000 UT) [contains soybean oil]

Dialyvite Vitamin D 5000: 125 MCG (5000 UT)

Pronutrients Vitamin D3: 25 MCG (1000 UT) [contains soybean oil]

Weekly-D: 1.25 MG (50000 UT) [contains fd&c red #40]

Generic: 1.25 MG (50000 UT), 250 MCG (10000 UT)

Capsule, Oral [preservative free]:

D-3-5: 125 MCG (5000 UT) [dairy free, dye free, egg free, gluten free, no artificial color(s), nut free, soy free, sugar free, wheat free, yeast free]

D3-50: 1.25 MG (50000 UT) [dairy free, egg free, fish derivative free, gluten free, kosher certified, no artificial color(s), nut free, soy free, sugar free, wheat free, yeast free]

Generic: 10,000 units, 125 MCG (5000 UT), 25 MCG (1000 UT), 50 MCG (2000 UT)

Liquid, Oral:

Aqueous Vitamin D: 10 mcg/mL (50 mL) [gluten free, lactose free, sugar free; contains corn oil, methylparaben, polysorbate 80]

Bio-D-Mulsion: 10 mcg/0.03 mL (30 mL [DSC]) [contains sesame oil]

Bio-D-Mulsion Forte: 50 mcg/0.03 mL (30 mL [DSC]) [contains sesame oil]

BProtected Pedia D-Vite: 10 mcg/mL (50 mL) [alcohol free, sugar free; contains polysorbate 80, propylene glycol, sodium benzoate; cherry flavor]

D-Vi-Sol: 10 mcg/mL (50 mL) [gluten free, lactose free, sugar free; contains polysorbate 80]

D-Vita: 10 mcg/mL (50 mL [DSC]) [alcohol free, gluten free, lactose free, sugar free; contains polysorbate 80, propylene glycol, sodium benzoate; fruit flavor]

D-Vite Pediatric: 10 mcg/mL (50 mL) [alcohol free, gluten free, lactose free, no artificial color(s), sugar free; contains disodium edta, polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate]

D3 Vitamin: 10 mcg/mL (50 mL) [contains polysorbate 80, sodium benzoate]

Generic: 10 mcg/mL (50 mL, 52 mL)

Liquid, Oral [preservative free]:

Generic: 125 mcg/mL (52 mL)

Liquid, Sublingual:

Generic: 5000 units/mL (60 mL)

Tablet, Oral:

Delta D3: 10 MCG (400 UNIT) [gelatin free, gluten free, lactose free, no artificial color(s), no artificial flavor(s), starch free, sugar free, yeast free]

Dialyvite Vitamin D3 Max: 1.25 MG (50000 UT) [scored]

Vitamin D3 Super Strength: 50 MCG (2000 UT) [gluten free]

Vitamin D3 Ultra Potency: 1.25 MG (50000 UT)

Generic: 10 MCG (400 UNIT), 125 MCG (5000 UT), 20 MCG (800 UNIT), 25 MCG (1000 UT), 50 MCG (2000 UT), 75 MCG (3000 UT)

Tablet, Oral [preservative free]:

Generic: 5000 units, 10 MCG (400 UNIT), 25 MCG (1000 UT), 50 MCG (2000 UT)

Tablet Chewable, Oral:

Generic: 10 MCG (400 UNIT)

Tablet Chewable, Oral [preservative free]:

Generic: 50 MCG (2000 UT)

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Generic: 1.25 MG (50000 UT), 125 MCG (5000 UT), 250 MCG (10000 UT), 50 MCG (2000 UT), 625 MCG (25000 UT)

Tablet, Oral:

Generic: 250 MCG (10000 UT)

Anatomic Therapeutic Chemical (ATC) Classification

• A11CC05

Generic Available (US)

Yes

Pricing: US

Capsules (D3-50 Oral)

1.25 MG(50000 UT) (per each): $0.18

Capsules (Decara Oral)

1.25 MG(50000 UT) (per each): $1.17

250 MCG(10000 UT) (per each): $0.80

625 MCG(25000 UT) (per each): $1.91

Capsules (Dialyvite Vitamin D 5000 Oral)

125 MCG(5000 UT (per each): $0.12

Capsules (Pronutrients Vitamin D3 Oral)

25 MCG(1000 UT) (per each): $0.07

Capsules (Weekly-D Oral)

1.25 MG(50000 UT) (per each): $1.10

Liquid (BProtected Pedia D-Vite Oral)

10 mcg/mL (per mL): $0.17

Liquid (D-Vi-Sol Oral)

10 mcg/mL (per mL): $0.17

Tablets (Dialyvite Vitamin D3 Max Oral)

1.25 MG(50000 UT) (per each): $1.08

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Cholecalciferol (vitamin D3) is a provitamin. The active metabolite, 1,25-dihydroxyvitamin D (calcitriol), stimulates calcium and phosphate absorption from the small intestine, promotes secretion of calcium from bone to blood; promotes renal tubule phosphate resorption (IOM 2011)

Pharmacodynamics/Kinetics

Absorption: Absorbed in the small intestine; fat soluble; requires bile (IOM 2011)

Metabolism: Inactive until hydroxylated hepatically to 25-hydroxyvitamin D [25(OH)D; calcifediol] then renally to the active metabolite 1,25-dihydroxyvitamin D (calcitriol) (IOM 2011)

Half-life, circulating: 25(OH)D: 2 to 3 weeks; 1,25-dihydroxyvitamin D: ~4 hours

Excretion: Feces (IOM 2011)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Metallic taste and xerostomia (normal salivary flow resumes upon discontinuation).

Effects on Bleeding

No information available to require special precautions

Index Terms

D3

References

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Decara 25,000 IU Capsules (cholecalciferol) [prescribing information]. Baton Rouge, LA; Medecor Pharma LLC; February 2014.

Decara 50,000 IU Capsules (cholecalciferol) [prescribing information]. Baton Rouge, LA: Medecor Pharma LLC; February 2014.

D-Vi-Sol (cholecalciferol) [prescribing information]. Evansville, IN: Mead Johnson Nutritionals; November 2014.

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Replesta (cholecalciferol) [prescribing information]. St. Louis, MO: Everidis Health Sciences; 2015.

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Brand Names: International

Adalben (ES); Arachitol (IN); Aviticol (GB); Baby D Drops (SG); D Drops (SG); D-Cure (BE, LU); D3 Capsules (AU); D3 Drops (AU); D3 Drops Forte (AU); D4U (LK); Deetipat (FI); Dekristol 400 (DE); Dekristolmin (AT); Deltius (ES); Desunin (GB, IE); Devaron (NL); Devitre (SE); Divisun (NO); Duvit D3 (IT); Forti-D (PH); Fultium-D3 (GB); Hello-D (TH); Hello-D 2000 IU (TH); Iper D3 (IT); Laevovit (HU); Laevovit D3 (AT); Ostelavit (PL); Plivit D3 (HR); Teorol (ID); Thorens (IE); Tridelta (IT); Uvedose (FR, LU); Vi-De 3 (CH); Vigantol (CZ, HU, LU, PL, PT); Vigantoletten (LU, PL); Vitamin D3 (HU); Vitamin D3 Fresenius (HU); Vitamin D3 Streuli (CH); Vitamine D3 BON (FR); Vitaminum D3 (PL); Vitamon D3 (BE)

Last Updated 3/24/20