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Alfacalcidol (United States: Not available): Drug information

Alfacalcidol (United States: Not available): Drug information
(For additional information see "Alfacalcidol (United States: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • One Alpha [DSC];
  • One-Alpha;
  • SANDOZ Alfacalcidol
Pharmacologic Category
  • Vitamin D Analog
Dosing: Adult
Chronic kidney disease-mineral and bone disorder

Chronic kidney disease-mineral and bone disorder (hypocalcemia, secondary hyperparathyroidism, or osteodystrophy):

Note: Kidney Disease: Improving Global Outcomes (KDIGO) guidelines do not recommend routine use of vitamin D analogs in patients not on dialysis with chronic kidney disease (CKD) stages G3 to G5; it is reasonable to reserve use for patients with CKD stages G4 or G5 and with severe and progressive hyperparathyroidism. Caution is advised to avoid hypercalcemia or elevated phosphate levels (Ref).

Patients with moderate to severe chronic kidney disease not yet on dialysis: Note: The magnitude of parathyroid hormone (PTH) response is highly variable (Ref). KDIGO guidelines recommend initiating with low doses independent of initial PTH concentration and then titrating based on PTH response while avoiding hypercalcemia (Ref).

Oral: Initial: 0.25 mcg once daily (Ref); however, lower doses have been reported (eg, 0.25 mcg 3 times weekly) (Ref); may titrate dose upward in increments of 0.25 mcg/day every 2 months (maximum dose: 1 mcg/day).

Patients on dialysis:

Oral: Initiate carefully; 0.25 mcg once daily is the lowest recommended dose in the manufacturer's labeling and has been reported elsewhere (Ref). If necessary, may titrate dose upward in increments of 0.25 to 0.5 mcg/day every 2 to 4 weeks (maximum dose: 3 mcg/day).

IV: Initiate carefully; 0.5 mcg 3 times weekly is the lowest recommended dose in the manufacturer's labeling. If inadequate response, may titrate dose upward in increments of 0.5 to 1 mcg per dialysis (maximum dose: 12 mcg/week).

Hypoparathyroidism, chronic

Hypoparathyroidism, chronic (off-label use): Oral: Initial (low end of range): 0.5 mcg/day; may adjust dose carefully in increments of 0.25 to 0.5 mcg/day not more frequently than every 2 to 3 days to achieve desired calcium levels while avoiding hypercalcemia. Usual range: 0.5 to 4 mcg/day (Ref).

Patients discontinuing recombinant PTH therapy: Significantly increased doses of alfacalcidol and supplemental calcium may be acutely required to prevent severe hypocalcemia, especially if recombinant PTH therapy is discontinued abruptly (Ref); consider using alfacalcidol (and supplemental calcium) at higher doses than the pre-rPTH treatment doses, with careful monitoring of calcium levels (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

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

Dosing: Adjustment for Toxicity: Adult

Predialysis patients: If hypercalcemia develops within the first 2 months of therapy reduce dose to 0.25 mcg every other day; at any other time during therapy, reduce dose by 50% and discontinue all calcium supplements until serum calcium levels normalize.

Dialysis patients: Oral, IV: Discontinue immediately for hypercalcemia; may consider reintroducing therapy at a reduced dose after serum calcium levels normalize.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Frequency not defined:

Cardiovascular: Cardiac arrhythmia, hypertension

Dermatologic: Pruritus

Endocrine & metabolic: Albuminuria, decreased libido, hypercholesterolemia, polydipsia, weight loss

Gastrointestinal: Anorexia, constipation, diarrhea, nausea, pancreatitis, vomiting, xerostomia

Genitourinary: Ectopic calcification, nocturia

Hepatic: Increased serum alanine aminotransferase, increased serum aspartate aminotransferase

Nervous system: Asthenia, drowsiness, fatigue, headache, hyperthermia, metallic taste, psychosis, vertigo

Neuromuscular & skeletal: Myalgia, ostealgia

Ophthalmic: Conjunctivitis, corneal deposits (calcification), photophobia

Renal: Increased blood urea nitrogen, polyuria, renal insufficiency

Respiratory: Rhinorrhea

Postmarketing:

Dermatologic: Skin rash

Endocrine & metabolic: Hypercalcemia (Tamiya 2011), hyperphosphatemia

Gastrointestinal: Abdominal pain

Genitourinary: Hypercalciuria

Renal: Nephrolithiasis, renal failure syndrome

Contraindications

Hypersensitivity to 1-α-hydroxyvitamin D3, vitamin D or its analogues and derivatives, or any component of the formulation; hypercalcemia; hyperphosphatemia; evidence of vitamin D toxicity

Warnings/Precautions

Concerns related to adverse effects:

• Excessive vitamin D: Excessive vitamin D administration may lead to over suppression of parathyroid hormone (PTH), progressive or acute hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease.

• Hypercalcemia: Monitor calcium levels closely; patients with chronic renal failure are at an increased risk for hypercalcemia. Dose reduction or discontinuation of therapy may be necessary. Withhold calcium supplementation until calcium levels normalize. Discontinue use with hypercalcemia in dialysis patients; may reinstitute therapy at 50% of previous dose 1 week after calcium levels have normalized. Chronic hypercalcemia may result in generalized vascular and soft tissue calcification, exacerbate nephrolithiasis, and has been associated with increased mortality in adults with chronic kidney disease (CKD) (KDIGO 2017).

• Hyperphosphatemia: Monitor serum phosphate; in cases of progressively or persistently elevated serum phosphate, the use of phosphate-lowering agents may be necessary.

Disease-related concerns:

• Cardiovascular: Avoid prolonged hypercalcemia; may aggravate arteriosclerosis or cardiac valve sclerosis. Use with caution in patients with calcification of pulmonary tissue; may result in cardiac disease. Severe hypercalcemia may increase risk of cardiac arrhythmias.

• Granulomatous diseases: Use with caution in patients with granulomatous diseases (eg, sarcoidosis) due to increased sensitivity to vitamin D.

Product Availability

Not available in the United States.

Generic Equivalent Available: US

May be product dependent

Dosage Forms: Canada

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

Capsule, Oral:

One Alpha: 0.5 mcg [DSC]

One-Alpha: 0.25 mcg, 1 mcg [contains sesame oil]

Generic: 0.25 mcg, 1 mcg

Solution, Intravenous:

One-Alpha: 2 mcg/mL (0.5 mL, 1 mL) [contains alcohol, usp, propylene glycol]

Solution, Oral:

One-Alpha: 2 mcg/mL (10 mL) [contains alcohol, usp, methyl hydroxybenzoate]

Administration: Adult

Oral: Administer oral solution (drops) and capsules with or without food and/or drink. Swallow capsules whole. Do not shake oral solution bottle.

IV: Shake injection solution well (at least 5 seconds) prior to use and administer as bolus IV injection.

Use: Labeled Indications

Note: Not approved in the United States.

Chronic kidney disease-mineral and bone disorder: Management of hypocalcemia, secondary hyperparathyroidism, and osteodystrophy in patients with chronic renal failure

Use: Off-Label: Adult

Hypoparathyroidism (chronic)

Medication Safety Issues
Sound-alike/look-alike issues:

Alfacalcidol may be confused with calcitriol, cholecalciferol, ergocalciferol, paricalcitol

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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. Management: Consider avoiding chronic use of aluminum and aluminum-containing products in patients who are also taking active vitamin D analogs. If coadministered, monitor aluminum status and for signs and symptoms of aluminum-related toxicities. Risk D: Consider therapy modification

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

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

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

CYP3A4 Inducers (Strong): May decrease the serum concentration of Alfacalcidol. 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

Magnesium Salts: Alfacalcidol may increase the serum concentration of Magnesium Salts. Management: Consider using a non-magnesium-containing antacid or phosphate-binding product in patients also receiving alfacalcidol. If magnesium-containing products must be used with alfacalcidol, serum magnesium concentrations should be monitored closely. 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 absorption of Vitamins (Fat Soluble). Management: Administer oral fat soluble vitamins at least 2 hours before or 2 hours after the administration of orlistat. Avoid concomitant administration due to the risk of impaired vitamin absorption. 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. Management: Consider avoiding chronic use of aluminum and aluminum-containing products, such as sucralfate, in patients who are also taking active vitamin D analogs. If combined, monitor for signs and symptoms of aluminum-related toxicities. Risk D: Consider therapy modification

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

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies.

Breastfeeding Considerations

Alfacalcidol may be present in breast milk. Breastfeeding is not recommended by the manufacturer.

Monitoring Parameters

Secondary hyperparathyroidism (CKD patients)

Note: The frequency of serum calcium, phosphate, and parathyroid hormone (PTH) measurements may be dependent upon the presence and magnitude of abnormalities, the rate of progression of CKD, and the use of treatments for chronic kidney disease-mineral and bone disorder (KDIGO 2017)

During therapy initiation and dosage adjustments: Frequent monitoring of serum calcium and phosphate levels (eg, at least twice weekly) is recommended (manufacturer’s labeling).

KDIGO guidelines (2017): Note: During treatment or when biochemical abnormalities are identified more frequent monitoring may be reasonable.

CKD stage G3a-G3b: Serum calcium and phosphate: Every 6 to 12 months; PTH: Frequency based on baseline level and progression of CKD; alkaline phosphatase

CKD stage G4: Serum calcium and phosphate: Every 3 to 6 months; PTH: Every 6 to 12 months; alkaline phosphatase every 12 months or more frequently in the presence of elevated PTH

CKD stage G5 and G5D: Serum calcium and phosphate: Every 1 to 3 months; PTH: Every 3 to 6 months; alkaline phosphatase every 12 months or more frequently in the presence of elevated PTH

Additionally, during maintenance therapy, periodic 24-hour urinary calcium and phosphate; periodic ophthalmologic exams (manufacturer’s labeling)

Hypoparathyroidism, chronic (off-label use) (Endocrine Society [Brandi 2016]):

Note: Frequency of measurement is dependent upon on how stable a patient is to a given dosage regimen with more frequent measurements (eg, weekly) required initially during dosage titration. Once patient is well controlled, monitoring may be required on a yearly or twice-yearly basis.

Serum calcium, phosphate, and magnesium; renal function [ie, 24-hour urinary calcium and creatinine, blood urea nitrogen (BUN), measured creatinine clearance or estimated glomerular filtration rate (eGFR)]; renal imaging (every 5 years in asymptomatic patients with a history of renal lithiasis or calcinosis or more frequently as indicated); CNS imaging (basal ganglia and other sites of calcification), ophthalmologic exam, and/or BMD as clinically indicated

Reference Range

Note: Due to the complexity and interdependency of the laboratory parameters used for therapeutic decisions in chronic kidney disease-mineral and bone disorder (CKD-MBD) patients, serial assessments of phosphate, calcium, and parathyroid hormone (PTH) levels should be considered together (KDIGO 2017).

Calcium (total): Adults: Normal range: 8.6 to 10.2 mg/dL (SI: 2.2 to 2.6 mmol/L). Avoid hypercalcemia for chronic kidney disease (CKD) stages G3a-G5D (KDIGO 2017).

Serum phosphate: 3 to 4.5 mg/dL (SI: 1 to 1.5 mmol/L). Lower elevated phosphate levels toward the normal range for CKD stages G3a-G5D (KDIGO 2017).

PTH:

CKD stage G3a-G5: Optimal PTH level is unknown; evaluate patients with progressively elevated intact PTH levels or if levels are consistently above the normal range (assay-dependent) (KDIGO 2017).

Dialysis patients: Maintain intact parathyroid hormone (iPTH) within 2 to 9 times the upper limit of normal for the assay used (KDIGO 2017).

Mechanism of Action

Alfacalcidol is rapidly converted to the active metabolite of vitamin D (1,25-dihydroxyvitamin D3) in the liver, effectively bypassing renal metabolic conversion; promotes intestinal absorption of calcium and phosphorous, resorption of calcium from the bone, and possibly renal reabsorption of calcium

Pharmacokinetics (Adult Data Unless Noted)

Onset: 6 hours

Duration of effect on intestinal calcium absorption levels: 1,25-(OH)2 D3: 48 hours

Protein binding: Extensively to vitamin D-binding protein

Metabolism: Hepatic to 1,25-(OH)2 D3

Half-life elimination: ~3 hours in renal insufficiency

Time to peak of active vitamin D levels: Oral: 12 hours; IV: 4 hours

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: One alpha | Osteo Alfa;
  • (AR) Argentina: Alfa calcimax | Alpha d3;
  • (AT) Austria: Alfacalcidol teva | Bondiol | Etalpha;
  • (BD) Bangladesh: One alpha;
  • (BE) Belgium: 1-alpha leo | Etalpha;
  • (BG) Bulgaria: Alpha d3;
  • (BR) Brazil: Alfad | Sigmacalcidol;
  • (CI) Côte d'Ivoire: Un alfa;
  • (CL) Chile: Alfa d | Etalpha;
  • (CN) China: Alfacalcido | Alpha d3 | Ao sen | Ao si hui | Bon-one | Etalpha | Fa neng | Gai nuo zhen | Li qing | Lonpryl | Shuang ye hong | Yan di nuo | Yaoyou liqing;
  • (CO) Colombia: Etalpha;
  • (CZ) Czech Republic: Alfacalcidol cande | Alpha d3;
  • (DE) Germany: Alfacalcidol 1 a pharma | Alfacalcidol Aristo | Alfacalcidol fairmed healtcare | Alfacalcidol hexal | Alfacalcidol Medice | Alfacalcidol ratiopharm | Alfacalcidol teva | Bondiol | Doss | Einsalpha | Etalpha | One alpha | Onealpha | Tevacidol | Un alfa;
  • (DO) Dominican Republic: Etalpha;
  • (EC) Ecuador: Etalpha;
  • (EE) Estonia: Alpha d3 | Einsalpha | One -alpha;
  • (EG) Egypt: Alfabonid | Alfacareno | Bon one | Bone Care | Calcidol | One alpha | One-alpha | Taminorig;
  • (ES) Spain: Alfadelta | Etalpha;
  • (FI) Finland: Alfacalcidol orifarm | Etalpha;
  • (FR) France: Alfacalcidol teva | Un alfa;
  • (GB) United Kingdom: Alfa d | Alfacalcidol kent | Alpha d | One alpha;
  • (GR) Greece: A-ostin-d3 | Alcidolin | Alestopor | Alpha d3 | Alphabikal | Alphazol | Antebe | Axelanol | Baludol | Biovit | Calcidrops | Calculus | Emarfen | Iasvest | Losefan | Mega-Alpha | One alpha | Ossidrol | Osteovile | V D Bone | Vitocalcit;
  • (HK) Hong Kong: Alfarol | Alpha d3 | Bon one | One-alpha;
  • (HR) Croatia: Alpha d3;
  • (HU) Hungary: Alpha d3;
  • (ID) Indonesia: Bon one | One alpha;
  • (IE) Ireland: One alpha;
  • (IL) Israel: Alpha d3;
  • (IN) India: Alfa-calcirol | Alfabond | Alfacal | Alfacip | Alfarich | Alfaset | Alpha-d3 | Alphadol | Bonydil | Calcit sg | Calfa-d | Gr-alfa | Minroset | One-alpha | Qtr-alfa | Vitalpha | Zaxial;
  • (IT) Italy: Alpha d3 | Dediol | Deril | Diseon | Diserinal | Geniad | Ostidil-d3 | Sefal;
  • (JO) Jordan: One alpha | Osteo Alfa;
  • (JP) Japan: Alcadol | Alfacalcidol amel | Alfagard | Alfarol | Alfasuly | Alsiodol | Alsiodol amel | Alsiodol choseido | Alsiodol daiko | Alsiodol kayaku | Alsiodol merck hoei | Alsiodol ohta | Alsiodol taiyo | Alsiodol tatumi | Alsiodol teiyaku | Antul | Arowthol merck hoei | Arowtohl | Arowtohl kaken | Asravtal | Calcitamin | Calcitamin hexal | Calcitamin takata | Calfalead taiyo | Calfalead towa | Calfina | Calfina amel | Calfina maruho | Calmadol amel | Calmadol takata | Calsup | D alfa mitsubishi | D alfa sawai | Deslee | Ersibon | Kobalfa | Lonpryl maruko | Lonpryl mikasa | Onealfa fujisawa | Onealfa teijin | Platibit | Porosave | Remodellin | Toyofarol | Vitamilo alfa | Warkmin;
  • (KE) Kenya: Alphadol | Losefan;
  • (KR) Korea, Republic of: Alfa d | Alfa-d3 | Alfabon | Alfabone | Alfacal | Alfadol | Alfarol | Alphagen | Alphasidol | Asidol | D calci | Hwanidol | Onealfa | Porosis | Propent | Richcalcium | Roical alpha;
  • (KW) Kuwait: Bonavit | One alpha;
  • (LB) Lebanon: One alpha | Osteo Alfa;
  • (LT) Lithuania: Alfacalcidol alvogen | Alpha d3 | Einsalpha | One alpha;
  • (LU) Luxembourg: 1-alpha | Etalpha;
  • (LV) Latvia: Alfacalcidol alvogen | Alfacalcidol zentiva | Alpha d3 | Dediol | Etalpha | One alpha;
  • (MA) Morocco: Un alfa;
  • (MX) Mexico: Alfa d | Alfad;
  • (MY) Malaysia: Alfa d | Alfacip | Alpha D3 Biogal | Bon one | Medi-alpha | One alpha | Osteo Alfa;
  • (NL) Netherlands: Alfacalcid | Alfacalcidol aurobindo | Alfacalcidol focus | Alphacalcidol | Etalpha;
  • (NO) Norway: Etalpha;
  • (NZ) New Zealand: One alpha;
  • (PH) Philippines: Alpha d3 | Bon one;
  • (PK) Pakistan: A bone | Adacidol | Adecal | Adela | Albone D | Alcal | Alfa d | Alfa one | Alfabone | Alfacal | Alfacal-d | Alfadin | Alfadol | Alfagen | Alfason | Alfasta | Alfaton | Alfawitt | Alflah | Alfox | Alpha Vit | Anibone | Bio d3 | Bioalfa | Biodol | Bon grow | Bon one | Boncidol | Bone Care | Bone Lift | Bonedol | Bonion | Cadla | Calfram | Caracal | Dyalfa | Everalfa | Facal D | Helpha | Kaid | Magcal d | Nexbone | One-alpha | Orthodol | Reboost | Recalbon | Searl Alpha | X Bone;
  • (PL) Poland: Alfadiol | Alfakalcydol | Alpha d3 | One alpha;
  • (PT) Portugal: Etalpha;
  • (PY) Paraguay: Alfacalcidol bergamo | Alfacalcidol cipla | Alfacalcidol prosalud | Innosfen;
  • (QA) Qatar: One-Alpha | Osteo-Alfa;
  • (RO) Romania: Alfacalcidol heaton | Alfacalcidol sandoz | Alpha d3 | Medirazin | One alpha;
  • (RU) Russian Federation: Alpha d3 | Alphadol | Etalfa | Etalpha | Onealfa | Oxidevit;
  • (SA) Saudi Arabia: One alpha;
  • (SE) Sweden: Alfacalcidol Alternova | Alfacalcidol Aristo | Alfacalcidol orifarm | Etalpha;
  • (SG) Singapore: Alpha d3 | Asravtal | Bon one | One alpha;
  • (SI) Slovenia: Alpha d3;
  • (SK) Slovakia: Alfakalcidol sandoz | Alfamed | Alpha d3;
  • (TH) Thailand: Alpha d3 | Bon one | Kalsidol | Medi-alpha | One-alpha;
  • (TN) Tunisia: Un alfa;
  • (TR) Turkey: Alpha d3 | One alpha | Osivit D3;
  • (TW) Taiwan: Alfadiol | Alfarol | Alfasuly | Asravtal | Calfalead | D Alfa | Etalpha | Lonpryl | Onealfa | Ostalfa | Platibit | Remodellin | Tevalfa;
  • (UA) Ukraine: Alfaforcal | Alphaphorcal | Forcal;
  • (UY) Uruguay: Alfa calcimax | Alpha d3;
  • (VE) Venezuela, Bolivarian Republic of: Alpha d3;
  • (ZA) South Africa: One alpha | Zodoray
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  12. One-Alpha (alfacalcidol) [product monograph]. Mississauga, Ontario, Canada: Xediton Pharmaceuticals Inc; January 2022.
  13. Refer to manufacturer's labeling.
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