Please wait while the formulary information is being retrieved.
Drug overview for ROCALTROL (calcitriol):
Generic name: CALCITRIOL (KAL-si-TRYE-ol)
Drug class: Vitamin D
Therapeutic class: Electrolyte Balance-Nutritional Products
Calcitriol, the 1,25-dihydroxylated form of cholecalciferol, is a vitamin D analog.
No enhanced Uses information available for this drug.
Generic name: CALCITRIOL (KAL-si-TRYE-ol)
Drug class: Vitamin D
Therapeutic class: Electrolyte Balance-Nutritional Products
Calcitriol, the 1,25-dihydroxylated form of cholecalciferol, is a vitamin D analog.
No enhanced Uses information available for this drug.
DRUG IMAGES
ROCALTROL 0.25 MCG CAPSULE
ROCALTROL 0.5 MCG CAPSULE
ROCALTROL 1 MCG/ML ORAL SOLN
The following indications for ROCALTROL (calcitriol) have been approved by the FDA:
Indications:
Hyperparathyroidism secondary to chronic renal failure
Hypocalcemia from end-stage renal disease with dialysis
Hypocalcemia
Hypoparathyroidism
Hypophosphatemia
Renal osteodystrophy
Professional Synonyms:
Abnormally decreased blood phosphate level
Abnormally decreased serum calcium
Condition due to low levels of PTH
Decreased serum calcium due to chronic dialysis
Hyperparathyroidism secondary to CRF
Hypocalcemia from end stage renal disease with dialysis
Hypocalcemia secondary to chronic dialysis
Indications:
Hyperparathyroidism secondary to chronic renal failure
Hypocalcemia from end-stage renal disease with dialysis
Hypocalcemia
Hypoparathyroidism
Hypophosphatemia
Renal osteodystrophy
Professional Synonyms:
Abnormally decreased blood phosphate level
Abnormally decreased serum calcium
Condition due to low levels of PTH
Decreased serum calcium due to chronic dialysis
Hyperparathyroidism secondary to CRF
Hypocalcemia from end stage renal disease with dialysis
Hypocalcemia secondary to chronic dialysis
The following dosing information is available for ROCALTROL (calcitriol):
During therapy with calcitriol, dosage depends on the nature and severity of the patient's hypocalcemia and must be individualized to maintain serum calcium concentrations of 9-10 mg/dL. The manufacturers recommend that serum calcium concentrations be measured at least twice weekly during initial dosage adjustments and after subsequent dosage changes; however, some clinicians recommend that serum calcium concentrations be measured at least weekly for the first 12 weeks of therapy and monthly after stabilization of dosage.
Nephrology experts state that the optimal intact parathyroid hormone (iPTH) concentration for patients with stage 3a (estimated glomerular filtration rate (eGFR) 45-59 mL/minute per 1.73 m2) to stage 5 (eGFR less than 15 mL/minute per 1.73 m2) chronic kidney disease (CKD) who are not undergoing dialysis is unknown, but modest increases in iPTH concentration may represent an appropriate adaptive response to declining renal function. For patients with stage 5 CKD undergoing dialysis, some experts suggest that iPTH concentrations may be maintained within a range of approximately 2-9 times the assay's upper limit of normal (ULN) (which may correspond to a range of approximately 130-600 pg/mL for commercially available assays ).
Although some clinicians suggest that this range is too broad, available assays for PTH exhibit substantial variability; the previously recommended range of 150-300 pg/mL for patients with stage 5 CKD requiring dialysis was based on an assay that is no longer commercially available. Oversuppression of PTH may increase the risk of adynamic bone disease and should be avoided. (See Uses: Mineral and Bone Disorder Secondary to Chronic Renal Disease, in the Vitamin D Analogs General Statement 88:16.) Nephrology experts currently recommend that the individual values for serum calcium and phosphorus (evaluated together) be used instead of the mathematical construct of calcium times phosphorus product to guide clinical practice.
For the management of hypocalcemia and resultant metabolic bone disease in patients with chronic renal failure undergoing dialysis, the usual initial adult oral dosage of calcitriol is 0.25 mcg daily. Some patients with normal or slightly reduced serum calcium concentrations require only 0.25
mcg every other day. If adequate clinical and biochemical responses are not obtained with the initial dosage, the dosage may be increased by 0.25 mcg daily at 4- to 8-week intervals.
If hypercalcemia occurs, calcitriol should be withheld immediately, a low-calcium diet instituted, calcium supplements withdrawn, and serum calcium concentrations determined daily; when normocalcemia ensues (generally in 2-7 days), the drug can be reinstituted at a dosage that is 0.25 mcg daily less than that which induced hypercalcemia. Most patients undergoing hemodialysis require oral calcitriol dosages of 0.5-1
mcg daily.
In children undergoing hemodialysis+, oral calcitriol dosages of 0.25-2 mcg daily have been used to increase serum calcium and decrease PTH concentrations.
For the management of hypocalcemia in patients with chronic renal failure undergoing hemodialysis, the manufacturer states that the initial adult IV dosage of calcitriol is 1 mcg (0.02 mcg/kg) to 2 mcg given 3 times weekly (approximately every other day), depending on the severity of the hypocalcemia and/or secondary hyperparathyroidism. Initial dosages have ranged from 0.5-4 mcg 3 times weekly.
The drug may be administered IV by rapid injection through the catheter at the end of a session of hemodialysis. If adequate clinical and biochemical responses are not obtained with the initial dosage, the dose given 3 times weekly may be increased by 0.5-1 mcg at 2- to 4-week intervals.
The manufacturer states that calcitriol dosage should be increased if response is inadequate (i.e., the PTH concentration remains unchanged, is increasing, or is not reduced by at least 30%). The manufacturer states that dosage of calcitriol should be maintained in patients whose PTH concentration has decreased more than 30% but less than 60% or in whom the PTH concentration is 1.5-3 times the upper limit of normal.
Dosage should be reduced if the PTH concentration decreases by more than 60%. If hypercalcemia occurs during dosage titration or if the serum calcium times serum phosphorus product (Ca x P) exceeds 70 mg2/dL2, calcitriol should be withheld immediately; when normocalcemia ensues, the drug can be reinstituted at a lower dosage. Dosage reduction may be required as PTH concentrations decrease in response to therapy.
Most patients require IV calcitriol dosages of 0.5-3 mcg (0.01-0.05 mcg/kg) 3 times weekly.
Nephrology experts state that the optimal intact parathyroid hormone (iPTH) concentration for patients with stage 3a (estimated glomerular filtration rate (eGFR) 45-59 mL/minute per 1.73 m2) to stage 5 (eGFR less than 15 mL/minute per 1.73 m2) chronic kidney disease (CKD) who are not undergoing dialysis is unknown, but modest increases in iPTH concentration may represent an appropriate adaptive response to declining renal function. For patients with stage 5 CKD undergoing dialysis, some experts suggest that iPTH concentrations may be maintained within a range of approximately 2-9 times the assay's upper limit of normal (ULN) (which may correspond to a range of approximately 130-600 pg/mL for commercially available assays ).
Although some clinicians suggest that this range is too broad, available assays for PTH exhibit substantial variability; the previously recommended range of 150-300 pg/mL for patients with stage 5 CKD requiring dialysis was based on an assay that is no longer commercially available. Oversuppression of PTH may increase the risk of adynamic bone disease and should be avoided. (See Uses: Mineral and Bone Disorder Secondary to Chronic Renal Disease, in the Vitamin D Analogs General Statement 88:16.) Nephrology experts currently recommend that the individual values for serum calcium and phosphorus (evaluated together) be used instead of the mathematical construct of calcium times phosphorus product to guide clinical practice.
For the management of hypocalcemia and resultant metabolic bone disease in patients with chronic renal failure undergoing dialysis, the usual initial adult oral dosage of calcitriol is 0.25 mcg daily. Some patients with normal or slightly reduced serum calcium concentrations require only 0.25
mcg every other day. If adequate clinical and biochemical responses are not obtained with the initial dosage, the dosage may be increased by 0.25 mcg daily at 4- to 8-week intervals.
If hypercalcemia occurs, calcitriol should be withheld immediately, a low-calcium diet instituted, calcium supplements withdrawn, and serum calcium concentrations determined daily; when normocalcemia ensues (generally in 2-7 days), the drug can be reinstituted at a dosage that is 0.25 mcg daily less than that which induced hypercalcemia. Most patients undergoing hemodialysis require oral calcitriol dosages of 0.5-1
mcg daily.
In children undergoing hemodialysis+, oral calcitriol dosages of 0.25-2 mcg daily have been used to increase serum calcium and decrease PTH concentrations.
For the management of hypocalcemia in patients with chronic renal failure undergoing hemodialysis, the manufacturer states that the initial adult IV dosage of calcitriol is 1 mcg (0.02 mcg/kg) to 2 mcg given 3 times weekly (approximately every other day), depending on the severity of the hypocalcemia and/or secondary hyperparathyroidism. Initial dosages have ranged from 0.5-4 mcg 3 times weekly.
The drug may be administered IV by rapid injection through the catheter at the end of a session of hemodialysis. If adequate clinical and biochemical responses are not obtained with the initial dosage, the dose given 3 times weekly may be increased by 0.5-1 mcg at 2- to 4-week intervals.
The manufacturer states that calcitriol dosage should be increased if response is inadequate (i.e., the PTH concentration remains unchanged, is increasing, or is not reduced by at least 30%). The manufacturer states that dosage of calcitriol should be maintained in patients whose PTH concentration has decreased more than 30% but less than 60% or in whom the PTH concentration is 1.5-3 times the upper limit of normal.
Dosage should be reduced if the PTH concentration decreases by more than 60%. If hypercalcemia occurs during dosage titration or if the serum calcium times serum phosphorus product (Ca x P) exceeds 70 mg2/dL2, calcitriol should be withheld immediately; when normocalcemia ensues, the drug can be reinstituted at a lower dosage. Dosage reduction may be required as PTH concentrations decrease in response to therapy.
Most patients require IV calcitriol dosages of 0.5-3 mcg (0.01-0.05 mcg/kg) 3 times weekly.
Calcitriol is administered orally, usually in a single daily dose, or by IV injection, usually 3 times weekly.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ROCALTROL 1 MCG/ML ORAL SOLN | Maintenance | Adults take 1 milliliter (1 mcg) by oral route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CALCITRIOL 0.25 MCG CAPSULE | Maintenance | Adults take 1 capsule (0.25 mcg) by oral route once daily |
| CALCITRIOL 1 MCG/ML SOLUTION | Maintenance | Adults take 1 milliliter (1 mcg) by oral route once daily |
| CALCITRIOL 0.5 MCG CAPSULE | Maintenance | Adults take 1 capsule (0.5 mcg) by oral route once daily |
The following drug interaction information is available for ROCALTROL (calcitriol):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Burosumab/Oral Phosphates; Active Vitamin D Analogs SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Both burosumab and phosphates or vitamin D may increase serum phosphate levels. This combination may lead to greater increases in serum phosphate than anticipated. CLINICAL EFFECTS: The combination of burosumab with oral phosphates or active vitamin D analogs may result in hyperphosphatemia and may increase the risk of nephrocalcinosis.(1) PREDISPOSING FACTORS: Patients with renal impairment have alterations in mineral metabolism that may increase the risk of hyperphosphatemia.(1) PATIENT MANAGEMENT: The concomitant use of burosumab with oral phosphates or active vitamin D analogs is contraindicated. Discontinue oral phosphate and/or active vitamin D analogs one week before starting burosumab.(1) DISCUSSION: Burosumab restores dysfunctional renal phosphate reabsorption and renal production of 1,25-dihydroxyvitamin D to treat X-linked hypophosphatemia. Additional oral phosphates and/or active vitamin D analogs may raise serum phosphate higher than anticipated. |
CRYSVITA |
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Erdafitinib/Serum Phosphate Level-Altering Drugs SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Medications that alter serum phosphate may interfere with interpretation of phosphate levels that are needed to determine initial erdafitinib dose.(1) CLINICAL EFFECTS: Serum phosphate levels that are elevated by concomitant medications may result in an inappropriately low dose and decreased effectiveness of erdafitinib. Serum phosphate levels that are decreased by concomitant medications may result in an inappropriately high dose and increased toxicity from erdafitinib. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of erdafitinib states that agents that alter serum phosphate levels should be avoided before the initial dose increase period for erdafitinib based on serum phosphate levels (days 14 to 21).(1) DISCUSSION: Concomitant administration of serum phosphate level-altering agents during the initial dose increase period of erdafitinib based on serum phosphate levels (days 14 to 21) may interfere with serum phospate levels and lead to incorrect dosing of erdafitinib.(1) Agents that may alter serum phosphate levels linked to this monograph include: aluminum carbonate, aluminum hydroxide, calcium acetate, calcium carbonate, calcium citrate, cod liver oil, ferric citrate, lanthanum, magnesium carbonate, magnesium hydroxide, potassium phosphate, sevelamer, sodium phosphate, sucroferric oxyhydroxide, tenapanor, and vitamin D.(1) |
BALVERSA |
There are 2 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Orlistat/Fat Soluble Vitamins SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The acetate ester forms of vitamin A and vitamin E must undergo hydrolysis for absorption from the gastrointestinal tract.(1) The enzyme responsible for this hydrolysis is inhibited by orlistat.(2) CLINICAL EFFECTS: Orlistat may reduce absorption of fat soluble vitamins, leading to a deficiency state. PREDISPOSING FACTORS: A pre-existing deficiency of fat soluble vitamins (A,D,E and K) or chronic malabsorption syndrome. PATIENT MANAGEMENT: The inhibition of fat soluble vitamin absorption by orlistat should be borne in mind during implementation of a vitamin supplementation strategy. Patients should be strongly encouraged to take a multivitamin supplement which contains fat soluble vitamins, particularly Vitamin D as it appears most susceptible to this interaction.(4,5) Multivitamin supplements should be taken at least two hours before or after the dose of orlistat, or at bedtime.(4) Patients with chronic malabsorption syndromes should not receive orlistat.(4) DISCUSSION: Adult patients taking orlistat without supplementation showed a greater reduction in vitamin A,D,E and beta-carotene levels compared to placebo during two or more consecutive visits in studies of 1-2 years duration; these patients had normal baseline values prior to orlistat therapy. Low vitamin values in orlistat patients were as follows: low Vitamin D 12%, low beta-carotene 6.1%, low Vitamin E 5.8%, low Vitamin A 2.2%.(4) A pharmacokinetic interaction study showed a 30% reduction in beta-carotene supplement absorption and a 60% decreased in vitamin E acetate absorption with concomitant orlistat.(4) In a study, orlistat produced the vitamin net concentration by approximately 43%.(1) In a study, no statistically significant decrease in vitamin A absorption was observed with concurrent orlistat.(2) In a study, mean vitamin D levels were significantly reduced compared with baseline after one month of orlistat therapy despite multivitamin supplementation.(5) |
ORLISTAT, XENICAL |
| Colesevelam/Fat Soluble Vitamins SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Colesevelam may decrease the absorption of fat-soluble vitamins A, D, E, and K.(1) CLINICAL EFFECTS: Colesevelam may reduce absorption of fat soluble vitamins, leading to a deficiency state. PREDISPOSING FACTORS: A pre-existing deficiency of fat soluble vitamins (A,D,E and K) or chronic malabsorption syndrome. PATIENT MANAGEMENT: The inhibition of fat soluble vitamin absorption by colesevelam should be borne in mind during implementation of a vitamin supplementation strategy. Oral multivitamin supplements should be taken at least four hours before the dose of colesevelam.(1) DISCUSSION: Colesevelam may decrease the absorption of fat-soluble vitamins A, D, E, and K.(1) |
COLESEVELAM HCL, WELCHOL |
The following contraindication information is available for ROCALTROL (calcitriol):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Hypervitaminosis D |
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Hypercalcemia |
| Hyperphosphatemia |
| Kidney stone |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Kidney disease with reduction in glomerular filtration rate (GFr) |
| Sarcoidosis |
The following adverse reaction information is available for ROCALTROL (calcitriol):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 14 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Acute pancreatitis Anaphylaxis Bone pain Cardiac arrhythmia Conjunctivitis Dehydration Drug-induced psychosis Erythema multiforme Fever Hypercalcemia Hypersensitivity drug reaction Hypertension Urinary tract infection |
There are 21 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Abdominal pain with cramps Anorexia Constipation Drowsy Dysgeusia General weakness Headache disorder Hypercholesterolemia Libido changes Myalgia Nausea Nocturia Photophobia Polydipsia Polyuria Proteinuria Pruritus of skin Rhinorrhea Vomiting Weight loss Xerostomia |
The following precautions are available for ROCALTROL (calcitriol):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ROCALTROL (calcitriol):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ROCALTROL (calcitriol)'s list of indications:
| Hyperparathyroidism secondary to chronic renal failure | |
| N25.81 | Secondary hyperparathyroidism of renal origin |
| Hypocalcemia | |
| E20.810 | Autosomal dominant hypocalcemia |
| E83.51 | Hypocalcemia |
| P71.0 | Cow's milk hypocalcemia in newborn |
| P71.1 | Other neonatal hypocalcemia |
| Hypocalcemia from ESRD with dialysis | |
| E83.51 | Hypocalcemia |
| Hypoparathyroidism | |
| E20 | Hypoparathyroidism |
| E20.0 | Idiopathic hypoparathyroidism |
| E20.1 | Pseudohypoparathyroidism |
| E20.8 | Other hypoparathyroidism |
| E20.81 | Hypoparathyroidism due to impaired parathyroid hormone secretion |
| E20.810 | Autosomal dominant hypocalcemia |
| E20.811 | Secondary hypoparathyroidism in diseases classified elsewhere |
| E20.812 | Autoimmune hypoparathyroidism |
| E20.818 | Other specified hypoparathyroidism due to impaired parathyroid hormone secretion |
| E20.819 | Hypoparathyroidism due to impaired parathyroid hormone secretion, unspecified |
| E20.89 | Other specified hypoparathyroidism |
| E20.9 | Hypoparathyroidism, unspecified |
| E89.2 | Postprocedural hypoparathyroidism |
| Hypophosphatemia | |
| E83.31 | Familial hypophosphatemia |
| Renal osteodystrophy | |
| N25.0 | Renal osteodystrophy |
Formulary Reference Tool