Doxercalciferol Injection
Generic: Doxercalciferol
Doxercalciferol Injection
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Identification
Doxercalciferol
Doxercalciferol
Meitheal Pharmaceuticals Inc.
HUMAN PRESCRIPTION DRUG
Administration
INJECTION, SOLUTION
INTRAVENOUS
ANDA211670
Active Ingredients
| Ingredient | Strength |
|---|---|
| DOXERCALCIFEROL | 4 ug/2mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis. Doxercalciferol Injection is a synthetic vitamin D 2 analog: Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Before initiating treatment, ensure serum calcium is not above the upper limit of normal. ( 2.1 ) Dosage for doxercalciferol injection in patients with CKD on dialysis : Initiate dosing at 4 mcg by bolus intravenous administration three times weekly at the end of dialysis (no more frequently than every other day). Maximum dose is 18 mcg weekly. ( 2.4 ) Target the maintenance dose of doxercalciferol injection to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits. ( 2 ) See Full Prescribing Information for dose titration, laboratory monitoring, and important administration instructions. ( 2 ) 2.1 Prior to Initiation of Doxercalciferol Injection Ensure serum calcium is not above the upper limit of normal before initiating treatment with doxercalciferol injection [see Warnings and Precautions ( 5.1 )]. 2.4 Important Administration Instructions for Doxercalciferol Injection Administer doxercalciferol injection intravenously as a bolus dose at the end of dialysis. Inspect doxercalciferol injection visually prior to administration; the solution should appear clear and colorless. Do not use if the solution is not clear or particles are present. After initial vial use, store opened multi-dose vial for up to 3 days at 2°C to 8°C (36°F to 46°F). Discard unused portion of multi-dose vial after 3 days [see How Supplied/Storage and Handling ( 16 )]. 2.5 Dosage Recommendations for Doxercalciferol Injection in Patients with CKD on Dialysis Initiate doxercalciferol injection at a dose of 4 mcg given by bolus intravenous administration three times weekly at the end of dialysis (no more frequently than every other day). Target the maintenance dose of doxercalciferol to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits. Monitor serum calcium, phosphorus, and intact PTH levels weekly after initiation of therapy or dose adjustment. Titrate the dose of doxercalciferol injection based on intact PTH. The dose may be increased at 8-week intervals by 1 mcg to 2 mcg if intact PTH is not lowered by 50% and fails to reach the target range. The maximum dose is 18 mcg weekly. Prior to raising the dose, ensure serum calcium is within normal limits. Suspend or decrease the dose if intact PTH is persistently and abnormally low to reduce the risk of adynamic bone disease [see Warnings and Precautions ( 5.4 )] or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia [see Warnings and Precautions ( 5.1 )]. If suspended, the drug should be restarted one week later at a dose that is at least 1 mcg lower. 2.6 Drug Interactions that May Require Dosage Adjustments of Doxercalciferol Injection Increased monitoring of serum calcium and dose adjustment of doxercalciferol may be necessary when given concomitantly with drugs that may increase the risk of hypercalcemia [see Drug Interactions ( 7 )]. Increased monitoring of both serum calcium and intact PTH as well as dose adjustment of doxercalciferol may be necessary when given concomitantly with cytochrome P450 inhibitors or enzyme inducers [see Drug Interactions ( 7 )].
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in another section of the label: Hypercalcemia [see Warnings and Precautions ( 5.1 )] Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Adynamic Bone Disease [see Warnings and Precautions ( 5.4 )] The most common adverse reactions in patients with Stage 3 or 4 CKD (incidence >5%) were infection, urinary tract infection, chest pain, angina pectoris, constipation, dyspepsia, anemia, leucopenia, dehydration, edema, depression, hypertonia, insomnia, asthenia, paresthesia, cough increased, dyspnea, pruritus, sinusitis, and rhinitis. ( 6.1 ) The most common adverse reactions in patients with CKD on dialysis (incidence >5%) were headache, malaise, edema, nausea/vomiting, dyspnea, dizziness, pruritus, and bradycardia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Doxercalciferol Capsules Adverse reactions in patients with stage 3 or 4 CKD Doxercalciferol capsules have been evaluated in two placebo-controlled, double-blind 24 week studies in patients with Stage 3 or 4 CKD. Patients were treated with doxercalciferol capsules (n=27) or placebo (n=28) [see Clinical Studies ( 14.1 )] . Adverse reactions occurring in the doxercalciferol capsules group at a frequency of 5% or greater and more frequently than in the placebo group are presented in Table 1 . Table 1: Adverse Reactions Occurring in ≥5% Doxercalciferol Capsule-Treated Patients with CKD on Predialysis and Greater than Placebo in Two Double-Blind Clinical Studies * Pooled data on adverse reactions from clinical study reports (Studies BCI-CH-115 and BCI-CH-119). Adverse Reaction* Doxercalciferol (n=27) % Placebo (n=28) % Infection/bacterial infection/viral infection 30 25 Constipation 26 11 Rhinitis 22 11 Anemia 19 4 Cough 19 4 Dyspnea 19 11 Paresthesia 15 11 Asthenia 15 11 Insomnia 15 4 Hypertonia 11 4 Angina pectoris 8 0 Dehydration 7 4 Depression 7 0 Dyspepsia 7 4 Edema 7 4 Urinary tract infection 7 4 Leukopenia 7 0 Chest pain 7 4 Pruritus 7 4 Sinusitis 7 4 Adverse reactions in patients with CKD on dialysis Doxercalciferol capsules have been evaluated in two placebo-controlled, double-blind studies in patients with CKD on hemodialysis. Patients were treated with doxercalciferol capsules (n=61) or placebo (n=61) [see Clinical Studies ( 14.2 )] . After randomization to two groups, eligible patients underwent an 8-week washout period during which no vitamin D derivatives were administered to either group. Subsequently, all patients received doxercalciferol capsules in an open-label fashion for 16 weeks followed by a double-blind period of 8 weeks during which patients received either doxercalciferol capsules or placebo. Adverse reactions occurring in the doxercalciferol capsule groups at a frequency of 2% or greater, and more frequently than in the placebo group are presented in Table 2 . Table 2: Adverse Reactions Occurring in ≥2% Doxercalciferol Capsule-Treated Patients with CKD on Dialysis and Greater than Placebo in Two Double-Blind Clinical Studies * A patient who reported the same medical term more than once was counted only once for that medical term. Adverse Reaction* Doxercalciferol (n=61) % Placebo (n=61) % Edema 34 21 Malaise 28 20 Headache 28 18 Nausea/Vomiting 21 20 Dizziness 12 10 Dyspnea 12 7 Pruritus 8 7 Bradycardia 7 5 Anorexia 5 3 Dyspepsia 5 2 Arthralgia 5 0 Weight increase 5 0 Abscess 3 0 Sleep disorder 3 0 Doxercalciferol Injection Adverse reactions in patients with CKD on hemodialysis Doxercalciferol injection has been studied in 70 patients with CKD on hemodialysis in two 12-week, open-label, single-arm, multicenter studies [see Clinical Studies ( 14.3 )] . The incidence of hypercalcemia and hyperphosphatemia increased during therapy with doxercalciferol injection. Patients with higher pretreatment serum levels of calcium (>10.5 mg/dL) or phosphorus (>6.9 mg/dL) were more likely to experience hypercalcemia or hyperphosphatemia. There was no placebo group included in the studies of doxercalciferol injection. Adverse reactions in patients with CKD on hemodialysis receiving doxercalciferol injection are expected to be similar to those reported in placebo-controlled studies of doxercalciferol capsules presented in Table 2 . 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of doxercalciferol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure. Hypersensitivity reactions, including fatal outcome, have been reported in patients on hemodialysis following administration of doxercalciferol injection. Hypersensitivity reactions include anaphylaxis with symptoms of angioedema (involving face, lips, tongue and airways), hypotension, unresponsiveness, chest discomfort, shortness of breath, cardiopulmonary arrest, pruritus, and skin burning sensation.
Information for Patients
17 PATIENT COUNSELING INFORMATION Hypercalcemia Advise patients to contact a health care provider if they develop symptoms of elevated calcium (e.g. feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss) [see Warnings and Precautions ( 5.1 )] . Hypersensitivity Inform patients that hypersensitivity reactions can occur with doxercalciferol [see Warnings and Precautions ( 5.3 )] . Monitoring Inform patients that they will need routine monitoring of laboratory parameters such as calcium and intact PTH while receiving doxercalciferol. Inform patients that more frequent monitoring is necessary during the initiation of therapy, following dose changes or when potentially interacting medications are started or discontinued [see Dosage and Administration ( 2 ), Drug Interactions ( 7 )] . Drug Interactions Advise patients to inform their physician of all medications, including prescription and nonprescription drugs, and supplements they are taking. Advise patients to also inform their physician that they are receiving doxercalciferol if a new medication is prescribed [see Drug Interactions ( 7 )] . meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2024 Meitheal Pharmaceuticals Inc. Revised: July 2024 8C5ABU9-02
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.