Trade Name: Doxercalciferol

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amneal Pharmaceuticals LLC

Presentation: INJECTION, SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 4 ug/2mL

Storage and handling

DOXERCALCIFEROL Ergocalciferols [CS],Vitamin D2 Analog [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Doxercalciferol (Doxercalciferol) which is also known as Doxercalciferol and Manufactured by Amneal Pharmaceuticals LLC. It is available in strength of 4 ug/2mL.

Doxercalciferol (Doxercalciferol) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

  • No data
  • Doxercalciferol is a synthetic vitamin D analog:
  • Doxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis. ()
  • No data
  • Before initiating treatment, ensure serum calcium is not above the upper limit of normal. ()
  • Dosage for doxercalciferol injection in patients with CKD on dialysis
  • Target the maintenance dose of doxercalciferol injection to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits. ()
  • See Full Prescribing Information for dose titration, laboratory monitoring, and important administration instructions. ()
  • Injection: Sterile, clear, colorless aqueous solution available as 4 mcg/2 mL (2 mcg/mL) multiple-dose vial.
  • Injection:u00a04 mcg/2 mL (2 mcg/mL) multiple-dose vial ()
  • Doxercalciferol is contraindicated in patients with:
  • Hypercalcemia ()
  • Vitamin D toxicity ()
  • Know hypersensitivity to doxercalciferol or any of the inactive ingredients of doxercalciferol injection. ()
  • No data
  • Hypercalcemia
  • Digitalis Toxicity
  • Serious Hypersensitivity Reactions
  • Adynamic Bone Disease
  • The following adverse reactions are discussed in greater detail in another section of the label:
  • The most common adverse reactions in patients with CKD on dialysis (incidence > 5%) were headache, malaise, edema, nausea/vomiting, dyspnea, dizziness, pruritus, and bradycardia. ()
  • Tables 3 include clinically significant drug interactions with doxercalciferol injection.
  • Table 3: Clinically Significant Drug Interactions with Doxercalciferol Injection
  • Cytochrome P450 inhibitors
  • Enzyme inducers
  • Magnesium-containing products
  • No data
  • Overdosage of doxercalciferol may lead to hypercalcemia, hypercalciuria, and hyperphosphatemia . The treatment of acute overdosage should consist of supportive measures and discontinuation of doxercalciferol administration. Serum calcium levels should be measured until normal. Based on similarities between doxercalciferol and its active metabolite, 1u03b1,25-(OH)D, it is expected that doxercalciferol is not removed from the blood by dialysis.
  • Doxercalciferol injection contains doxercalciferol, which is a synthetic vitamin D analog. Doxercalciferol undergoes metabolic activation to form 1u03b1,25-dihydroxyvitamin D (1u03b1,25-(OH)D), a naturally occurring, biologically active form of vitamin D.
  • Doxercalciferol, USP is a colorless crystalline compound with a calculated molecular weight of 412.66 and a molecular formula of CHO. It is soluble in oils and organic solvents, but is relatively insoluble in water. Chemically, doxercalciferol is (1u03b1,3u03b2,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-1,3-diol. The structural formula is:
  • Doxercalciferol injection 2 mL multiple-dose vials contain 4 mcg/2 mL (2 mcg/mL) of doxercalciferol, USP. Each milliliter (mL) of solution contains 2 mcg doxercalciferol, USP and the following inactive ingredients: butylated hydroxytoluene (0.02 mg); disodium edetate (1.1 mg); ethanol, 100% (0.075 mL); polysorbate 20 (10 mg); sodium chloride (1.5 mg); sodium phosphate dibasic, heptahydrate (14.4 mg); and sodium phosphate monobasic, monohydrate (1.8 mg).
  • No data
  • In a 104-week carcinogenicity study in rats, there was an increased incidence of benign and malignant adrenal pheochromocytomas in both males and females at oral doses of 0.04, 0.13, and 0.39 mcg/kg/day (less than the maximum recommended human oral dose of 60 mcg/week based on mcg/m body surface area). This increased incidence of pheochromocytomas in rats may be due to altered calcium homeostasis by doxercalciferol. No evidence of genetic toxicity was observed in an bacterial mutagenicity assay (Ames test) or a mouse lymphoma gene mutation assay. Doxercalciferol caused structural chromatid and chromosome aberrations in an human lymphocyte clastogenicity assay with metabolic activation. However, doxercalciferol was negative in an mouse micronucleus clastogenicity assay.
  • Doxercalciferol had no effect on male or female fertility in rats at oral doses up to 2.5 mcg/kg/day (approximately 3 times the maximum recommended human oral dose of 60 mcg/week based on mcg/m body surface area).
  • The safety and effectiveness of doxercalciferol injection were evaluated in two open-label, single-arm, multicenter clinical studies (Study C and Study D) in a total of 70 patients with CKD on hemodialysis. Patients in Study C were an average age of 54 years (range: 23 to 73), were 50% male, and were 61% African-American, 25% Caucasian, and 14% Hispanic, and had been on hemodialysis for an average of 65 months. Patients in Study D were an average age of 51 years (range: 28 to 76), were 48% male, and 100% African-American and had been on hemodialysis for an average of 61 months. This group of 70 of the 138 patients who had been treated with doxercalciferol capsules in prior clinical studies (Study A and Study B) received doxercalciferol injection in an open-label fashion for 12 weeks following an 8-week washout (control) period. Dosing of doxercalciferol injection was initiated at the rate of 4 mcg administered at the end of each dialysis session (3 times weekly) for a total of 12 mcg per week. The dosage of doxercalciferol was adjusted to achieve intact PTH levels (measured weekly) within a targeted range of 150 pg/mL to 300 pg/mL. The dosage was increased by 2 mcg per dialysis session after 8 weeks of treatment if the intact PTH levels remained above 300 pg/mL and were greater than 50% of baseline levels. The maximum dosage was limited to 18 mcg per week. If at any time during the study intact PTH fell below 150 pg/mL, doxercalciferol injection was immediately suspended and restarted at a lower dosage the following week. Mean weekly doses ranged from ranged from 9 mcg to 13 mcg in Study C and ranged from 9 mcg to 12 mcg in Study D.
  • Fifty-two (74%) of the 70 patients who were treated with doxercalciferol injection achieved intact PTH levels u2264 300 pg/mL. Forty-one (59%) of these patients exhibited plasma intact PTH levels u2264 300 pg/mL on at least 3 occasions. Thirty-six (51%) patients had plasma intact PTH levels < 150 pg/mL on at least one occasion during study participation. Decreases in plasma intact PTH from baseline values were calculated using as baseline the average of the last 3 values obtained during the 8-week washout period and are displayed in Table 6.
  • Table 6: Intact PTH Summary Data for Patients with CKD on Dialysis Receiving Doxercalciferol Injection in Studies C and D
  • Doxercalciferol treatment resulted in at least 30% reduction from baseline in mean intact PTH levels during the 12-week open-label treatment period in more than 92% of the 70 treated patients.
  • How Supplied
  • Doxercalciferol Injection is a sterile, clear, colorless aqueous solution for intravenous injection supplied in multi-dose amber glass vials containing doxercalciferol in 2 mL of solution. The closure consists of a fluorocarbon-coated chlorobutyl stopper, with an aluminum seal and a red plastic flip-off cap.
  • It is available as follows:
  • 4 mcg/ 2 mL (2 mcg/mL)
  • 2 mL, Multi-dose Vial:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1408-1
  • 50 Multi-dose Vials in a Carton:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1408-5
  • Storage and Handling
  • Store unopened multi-dose vials at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
  • Store opened multi-dose vials at 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F). Discard 3 days after opening.
  • Protect from light. Store unopened vial in original carton.
  • 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) .
  • Hypersensitivity
  • Inform patients that hypersensitivity reactions can occur with doxercalciferol .
  • 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 .
  • 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 .
  • Manufactured by:
  • Amneal Pharmaceuticals Pvt. Ltd.
  • Parenteral Unit
  • Ahmedabad 382213, INDIA
  • Distributed by:
  • Amneal PharmaceuticalsLLC
  • Bridgewater, NJ 08807
  • Rev. 05-2019-03
  • NDC 70121-1408-1
  • Doxercalciferol Injection, 4 mcg/2 mLn
  • Rx Only
  • Vial Label
  • Amneal Pharmaceuticalsu00a0LLC
  • NDC 70121-1408-5
  • Doxercalciferol Injection, 4 mcg/2 mLn
  • Rx Only
  • Carton Label
  • Amneal n- Pharmaceuticalsn- LLC

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