Doxercalciferol (Doxercalciferol)

Trade Name : Doxercalciferol

Amneal Pharmaceuticals LLC

INJECTION, SOLUTION

Strength 2 ug/mL

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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

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. Read less

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About GNH

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. n n

No data

Before initiating treatment, ensure serum calcium is not above the upper limit of normal. n n
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. n n
See Full Prescribing Information for dose titration, laboratory monitoring, and important administration instructions. n n

Injection: Sterile, clear and colorless aqueous solution available as follows:
Injection: n n

2 mcg/mL single-dose vial
4 mcg/2 mL (2 mcg/mL) single-dose vial

Doxercalciferol is contraindicated in patients with:

Hypercalcemia n n
Vitamin D toxicity n n
Know hypersensitivity to doxercalciferol or any of the inactive ingredients of doxercalciferol injection. n n

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. n n

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 1 mL single-dose vials contain 2 mcg/mL of doxercalciferol, USP. Doxercalciferol injection 2 mL single-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% (0.05 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 solution supplied in 2 mL amber glass vials containing doxercalciferol in 2 mL of solution or in 1 mL of solution, The closure consists of a fluorocarbon-coated chlorobutyl stopper, with an aluminum seal and either a yellow (4 mcg/2 mL) or purple (2 mcg/mL) plastic flipu2013off cap.
It is available as follows:
2 mcg/mL, 1 mL
1 mL, Single-dose Vial:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1393-125 Single-dose Vials in a Carton u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 NDC 70121-1393-650 Single-dose Vials in a Carton:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1393-5
2 mcg/mL, 2 mL
2 mL, Single-dose Vial:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1392-125 Single-dose Vials in a Carton:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1392-650 Single-dose Vials in a Carton:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1392-5
Storage and Handling
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Discard unused portion.
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:n Ahmedabad 382213, INDIA
Distributed by:
Amneal Pharmaceuticals LLC
Rev. 12-2019-03

NDC 70121-1393-1
Doxercalciferol Injection, 2 mcg/mLn
Rx Only
Vial Label
Amneal Pharmaceuticals LLC
u00a0
NDC 70121-1393-6
Doxercalciferol Injection,u00a02 mcg/mL n
Rx Only
25 single-dose Vial in a Carton
Amneal Pharmaceuticals LLC
Arrayn- Array
NDC 70121-1393-5
Doxercalciferol Injection,u00a02 mcg/mL n
Rx Only
50 single-dose Vial in a n- arton
Amneal Pharmaceuticals LLC
NDC 70121-1392-1
Doxercalciferol Injection, 4 mcg/2 mLn
Rx Only
Vial Label
Amneal Pharmaceuticals LLC
NDC 70121-1392-6
Doxercalciferol Injection, 4 mcg/2 mLn
Rx Only
25 single-dose Vial in a Carton
Amnealn- Pharmaceuticals LLC
Arrayn- Array
NDC 70121-1392-5
Doxercalciferol Injection, 4 mcg/2 mLn
Rx Only
50 single-dose Vialn- a Carton
Amnealn- Pharmaceuticals LLC

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Doxercalciferol (Doxercalciferol)

Trade Name : Doxercalciferol

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Doxercalciferol (Doxercalciferol)

Trade Name : Doxercalciferol

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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