DOXERCALCIFEROL injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOXERCALCIFEROL (UNII: 3DIZ9LF5Y9) (DOXERCALCIFEROL - UNII:3DIZ9LF5Y9)

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

DOXERCALCIFEROL

Composition:

DOXERCALCIFEROL 2 ug in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- Doxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis. Doxercalciferol is contraindicated in patients with: - Hypercalcemia [see Warnings and Precautions (5.1)] - Vitamin D toxicity [see Warnings and Precautions (5.1)] - Known hypersensitivity to doxercalciferol or any of the inactive ingredients of doxercalciferol injection; serious hypersensitivity reactions including anaphylaxis and angioedema have been reported [see Warnings and Precautions (5.3), Adverse Reactions (6.2)]. Risk Summary The limited available data with doxercalciferol in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see Clinical Considerations] . In reproduction studies in rats and rabbits administered doxercalciferol during organogenesis at up to 20 mcg/kg/day and 0.1 mcg/kg/day, respectively (approximately 25 times (rats) and less than (rabbits) the maximum recommended human oral dose of 60 mcg/week based on mcg/m2 body surface area), no adverse developmental effects were observed [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Chronic kidney disease in pregnancy increases the risk for maternal hypertension and preeclampsia, miscarriage, preterm delivery polyhydramnios, stillbirth, and low-birth-weight infants. Data Animal data There were no adverse effects on fetal development when doxercalciferol was administered at doses up to 20 mcg/kg/day in pregnant rats or doses up to 0.1 mcg/kg/day in pregnant rabbits during the period of organogenesis. Risk Summary There is no information available on the presence of doxercalciferol in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Infants exposed to doxercalciferol through breast milk should be monitored for signs and symptoms of hypercalcemia [see Clinical Considerations] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for doxercalciferol and any potential adverse effects on the breastfed child from doxercalciferol or from the underlying maternal condition. Clinical Considerations Infants exposed to doxercalciferol injection through breast milk should be monitored for signs and symptoms of hypercalcemia, including seizures, vomiting, constipation and weight loss. Monitoring of serum calcium in the infant should be considered. Safety and efficacy of doxercalciferol in pediatric patients have not been established. Clinical studies of doxercalciferol did not include sufficient numbers of patients 65 years or over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic or cardiac function, and of concomitant disease or other drug therapy. Patients with hepatic impairment may not metabolize doxercalciferol appropriately. More frequent monitoring of intact PTH, calcium, and phosphorus levels should be done in patients with hepatic impairment.

Product summary:

How Supplied Doxercalciferol Injection is a sterile, clear, colorless solution supplied in 2 mL amber glass vials containing 4 mcg doxercalciferol in 2 mL of solution or 2 mcg 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 flip–off cap. It is available as follows: 2 mcg/mL, 1 mL 1 mL, Single-dose Vial:                                 NDC 70121-1393-1 25 Single-dose Vials in a Carton                   NDC 70121-1393-6 50 Single-dose Vials in a Carton:                  NDC 70121-1393-5 2 mcg/mL, 2 mL 2 mL, Single-dose Vial:                                 NDC 70121-1392-1 25 Single-dose Vials in a Carton:                  NDC 70121-1392-6 50 Single-dose Vials in a Carton:                  NDC 70121-1392-5 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Discard unused portion. Protect from light. Store unopened vial in original carton.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXERCALCIFEROL- DOXERCALCIFEROL INJECTION, SOLUTION
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXERCALCIFEROL
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DOXERCALCIFEROL
INJECTION. DOXERCALCIFEROL INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Doxercalciferol is a synthetic vitamin D analog:
Doxercalciferol injection is indicated for the treatment of secondary
hyperparathyroidism in adult
patients with CKD on dialysis. (1)
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)
DOSAGE FORMS AND STRENGTHS
Injection: (3)
2 mcg/mL single-dose vial
4 mcg/2 mL (2 mcg/mL) single-dose vial
CONTRAINDICATIONS
Hypercalcemia (4)
Vitamin D toxicity (4)
Know hypersensitivity to doxercalciferol or any of the inactive
ingredients of doxercalciferol injection. (4)
WARNINGS AND PRECAUTIONS
Hypercalcemia: Can occur during treatment with doxercalciferol and can
lead to cardiac arrhythmias
and seizures. Severe hypercalcemia may require emergency attention.
Risk may be increased when
used concomitantly with high dose calcium preparations, thiazide
diuretics, or vitamin D compounds.
Monitor serum calcium prior to initiation and during treatment and
adjust dose accordingly. (2, 5.1)
Digitalis Toxicity: Hypercalcemia increases the risk of digitalis
toxicity. In pati