DOXERCALCIFEROL injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Doxercalciferol (UNII: 3DIZ9LF5Y9) (Doxercalciferol - UNII:3DIZ9LF5Y9)

Tilgjengelig fra:

Akorn

INN (International Name):

Doxercalciferol

Sammensetning:

Doxercalciferol 4 ug in 2 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

- 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/da

Produkt oppsummering:

Doxercalciferol Injection is supplied in single-dose 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 gray (4 mcg/2 mL) or aqua (2 mcg/mL) plastic flip-off cap. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Store unopened vial in original carton. Discard unused portion.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

DOXERCALCIFEROL- DOXERCALCIFEROL INJECTION, SOLUTION
AKORN
----------
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 patients using digitalis
c