DOXERCALCIFEROL capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Rising Pharmaceuticals, Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

- Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and 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 capsules; 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 r

Produkt oversigt:

How Supplied Doxercalciferol Capsules 0.5 mcg are available in opaque red oval soft gel capsules with “L” imprinted on one side and plain on the other side. Bottle of 50 count     NDC 64980-228-50 Doxercalciferol Capsules 1 mcg are available in opaque pink oval soft gel capsules with "M" imprinted on one side and plain on the other side. Bottle of 50 count     NDC 64980-229-50 Doxercalciferol Capsules 2.5 mcg are available in opaque yellow oval soft gel capsules with "H" imprinted on one side and plain on the other side. Bottle of 50 count     NDC 64980-230-50 Storage Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

DOXERCALCIFEROL- DOXERCALCIFEROL CAPSULE
RISING PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXERCALCIFEROL
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DOXERCALCIFEROL
CAPSULES.
DOXERCALCIFEROL CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Doxercalciferol Capsules is a synthetic vitamin D analog:
Doxercalciferol capsules are indicated for the treatment of secondary
hyperparathyroidism in adult
patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and
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 capsules in patients with:
Stage 3 or 4 CKD: Initiate dosing at 1 mcg orally once daily. Maximum
dose is 3.5 mcg once daily.
(2.2)
CKD on dialysis: Initiate dosing at 10 mcg orally three times weekly
at dialysis (no more frequently
than every other day). Maximum dose is 20 mcg three times weekly for a
total of 60 mcg weekly.
(2.3)
Target the maintenance dose of doxercalciferol 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
Capsules: 0.5 mcg, 1 mcg, and 2.5 mcg (3)
CONTRAINDICATIONS
Hypercalcemia (4)
Vitamin D toxicity (4)
Know hypersensitivity to doxercalciferol or any of the inactive
ingredients of doxercalciferol capsules (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