TACROLIMUS capsule, gelatin coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

TACROLIMUS (UNII: WM0HAQ4WNM) (TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J)

Tilgængelig fra:

BionPharma Inc.,

INN (International Name):

TACROLIMUS

Sammensætning:

TACROLIMUS ANHYDROUS 0.5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Tacrolimus Capsules is indicated for the prophylaxis of organ rejection, in patients receiving allogeneic kidney transplant  [see Clinical Studies ( 14.1)] , liver transplants  [see Clinical Studies ( 14.2)]  and heart transplant  [see Clinical Studies ( 14.3)] , in combination with other immunosuppressants. Tacrolimus capsules are contraindicated in patients with a hypersensitivity to tacrolimus. Tacrolimus injection is contraindicated in patients with a hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil). Hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome [see Adverse Reactions ( 6)] . Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to tacrolimus during pregnancy. The Transplantation Pregnancy Registry

Produkt oversigt:

Tacrolimus Capsules, USP, 0.5 mg: Light yellow color, oblong shape, size “5” hard gelatin capsules printed with “PBT” and “0.5” in red ink on cap and body respectively. Capsules are supplied as follows: NDC 69452- 153 -20               Bottle of 100 Tacrolimus Capsules, USP, 1 mg: White color, oblong shape, size “5” hard gelatin capsules printed with “PBT” and “1.0” in red ink on cap and body respectively. Capsules are supplied as follows: NDC 69452- 154 -20               Bottle of 100 Tacrolimus Capsules, USP, 5 mg: Pink color, oblong shape, size “4” hard gelatin capsules printed with “PBT” and “5.0” in red ink on cap and body respectively. Capsules are supplied as follows: NDC 69452- 155 -20               Bottle of 100 Note: Tacrolimus capsule are not filled to maximum capsule capacity. Capsule contains labeled amount. Store and Dispense Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Tacrolimus can cause fetal harm. Tacrolimus capsules should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in tacrolimus capsules. If such contact  occurs wash the skin thoroughly with soap and water; if ocular contact occurs, rinse eyes with water. In case a spill occurs, wipe the surface with a wet paper towel. Follow applicable special handling and disposal procedures 1 .

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

TACROLIMUS- TACROLIMUS CAPSULE, GELATIN COATED
BIONPHARMA INC.,
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TACROLIMUS CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TACROLIMUS CAPSULES.
TACROLIMUS CAPSULES, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
RX OLNY
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
INCREASED RISK FOR DEVELOPING SERIOUS INFECTIONS AND MALIGNANCIES WITH
TACROLIMUS CAPSULES OR OTHER
IMMUNOSUPPRESSANTS THAT MAY LEAD TO HOSPITALIZATION OR DEATH. (5.1,
5.2)
INDICATIONS AND USAGE
Tacrolimus Capsules are a calcineurin-inhibitor immuno-suppressant
indicated for the prophylaxis of organ rejection in
adult and pediatric patients receiving allogeneic liver, kidney or
heart transplants, in combination with other
immunosuppressants. ( 1.1)
DOSAGE AND ADMINISTRATION
Patient Population
Initial Oral Dosage
(formulation)
Whole Blood
Trough Concentration range
ADULT
Kidney Transplant
with azathioprine
0.2 mg/kg/day capsules divided in two doses, every 12
hours
Month 1-3: 7-20 ng/mL Month 4-
12: 5-15 ng/mL
With MMF/IL-2 receptor
antagonist
0.1 mg/kg/day capsules, divided in two doses, every 12
hours
Month 1-12: 4-11 ng/mL
Liver Transplant
With corticosteroids
only
0.1-0.15 mg/kg/day capsules, divided in two
doses, every 12 hours
Month 1-12: 5-20 ng/mL
Heart Transplant
With azathioprine or
MMF
0.075 mg/kg/day capsules, divided in two doses, every 12
hours
Month 1-3: 10-20 ng/mL Month
≥ 4: 5-15 ng/mL
PEDIATRIC
Kidney Transplant
0.3 mg/kg/day capsules, divided in two
doses, every 12 hours
Month 1-12: 5-20 ng/mL
Liver Transplant
0.15-0.2 mg/kg/day capsules 0.2 mg/kg/day, divided in
two doses, every 12 hours
Month 1-12: 5-20 ng/mL
Heart Transplant
0.3 mg/kg/day* capsules divided in two
doses, every 12 hours
Month 1-12: 5-20 ng/mL
MMF= Mycophenolate mofetil
*0.1 mg/kg/day if cell depleting induction treatment is administered
Administer capsules consistently wi