TACROLIMUS capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

tacrolimus (UNII: WM0HAQ4WNM) (tacrolimus anhydrous - UNII:Y5L2157C4J)

Tilgængelig fra:

Major Pharmaceuticals

INN (International Name):

tacrolimus

Sammensætning:

tacrolimus anhydrous 0.5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [see Clinical Studies (14.1)], liver transplant [see Clinical Studies (14.2)], heart transplant [see Clinical Studies (14.3)], or lung transplant [see Clinical Studies (14.4)] and pediatric patients receiving allogeneic liver transplants [see Clinical Studies (14.2)] in combination with other immunosuppressants. Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. 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 [seeAdverse Rea

Produkt oversigt:

Tacrolimus Capsules USP, 0.5 mg are white to off white powder filled in hard gelatin capsule of size ‘4’, dark yellow opaque cap imprinted with ‘0.5 MG’ and dark yellow opaque body imprinted with ‘RDY 525’using red ink and are supplied in: Carton of 100 Capsules (10 capsules per blister pack x 10), NDC 0904-6623-61 Tacrolimus Capsules USP, 5 mg are white to off white powder filled in hard gelatin capsule of size ‘4’, dark grayish red opaque cap imprinted with ‘5 MG’ and dark grayish red  opaque body imprinted with ‘RDY 527’ using white ink and are supplied in:  Carton of 100 Capsules (10 capsules per blister pack x 10), NDC 0904-6624-61 Note: Tacrolimus capsules, USP 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) [See USP Controlled Room Temperature]. Tacrolimus can cause fetal harm. Tacrolimus capsules should not be opened or crushed. Wearing disposable gloves is recommended during dilution of the injection in the hospital and when wiping any spills. 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 procedures1 .

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

TACROLIMUS- TACROLIMUS CAPSULE
MAJOR PHARMACEUTICALS
----------
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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
2.
RECENT MAJOR CHANGES
Indications and Usage (1.1) 7/2021
Dosage and Administration (2.2, 2.3) 7/2021
Warnings and Precautions (5.11) 12/2020
INDICATIONS AND USAGE
Tacrolimus capsule is a calcineurin-inhibitor immunosuppressant
indicated for the prophylaxis of organ
rejection in adult patients receiving allogeneic liver, kidney, heart,
or lung transplants, and pediatric
patients receiving allogeneic liver transplants in combination with
other immunosuppressants. (1.1)
DOSAGE AND ADMINISTRATION
ADULT
PATIENT POPULATION
INITIAL
ORALDOSAGE (FORMULATION)
WHOLE BLOOD TROUGH
CONCENTRATION RANGE
Kidney Transplant
With azathioprine
0.2 mg/kg/day capsules, divided in
two doses, every 12 hours
Month 1 to 3: 7 to 20 ng/mL Month
4 to 12: 5 to 15 ng/mL
With MMF/IL-2 receptor antagonist
0.1 mg/kg/day capsules, divided in
two doses, every 12 hours
Month 1 to 12: 4 to 11 ng/mL
Liver Transplant
With corticosteroids only
0.1 to 0.15 mg/kg/day capsules,
divided in two doses, every 12
hours
Month 1 to 12: 5 to 20 ng/mL
Heart Transplant
With azathioprine or MMF
0.075 mg/kg/day capsules, divided
in two doses, every 12 hours
Month 1 to 3: 10 to 20 ng/mL
Month ≥ 4: 5 to 15 ng/mL
Lung Transplant
With azathioprine or MMF
0.075 mg/kg/day capsules,
divided in two doses, every 12
hous
Month 1 to 3: 10 to 15
ng/mLMonth 4 to 12: 8 to 12
ng/mL
PEDIATRIC
Liver Transplant
0.15 to 0.2 mg/kg/day capsules
divided in two doses, every 12
hours
Month 1 to 12: 5 to 20 ng/mL
Lung Transplant
0.3 mg/kg/day capsules divided in
two doses, every 12 hours
Weeks 1 to 2: 10 to 20 ng/mLWeek
2 to Month 12: 10 to 15 ng/mL
MMF= Myco