TACROLIMUS capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Glenmark Pharmaceuticals Inc., USA

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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)] and heart transplant [see Clinical Studies (14.3)] , and pediatric patients receiving allogeneic liver transplants [see Clinical Studies (14.2)] in combination with other immunosuppressants. Additional pediatric use and lung transplant 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 [see Adverse Reactions (6)] . Pregnan

Περίληψη προϊόντος:

Tacrolimus Capsules, USP are available as follows: 0.5 mg: Size “4” hard gelatin capsule with light yellow cap and light yellow body, imprinted with a Glenmark logo “G” on the cap and “685” on the body in red ink, filled with white to off-white granular powder. Bottles of 100 with child-resistant closure, NDC 68462-685-01 1 mg: Size “4” hard gelatin capsule with white cap and white body, imprinted with a Glenmark logo “G” on the cap and “686” on the body in red ink, filled with white to off-white granular powder. Bottles of 100 with child-resistant closure, NDC 68462-686-01 Cartons of 100 (10 x 10 unit-dose), NDC 68462-686-14 5 mg: Size “4” hard gelatin capsule with greyish red cap and greyish red body, imprinted with a Glenmark logo “G” on the cap and “687” on the body in white ink, filled with white to off-white granular powder. Bottles of 100 with child-resistant closure, NDC 68462-687-01 Cartons of 100 (10 x 10 unit-dose), NDC 68462-687-14 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); 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. 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 .

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

TACROLIMUS- TACROLIMUS CAPSULE
GLENMARK PHARMACEUTICALS INC., USA
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK FOR DEVELOPING SERIOUS INFECTIONS AND MALIGNANCIES WITH
TACROLIMUS OR
OTHER IMMUNOSUPPRESSANTS THAT MAY LEAD TO HOSPITALIZATION OR DEATH.
(5.1, 5.2)
RECENT MAJOR CHANGES
Warnings and Precautions (5.5, 5.10, 5.16) 11/2022
Warnings and Precautions, Cannabidiol Drug Interactions (5.17) 08/2023
INDICATIONS AND USAGE
Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant
indicated for the prophylaxis of organ
rejection in adult patients receiving allogeneic liver, kidney or
heart transplants, and pediatric patients
receiving allogeneic liver transplants in combination with other
immunosuppressants. (1.1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
ADULT
PATIENT POPULATION
INITIAL ORAL DOSAGE
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
PEDIATRIC
PATIENT POPULATION
INITIAL ORAL DOSAGE
WHOLE BLOOD TROUGH
CONCENTRATION RANGE
Intravenous (IV) use recommended for patients who cannot tolerate oral
formulations (capsules).
(2.1, 2.2)
Administer capsules consistently with or without food. (2