POSACONAZOLE tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Posaconazole (UNII: 6TK1G07BHZ) (POSACONAZOLE - UNII:6TK1G07BHZ)

Available from:

Biocon Phama Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus- host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see Clinical Studies (14.2) ] as follows • Posaconazole delayed-release tablets: Adults and pediatric patients 13 years of age and older. Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.’s NOXAFIL (posaconazole delayed-release tablets). However, due to Merck Sharp & Dohme Corp.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Posaconazole is contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. Posaconazole is contraindicated with sirolimus. Concomitant administration of posaconazo

Product summary:

Posaconazole delayed-release tablets are available as pale yellow to yellow, oval, biconvex, film coated tablets debossed with ‘B100’ on one side and plain on the other side containing 100 mg of posaconazole. Bottles with child-resistant closures of 60 delayed-release tablets (NDC 70377-038-11). Store at 20°C to 25°C (68°F to 77°F) with excursions between 15°C and 30°C (59°F and 86°F) permitted [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Biocon Phama Inc.
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PATIENT INFORMATION
This Patient Information has been approved by the U.S. Food and Drug
Administration
Revised. 01/2022
Patient Information
Posaconazole (poe'' sa kon' a zole)
Delayed-Release Tablets
What are posaconazole delayed-release tablets?
Posaconazole delayed release tablets are prescription medicines used
in adults and children 13 years of age
and older to help prevent fungal infections that can spread throughout
your body (invasive fungal
infections). These infections are caused by fungi called Aspergillus
or Candida. Posaconazole delayed
release tablets are used in people who have an increased chance of
getting these infections due to a weak
immune system. These include people who have had a hematopoietic stem
cell transplantation (bone marrow
transplant) with graft versus host disease or those with a low white
blood cell count due to chemotherapy for
blood cancers (hematologic malignancies).
Posaconazole delayed-release tablets are used for:
•prevention of fungal infections in adults and children 13 years of
age and older.
It is not known if Posaconazole delayed release tablets are safe and
effective in children under 2 years of
age.
Who should not take posaconazole delayed-release tablets?
Do not take posaconazole delayed-release tablets if you:
•
are allergic to posaconazole, any of the ingredients in posaconazole
delayed-release tablets, or other
azole antifungal medicines. See the end of this leaflet for a complete
list of ingredients in
posaconazole delayed-release tablets..
•
are taking any of the following medicines:
•
sirolimus
•
pimozide
•
quinidine
•
certain statin medicines that lower cholesterol (atorvastatin,
lovastatin, simvastatin)
•
ergot alkaloids (ergotamine, dihydroergotamine).
•
have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma
(SLL) and you have just
started taking venetoclax or your venetoclax dose is being slowly
increased.
Ask your healthcare provider or pharmacist if you are not sure if you
are taking any of t

Summary of Product characteristics

POSACONAZOLE- POSACONAZOLE TABLET, DELAYED RELEASE
BIOCON PHAMA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POSACONAZOLE
DELAYED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
POSACONAZOLE DELAYED-RELEASE TABLETS.
POSACONAZOLE DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Contraindications (4) 1/2022
Warnings and Precautions (5) 1/2022
INDICATIONS AND USAGE
Posaconazole is an azole antifungal indicated as follows: (1)
• Posaconazole is indicated for the prophylaxis of invasive
Aspergillus and Candida infections in patients
who are at high risk of developing these infections due to being
severely immunocompromised, such as
hematopoietic stem cell transplant (HSCT) recipients with graft
versus-host disease (GVHD) or those with
hematologic malignancies with prolonged neutropenia from chemotherapy
as follows (1.2) (1)
(1)
° POSACONAZOLE DELAYED-RELEASE TABLETS: Adults and pediatric patients
13 years of age and older. (1)
DOSAGE AND ADMINISTRATION
•NOXAFIL ORAL SUSPENSION is not substitutable with POSACONAZOLE
DELAYED-RELEASE TABLETS or
NOXAFIL POWDERMIX FOR DELAYED-RELEASE ORAL SUSPENSION due to the
differences in the dosing of
each formulation. (2)
•Administer Posaconazole delayed release tablets with or without
food. (2.1) (2)
TABLE 1. RECOMMENDED DOSAGE IN ADULT PATIENTS AND PEDIATRIC PATIENTS
AGED 13 YEARS AND
OLDEr
INDICATION
DOSAGE FORM, DOSE, AND DURATION OF THERAPY
POSACONAZOLE DELAYED-RELEASE TABLETS
Prophylaxis of Invasive
Aspergillus and
Candida Infections
Loading dose: 300 mg (three 100 mg delayed-release tablets) twice a
day on the
first day.
Maintenance dose: 300 mg (three 100 mg delayed-release tablets) once a
day,
starting on the second day. Duration of therapy is based on recovery
from
neutropenia or immunosuppression. (2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
Posaconazole delayed-release tablet 100 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to pos