NOXAFIL- posaconazole suspension NOXAFIL- posaconazole tablet, coated NOXAFIL- posaconazole solution NOXAFIL- posaconazole po

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

posaconazole (UNII: 6TK1G07BHZ) (posaconazole - UNII:6TK1G07BHZ)

זמין מ:

Merck Sharp & Dohme LLC

INN (שם בינלאומי):

posaconazole

הרכב:

posaconazole 40 mg in 1 mL

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Noxafil® injection and Noxafil delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. Noxafil 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 [see Clinical Studies (14.1)] as follows: - Noxafil injection: adults and pediatric patients 2 years of age and older - Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg - Noxafil oral suspension: adults and pediatric patients 13 years of age and older - Noxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 40 kg or less Noxafil oral susp

leaflet_short:

Noxafil Injection Noxafil injection is available as a clear, colorless to yellow sterile liquid in single-dose Type I glass vials closed with bromobutyl rubber stopper and aluminum seal (NDC 0085-4331-01) containing 300 mg of posaconazole in 16.7 mL of solution (18 mg of posaconazole per mL). Noxafil Delayed-Release Tablets Noxafil delayed-release tablets are available as yellow, coated, oblong, debossed with "100" on one side containing 100 mg of posaconazole. Bottles with child-resistant closures of 60 delayed-release tablets (NDC 0085-4324-02). Noxafil Oral Suspension Noxafil oral suspension is available as a white, cherry-flavored suspension in 4-ounce (123 mL) amber glass bottles with child-resistant closures (NDC 0085-1328-01) containing 105 mL of suspension (40 mg of posaconazole per mL). Supplied with each oral suspension bottle is a plastic dosing spoon calibrated for measuring 2.5-mL and 5-mL doses. Noxafil PowderMix for Delayed-Release Oral Suspension Noxafil PowderMix for delayed-release oral suspension is supplied as: NDC 0085-2224-02 unit of use carton with 8 packets. NDC 0085-2224-01 individual packet. Noxafil Injection Noxafil injection vial should be stored refrigerated at 2 to 8°C (36 to 46°F). Storage conditions for the diluted solution are presented in another section of the prescribing information [see Dosage and Administration (2.4)]. Noxafil Delayed-Release Tablets Store at 20 to 25°C (68 to 77°F), excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Noxafil Oral Suspension Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. DO NOT FREEZE. Noxafil PowderMix for Delayed-Release Oral Suspension Store the entire kit at 20 to 25°C (68 to 77°F), excursions permitted to 15 to 30°C (59 to 86°F) in a clean, dry place. Do not open foil packet containing Noxafil PowderMix for delayed-release oral suspension until ready for use. Storage conditions for the reconstituted solution are presented in another section of the prescribing information [see Dosage and Administration (2.8)].

מצב אישור:

New Drug Application

מאפייני מוצר

NOXAFIL- POSACONAZOLE SUSPENSION
NOXAFIL- POSACONAZOLE TABLET, COATED
NOXAFIL- POSACONAZOLE SOLUTION
NOXAFIL- POSACONAZOLE POWDER, FOR SUSPENSION
MERCK SHARP & DOHME LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NOXAFIL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NOXAFIL.
NOXAFIL (POSACONAZOLE) INJECTION, FOR INTRAVENOUS USE
NOXAFIL (POSACONAZOLE) DELAYED-RELEASE TABLETS, FOR ORAL USE
NOXAFIL (POSACONAZOLE) ORAL SUSPENSION
NOXAFIL POWDERMIX (POSACONAZOLE) FOR DELAYED-RELEASE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Contraindications (4)
1/2022
Warnings and Precautions (5)
1/2022
INDICATIONS AND USAGE
Noxafil is an azole antifungal indicated as follows:
NOXAFIL INJECTION AND NOXAFIL DELAYED-RELEASE TABLETS are indicated
for the treatment of invasive
aspergillosis in adults and pediatric patients 13 years of age and
older. (1.1)
NOXAFIL 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)
NOXAFIL INJECTION: adults and pediatric patients 2 years of age and
older
NOXAFIL DELAYED-RELEASE TABLETS: adults and pediatric patients 2 years
of age and older who
weigh greater than 40 kg
NOXAFIL ORAL SUSPENSION: adults and pediatric patients 13 years of age
and older
NOXAFIL POWDERMIX FOR DELAYED-RELEASE ORAL SUSPENSION: pediatric
patients 2 years of age
and older who weigh 40 kg or less
NOXAFIL ORAL SUSPENSION is indicated for the treatment of
oropharyngeal candidiasis (OPC), including
OPC refractory (rOPC) to itraconazole and/or fluconazole in adult and
pediatric patients aged 13 years
and older. (1.3)
DOSAGE AND ADMINISTRATION
NOXAFIL ORAL SUSPENSION is not substitutable with NOXAF