Voriconazole (Page 10 of 10)

14.4 Other Serious Fungal Pathogens

In pooled analyses of patients, voriconazole was shown to be effective against the following additional fungal pathogens:

Scedosporium apiospermum — Successful response to voriconazole therapy was seen in 15 of 24 patients (63%). Three of these patients relapsed within 4 weeks, including 1 patient with pulmonary, skin and eye infections, 1 patient with cerebral disease, and 1 patient with skin infection. Ten patients had evidence of cerebral disease and 6 of these had a successful outcome (1 relapse). In addition, a successful response was seen in 1 of 3 patients with mixed organism infections.

Fusarium spp.- Nine of 21 (43%) patients were successfully treated with voriconazole. Of these 9 patients, 3 had eye infections, 1 had an eye and blood infection, 1 had a skin infection, 1 had a blood infection alone, 2 had sinus infections, and 1 had disseminated infection (pulmonary, skin, hepatosplenic). Three of these patients (1 with disseminated disease, 1 with an eye infection and 1 with a blood infection) had Fusarium solani and were complete successes. Two of these patients relapsed, 1 with a sinus infection and profound neutropenia and 1 post surgical patient with blood and eye infections.

14.5 Pediatric Studies

A total of 22 patients aged 12 to 18 years with IA were included in the adult therapeutic studies. Twelve out of 22 (55%) patients had successful response after treatment with a maintenance dose of voriconazole 4 mg/kg every 12 hours.

Additional pediatric use information is approved for PF PRISM C.V.’s VFEND (voriconazole). However, due to PF PRISMC.V.’s marketing exclusivity rights, this drug product is not labeled with that information .

16 HOW SUPPLIED/STORAGE AND HANDLING

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16.1 How Supplied

Voriconazole tablets, 50 mg are white to off-white, round, biconvex film coated tablets debossed with “283” on one side and “S” on the other side.

Voriconazole tablets, 200 mg are white to off-white, capsule shaped, biconvex film coated tablets debossed with “285” on one side and “S” on the other side.

NDC 50268-803-12 (10 tablets per card, 2 cards per card).

Dispensed in Unit Dose Package. For Institutional Use Only.

16.2 Storage

Voriconazole tablets should be stored at 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-Approved Patient Labeling (Patient Information).

Embryo-Fetal Toxicity

• Advise female patients of the potential risks to a fetus.

• Advise females of reproductive potential to use effective contraception during treatment with voriconazole tablets.

Manufactured for:
AvKARE
Pulaski, TN 38478

Mfg. Rev. 03/21
AV 08/22 (P) AvPAK

PATIENT INFORMATION Voriconazole Tablets (Vor-ih-CON-ah-zole) for oral use

20
(click image for full-size original)

VORICONAZOLE voriconazole tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-803(NDC:43547-378)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VORICONAZOLE (VORICONAZOLE) VORICONAZOLE 200 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
CROSCARMELLOSE SODIUM
POVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
POLYVINYL ALCOHOL (40000 MW)
TITANIUM DIOXIDE
TALC
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE (biconvex film coated round) Size 16mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-803-12 20 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-803-11)
1 NDC:50268-803-11 1 TABLET, COATED in 1 BLISTER PACK This package is contained within the BOX (50268-803-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206654 08/19/2022
Labeler — AvPAK (832926666)

Revised: 08/2022 AvPAK

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