Rx Item-Nuwiq Lfp Vial Kit 864Iu

ANTIHEMOPHILIC FACTOR HUM REC These highlights do not include all the information needed to use NUWIQ safely and effectively. See full prescribing information for NUWIQ.

NUWIQ�, Antihemophilic Factor (Recombinant)
Lyophilized Powder for Solution for Intravenous Injection
Initial U.S. Approval: 2015
INDICATIONS AND USAGE

NUWIQ is a recombinant antihemophilic factor [blood coagulation factor VIII (Factor VIII)] indicated in adults and children with Hemophilia A for:

On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to reduce the frequency of bleeding episodes

�NUWIQ is not indicated for the treatment of von Willebrand Disease. ( 1 )
DOSAGE AND ADMINISTRATION

For intravenous use after reconstitution (2)

Each vial of NUWIQ is labeled with the actual amount of Factor VIII potency in international units (IU).
Determine dose using the following formula for adolescents and adults:

�Required IU = body weight (kg) x desired Factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL) (2)

Dosing for routine prophylaxis:

Subjects Dose (IU/kg) Frequency of infusions

Adolescents [12 - 17 yrs] and adults (2)


30 - 40 (2)


Every other day (2)

Children [2 - 11 yrs] (2)


30 - 50 (2)


Every other day or three times per week (2)

Frequency and duration of therapy depends on severity of the FVIII deficiency, location and extent of bleeding, and patient's clinical condition.

DOSAGE FORMS AND STRENGTHS

�NUWIQ is available as a white sterile, non-pyrogenic, lyophilized powder for reconstitution in single-use vials containing nominally 250, 500, 1000, 2000, 2500, 3000 or 4000 IU Factor VIII potency. (3)
CONTRAINDICATIONS

� NUWIQ is contraindicated in patients who have manifested life-threatening hypersensitivity reactions, including anaphylaxis, to the product or its components ( 4 )
WARNINGS AND PRECAUTIONS

Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue NUWIQ and administer appropriate treatment. ( 5.1 )
Development of Factor VIII neutralizing antibodies (inhibitors) may occur. If expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor VIII inhibitor concentration. ( 5.2 )
Monitor all patients for Factor VIII activity and development of Factor VIII inhibitor antibodies. ( 5.3 )

ADVERSE REACTIONS

The most frequently occurring adverse reactions (> 0.5%) in clinical trials were paresthesia, headache, injection site inflammation, injection site pain, non-neutralizing anti-Factor VIII antibody formation, back pain, vertigo, and dry mouth. ( 6 )

�To report SUSPECTED ADVERSE REACTIONS, contact Octapharma USA Inc. at 1- 866-766-4860 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS

Pediatric Use: Lower recovery, shorter half life and faster clearance in children aged 2 - ≤12 years. Higher doses and/or a more frequent dosing schedule for prophylactic treatment should be considered in pediatric patients aged 2 to 5 years. ( 8.4 ).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 7/2017

68982-0143-01
Generic Name: ANTIHEMOPHILIC FACTOR HUM REC Description: NUWIQ, 0864U, (864 UNITS), POWDER VIAL, 1X1 EA NDC: 68982-0143-01 68982-143-01 68982014301 6898214301 UPC: 368982-143017

Nuwiq Lfp Vial Kit 864Iu
BRAND: NUWIQ NDC: RX68982-0143-01 ,RX68982014301 UPC: 368982-143017,368982143017 NUWIQ LFP VL KIT 864IU NDC 68982-0143-01 Unit Each Alternative Name Antihemophilic Factor VIII (Recombinant) Manufac

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68982-0143-01
Generic Name: ANTIHEMOPHILIC FACTOR HUM REC Description: NUWIQ, 0864U, (864 UNITS), POWDER VIAL, 1X1 EA NDC: 68982-0143-01 68982-143-01 68982014301 6898214301 UPC: 368982-143017

OCTA PHARMA
OCTA PHARMA