Rx Item-COAGADEX- coagulation factor x human kit BY Bio Products Lab

For: Hereditary Factor X Deficiency

Coagadex (coagulation factor X (human)) is a human factor X concentrate for the treatment of hereditary factor X deficiency. These highlights do not include all the information needed to use COAGADEX� safely and effectively. See full prescribing information for COAGADEX�.

COAGADEX� (Coagulation Factor X (Human))
Lyophilized Powder for Solution for Intravenous Injection
Initial U.S. Approval: [2015]
RECENT MAJOR CHANGES
Indications and Usage (1) 09/2018
Dosage and Administration (2.1, 2.2) 09/2018
Contraindications (4) 09/2018
INDICATIONS AND USAGE

COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation factor indicated in adults and children with hereditary Factor X deficiency for:

Routine prophylaxis to reduce the frequency of bleeding episodes (1)
On-demand treatment and control of bleeding episodes (1)
Perioperative management of bleeding in patients with mild and moderate hereditary Factor X deficiency (1)

Limitation of Use

Perioperative management of bleeding in major surgery in patients with severe hereditary Factor X deficiency has not been studied.
DOSAGE AND ADMINISTRATION

For intravenous use only after reconstitution.

Each vial of COAGADEX contains the labeled amount of Factor X in international units (IU) (2)
The dosage and duration of treatment depend on the severity of the Factor X deficiency, on the location and extent of the bleeding and on the patient's clinical condition (2.1)
For prophylaxis of bleeding episodes (2.1):

Age Initial dose Further management
Children: Less than 12 years of age 40 IU/kg twice weekly Monitor trough blood levels of Factor X targeting ?5 IU/dL and adjust dosage to clinical response and trough levels. Do not exceed a peak level of 120 IU/dL.
Adults and adolescents: 12 years of age or older 25 IU/kg twice weekly

For treatment of bleeding episodes (2.1):

Age Initial dose Further management
Children: Less than 12 years of age 30 IU/kg Repeat at intervals of 24 hours until the bleed stops.
Adults and adolescents: 12 years of age or older 25 IU/kg

For perioperative management (2.1):

Age Initial dose Further management
Children: Less than 12 years of age Use a factor of 0.6 to calculate the required dose (see formula in 2.1) Pre-surgery: raise plasma Factor X levels to 70-90 IU/dL
Post-surgery: maintain plasma Factor X levels at ?50 IU/dL until the patient is no longer at risk of bleeding due to surgery
Adults and adolescents: 12 years of age or older Use a factor of 0.5 to calculate the required dose (see formula in 2.1)
DOSAGE FORMS AND STRENGTHS

COAGADEX is available as a lyophilized powder for reconstitution in single-use vials containing nominally (approximately) 250 IU or 500 IU of Factor X activity. When reconstituted using the Sterile Water for Injection supplied with the kit, the final concentration is approximately 100 IU/mL (3).
CONTRAINDICATIONS

Do not use in patients who have had life-threatening hypersensitivity reactions to COAGADEX (4).
WARNINGS AND PRECAUTIONS

Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue COAGADEX and administer appropriate treatment (5.1).
Development of neutralizing antibodies (inhibitors) may occur. If expected plasma Factor X activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor X inhibitor concentration (5.2).
COAGADEX is made from human blood and therefore carries a risk of transmitting infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent (5.4).

ADVERSE REACTIONS

The most common adverse drug reactions (frequency ? 5% of subjects) observed in clinical trials were infusion site erythema, infusion site pain, fatigue and back pain (6).

To report SUSPECTED ADVERSE REACTIONS, contact BPL USA Inc., at 1-844-427-5872 or [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

Revised: 9/2018

Rx Item-COAGADEX- coagulation factor x h
RX64208-7752-01

Rx Item-COAGADEX- coagulation factor x h
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop