THROMBATE III (antithrombin iii- human kit THROMBATE III (antithrombin iii- human kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Antithrombin Iii Human (UNII: T0LTO7L82X) (Antithrombin Iii Human - UNII:T0LTO7L82X)

Available from:

GRIFOLS USA, LLC

INN (International Name):

Antithrombin Iii Human

Composition:

Antithrombin Iii Human 50 [iU] in 1 mL

Therapeutic indications:

THROMBATE III is a human antithrombin (AT) indicated in patients with hereditary antithrombin deficiency for: - Treatment and prevention of thromboembolism - Prevention of peri-operative and peri-partum thromboembolism None. Risk Summary There are no data with THROMBATE III use in pregnant women to inform a drug-associated risk. However, there are clinical considerations [see Clinical Considerations] . It is not known whether THROMBATE III can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. THROMBATE III should be given to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to THROMBATE III. Clinical Considerations Labor or Delivery Suspend heparin (or low molecular weight heparin) administration and continue THROMBATE III administration during labor and delivery. Risk Summary There is no information regarding the presence of THROMBATE III in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for THROMBATE III and any potential adverse effects on the breastfed infant from THROMBATE III or from the underlying maternal condition. Safety and effectiveness in the pediatric population have not been established. The safety and effectiveness in the geriatric population have not been established.

Product summary:

THROMBATE III is supplied in a kit containing one single use vial of THROMBATE III lyophilized powder for reconstitution, one vial of Sterile Water for Injection, USP, one sterile double-ended transfer needle, and one sterile filter needle. The total activity of AT in International Units is stated on the label of the THROMBATE III vial.  Components of the packaging do not contain natural rubber latex.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

THROMBATE III - ANTITHROMBIN III (HUMAN)
THROMBATE III- ANTITHROMBIN III (HUMAN)
GRIFOLS USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
THROMBATE III SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR THROMBATE III.
THROMBATE III [ANTITHROMBIN III (HUMAN)]
LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
THROMBATE III is a human antithrombin (AT) indicated in patients with
hereditary antithrombin deficiency
for:
Treatment and prevention of thromboembolism
Prevention of peri-operative and peri-partum thromboembolism (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY
Individualize dose to achieve AT level of 80% to 120% of normal human
plasma (2.1)
Dose
Target AT
Level
Dose (Units)
Monitor AT Level
Loading
120% of normal
120 % - baseline x body
weight(kg)
divided by 1.4%
baseline
20 minutes (peak) post-
injection
12 hours post-injection
pre-injection (trough)
Adjustment
(as needed)
80% to 120% of
normal
Target % - trough % x body
weight (kg)
divided by 1.4%
20 minutes (peak) post-
injection
at least every 12 hours post-
injection
pre-injection (trough)
Maintenance
(every 24 hours, as
needed)
80% to 120% of
normal
Loading Dose x 0.6
approximately every 24 hours,
as needed
Adapt the rate of administration to the response of the patient;
typically the full dose is given over 10 to
20 minutes. (2.3)
DOSAGE FORMS AND STRENGTHS
For injection: approximately 500 units, lyophilized powder in
single-use vial for reconstitution. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions, including anaphylaxis, are possible.
Should symptoms occur, discontinue
THROMBATE III infusion and begin appropriate treatment. (5.1)
Because THROMBATE III is made from human blood, it may carry a risk of
transmitting infectious
agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD)
agent and, theoretically, the
Creutzfeldt-Jakob (CJD) d