Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Thromboembolic adverse reactions were reported in 6% of surgical patients treated with RECOTHROM Thrombin topical (Recombinant) in all completed clinical trials (N=644) [see Warnings and Precautions (5.1) ] .
Antibody formation to RECOTHROM occurred in <1% of patients.
None of the antibodies detected neutralized native human thrombin [see Adverse Reactions (6.2) ] .
• The most common adverse reaction (incidence 6%) was thromboembolic events.
(5.1 , 6) • Antibody formation to RECOTHROM Thrombin topical (Recombinant) occurred in <1% of patients.
None of the antibodies detected neutralized native human thrombin.
(6.2) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug product cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical trials have been performed with RECOTHROM Thrombin topical (Recombinant) applied with absorbable gelatin sponge and applied with a spray applicator.
A total of 644 patients were exposed to RECOTHROM in these studies.
5 WARNINGS AND PRECAUTIONS • RECOTHROM Thrombin topical (Recombinant) causes thrombosis if it enters the circulatory system.
(5.1) • Hypersensitivity reactions, including anaphylaxis, may occur.
(5.2) 5.1 Thrombosis RECOTHROM Thrombin topical (Recombinant) causes thrombosis if it enters the circulatory system.
Apply topically.
DO NOT INJECT.
Like all medications, Recothrom can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: