How DigiFab® Is Produced
DigiFab® Digoxin Immune Fab (Ovine) is produced through a time intensive, complex process. Immunogens consisting of an analog of digoxin medication are produced in a laboratory and used to immunize sheep. These immunogens are recognized by the immune system as foreign antigens to which antibodies are produced. These antibodies are then collected, separated, purified, and formulated into the drug DigiFab® Digoxin Immune Fab (Ovine).1
Our Commitment to Ethical Practices
BTG is committed to strict adherence to ethical research and development policy. We believe the rights, safety, and well-being of the trial subjects prevail over the interests of science and society. Thus, we respect the safety of clinical research participants and our clinical trials are performed in accordance with the listed directives, regardless of where they are performed. We ensure that all medical care and medical decisions made on the behalf of research participants are the responsibility of a qualified physician. We ensure that all patient data is recorded confidentially and handled and stored in a way that allows accurate reporting, interpretation, and verification according to best practice, including reporting of adverse clinical events.
Our policy is that the use of animals in research will be performed to the highest standard of ethics, adhering to the three guiding principles of reduction, refinement and replacement. All animal studies are performed at external Clinical Research Organizations (CROs) and academic units, and we will only work with external parties that evaluate animal studies using a local ethical review process. In addition, we will only perform animal studies in territories where they are strictly regulated. Alternatives to animal use will always be assessed and in vitro testing performed as an alternative wherever possible.
To report an adverse event or for 24-hour medical information, call 1-844-293-0007.References
- Data on file. BTG International Inc.
DigiFab® Digoxin Immune Fab (Ovine) is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. DigiFab® is not indicated for milder cases of digitalis toxicity.
Important Safety Information
Patients with poor cardiac function may deteriorate secondary to the withdrawal of the inotropic action of digoxin by DigiFab®. Rapid drop in serum potassium concentration may occur after treatment with DigiFab®. Patients with known allergies to sheep protein, papaya, or papain are at higher risk of an anaphylactic reaction. Suicidal ingestion may involve more than one drug. Toxic effects of other drugs or poisons should not be overlooked. The most common adverse reactions (>7%) related to DigiFab® are worsening congestive heart failure (13%), hypokalemia (13%) and worsening atrial fibrillation (7%). Please see full prescribing information, including events, precautions, or warnings.