Patient Medication Information: uses, side effects, how to take - Digibind
ABOUT THIS MEDICATION
What the medication is used for:
DIGIBIND®, Digoxin Immune Fab (Ovine) is used in the treatment of life-threatening digoxin intoxication. It has also been used successfully to treat life-threatening toxicity due to digitoxin.
What it does:
DIGIBIND®, Digoxin Immune Fab (Ovine) is a sterile freeze-dried powder of antigen binding fragments (Fab) derived from specific antidigoxin antibodies raised in sheep. DIGIBIND® binds molecules of digoxin, making them unavailable for binding at their site of action on cells in the body.
When it should not be used:
Do not use DIGIBIND®, Digoxin Immune Fab (Ovine) if:
- you are hypersensitive to any of the ingredients.
- you have allergies to papain, chymopain or other papaya extracts.
- you have previously received antibodies or Fab fragments raised in sheep.
What the medicinal ingredient is:
DIGIBIND®, Digoxin Immune Fab (Ovine) contains 38 mg of digoxin-specific Fab fragments.
What the important nonmedicinal ingredients are:
DIGIBIND®, Digoxin Immune Fab (Ovine) contains 28 mg of sodium chloride and 75 mg of sorbitol as a stabilizer. There are no preservatives added.
What dosage forms it comes in:
DIGIBIND®, Digoxin Immune Fab (Ovine) is available as a sterile freeze-dried powder supplied in boxes of one (1) vial containing 38 mg of purified freeze-dried digoxin-specific Fab fragments.
WARNINGS AND PRECAUTIONS
BEFORE you use DIGIBIND®, Digoxin Immune Fab (Ovine) talk to your doctor or pharmacist if:
- You have any allergies to this drug or its ingredients.
You are pregnant or breastfeeding.
INTERACTIONS WITH THIS MEDICATION
There are no known drug interactions to the use of DIGIBIND®
Digoxin Immune Fab (Ovine)
PROPER USE OF THIS MEDICATION
Usual dose:
The dosage of DIGIBIND®, Digoxin Immune Fab (Ovine) varies according to the amount of digoxin (digitoxin) to be neutralized. The average dose used during clinical testing was 10 vials.
Dosage for Acute Ingestion of Unknown Amount: 20 vials (760 mg) of DIGIBIND® is adequate to treat most life-threatening ingestions in both adults and children. However, in children it is important to monitor for volume overload, (fluid buildup in the body causing rapid heartbeat, shortness of breath, and swelling in the hands and feet). The physician may consider administering 10 vials, observing the patient’s response, and follow with an additional 10 vials if necessary
Dosage for Toxicity During Chronic Therapy: For adults, 6 vials (228 mg) usually is adequate to reverse most cases of toxicity. This dose can be used in patients who are in acute distress for whom a serum digoxin concentration is not available. In infants and small children (≤ 20 kg) a single vial usually should suffice.
The methods for calculating the dose of DIGIBIND® required to neutralize a known or estimated amount of digoxin or digitoxin in the body is provided in Part I: DOSAGE AND ADMINISTRATION section.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Allergic reactions to DIGIBIND®, Digoxin Immune Fab (Ovine) have been reported rarely. Patients with a history of allergy, especially to antibiotics, appear to be at particular risk. In a few instances :
- low cardiac output states (low volume of blood being pumped by the heart) and,
- congestive heart failure,
allergic reactions could have been worsened by withdrawal of the inotropic (force of muscle contraction) effects of digitalis.
IMPORTANT: PLEASE READ
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Low plasma potassium concentrations may occur from reactivation of (sodium, potassium) ATPase ( a protein complex responsible for converting potential energy into ATP, the molecule the body uses for fuel). Patients with atrial fibrillation (an irregular heartbeat) may develop a rapid ventricular response to withdrawal of the effects of digitalis on the atrioventricular node.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
One should consider the possibility of anaphylactic (a severe allergic reaction, that may be life threatening),
hypersensitivity or febrile reactions (related to or characterised by fever) to DIGIBIND®, Digoxin Immune Fab (Ovine). If a severe allergic reaction occurs, the drug infusion should be discontinued and appropriate therapy initiated.
HOW TO STORE IT
Store under refrigeration (2° to 8°C). Unreconstituted vials can be stored at up to 30°C for a total of 30 days.
Reconstituted product should be used promptly. If it is not used immediately, it may be stored under refrigeration at 2° to 8°C for up to 4 hours.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax: 866-678-6789
Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.gsk.ca
or by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
Last revised: 2009-05-25
© 2009 GlaxoSmithKline Inc. All Rights Reserved ®DIGIBIND is a registered trademark, used under license by GlaxoSmithKline Inc.