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 The most common adverse reactions are rigors, hypotension/decreased BP, tachycardia/increased heart rate, pyrexia, feeling cold (chills), nausea, vomiting, dyspnea/bronchospasm, rash/pruritus.
Stop the infusion if anaphylaxis, with or without shock, is observed.
To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma, Inc.
at 1-855-3KDRION (1-855-353-7466) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 General In general, human albumin solutions are well-tolerated and no specific, clinically relevant alterations in organ function or coagulopathy have been substantiated.
26 The most common adverse reactions associated with infusion of human albumin solutions are rigors, hypotension/decreased BP, tachycardia/increased heart rate, pyrexia, feeling cold (chills), nausea, vomiting, dyspnea/bronchospasm, rash/pruritus.
Reactions usually resolve when the infusion is slowed or stopped.
Anaphylaxis, with or without shock, may occur and in this situation, stop the infusion.
6.2 Clinical Trials Experience No clinical studies were done using ALBUMINEX 25%.
5 WARNINGS AND PRECAUTIONS Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the injection and implementation of appropriate medical treatment.
( 5.1 ) Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient's volume status.
Use with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk to the patient.
( 5.2 ) When concentrated albumin is administered, care must be taken to assure adequate hydration of the patient.
( 5.3 ) Assessment of electrolytes, coagulation and hematology parameters, and hemodynamic status when albumin is administered.
Like all medications, Albuminex 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: