About ALBUMINEX

ALBUMINEX is a High-Purity Albumin Product

ALBUMINEX 5% and ALBUMINEX 25% are purified from human plasma using a four-step process^1-4:

Fractionation
(Cohn cold ethanol process)

Diafiltration

Anion exchange
chromatography (DEAE Sepharose purification)

This chromatography “polishing” step reduces denatured impurities and increases the purity of ALBUMINEX 5% and ALBUMINEX 25% to
≥99%

Pasteurization
(at 60°C for 10 hours in final container)

Product Attributes

Sterile, ready-for-use, clear, slightly viscous, almost colorless, yellow, amber or slightly green aqueous solution of human albumin for single-dose intravenous infusion
Prepared from the pooled plasma of US donors in FDA-licensed facilities in the US
Dual stabilizers: caprylate (0.08 mmol/g albumin) and acetyltryptophanate (0.08 mmol/g albumin)
No preservatives
Low aluminum content (<200 micrograms/L albumin)
Latex free
Can be stored at room temperature (not above 30°C [86°F])

References: 1. Albuminex^® 5% (human albumin) Prescribing Information. Durham, NC: BPL Limited. 2. Albuminex^® 25% (human albumin) Prescribing Information. Durham, NC: BPL Limited. 3. Matejtschuk P, Dash CH, Gascoigne EW. Production of human albumin solution: a continually developing colloid. Br J Anaesth. 2000;85(6):887-95. 4. Data on file: BPL-RD006-0220. Bio Products Laboratory Ltd.

ALBUMINEX 5% and ALBUMINEX 25% are indicated for:

Hypovolemia
Ascites
Hypoalbuminemia, including from burns
Acute nephrosis
Acute respiratory distress syndrome (ARDS)
Cardiopulmonary bypass

Important Safety Information

ALBUMINEX 5% and ALBUMINEX 25% are contraindicated in patients with:

Hypersensitivity to human albumin or any of the excipients
Severe anemia or cardiac failure with normal or increased intravascular volume

Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the infusion and implementation of appropriate medical treatment.

Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient’s volume status. At the first clinical signs of cardiovascular overload (headache, dyspnea, jugular venous distention, increased blood pressure), the infusion must be slowed or stopped immediately. Use albumin with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk to the patient.

Colloid-osmotic effect of human albumin 25% is approximately five times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration.

Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for ALBUMINEX 5% or ALBUMINEX 25%.

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.

Please see Full Prescribing Information for complete prescribing details.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.

For medical inquiries, you may email Kedrion at US_MedicalInfo@kedrion.com.

For customer service, you may call Kedrion at 855-353-7466.