Albuminex 5% Albumin (Human) - kjda logo
Albuminex 25% Albumin (Human) - kjda logo

ALBUMINEX FAQs

Q:
Are ALBUMINEX 5% and ALBUMINEX 25% biosimilars?

A:

No. ALBUMINEX 5% and ALBUMINEX 25% are not biosimilars. ALBUMINEX 5% and ALBUMINEX 25% are approved through the FDA 351(a) process for biologics. Biosimilars are approved through a different process—the 351(k) process.

This can be verified online through the FDA Purple Book Database of Licensed Biological Products website at https://purplebooksearch.fda.gov/advanced-search

  • In the Search box, enter: albumin (human)
  • This generates a list of all approved albumin (human) products
  • Find the column marked “BLA Type” (Biologics License Type)
  • Note that all listed albumin (human) products, including ALBUMINEX 5% and ALBUMINEX 25%, have a BLA type of 351(a)

Contact BPL Medical Affairs if a customer requires a more detailed response letter.

Q:
What does the suffix kjda mean?

A:

The suffix “kjda” is intentionally without meaning. The suffix is included to meet the FDA guidance for non-proprietary naming of biological products. FDA requires new biologic products approved after 2017 to include a distinguishing suffix that is devoid of any meaning, and comprised of four lower-case letters. Application of the naming convention to biological products licensed under the PHS Act should (1) encourage routine use of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices and (2) avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway.

This can be verified online through the FDA Nonproprietary Naming of Biological Products Guidance for Industry document at https://www.fda.gov/media/93218/download

ALBUMINEX 5% and ALBUMINEX 25% are indicated for:

Important Safety Information

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

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.

You may also call BPL at 1-844-4BPLUSA or email MedInfo@bpl-us.com.