Grifols introduces ALBUTEIN FlexBag™ (Albumin [Human] U.S.P.) in 5% and 25% concentrations, a more convenient option for healthcare professionals

Barcelona, Spain, November 4, 2021 – Grifols (MCE: GRF, MCE: GRF.P, and NASDAQ: GRFS), a leading global producer of plasma-derived medicines, today announced the launch of its latest albumin portfolio innovation, ALBUTEIN FlexBag™ (Albumin [Human] U.S.P.) in 5% and 25% concentrations.

Meeting the needs of hospitals and pharmacies across the U.S., the ALBUTEIN FlexBag features a port that is easy-to-use, allowing the minimization of bubble accumulation during infusion, and easy-to-spike, helping nurse and hospital teams avoid needle sticks. The FlexBag also features a flexible container that allows for simple storage and greater convenience, with no requirements for vented infusion sets or filters.

“Grifols’ first 5% and 25% FlexBag is another example of the company’s continued dedication to innovation and listening to customers’ needs,” said Bill Zabel, President, Grifols North America Sales and Commercial Operations. “This step forward will expand and differentiate Grifols’ industry-leading albumin portfolio to benefit patients and bring convenient, flexible container options to our customers.”

ALBUTEIN FlexBag 5% and 25% each come in two sizes. The 5% concentration, approved by the U.S. Food and Drug Administration (FDA) in July 2021, features 250 mL and 500 mL bags. Earlier in the year the FDA approved 25% concentration, which features 50 mL and 100 mL bags.

Sustainability was key for Grifols when developing the environmentally friendly ALBUTEIN FlexBag. Both the ALBUTEIN FlexBag flexible container and protective overwrap are latex-free and do not contain polyvinyl chloride (PVC), diethylhexyl phthalate (DEHP), or other plasticizers. In fact, in a study comparing the manufacturing process of ALBUTEIN FlexBag and ALBUTEIN vials, the FlexBag manufacturing life cycle resulted in a 40% reduction in carbon footprint,¹ creating a more sustainable option for hospitals and pharmacies.

The launch of ALBUTEIN FlexBag solidifies Grifols commitment to R+D+i, which has enabled the company to further expand its industry-leading portfolio of plasma-derived medicines for patients and healthcare professionals. It is now available to U.S. healthcare professionals through a broad distribution network.

Please see Important Safety Information for ALBUTEIN FlexBag 5% below and click to access the full Prescribing Information.

Please see Important Safety Information for ALBUTEIN FlexBag 25% below and click to access the full Prescribing Information.

For more information, visit our website. For Grifols USA Customer Service during regular business hours, 8:30 AM – 5:00 PM Eastern Standard Time, call 1-800-243-4153 and 1-888-325-8579, option 3, during the hours of 5:00 PM – 8:00 PM Eastern Standard Time.

IMPORTANT SAFETY INFORMATION

ALBUTEIN^® 25% (albumin [human] U.S.P.) is indicated for: hypovolemia, cardiopulmonary bypass procedures, acute nephrosis, hypoalbuminemia, ovarian hyperstimulation syndrome, neonatal hyperbilirubinemia, adult respiratory distress syndrome (ARDS), and prevention of central volume depletion after paracentesis due to cirrhotic ascites.

ALBUTEIN^® 5% (albumin [human] U.S.P.) is indicated for: hypovolemia, cardiopulmonary bypass procedures, hypoalbuminemia, and plasma exchange.

ALBUTEIN 5% and 25% are contraindicated in patients with a history of hypersensitivity to albumin preparations or to any of the excipients, and in patients with severe anemia or cardiac failure with normal or increased intravascular volume.

Allergic or anaphylactic reactions require 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 fluid overload, 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.

The 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. Patients with marked dehydration require administration of additional fluids

Concentrated (20% - 25%) human albumin solutions are relatively low in electrolytes compared to 4% - 5% human albumin solutions. Regularly monitor the electrolyte status of the patient and take appropriate steps to restore or maintain the electrolyte balance when albumin is administered.

Regular monitoring of coagulation and hematology parameters is necessary if comparatively large volumes are to be replaced. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).

Regularly monitor hemodynamic parameters during administration of ALBUTEIN^® 5% and 25% (albumin [human] U.S.P.).

ALBUTEIN 5% and 25% must not be diluted with sterile water for injection as this may cause hemolysis in recipients.

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 ALBUTEIN 5% or 25%.

The most serious adverse reactions with use of albumin are anaphylactic shock, heart failure and pulmonary edema. The most common adverse reactions are anaphylactoid type reactions. Adverse reactions to ALBUTEIN normally resolve when the infusion rate is slowed or the infusion is stopped. In case of severe reactions, the infusion should be stopped and appropriate treatment initiated.

Please see accompanying full Prescribing Information for ALBUTEIN FlexBag™ 5% and ALBUTEIN FlexBag™ 25%.

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