IMPORTANT SAFETY INFORMATION

Flexbumin® 20% & 25% [Albumin (Human) Solution IP]

Brief Safety Information

Before prescribing and for complete details please consult the India Package Insert. Do not dilute with Sterile Water for Injection. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water. Do not mix or add with other medicinal products including blood and blood components, protein hydrolysates or solutions containing alcohol. Do not add supplementary medication. Administer within 4 hours after the container has been entered. Monitor hemodynamic parameters and check for the risk of hypervolemia and cardiovascular overload. Record the name and batch number of the product to maintain a link between the patient and the product. Discard unused portion. Flexbumin® is not indicated as an intravenous nutrient.

Detailed Safety Information

Please consult the Flexbumin® India Prescribing Information before prescribing.

Guidance for use

For intravenous use only. The dose required depends on the patient’s body weight, severity of injury/illness and on continuing fluid and protein losses. Adjust the concentration, dosage, and infusion rate to the patient’s individual requirements. Use adequacy of circulating blood volume, not plasma albumin levels, to determine the dose required. Do not exceed 2 g of albumin per kg of body weight for the daily dose and 1 mL/min for patients with normal blood volume. More rapid administration can cause circulatory overload and pulmonary edema

• Patients with a history of Hypersensitivity reaction to albumin preparations or to any of the excipients (N-acetyltryptophan and sodium caprylate). Reactions have included anaphylactic shock, anaphylactic reaction, or hypersensitivity/allergic reactions
• Patients with severe anemia or cardiac failure with normal or increased intravascular volume. (See Warnings & Precautions)

Special warnings and precautions for use

Hypersensitivity Reactions: Hypersensitivity reactions (including anaphylactic reactions) have been observed. Discontinue administration immediately if a hypersensitivity reaction (including anaphylactic type reactions) is suspected. In case of shock, implement standard medical treatment for shock. Hypervolemia/Hemodilution: Under conditions where hypervolemia and/or hemodilution may occur adjust dose and rate of infusion to the patient’s volume status. Monitor coagulation and hematology parameters when comparatively large volumes are replaced. Ensure adequate substitution of other blood constituents (coagulation factors, platelets, and erythrocytes). Monitor electrolyte status to maintain the electrolyte balance. Discontinue administration at the first clinical signs of cardiovascular overload (e.g., headache, dyspnea, jugular venous distention, rales and abnormal elevations in systemic or central venous blood pressure). Conditions that pose increased risk of hypervolemia and/or hemodilution include but are not limited to: Heart failure, Hypertension, Esophageal varices, Pulmonary edema, Hemorrhagic diathesis, Severe anemia, Renal failure. Hemodynamics: Closely monitor hemodynamic parameters after administering Flexbumin® for evidence of cardiac or respiratory failure, renal failure, or increasing intracranial pressure. Blood Pressure: 

Monitor blood pressure in trauma patients and postoperative surgery patients resuscitated with Flexbumin® in order to detect re-bleeding secondary to clot disruption. Hemolysis: Do not dilute Flexbumin® with Sterile Water for Injection as this can cause hemolysis in recipients. There exists a risk of potentially fatal hemolysis and acute renal failure from the use of Sterile Water for Injection as a diluent for Albumin (Human) in concentrations of 20% or higher. Transmission of Infectious Agents: Flexbumin® is a derivative of human blood. There is a theoretical risk for transmission of viral infections such as Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD, have ever been identified for licensed albumin. All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Manufacturer/Importer and via the national reporting system. 

Warning: “To be sold by retail on the prescription of a Registered Medical Practitioner Only”

Interactions

No interaction studies of Flexbumin® with other medicinal products have been performed.

Adverse Reactions

Adverse Reactions The most serious adverse reactions are hypersensitivity reaction (including anaphylactic reaction) and pulmonary edema. 

Clinical Trial Experience

No sponsor initiated clinical studies have been conducted with Flexbumin®

Post marketing Experience

The following adverse reactions have been reported in the post approval use of Flexbumin® . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been reported in the post approval use of Flexbumin®

• Immune System Disorders: Anaphylactic shock, anaphylactic reaction, hypersensitivity/allergic reactions
• Nervous System Disorders: Headache, dysgeusia
• Cardiac Disorders: Myocardial infarction, atrial fibrillation, tachycardia
• Respiratory, Thoracic, and Mediastinal Disorders: Pulmonary edema, dyspnea
• Gastrointestinal Disorders: Vomiting, nausea
• Skin and Subcutaneous Tissue Disorders: Urticaria, rash, pruritus
• General Disorders and Administration Site Conditions: Pyrexia, chills

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the Manufacturer/Importer and via the national reporting system. The physician should discuss the risks and benefits of this product with the patient. Suspected Adverse Events should be reported to Takeda at: AE.India@takeda.com

“Disclaimer: This information is solely intended for the use of Registered Medical Practitioner and Hospital only. This information should not be used or shared or distributed to any other person / party and should be strictly by the intended parties for the intended purposes only. For more information, please refer to full Prescribing Information.

This material contains copyright protected information, content; the use of which is limited by law and this material cannot be reproduced, replicated, used or modified by any person for their own use or further distribution. TAKEDA and the TAKEDA logo are trademarks or registered trademarks of Takeda Pharmaceutical Company Limited.

Material code: pi-01929
Date of Preparation of SI: 22nd February 2022

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