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General: In order to minimize the possibility of thrombogenic complications, dosing guidelines should be strictly followed. Refer to "Dosage & Administration" for recommended amount of product to be administered.
AlphaNine SD should not be administered at a rate exceeding 10 mL/minute. Rapid administration may result in vasomotor reactions.
Nursing personnel and others who administer this material should exercise appropriate caution in handling due to the risk of exposure to viral infection.
Discard any unused contents into the appropriate safety container. Discard administration equipment after single use into the appropriate safety container. Do not resterilize components.
Information for Patients: Patients should be informed of the early symptoms and signs of hypersensitivity reaction, including hives, generalized urticaria, chest tightness, dyspnea, wheezing, faintness, hypotension, and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care, depending on the severity of the reaction, if these symptoms occur.
Some viruses, such as parvovirus B19 or hepatitis A, are particularly difficult to remove or inactivate at this time. Parvovirus B19 may most seriously affect sero-negative pregnant women, or immunocompromised individuals. The majority of parvovirus B19 and hepatitis A infections are acquired by environmental (natural) sources. Preliminary information suggests a relationship may exist between the presence of major deletion mutations in the Factor IX gene and an increased risk of inhibitor formation and of acute hypersensitivity reactions. Patients known to have major deletion mutations of the Factor IX gene should be observed closely for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product.
Use in Pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with AlphaNine SD. It is also not known whether AlphaNine SD can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AlphaNine SD should be given to a pregnant woman only if clearly indicated.
Use in Children: Clinical trials for safety and effectiveness in pediatric patients 16 years of age and younger have not been conducted. Across a well controlled half-life and recovery clinical trial in patients previously treated with Factor IX concentrates of Hemophilia B, the three pediatric patients receiving AlphaNine SD (solvent detergent treated) responded similarly when compared with 15 adult patients. In an ongoing safety and efficacy clinical trial in patients not previously treated with Factor IX concentrates for Hemophilia B, 21 pediatric patients received AlphaNine SD (solvent detergent treated) responded similarly when compared with the five adult patients above the age of 16 years. Adverse events were similar in this group compared to the patients above the age of 16 years. Anecdotal evaluation of the results indicates no safety and efficacy differences between pediatric and adult populations.
