General: Profilnine 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 handling due to the limited risk of exposure to viral infection.
Discard any unused Profilnine vial contents. Discard administration equipment after single use. Do not resterilize components. Do not reuse 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.
Use in Pregnancy: Pregnancy Category C.
Animal reproduction studies have not been conducted with Profilnine. It is also not known whether Profilnine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Profilnine should be given to a pregnant woman only if clearly indicated.
Pediatric Use: 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 for Hemophilia B, the two pediatric patients receiving Profilnine responded similarly when compared with the adult patients. There were no adverse events in the pediatric patients and one mild adverse event in the adult population (headache).
Anecdotal evaluation of the results indicate no safety and efficacy differences between pediatric and adult populations.