Koate-DVI Special Precautions

Koate-DVI is intended for treatment of bleeding disorders arising from a deficiency in factor VIII. This deficiency should be proven prior to administering Koate-DVI.
Administer within 3 hrs after reconstitution. Do not refrigerate after reconstitution.
Administer only by IV route.
Filter needle should be used prior to administering.
Koate-DVI contains levels of blood group isoagglutinins which are not clinically significant when controlling relatively minor bleeding episodes. When large or frequently repeated doses are required, patients of blood groups A, B or AB should be monitored by means of hematocrit for signs of progressive anemia, as well as by direct Coombs' tests.
Product administration and handling of the infusion set and needles must be done with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs. Place needles in sharps' container after single use. Discard all equipment including any reconstituted Koate-DVI product in accordance with biohazard procedures.
Information for Patients: Some viruses eg, parvovirus B19 or hepatitis A, are particularly difficult to remove or inactivate at this time. Parvovirus B19 most seriously affects pregnant women or immune-compromised individuals.
Symptoms of parvovirus B19 infection include fever, drowsiness, chills and runny nose followed about 2 weeks later by a rash and joint pain. Evidence of hepatitis A may include several days to weeks of poor appetite, tiredness and low-grade fever followed by nausea, vomiting and pain in the belly. Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physician if such symptoms appear.
Use in pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with Koate-DVI. It is also not known whether Koate-DVI can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Koate-DVI should be given to a pregnant woman only if clearly needed.
Use in children: Koate-DVI has not been studied in pediatric patients. Koate-HP, solvent/detergent-treated antihemophilic factor (human), has been used extensively in pediatric patients. Spontaneous adverse event reports with Koate-HP for pediatric use were within the experience of those reports for adult use.