KOATE-DVI Powder fo solution Ref.[50352] Active ingredients: Coagulation factor VIII

Koate-DVI is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. There is also the possibility that unknown infectious agents may be present in such products. 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 Grifols Therapeutics LLC [1-800-520-2807]. The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to a patient.

Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. It is emphasized that hepatitis B vaccination is essential for patients with hemophilia and it is recommended that this be done at birth or diagnosis.(8,9) Hepatitis A vaccination is also recommended for hemophilic patients who are hepatitis A seronegative.

Allergic-type reactions may result from the administration of Antihemophilic Factor (Human) preparations.(10,11) Ten adverse reactions related to 7 infusions were observed during a total of 1053 infusions performed during the clinical study of Koate-DVI, for a frequency of 0.7% infusions associated with adverse reactions. All reactions were mild and included paraesthesia, vision blurred, headache, nausea, abdominal pain, and feeling jittery.(2)

1. 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.
2. Administer within 3 hours after reconstitution. Do not refrigerate after reconstitution.
3. Administer only by the intravenous route.
4. Filter needle should be used prior to administering.
5. 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.
6. 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.

Some viruses, such as parvovirus B19 or hepatitis A, are particularly difficult to remove or inactivate at this time. Parvovirus B19 most seriously affects pregnant women and 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.

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.

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 and Koate-DVI for pediatric use were within the experience of those reports for adult use.