Adynovate (Antihemophilic Factor)

• You can have an allergic reaction to Adynovate.
• Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.
• The common side effects of Adynovate are headache and nausea. Tell your healthcare provider about any side effects that bother you or do not go away.
• These are not all the possible side effects with Adynovate. You can ask your healthcare provider for information that is written for healthcare professionals.

For intravenous use after reconstitution only.

Dose

• Each vial label of Adynovate states the actual factor VIII potency in international units. This may be more or less than the nominal vial potency/content. One international unit corresponds to the activity of factor VIII contained in one milliliter of normal human plasma.
• Dosage and duration of treatment depend on the severity of factor VIII deficiency, the location and extent of the bleeding, and the patient's clinical condition. Careful monitoring of replacement therapy is necessary in cases of serious or life-threatening bleeding episodes.
• Potency assignment is determined using a one-stage clotting assay. Plasma factor VIII levels can be monitored clinically using a one-stage clotting assay.
• Calculate the dose of Adynovate based on the empirical finding that one international unit of Adynovate per kg body weight increases the plasma factor VIII level by 2 IU per dL of plasma. Use the following formula to estimate the expected in vivo peak increase in factor VIII level expressed as IU per dL (or % of normal) and the dose to achieve a desired in vivo peak increase in factor VIII level:

Estimated Increment of factor VIII (IU/dL or % of normal) = [Total Dose (IU)/body weight (kg)] × 2 (IU/dL per IU/kg)

Dose (IU) = Body Weight (kg) × Desired factor VIII Rise (IU/dL or % of Normal) × 0.5 (IU/kg per IU/dL)

• Patients vary in their pharmacokinetic (e.g., clearance, half-life, in vivo recovery) and clinical response. Base the dose and frequency of Adynovate on the individual clinical response.

• The event of hypersensitivity was a mild transient non-serious rash, occurring in one 2-year old patient who had developed a previous rash while on Adynovate.
• There are no data with Adynovate use in pregnant women to inform a drug-associated risk.
• It is unknown whether Adynovate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Adynovate should be given to a pregnant woman only if clearly needed.
• There is no information regarding the presence of Adynovate in human milk, the effect on the breastfed infant, or the effects on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Adynovate and any potential adverse effects on the breastfed infant from Adynovate or from the underlying maternal condition.