NovoSeven is indicated for:

• treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX

• prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX

• treatment of bleeding episodes in patients with congenital FVII deficiency

• prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency

NovoSeven should be administered to patients only under the supervision of a physician experienced in the treatment of bleeding disorders.

Dosage

NovoSeven is intended for intravenous bolus administration only. Evaluation of hemostasis should be used to determine the effectiveness of NovoSeven and to provide a basis for modification of the NovoSeven treatment schedule; coagulation parameters do not necessarily correlate with or predict the effectiveness of NovoSeven.

For bleeding episodes, the recommended dose of NovoSeven for hemophilia A or B patients with inhibitors is 90 mg/kg given every two hours by bolus infusion until hemostasis is achieved, or until the treatment has been judged to be inadequate. Doses between 35 and 120 mg/kg have been used successfully in clinical trials for hemophilia A or B patients with inhibitors, and both the dose and administration interval may be adjusted based on the severity of the bleeding and degree of hemostasis achieved.¹³ The minimal effective dose has not been established. For patients treated for joint or muscle bleeds, a decision on outcome was reached for a majority of patients within eight doses although more doses were required for severe bleeds. A majority of patients who reported adverse experiences received more than twelve doses.

Post-Hemostatic Dosing: The appropriate duration of post-hemostatic dosing has not been studied. For severe bleeds, dosing should continue at 3-6 hour intervals after hemostasis is achieved, to maintain the hemostatic plug. The biological and clinical effects of prolonged elevated levels of Factor VIIa have not been studied; therefore, the duration of post-hemostatic dosing should be minimized, and patients should be appropriately monitored by a physician experienced in the treatment of hemophilia during this time period.

For surgical interventions, an initial dose of 90 mg per kg body weight should be given immediately before the intervention and repeated at 2-hour intervals for the duration of the surgery. For minor surgery, post-surgical dosing by bolus infusion should occur at 2-hour intervals for the first 48 hours and then at 2- to 6-hour intervals until healing has occurred. For major surgery, post-surgical dosing by bolus infusion should occur at 2 hour intervals for 5 days, followed by 4 hour intervals until healing has occurred. Additional bolus doses should be administered if required.

The recommended dose range for treatment of bleeding episodes or for prevention of bleeding in surgical interventions or invasive procedures in congenital Factor VII deficient patients is 15-30 mg per kg body weight every 4-6 hours until hemostasis is achieved. Effective treatment has been achieved with doses as low as 10 mg/kg. Dose and frequency of injections should be adjusted to each individual. The minimal effective dose has not been determined.

Reconstitution should be performed using the following procedures:

1. Always use aseptic technique.

2. Bring NovoSeven (white, lyophilized powder) and the specified volume of Sterile Water for Injection, USP, (diluent) to room temperature, but not above 37° C (98.6° F).

The specified volume of diluent corresponding to the amount of NovoSeven is as follows:

1.2 mg (1200 mg) vial + 2.2 mL Sterile Water for Injection, USP

2.4 mg (2400 mg) vial + 4.3 mL Sterile Water for Injection, USP

4.8 mg (4800 mg) vial + 8.5 mL Sterile Water for Injection, USP

After reconstitution with the specified volume of diluent, each vial contains approximately 0.6 mg/mL NovoSeven (600 mg/mL).

3. Remove caps from the NovoSeven vials to expose the central portion of the rubber stopper. Cleanse the rubber stoppers with an alcohol swab and allow to dry prior to use.

4. Draw back the plunger of a sterile syringe (attached to sterile needle) and admit air into the syringe.

5. Insert the needle of the syringe into the sterile water for injection vial. Inject air into the vial and withdraw the quantity required for reconstitution.

6. Insert the syringe needle containing the diluent into the NovoSeven vial through the center of the rubber stopper, aiming the needle against the side so that the stream of liquid runs down the vial wall (the NovoSeven vial does not contain a vacuum).

Do not inject the diluent directly on the NovoSeven powder.

7. Gently swirl the vial until all the material is dissolved. The reconstituted solution is a clear, colorless solution which may be used up to 3 hours after reconstitution.

Administration

Administration should take place within 3 hours after reconstitution. Any unused solution should be discarded. Do not store reconstituted NovoSeven in syringes. NovoSeven is intended for intravenous bolus injection only and should not be mixed with infusion solutions. As with all parenteral drug products, reconstituted NovoSeven should be inspected visually for particulate matter and discoloration prior to administration. Do not use if particulate matter or discoloration is observed. Administration should be performed using the following procedures:

1. Always use aseptic technique.

2. Draw back the plunger of a sterile syringe (attached to sterile needle) and admit air into the syringe.

3. Insert needle into the vial of reconstituted NovoSeven. Inject air into the vial and then withdraw the appropriate amount of reconstituted NovoSeven into the syringe.

4. Remove and discard the needle from the syringe; attach a suitable intravenous injection needle and administer as a slow bolus injection over 2 to 5 minutes, depending on the dose administered.

5. Discard any unused reconstituted NovoSeven after 3 hours.

REFERENCES

13. Hedner, U.: Dosing and Monitoring NovoSeven^Ò Treatment, Haemostasis 1996; 26 (suppl 1): 102-108.

NovoSeven^Ò Coagulation Factor VIIa (Recombinant) is supplied as a white, lyophilized powder in single-use vials, one vial per carton. The vials are made of Class I, Type I, hydrolytic, neutral, white glass, closed with a latex-free, bromobutyl rubber stopper, and sealed with an aluminum cap. The vials are equipped with a snap-off polypropylene cap. The amount of rFVIIa in milligrams and in micrograms is stated on the label as follows:

1.2 mg per vial (1200 mg/vial) NDC 0169-7060-01

2.4 mg per vial (2400 mg/vial) NDC 0169-7061-01

4.8 mg per vial (4800 mg/vial) NDC 0169-7062-01

Prior to reconstitution, keep refrigerated (2 - 8° C / 36 - 46° F). Avoid exposure to direct sunlight.

Do not use past the expiration date.

After reconstitution, NovoSeven may be stored either at room temperature or refrigerated for up to 3 hours. Do not freeze reconstituted NovoSeven or store it in syringes.

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