Medication Guide App

NovoSeven RT Dosage

Generic name: coagulation factor viia (recombinant)
Dosage form: injection

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

General

  • NovoSeven RT is intended for intravenous bolus administration only.
  • Evaluation of hemostasis should be used to determine the effectiveness of NovoSeven RT and to provide a basis for modification of the NovoSeven RT treatment schedule.
  • Coagulation parameters do not necessarily correlate with or predict the effectiveness of NovoSeven RT.
  • NovoSeven RT should be administered to patients only under the supervision of a physician experienced in the treatment of bleeding disorders.

Hemophilia A or B with Inhibitors

Treatment of Acute Bleeding Episodes

Hemostatic Dosing

  • 90 micrograms/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 micrograms/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.1
  • The minimum 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.
  • Patients should be appropriately monitored by a physician experienced in the treatment of hemophilia during this time period.

Dosing for Surgical Interventions

Minor Surgery

  • An initial dose of 90 micrograms 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 injection should occur at 2-hour intervals for the first 48 hours and then at 2- to 6-hour intervals until healing has occurred.

Major Surgery

  • An initial dose of 90 micrograms per kg body weight should be given immediately before the intervention and repeated at 2-hour intervals for the duration of the surgery.
  • For major surgery, post-surgical dosing by bolus injection 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.

Congenital Factor VII deficiency

  • 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 micrograms per kg body weight every 4-6 hours until hemostasis is achieved.
  • Effective treatment has been achieved with doses as low as 10 micrograms/kg.
  • Dose and frequency of injections should be adjusted to each individual.
  • The minimum effective dose has not been determined.

Acquired Hemophilia

  • The recommended dose range for the treatment of patients with acquired hemophilia is 70-90 micrograms/kg repeated every 2-3 hours until hemostasis is achieved.
  • The minimum effective dose in acquired hemophilia has not been determined.
  • The majority of the effective outcomes were observed with treatment in the recommended dose range. The largest number of treatments with any single dose was 90 micrograms/kg; of the 15 treated, 10 (67%) were effective and 2 (13%) were partially effective.

Reconstitution

Calculate the NovoSeven RT dosage you will need and select the appropriate NovoSeven RT vial package. The selected package contains 1 vial of NovoSeven RT powder and 1 vial of histidine diluent required to prepare reconstituted NovoSeven RT solution. Reconstitute only with the histidine diluent provided with NovoSeven RT. Do not reconstitute with sterile water or other diluent.

Reconstitution should be performed using the following procedures:

1. Always use aseptic technique.

2. Bring NovoSeven RT (white, lyophilized powder) and the specified volume of histidine (diluent) to room temperature, but not above 37° C (98.6° F). The specified volume of diluent corresponding to the amount of NovoSeven RT is as follows:

1 mg (1000 micrograms) vial + 1.1 mL Histidine diluent

2 mg (2000 micrograms) vial + 2.1 mL Histidine diluent

5 mg (5000 micrograms) vial + 5.2 mL Histidine diluent

8 mg (8000 micrograms) vial + 8.1 mL Histidine diluent

After reconstitution with the specified volume of diluent, each vial contains approximately 1 mg/mL NovoSeven RT (1000 micrograms/mL).

3. Remove caps from the NovoSeven RT 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. It is recommended to use syringe needles of gauge size 20-26.

5. Insert the needle of the syringe into the Histidine diluent vial. Inject air into the vial and withdraw the quantity required for reconstitution.

6. Insert the syringe needle containing the diluent into the NovoSeven RT 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 RT vial does not contain a vacuum). Do not inject the diluent directly on the NovoSeven RT powder.

7. Gently swirl the vial until all the material is dissolved. The reconstituted solution is a clear, colorless solution which may be stored either at room temperature or refrigerated for up to 3 hours after reconstitution.

Administration

  • NovoSeven RT is intended for intravenous bolus injection only and should not be mixed with infusion solutions.
  • Reconstituted NovoSeven RT should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is observed.
  • Administration should take place within 3 hours after reconstitution.
  • Any unused solution should be discarded. Do not freeze reconstituted NovoSeven RT or store it in syringes.

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 RT. Inject air into the vial and then withdraw the appropriate amount of reconstituted NovoSeven RT into the syringe.
  4. Remove and discard the needle from the syringe.
  5. Administer as a slow bolus injection over 2 to 5 minutes, depending on the dose administered.
  6. If line needs to be flushed before or after NovoSeven RT administration, use 0.9% Sodium Chloride Injection, USP.
  7. Discard any unused reconstituted NovoSeven RT after 3 hours.
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