Novoseven Rt

Novoseven Rt Manufacturers

• Novo Nordisk
  

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  Novoseven Rt | Novo Nordisk

  

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  For intravenous bolus administration only

  2.1 Dose • Treatment with NovoSeven RT should be initiated under the direction of a qualified healthcare professional experienced in the treatment of bleeding disorders. • Use hemostasis evaluation 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.

  Treatment of Acute Bleeding Episodes

  NovoSeven RT dosing for the treatment of acute bleeding episodes is provided in Table 1.

  Table 1: Dosing for Treatment of Acute Bleeding Episodes

  Dose* and
  Frequency Duration of Therapy Additional Information * The minimum effective dose has not been determined

  Congenital Hemophilia A or B with Inhibitors

  Hemostatic

  90 mcg/kg every two hours, adjustable based on severity of bleeding

  Post-Hemostatic

  90 mcg/kg every 3-6 hours for severe bleeds

  Until hemostasis is achieved, or until the treatment has been judged to be inadequate

  After hemostasis is achieved to maintain the hemostatic plug

  The appropriate duration of post-hemostatic dosing has not been studied

  Acquired Hemophilia

  70-90 mcg/kg every 2-3 hours

  Until hemostasis is achieved

  Congenital Factor VII Deficiency

  15-30 mcg/kg every 4-6 hours

  Until hemostasis is achieved

  Effective treatment has been achieved with doses as low as 10 micrograms per kg body weight.

  Adjust dose and frequency of injections to each individual patient

  Glanzmann’s Thrombasthenia

  90 mcg/kg every 2-6 hours

  In severe bleeding episodes requiring systemic hemostatic therapy until hemostasis is achieved

  Platelet transfusions are the primary treatment in patients with Glanzmann’s Thrombasthenia without refractoriness to platelets or in patients without platelet-specific antibodies

  Congenital Hemophilia A or B with inhibitors

  • Dose and administration interval may be adjusted to the individual patient based on the severity of the bleeding. 1 • 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. Monitor and minimize the duration of any post-hemostatic dosing.

  Perioperative Management

  NovoSeven RT dosing for prevention of bleeding in surgical interventions or invasive procedures (perioperative management) is provided in Table 2.

  Table 2: Dosing for Perioperative Management

  Type of Surgery Dose and Frequency Additional Information * The minimum effective dose has not been determined.

  Congenital Hemophilia A or B with Inhibitors

  Minor

  Initial:
  90 mcg/kg immediately before surgery and repeat every 2 hours for the duration of the surgery

  Post surgical:

  90 mcg/kg every 2 hours for 48 hours then every 2-6 hours until healing occurs

  Major

  Initial:

  90 mcg/kg immediately before surgery and repeat every 2 hours for the duration of the surgery

  Post surgical:

  90 mcg/kg every 2 hours for 5 days then every 4 hours until healing occurs

  Additional bolus doses should be administered if required

  Acquired Hemophilia

  Minor or Major

  70-90 mcg/kg immediately before surgery and repeat every 2-3 hours for the duration of the surgery and until hemostasis is achieved*

  Congenital Factor VII Deficiency

  Minor or Major

  15-30 mcg/kg immediately before surgery and repeat every 4-6 hours for the duration of the surgery and until hemostasis is achieved*

  Adjust dose and frequency of injections to each individual patient

  Effective treatment has been achieved with doses as low as 10 micrograms per kg body weight

  Glanzmann’s Thrombasthenia

  Minor or Major

  Initial:

  90 mcg/kg immediately before surgery and repeat every 2 hours for the duration of the procedure*

  Post surgical:

  90 mcg/kg every 2-6 hours to prevent post-operative bleeding*

  Higher average infused doses (median dose was 100 micrograms per kg (IQR 90-140)) were noted for surgical patients who had clinical refractoriness with or without platelet-specific antibodies compared to those with neither

  2.2 Reconstitution • Follow the procedures below for the preparation and reconstitution of NovoSeven RT. For questions regarding reconstitution, please contact Novo Nordisk at 1-877-NOVO-777. • Calculate the NovoSeven RT dosage and select the appropriate NovoSeven RT package provided with either 1 histidine diluent vial or 1 pre-filled histidine diluent syringe. • Reconstitute only with the histidine diluent provided with NovoSeven RT.

  NovoSeven RT package containing 1 vial of NovoSeven RT powder and 1 vial of histidine diluent:

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

  NovoSeven RT package containing 1 vial of NovoSeven RT powder and 1pre-filled histidine diluent syringe with vial adapter for needleless reconstitution:

      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 mL Histidine diluent in pre-filled syringe   2 mg (2000 micrograms) vial + 2 mL Histidine diluent in pre-filled syringe   5 mg (5000 micrograms) vial + 5 mL Histidine diluent in pre-filled syringe   8 mg (8000 micrograms) vial + 8 mL Histidine diluent in pre-filled syringe 3. Remove cap from the NovoSeven RT vial. Cleanse the rubber stopper with an alcohol swab and allow to dry prior to use. 4. Peel back the protective paper from the vial adapter. Do not remove the vial adapter from the package. 5. Place the NovoSeven RT vial on a flat surface. While holding the vial adapter package, place the vial adapter over the NovoSeven RT vial and press down firmly on the package until the vial adapter spike penetrates the rubber stopper. 6. Attach the plunger rod to the syringe. Turn the plunger rod clockwise into the plunger inside the pre-filled diluent syringe until resistance is felt. Remove the syringe cap from the pre-filled diluent syringe and screw onto the vial adapter. 7. Push the plunger rod to slowly inject all the diluent into the vial. Keep the plunger rod pressed down and swirl the vial gently until the powder is dissolved. The reconstituted solution is a clear, colorless solution which may be stored fully assembled either at room temperature or refrigerated for up to 3 hours after reconstitution. After reconstitution with the specified volume of diluent, each vial contains approximately 1 mg per mL NovoSeven RT (1000 micrograms per mL). 2.3 Administration

  For intravenous bolus injection only

  • Inspect the reconstituted NovoSeven RT visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is observed. • Do not freeze reconstituted NovoSeven RT or store it in syringes. • Administer within 3 hours after reconstitution. • Do not mix with other infusion solutions. • Discard any unused solution.

  Perform the following procedures immediately prior to administration:

  NovoSeven RT package containing 1 vial of NovoSeven RT powder and 1 vial of histidine diluent:

  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.

  NovoSeven RT package containing 1 vial of NovoSeven RT powder and 1 pre-filled histidine diluent syringe with vial adapter for needleless reconstitution:

  1. Always use aseptic technique.

  2. Invert the NovoSeven RT vial. Stop pushing the plunger rod and let it move back on its own while the mixed

  solution fills the syringe. Pull the plunger rod slightly downwards to draw the mixed solution into the syringe. Tap

  the syringe to remove air bubbles and withdraw the required dose amount of reconstituted NovoSeven RT into the

  syringe.

  3. Unscrew the vial adapter with the vial. Discard the empty NovoSeven RT vial with the vial adapter attached.

  Caution:

  • The pre-filled diluent syringe is made of glass with an internal tip diameter of 0.037 inches, and is compatible with a standard Luer-lock connector. • Some needleless connectors for intravenous catheters are incompatible with the glass diluent syringes (for example, certain connectors with an internal spike, such as Clave ® /MicroClave ®, InVision-Plus ®, InVision-Plus CS ®, InVision-Plus ® Junior ®, Bionector ®), and their use can damage the connector and affect administration. To administer product through incompatible needleless connectors, withdraw reconstituted product into a standard 10 mL sterile Luer-lock plastic syringe. • If you have encountered any problems with attaching the pre-filled histidine diluent syringe to any Luer-lock compatible device, please contact Novo Nordisk at (877) 668-6777.

  Administer NovoSeven RT using the following procedures:

  1. Administer as a slow bolus injection over 2 to 5 minutes, depending on the dose administered.

  2. If line needs to be flushed before or after NovoSeven RT administration, use 0.9% Sodium Chloride Injection,

  USP.

  3. Discard any unused reconstituted NovoSeven RT after 3 hours.

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