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Helixate FS Dosage

Dosage form: injection

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

For Intravenous Use After Reconstitution

  • Treatment with Helixate FS should be initiated under the supervision of a physician experienced in the treatment of hemophilia A.
  • Each vial of Helixate FS has the recombinant factor VIII (rFVIII) potency in international units stated on the label.
  • Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition.1 Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes (see Table 1 and Table 2).

The expected in vivo peak increase in factor VIII level expressed as IU/dL (or % normal) can be estimated using the following formulas:

Dosage (units) = body weight (kg) × desired factor VIII rise (IU/dL or % or normal) × 0.5 (IU/kg per IU/dL)


IU/dL (or % normal) = Total Dose (IU)/body weight (kg) × 2 [IU/dL]/[IU/kg]

Examples (assuming patient's baseline factor VIII level is <1% of normal):

  1. A dose of 1750 IU Helixate FS administered to a 70 kg patient should be expected to result in a peak post-infusion factor VIII increase of 1750 IU × {[2 IU/dL]/[IU/kg]}/[70 kg] = 50 IU/dL (50% of normal).
  2. A peak level of 50% is required in a 15 kg child. In this situation, the appropriate dose would be: 50 IU/dL/{[2 IU/dL]/[IU/kg]} × 15 kg = 375 IU.

Doses administered should be titrated to the patient's clinical response. Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses to Helixate FS.2,3,4 Although the dose can be estimated by the calculations above, it is highly recommended that, whenever possible, appropriate laboratory tests including serial factor VIII activity assays be performed (see Monitoring Laboratory Tests [5.4] and Pharmacokinetics [12.3]).

Control and Prevention of Bleeding Episodes

The careful control of treatment dose is especially important in cases of life–threatening bleeding episodes or major surgery.

The following table can be used to guide dosing in bleeding episodes:

Table 1 Control and Prevention of Bleeding Episodes for Children and Adults
Type of Bleeding Episode Factor VIII Level Required
(IU/dL or % of normal)
Dosage and Frequency Necessary to Maintain the Therapeutic Plasma Level
Early hemarthrosis, minor muscle or oral bleeds.
20-40 10–20 IU per kg
Repeat dose if there is evidence of further bleeding.
Bleeding into muscles, bleeding into the oral cavity, definite hemarthroses, and known trauma.
30-60 15–30 IU per kg
Repeat dose every 12–24 hours until bleeding is resolved.
Gastrointestinal bleeding. Intracranial, intra-abdominal or intrathoracic bleeding, central nervous system bleeding, bleeding in the retropharyngeal or retroperitoneal spaces, or iliopsoas sheath.
Head trauma.
80-100 Initial dose 40–50 IU per kg
Repeat dose 20–25 IU per kg every 8–12 hours until bleeding is resolved.

Peri-operative Management

The careful control of treatment dose is especially important in cases of major surgery or life-threatening bleeding episodes.

The following table can be used to guide dosing in surgery:

Table 2 Peri-operative Management for Adults and Children
Type of Surgery Factor VIII Level Required
(IU/dL or % of normal)
Dosage and Frequency Necessary to Maintain the Therapeutic Plasma Level
Including tooth extraction.
30-60 15 – 30 IU per kg
Repeat dose every 12-24 hours until bleeding is resolved.
Examples include tonsillectomy, inguinal herniotomy, synovectomy, total knee replacement, craniotomy, osteosynthesis, and trauma.
100 Pre-operative dose 50 IU per kg
Verify 100% activity prior to surgery. Repeat as necessary after 6 to 12 hours initially, and for 10 to 14 days until healing is complete.

Routine Prophylaxis in Children with No Pre-existing Joint Damage

The recommended dose for routine prophylaxis is 25 IU/kg of body weight every other day.5

Instructions for Use

Helixate FS is administered by intravenous (IV) injection after reconstitution. Patients should follow the specific reconstitution and administration procedures provided by their physicians.

For instructions, patients should follow the recommendations in the FDA-Approved Patient Labeling (see FDA-Approved Patient Labeling).

Reconstitution, product administration, and handling of the administration 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 a sharps container after single use. Discard all equipment, including any reconstituted Helixate FS product, in an appropriate container.

Preparation and Reconstitution

The procedures below are provided as general guidelines for the reconstitution and administration of Helixate FS. Always work on a clean flat surface and wash hands before performing the following procedures.

1.Warm the unopened diluent and the concentrate to a temperature not to exceed 37°C or 99°F.

2.Place the product vial, diluent vial and Mix2Vial™ on a flat surface.

3.Ensure product and diluent vial flip caps are removed and the stoppers are treated with an aseptic solution and allowed to dry prior to opening the Mix2Vial package.

4.Open the Mix2Vial package by peeling away the lid (Fig. 1).

Figure 1

Figure 1

Leave the Mix2Vial in the clear package. Place the diluent vial on an even surface and hold the vial tight. Grip the Mix2Vial together with the package and snap the blue end onto the diluent stopper (Fig. 2).

Figure 2

Figure 2

5.Carefully remove the clear package from the Mix2Vial set. Make sure that you only pull up the package and not the Mix2Vial set (Fig. 3).

Figure 3

Figure 3

6.With the product vial firmly on a surface, invert the diluent vial with the set attached and snap the transparent adapter onto the product vial stopper (Fig. 4). The diluent will automatically transfer into the product vial.

Figure 4

Figure 4

7.With the diluent and product vial still attached, gently swirl the product vial to ensure the powder is fully dissolved (Fig. 5). Do not shake vial.

Figure 5

Figure 5

8.With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the blue diluent-side of the Mix2Vial set and unscrew the set into two pieces (Fig. 6)

Figure 6

Figure 6

9.Draw air into an empty, sterile syringe. While the product vial is upright, screw the syringe to the Mix2Vial set. Inject air into the product vial. While keeping the syringe plunger pressed, invert the system upside down and draw the concentrate into the syringe by pulling the plunger back slowly (Fig. 7).

Figure 7

Figure 7

10.Now that the concentrate has been transferred into the syringe, firmly grasp the barrel of the syringe (keeping the syringe plunger facing down) and unscrew the syringe from the Mix2Vial set (Fig. 8). Attach the syringe to an administration set made with microbore tubing. Use of other administration sets without microbore tubing may result in a larger retention of the solution within the administration set.

Figure 8

Figure 8

11.If the same patient is to receive more than one bottle, the contents of two bottles may be drawn into the same syringe through a separate unused Mix2Vial set before attaching the vein needle.

12.Helixate FS should be inspected visually for particulate matter and discoloration prior to administration.


For Intravenous Use Only After Reconstitution

  • Helixate FS should be inspected visually for particulate matter and discoloration prior to administration. Turbid or discolored solution should be discarded.
  • Reconstituted Helixate FS may be stored at room temperature prior to administration, but is to be administered within 3 hours.
  • A dose of Helixate FS may be administered over a period of 1 to 15 minutes. The rate of administration however, should be adapted to the response of each individual patient. The pulse rate should be determined before and during administration of Helixate FS. If there is a significant increase in pulse rate, reducing the rate of administration or temporarily halting the injection allows the symptoms to disappear promptly.