Source: FDA, National Drug Code (US) Revision Year: 2018
HEMOFIL M is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.
HEMOFIL M is not indicated in von Willebrand’s disease.
For intravenous use only.
The expected in vivo peak AHF level, expressed as IU/dL of plasma or % (percent) of normal, can be calculated by multiplying the dose administered per kg body weight (IU/kg) by two. This calculation is based on the clinical finding by Abildgaard, et al, which is supported by data from the collaborative study of in vivo recovery and survival with 15 different lots of HEMOFIL M on 56 hemophiliacs that demonstrated a mean peak recovery point above the mean pre-infusion baseline of about 2.0 IU/dL per infused IU/kg body weight.
Examples:
(1) Recommended Dosage Schedule
(2) Physician supervision of the dosage is required. The following dosage schedule may be used as a guide.
Physician supervision of the dosage is required. The following dosage schedule may be used as a guide.
HEMORRHAGE:
| Degree of hemorrhage | Required peak post-infusion AHF activity in the blood (as % of normal or IU/dL plasma) | Frequency of infusion |
|---|---|---|
| Early hemarthrosis or muscle bleed or oral bleed | 20-40 | Begin infusion every 12 to 24 hours for one-three days until the bleeding episode as indicated by pain is resolved or healing is achieved. |
| More extensive hemarthrosis, muscle bleed, or hematoma | 30-60 | Repeat infusion every 12 to 24 hours for usually three days or more until pain and disability are resolved. |
| Life threatening bleeds such as head injury, throat bleed, severe abdominal pain | 60-100 | Repeat infusion every 8 to 24 hours until threat is resolved. |
| SURGERY | ||
| Type of operation | ||
| Minor surgery, including tooth extraction | 60-80 | A single infusion plus oral antifibrinolytic therapy within one hour is sufficient in approximately 70% of cases. |
| Major surgery | 80-100 (pre- and post-operative) | Repeat infusion every 8 to 24 hours depending on state of healing. |
If bleeding is not controlled with the prescribed dose, determine the plasma level of Factor VIII and administer a sufficient dose of HEMOFIL M to achieve a satisfactory clinical response.
Under certain circumstances (e.g., presence of a low titer inhibitor) doses larger than those recommended may be necessary as per standard care. In patients with high titer Factor VIII inhibitors, HEMOFIL M therapy may not be effective and other therapeutic options should be considered. The 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 control of replacement therapy is especially important in cases of major surgery or life threatening hemorrhages.
Reconstitution: Us e As eptic Technique:
1. Bring HEMOFIL M (dry concentrate) and Sterile Water for Injection, USP, (diluent) to room temperature.
2. Remove caps from concentrate and diluent bottles to expose central portion of rubber stoppers.
3. Cleanse stoppers with germicidal solution.
4. Remove protective covering from one end of double-ended needle and insert exposed needle through diluent stopper.
5. Remove protective covering from other end of double-ended needle. Invert diluent bottle over upright HEMOFIL M bottle, then rapidly insert free end of the needle through the HEMOFIL M bottle stopper at its center. The vacuum in the HEMOFIL M bottle will draw in the diluent.
6. Disconnect the two bottles by removing needle from diluent bottle stopper, then remove needle from HEMOFIL M bottle. Swirl gently until all material is dissolved. Be sure that HEMOFIL M is completely dissolved; otherwise active material will be removed by the filter.
Note: Do not refrigerate after reconstitution.
Administration: Use Aseptic Technique:
Intravenous administration only.
Administer at room temperature not more than 3 hours after reconstitution.
Record the name and batch number of the product in order to maintain a link between the patient and the batch of the product.
Intravenous Syringe Injection:
1. Attach filter needle to a disposable syringe and draw back plunger to admit air into syringe.
2. Insert needle into reconstituted HEMOFIL M.
3. Inject air into bottle and then withdraw the reconstituted material into the syringe.
4. Remove and discard the filter needle from the syringe; attach a suitable needle and inject intravenously as instructed under Rate of Administration.
5. If a patient is to receive more than one bottle of HEMOFIL M, the contents of two bottles may be drawn into the same syringe by drawing up each bottle through a separate unused filter needle. This practice lessens the loss of HEMOFIL M. Filter needles are intended to filter the contents of a single bottle of HEMOFIL M only.
Rate of Administration:
Administer HEMOFIL M at a rate of up to 10 mL per minute. Infuse HEMOFIL M at a rate of administration that ensures the comfort of the patient [see Precautions: Increase of Pulse Rate].
HEMOFIL M can be stored at 2°C to 8°C (36°F to 46°F) or at room temperature, not to exceed 30°C (86°F), until expiration date noted on the package.
Do not freeze.
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