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.
DOSAGE AND ADMINISTRATION
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,2 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
- A dose of 1750 IU AHF administered to a 70 kg patient,
i.e., 25 IU/kg (1750/70), should be expected to cause a peak post-infusion AHF
increase of 25 x 2 = 50 IU/dL (50% of normal).
- A peak level of 70% is required in a 40 kg child. In this
situation the dose would be 70/2 x 40 = 1400 IU.
Recommended Dosage Schedule
Physician supervision of the dosage is required. The
following dosage schedule may be used as a guide.
|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
||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
||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
||Repeat infusion every 8 to 24 hours until threat is resolved.
|Type of operation
|Minor surgery, including tooth extraction
||A single infusion plus oral antifibrinolytic therapy within one hour is sufficient in approximately 70% of cases.
||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: Use Aseptic Technique
- Bring HEMOFIL M (dry concentrate) and Sterile Water for
Injection, USP, (diluent) to room temperature.
- Remove caps from concentrate and diluent bottles to
expose central portion of rubber stoppers.
- Cleanse stoppers with germicidal solution.
- Remove protective covering from one end of double-ended
needle and insert exposed needle through diluent stopper.
- 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.
- 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
- 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
- Visually inspect parenteral product for particulate
matter and discoloration prior to administration. The solution should be
colorless in appearance. Do not administer if particulate matter or discoloration
- Plastic syringes are recommended for use with this
product. The ground glass surface of allglass syringes tend to stick with
solutions of this type.
- Attach filter needle to a disposable syringe and draw
back plunger to admit air into syringe.
- Insert needle into reconstituted HEMOFIL M.
- Inject air into bottle and then withdraw the
reconstituted material into the syringe.
- Remove and discard the filter needle from the syringe;
attach a suitable needle and inject intravenously as instructed under Rate of
- 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 is available as single-dose bottles that
contain the following nominal potencies:
||Kit NDC Number
Each bottle is labeled with the potency in International
Units, and is packaged together with 10 mL of Sterile Water for Injection, USP,
a double-ended needle, and a filter needle.
Not made with natural rubber latex.
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
Do not freeze.
2. Abildgaard CF, Simone JV, Corrigan JJ, et al: Treatment
of hemophilia with glycine-precipitated Factor VIII. New Eng J Med 275:471-475,
3. Addiego, Jr. JE, Gomperts E, Liu S. et al: Treatment
of hemophilia A with a highly purified Factor VIII concentrate prepared by
Anti-FVIIIc immunoaffinity chromatography. Thrombos is and Haemos tas is 67:19-27,
Baxalta US Inc. Westlake Village, CA 91362 USA, U.S.
License No. 2020. Revised: Feb 2016