Hemofil M

Hemofil-M is part of the drug class:

• Blood coagulation factors

No drug interactions have been evaluated by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Hemofil-M, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Hemofil-M falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Hemofil-M should be given to a pregnant woman only if clearly needed.

Keep all appointments with your doctor and laboratory. Your doctor will order lab tests to check your levels of factor VIII to determine your dose and frequency of Hemofil-M.

• It is used to treat hemophilia.
• It is used to treat or prevent bleeding.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of certain infections (parvovirus B19, hepatitis A) like fever or chills, feeling very sleepy, runny nose, rash, joint pain, tiredness, poor appetite, upset stomach or throwing up, belly pain, or yellow skin or eyes.
• Shortness of breath.
• Very bad dizziness or passing out.
• Very upset stomach or throwing up.
• Flushing.
• Feeling very tired or weak.
• A fast heartbeat.
• Chest pain or pressure.
• A burning, numbness, or tingling feeling that is not normal.
• Restlessness.
• Blurred eyesight.

All products:

• Store in a refrigerator or at room temperature.
• Do not freeze.
• After mixing, do not refrigerate.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Koate or Monoclate-P:

• If stored at room temperature, throw away any unused vials after 6 months or after the expiration date, whichever comes first.

Adverse Reactions from Clinical Trials

The adverse reactions presented in this section have been identified based on clinical trial experience with Hemofil M in patients previously treated with other Factor VIII concentrates or blood products (N = 74), and previously untreated patients (PUPs; N = 50).

Hemofil M was administered to 11 patients previously untreated with Antihemophilic Factor (Human). They have shown no signs of hepatitis or HIV infection following three to nine months of evaluation.

A study of 25 patients treated with Hemofil M, and monitored for three to six months has demonstrated no evidence of antibody response to mouse protein. More than 1,000 infusions of Hemofil M have been administered during the clinical trials. Reported events included a single episode each of chest tightness, fuzziness and dizziness, and one patient reported an unusual taste after each infusion.

Post-marketing Adverse Reactions

In addition to clinical trials, the following adverse reactions have been reported in the post-marketing experience, listed by MedDRA System Organ Class (SOC), then by Preferred Term.

IMMUNE SYSTEM DISORDERS: Anaphylaxis, Hypersensitivity reactions

EYE DISORDERS: Visual impairment, Ocular hyperemia

CARDIAC DISORDERS: Cyanosis, Bradycardia, Tachycardia

VASCULAR DISORDERS: Hypotension, Flushing

RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: Bronchospasm, Dyspnea, Cough, Hyperventilation

GASTROINTESTINAL DISORDERS: Diarrhea, Vomiting, Nausea, Abdominal pain

SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Urticaria, Rash, Pruritus, Hyperhidrosis

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Facial edema, Edema, Chills, Fatigue, Chest pain, Musculoskeletal pain, Irritability

This section provides information on the proper use of a number of products that contain antihemophilic factor. It may not be specific to Hemofil-M. Please read with care.

A doctor or other trained health professional will give you or your child this medicine in a hospital or clinic setting. This medicine is given through a needle placed in one of your veins.

This medicine may also be given at home to patients who do not need to be in a hospital or clinic. If you or your child is using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Make sure you understand all of the instructions before giving yourself an injection. Your dose may change based on where you are bleeding. Do not use more medicine or use it more often than your doctor tells you to.

Use only the brand of this medicine that your doctor prescribed. Not all brands are prepared in the same way and the dose may be different.

Every package of medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

To prepare the medicine using 2 bottles (vials) or containers:

• Take the bottles of powder medicine and liquid (diluent) out of the refrigerator and warm them to room temperature.
• Wipe the rubber surface of the bottles with an alcohol swab and allow them to dry.
• Follow the specific directions for your brand of medicine when you prepare the injection.
• Add the liquid to the powder using the special transfer needle or transfer device that comes with the package.
• When injecting the liquid into the dry medicine, aim the stream of liquid against the wall of the container of dry medicine to prevent foaming.
• Swirl the bottle gently to dissolve the medicine. Do not shake the bottle. Shaking will create foam in the mixture.
• Check the mixture to make sure it is clear. Do not use the medicine if you can see anything solid in the mixture or if the mixture is cloudy.
• Use a plastic disposable syringe to remove the mixture from the bottle. Use a special filter needle if your brand of medicine provides one.
• Give the injection as directed by your doctor.
• If you are using more than one bottle of medicine for your dose, prepare the second bottle the same way. Add the mixture from the second bottle to the same syringe.

To prepare the medicine using a prefilled dual-chamber syringe (Xyntha®):

• Take the prefilled dual-chamber syringe out of the refrigerator and warm it to room temperature.
• The dual-chamber syringe has the powder medicine in one part and the liquid (diluent) in the second part of the syringe.
• Attach the plunger rod to the syringe according to the directions. Keep the syringe pointed up to prevent leaking of the liquid.
• Remove the white seal and the grey rubber tip cap. Put the blue vented cap on the syringe. Do not touch the open ends of the syringe and the blue cap.
• Slowly push the plunger until the 2 stoppers inside the syringe are together. This will push all of the liquid into the chamber with the powder medicine.
• Keep the syringe pointed up and gently swirl the syringe to mix the liquid and powder.
• Check the mixture to make sure it is clear. Do not use the medicine if you can see anything solid in the mixture or if the mixture is cloudy.
• Keep the syringe pointed up and push the plunger until most of the air is removed.
• A special infusion set comes with the package. Remove the blue cap and attach the infusion set to the syringe.
• Give the injection as directed by your doctor.
• If you are using more than one syringe of medicine for your dose, prepare the second dual-chamber syringe the same way. The mixture from each syringe will be combined together in a separate syringe before your injection. Your doctor will show you how to do this.

Use the mixture within 3 or 4 hours after it is prepared. It must not be stored and used later. Do not put the mixture in the refrigerator.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your doctor.

Talk to your doctor before traveling. You should plan to bring enough medicine for your treatment when traveling.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (injection):
  • For bleeding episodes in patients with hemophilia A:
    • Adults and teenagers—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your doctor.
    • Children—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your child's doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

The AHF products should be stored in the original container in the refrigerator. Do not let the packages freeze. They can also be kept at room temperature for short periods of time, such as 3 to 12 months. Store the medicine as directed by your doctor or by the manufacturer of the brand you are using. Protect the container from heat and direct light.

If you move the medicine from the refrigerator to room temperature, write the date you take it from the refrigerator on the container. The length of time the medicine can remain at room temperature will depend on the brand you use. If you have already stored the medicine at room temperature, do not return it to the refrigerator. If you do not use the medicine within the time recommended by the manufacturer, you must destroy the medicine.