Hemofil M
Hemofil M (factor VIII) is a clotting factor replacement made from human plasma (the liquid portion of your blood). It's used to prevent and control bleeding in people with hemophilia A (also known as factor VIII deficiency). This medication is given through the vein (intravenously, or IV) as an infusion. It's available as two brand-name products (Hemofil M and Koate).
What is Hemofil M (factor VIII)?
What is Hemofil M (factor VIII) used for?
- To prevent or treat bleeding in people with hemophilia A
How Hemofil M (factor VIII) works
Hemofil M (factor VIII) is a coagulation (clotting) factor replacement used for people who are missing a protein called factor VIII. This protein is one of many clotting factors that work in your blood to form blood clots, which help control bleeding. Hemofil M (factor VIII) replaces the missing factor VIII in the blood to help prevent and treat bleeding in people with hemophilia A.
Drug facts
Side effects of Hemofil M (factor VIII)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Nervousness
- Headache
- Stomach pain
- Nausea
- "Pins-and-needles" feeling
- Blurry vision
Less Common Side Effects
- Dizziness
- Unusual taste in mouth
- Rash
- Itching
- Swelling at the injection site
Hemofil M (factor VIII) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reaction: difficulty breathing, tightness in the throat, hives, itching, fast heartbeat, nausea, stomach pain, dizziness lightheadedness, swelling in the face or tongue
- Breakdown of red blood cells: tiredness, dizziness, weakness, yellowing of the skin or eyes, dark urine
The following Hemofil M (factor VIII) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Less common or rare
Changes in facial skin color
chills
fast or irregular breathing
puffiness or swelling of the eyelids or around the eyes
sensation of burning, warmth, heat, numbness, tightness, or tingling
tightness in the chest
trouble breathing
unusual tiredness or weakness
Incidence not known
Bluish color of the fingernails, lips, skin, palms, or nail beds
blurred vision
chest pain or discomfort
confusion
deep or fast breathing with dizziness
difficult or labored breathing
difficulty with swallowing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fast, pounding, or irregular heartbeat or pulse
noisy breathing
numbness of the feet, hands, and around the mouth
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
slow or irregular heartbeat
sweating
swelling of the face, throat, or tongue
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Headache
Less common
Burning, stinging, or swelling at the injection site
dizziness or lightheadedness
dry mouth or bad taste in the mouth
lack or loss of strength
nosebleed
redness of the face
vomiting
Rare
Change in taste
loss of taste
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Hemofil M (factor VIII)
Pros
- Works well to prevent and treat bleeding in people with hemophilia A
- Koate brand might be possible to give at home, if approved by your provider.
Cons
- Not approved for routine prevention of bleeding (only approved to prevent bleeding during surgeries)
- Potential risk of infections since it's made from human plasma
Pharmacist tips for Hemofil M (factor VIII)
- Hemofil M (factor VIII) comes in vials that contain different amounts of medication; these vials may be color coded. Make sure you have the correct vial strength for your prescribed dose so you receive the correct amount of medication.
- Store the medication in the refrigerator, but don't freeze it. You can also keep it at room temperature for up to 6 months (for Koate) or up to the expiration date written on the package (for Hemofil M). Keep the vials in the original carton and away from light.
- After you prepare Hemofil M (factor VIII) for your infusion, use the medication within 3 hours. Don't put the prepared medication in the refrigerator at any time.
- Throw away any used syringes and needles in a sharps container or something made of heavy-duty plastic (e.g., empty milk carton, laundry detergent bottle) to lower the risk of needle-stick injuries. Don't throw them away in your trash can. When your sharps container is almost full, close it tightly with the cap. For more information on how to throw away your sharps container safely and guidance for your specific state, visit the FDA's website.
Common questions about Hemofil M (factor VIII)
Hemophilia A is a rare, genetic blood condition that makes it difficult for your blood to clot. People with hemophilia A are missing factor VIII in their blood, which is one of the proteins (called clotting factors) responsible for making clots to stop bleeding from injuries. Symptoms of hemophilia A include bleeding for a longer time than other people, excessive bleeding from small cuts or injuries, or even bleeding inside your body. Hemofil M (factor VIII) helps your blood clot and prevent bleeding episodes by replacing factor VIII.
In some cases, Hemofil M (factor VIII) is used when it's needed (on an "as-needed" basis). This means you'll only receive treatment when you experience a bleed or to prevent bleeds during surgery. Your length of treatment typically ranges from 1 to 10 days, depending on how severe your bleed is and how well your body responds to this medication. Some people with hemophilia A need to have regular factor VIII replacements to prevent future bleeds. Talk with your provider if you have any questions about how long you need Hemofil M (factor VIII) treatment.
Ask your provider if it's okay for you to give yourself Hemofil M (factor VIII) infusions at home. When this product is used during an active bleed or for surgery, you'll probably receive the medication under the care of a healthcare provider. But sometimes, it might be possible for you to receive Hemofil M (factor VIII) at home. Ask your provider if or when home infusions might be appropriate for you.
Both Hemofil M (factor VIII) and Recombinate (factor VIII) are clotting factor replacements used to treat hemophilia A. The main difference between them is how they're made. Hemofil M (factor VIII) is made from donated human plasma, while Recombinate (factor VIII) is made in a lab using recombinant DNA technology. When using human blood products like Hemofil M (factor VIII), there's a very small chance that they can contain viruses or other infectious material (though the manufacturer takes many steps to make sure it's safe). Recombinant products, such as Recombinate (factor VIII), are generally considered safer because they're made in the lab and don't carry the same risk of potential infections from receiving human-derived products. Currently, many providers typically prefer recombinant factor VIII products over those made from human plasma.
Hemofil M (factor VIII) hasn't been studied in human pregnancy, so it's not known whether this medication is safe in pregnant females and their unborn baby. Hemofil M (factor VIII) should only be used in pregnancy if it's clearly needed. If you're pregnant or thinking of becoming pregnant, talk with your provider about the risks and benefits of using Hemofil M (factor VIII) before starting this medication.
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Risks and warnings for Hemofil M (factor VIII)
Hemofil M (factor VIII) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious allergic reactions
Serious allergic reactions to Hemofil M (factor VIII) are possible, including life-threatening reactions like anaphylaxis (e.g., closing of the throat). This can happen anytime during or after an infusion. If you notice chest tightness, difficulty breathing, dizziness, nausea, swelling of the lips, tongue, or face at any time during treatment, stop using the medication and get medical help right away.
Development of antibodies against factor VIII
It's possible you could develop certain antibodies (also known as inhibitors) against factor VIII. These antibodies can block the medication from working, which can make Hemofil M (factor VIII) less effective. Let your provider know if bleeding becomes difficult to control even after receiving Hemofil M (factor VIII). Your provider might need to check whether or not you have antibodies and make changes to your treatment.
Breakdown of red blood cells
- Risk factors: High or frequent doses of Hemofil M (factor VIII) | Blood type other than O | History of anemia
People with a blood type other than O who receive high or frequent doses of Hemofil M (factor VIII) can develop hemolytic anemia. This is when your red blood cells rapidly break down, leading to a drop in the number of red blood cells in the body and a higher risk of bleeding or clotting problems. Your provider will check your blood cell counts before and during treatment. Contact your provider if you experience symptoms of anemia such as tiredness, dizziness, and weakness.
Infections
- Risk factors: Medical conditions that weaken your immune system | Taking medications that can weaken your immune system
Because Hemofil M (factor VIII) is made from human blood products, there's a risk that it might contain viruses that can make you sick. But, your risk of infection is low because donors of these blood products are carefully screened. Also, there are high manufacturing standards put into place to make sure the viruses are killed or removed. To prevent serious infections in the rare case that your medication is affected, let your provider know right away if you start to feel sick. Make sure you're up to date on your vaccines before starting Hemofil M (factor VIII) to prevent infections.
Hemofil M (factor VIII) dosage
Kit| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| single dose of 1000iu | 1 kit | $1,507.00 | $1,507.00 |
| single dose of 1700iu | 1 kit | $2,465.00 | $2,465.00 |
Typical dosage for Hemofil M (factor VIII)
This medication is available as two brands: Hemofil M and Koate. It's given as an infusion through your veins. Your provider will determine how much, how often, and how long you need Hemofil M (factor VIII). This is based on your body weight, why you're using it, how severe your bleed is, the desired level of factor VIII in your blood, and how well your body responds to the medication.
Interactions between Hemofil M (factor VIII) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
How much does Hemofil M (factor VIII) cost?
$1,507.00
Hemofil M (factor VIII) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Hemofil M (factor VIII) will not be safe for you to take.
- Allergy to mice (Hemofil M only)
