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Hemofil M

antihemophilic factor VIII human plasma

Used for Hemophilia

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).

Reviewed by:

Robert Chad Hakim, PharmD, BCCCP

Kristianne Hannemann, PharmD

Last reviewed on August 23, 2022

Basics Side effects Pros & cons Pharmacist tips FAQs Warnings Dosage Interactions Contraindications Alternatives Prices Medicare

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.

Are you looking for information on Recombinate (recombinant factor VIII) or Advate (recombinant factor VIII) instead?

Drug Facts

Common BrandsHemofil M, Koate

Drug ClassCoagulation factor replacement

Controlled Substance ClassificationNot a controlled medication

Generic StatusNo lower-cost generic available

AvailabilityPrescription only

What are the 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

Other Side Effects

Dizziness
Unusual taste in mouth
Rash
Itching
Swelling at the injection site

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

Source: DailyMed

The following 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

Fever

Less common or rare

Changes in facial skin color

chills

fast or irregular breathing

nausea

puffiness or swelling of the eyelids or around the eyes

sensation of burning, warmth, heat, numbness, tightness, or tingling

skin rash, hives, or itching

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

cough

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

diarrhea

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

Incidence not known

Feeling of warmth

increased sweating

irritability

muscle or bone pain

redness of the eye

redness of the face, neck, arms, and occasionally, upper chest

redness of the skin

stomach pain

trouble seeing

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.

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.

Frequently asked questions about Hemofil M (factor VIII)

What is hemophilia A?

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.

How long do I need to be treated with Hemofil M (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.

Can I give myself Hemofil M (factor VIII) infusions at home?

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.

What's the difference between Hemofil M (factor VIII) and Recombinate (factor VIII)?

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.

Can I use Hemofil M (factor VIII) if I'm pregnant?

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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What are the 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 forms

Typical dosing 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

Hemofil M (factor VIII) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Hemofil M (factor VIII). Please note that only the generic name of each medication is listed below.

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.

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)

What are alternatives to Hemofil M (factor VIII)?

There are a number of medications that your doctor can prescribe in place of Hemofil M (factor VIII). Compare a few possible alternatives below.

Hemofil M (factor VIII)

Used for:

To prevent or treat bleeding in people with hemophilia A

View Prices

Recombinate (factor VIII)