Hemlibra is a brand-name prescription medication. It's prescribed to prevent bleeding episodes or make them less frequent in people with hemophilia A, either with or without factor VIII (eight) inhibitors. Hemlibra is approved for use in people of all ages.

Hemlibra contains the drug emicizumab, which is a monoclonal antibody. This is a drug that's made from immune system cells.

Hemlibra comes as a solution that's given as an injection under your skin (subcutaneous). Your healthcare provider can give you the injection, or it can be self-injected at home by people ages 7 years or older.

In clinical studies lasting six months or longer, Hemlibra reduced the number of total bleeds by:

  • at least 94 percent in people without factor VIII inhibitors
  • at least 80 percent in people with factor VIII inhibitors

A new kind of drug

Before the Food and Drug Administration (FDA) approved Hemlibra, the main type of therapy used to treat hemophilia A was factor VIII replacement.

People with hemophilia A don't have factor VIII, a protein your body needs to form blood clots. Factor VIII replacement therapy puts factor VIII into your blood. Typically, factor VIII replacement is created in a lab, but it can also be made from donated blood plasma. The therapy is given as an injection into one of your veins (intravenous).

Hemlibra is made from cells in a lab. Instead of replacing factor VIII, Hemlibra works by attaching to specific clotting factors (proteins) in the blood. This enables the blood to clot properly without factor VIII, helping to prevent uncontrolled bleeding.

Hemlibra is the first drug that's used to prevent bleeding in people with hemophilia A either with or without factor VIII inhibitors. Inhibitors are antibodies (immune system proteins) that attack factor VIII and prevent it from forming clots. Some people develop inhibitors when given factor VIII replacement therapy, making the treatment ineffective.

Hemlibra is also the first drug for hemophilia A that you can take as an injection under your skin (subcutaneous). In addition, there are several possible dosing schedules, including weekly, every two weeks, or every four weeks. Other treatments for hemophilia A require you to take them much more often, from every other day to several times a week.

FDA approval

The Food and Drug Administration (FDA) first approved Hemlibra in 2017 for people with hemophilia A with factor VIII inhibitors.

In 2018, the FDA expanded its approval to include people with hemophilia A who don't have factor VIII inhibitors.

Hemlibra is available only as a brand-name medication. It's not currently available in generic form.

Hemlibra contains the active drug emicizumab, which is sometimes called emicizumab-kxwh. The "-kxwh" ending helps set the drug apart from similar medications that may be available in the future. This is a typical naming format for monoclonal antibodies (drugs made from immune system cells).

The Food and Drug Administration (FDA) collects reports about negative drug effects. The public and healthcare professionals submit these reports to the FDA by using the MedWatch Voluntary Reporting Form and by calling 800-FDA-1088 (800-322-1088). Both the FDA and Genentech, the maker of Hemlibra, carefully monitor the safety reports about Hemlibra.

Reports of death

The maker of Hemlibra has reported 10 deaths worldwide that occurred while people took Hemlibra. These deaths occurred after the FDA approved the drug. It's not clear whether the drug caused any of the deaths.

The maker of Hemlibra continues to monitor safety reports about the drug. If you have questions about whether Hemlibra is safe for you, talk with your doctor.

As with all medications, the cost of Hemlibra can vary. To find current prices for Hemlibra in your area, check out GoodRx.com.

The cost you find on GoodRx.com is what you may pay without insurance. The actual price you'll pay depends on your insurance coverage and the pharmacy you use.

Financial and insurance assistance

If you need financial support to pay for Hemlibra, or if you need help understanding your insurance coverage, help is available.

Genentech, the manufacturer of Hemlibra, offers a program called Access Solutions. For more information and to find out if you're eligible for support, call 877-233-3981 or visit the program website.

The Hemlibra dosage your doctor prescribes will depend on several factors. These include:

  • your weight
  • the treatment schedule your doctor decides is best for you

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Hemlibra comes in single-dose vials that contain different dosage strengths:

  • 30 mg/mL
  • 60 mg/0.4 mL
  • 105 mg/0.7 mL
  • 150 mg/mL

Each dose is given by an injection under your skin (subcutaneous). You use one vial per injection, then discard the vial and any remaining liquid in the vial.

Dosage for hemophilia A

Hemlibra is typically given first in loading doses, which are followed by maintenance doses. Loading doses quickly bring the drug to peak levels in your body. They're either higher than maintenance doses or are given more frequently.

The first four doses of Hemlibra are loading doses. They're given as 3 mg/kg once per week.

Each dose after that is a maintenance dose. Your doctor will decide the best maintenance dose for you. Your specific dosage will be based on your weight. It may be:

  • 1.5 mg/kg once a week
  • 3 mg/kg once every two weeks
  • 6 mg/kg once every four weeks

Note: One kilogram (kg) of body weight is equal to 2.2 pounds. For example, if you weigh 150 pounds (68 kg), your loading dose of 3 mg/kg would be 204 mg of Hemlibra per week.

Pediatric dosage

Dosages for children are based on their weight, just like dosages for adults.

What if I miss a dose?

If you miss a dose of Hemlibra, take it as soon as you remember. Then take the next dose according to your regular schedule. Don't take two doses in the same day. Taking more than one dose on the same day will increase your risk for serious side effects.

Will I need to use this drug long term?

Hemlibra is not a cure for hemophilia, and it needs to be taken on a regular basis for it to help prevent bleeding. So if your doctor decides that Hemlibra is a safe and effective treatment option for you, they will likely prescribe it on a long-term basis.

There's no cure for hemophilia at this time.

Hemlibra can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Hemlibra. This list does not include all possible side effects.

For more information on the possible side effects of Hemlibra, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects of Hemlibra can include:

  • injection site reaction (redness, pain, or tenderness around the spot where Hemlibra was injected)
  • headache
  • joint pain

Most of these side effects may go away within a few days or a couple of weeks. If they're more severe or don't go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Hemlibra aren't common, but they can occur.

Allergic reaction

Allergic reactions did not occur in clinical trials for Hemlibra. However, as with most drugs, some people can have an allergic reaction after taking Hemlibra. Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Hemlibra. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Blood clots (when used with aPCC)

During treatment with Hemlibra, some people may sometimes receive drugs that help stop bleeding, such as activated prothrombin complex concentrate (aPCC). Serious side effects can occur if you take these drugs together, such as increased risk for blood clots. The risk is greatest in people taking Hemlibra who receive more than 100 units/kg of aPCC a day for longer than 24 hours.

The types of blood clots that can occur if you take Hemlibra with aPCC include:

  • Thrombotic microangiopathy (blood clots and injuries in small blood vessels, including those in the kidneys, eyes, brain, and other organs). Symptoms can include:
    • nausea
    • vomiting
    • swelling of your legs and arms
    • weakness
    • urinating less often than normal
    • belly pain
    • back pain
    • yellowing of your skin and the whites of your eyes
    • confusion
  • Blood clots in other blood vessels, including those in the lungs, head, arms, and legs. Symptoms can include:
    • headache
    • trouble seeing
    • coughing up blood
    • chest pain
    • trouble breathing
    • fast heart rate
    • swelling of your legs and arms
    • pain in your legs or arms

If you have symptoms of a blood clot, call your doctor right away. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

If you develop a blood clot during treatment with Hemlibra and aPCC, your doctor will likely have you stop taking both drugs for a time. Your doctor will decide if it's safe for you to start taking Hemlibra again.

The Food and Drug Administration (FDA) approves prescription drugs such as Hemlibra to treat certain conditions.

Hemlibra for hemophilia A

Hemlibra is FDA-approved to treat people of all ages who have hemophilia A. It's approved for use in people with or without factor VIII inhibitors to prevent bleeding.

Factor VIII (eight) is a naturally occurring protein in the blood that plays an important role in forming blood clots. People with hemophilia A are missing factor VIII, so their blood doesn't clot. Not being able to form blood clots puts people with hemophilia at risk for bleeding that doesn't stop. Sometimes this can be fatal.

Before Hemlibra was approved, the main treatment for hemophilia A was factor VIII replacement therapy. This treatment replaces the factor VIII that's missing in the blood.

But some people develop inhibitors when they're given factor VIII replacement therapy. Inhibitors are antibodies (immune system proteins) that attack factor VIII, preventing the factor VIII replacement therapy from working.

Hemlibra works in a different way. Instead of replacing factor VIII, Hemlibra links other blood proteins together. This enables the blood to clot properly without factor VIII. Because it doesn't involve replacing factor VIII, Hemlibra works effectively even if there are inhibitors in the blood.

Hemlibra for other conditions

Hemlibra isn't used to treat any other bleeding conditions.

Hemlibra for hemophilia B (not an appropriate use)

Hemlibra isn't used to prevent bleeds in people with hemophilia B. That's because people with hemophilia B are missing a different clotting factor (blood protein) than people with hemophilia A.

  • hemophilia A: missing clotting factor VIII (eight)
  • hemophilia B: missing clotting factor IX (nine)

Hemlibra doesn't make up for the missing factor IX. So it can't be used to prevent bleeding in people with hemophilia B.

Hemlibra and children

Hemlibra is FDA-approved for use in children of all ages, even newborns. The drug is used for the same purpose as for adults. Hemlibra helps prevent bleeding in people with hemophilia A with or without factor VIII inhibitors.

You should take Hemlibra according to your healthcare provider's instructions.

Your healthcare provider may give you Hemlibra injections in the clinic or office. Or they may teach you how to give yourself injections.

It may help to keep a log of your injections. Include information such as:

  • the date of each injection
  • the injection site
  • the vial lot information (you can find this on the vial)*

* Recording the vial lot information helps healthcare providers trace the use of biological medications, such as Hemlibra. This information is useful if a serious side effect occurs.

Below is information on how to inject Hemlibra yourself. For more details, a video, and helpful how-to images, see the Hemlibra website, including this step-by-step guide.

Preparing to inject Hemlibra

Read through these steps before you give yourself a Hemlibra injection.

  1. Take the vial (or vials, depending on your dose) of Hemlibra out of the refrigerator 15 minutes before you plan to inject. This allows the medication to come to room temperature before your injection.
  2. Don't try to warm up the solution in the microwave or by running it under hot water. This can make Hemlibra less safe, and it may not work as well.
  3. Check the vial to make sure the solution is clear to slightly yellow. If it's cloudy, colored, or contains particles, don't use it. Don't shake the vial.
  4. While you wait for Hemlibra to come to room temperature, gather your supplies. Other than the Hemlibra vial(s), you will need: Alcohol wipes, cotton gauze, cotton balls, transfer needle, syringe, injection needle with safety shield, and sharps disposal container
  5. Wash your hands with soap and water.
  6. Choose your injection site. It can be one of these three sites: Stomach area (at least 2 inches away from your belly button), front of your thigh, and back of your upper arm (if someone else is giving you the injection)
  7. Avoid injecting into moles or any skin that is red, bruised, or scarred.

Injecting Hemlibra

Follow these steps to inject Hemlibra.

Preparing the vial and syringe

To get the vial and syringe ready for the injection, follow these steps:

  1. Remove the cap from the vial and throw it away in your sharps disposal container.
  2. Clean the top of the vial stopper with an alcohol wipe.
  3. Attach the transfer needle (still in its protective cap) to the syringe. Do this by pushing and twisting the transfer needle clockwise until it's attached.
  4. Slowly pull back on the plunger of the syringe to draw in air. Your doctor will tell you the correct amount.
  5. Hold the syringe by the barrel with one hand. Make sure the needle is pointing up.
  6. Carefully pull the needle cap straight off the needle. Don't throw the cap away. You'll need it to recap the transfer needle after you use it. Put the cap on a clean, flat surface. Don't place the transfer needle down after it's uncapped.

Filling the syringe

Here are the steps to fill the syringe:

  1. Hold the vial on a flat surface. Inject the transfer needle straight down into the center of the vial stopper.
  2. Keeping the needle in the vial, pick up the vial and turn it upside down.
  3. With the needle point above the medication level, push the plunger to inject the air into the space above the medication. Don't inject air into the medication.
  4. Keeping your finger on the plunger, pull the whole syringe down until the needle tip is within the medication.
  5. Slowly pull the plunger down to fill the syringe with more than the amount needed for your dose. (Note: If your dose is more than the amount in the vial, fill the syringe with all the medication from the vial. See the manufacturer instructions if you need to use more than one vial for your prescribed dose.)
  6. Keeping the syringe in the vial, check for any large air bubbles that may prevent you from taking your full prescribed dose. If you see any, gently tap the syringe barrel with your fingers so the bubbles rise to the top. Then slowly push the plunger so the needle is in the air above the medication. Keep pushing the plunger to remove the bubbles from the syringe.
  7. Check whether the amount of medication in the syringe is now less than or the same as your prescribed dose. If it is, pull the plunger so the needle is within the medication again. Then keep pulling the plunger until the amount in the syringe is more than your prescribed dose.
  8. Repeat steps 6 and 7 to make sure there are no bubbles in the syringe and you have the correct dose in the syringe.
  9. Remove the syringe and transfer needle from the vial.

Disposing of the transfer needle

Once you've filled the syringe, you'll need to cap and dispose of the transfer needle. Here's how:

  1. Hold the syringe in one hand and slide the transfer needle into its cap, which you placed on a flat surface. Scoop upward so that the cap slides down to cover the needle.
  2. Make sure the needle is covered with the cap. With your other hand, press down on the cap to fully attach it to the syringe.
  3. Remove the transfer needle from the syringe by twisting it counterclockwise and gently pulling. (You won't use the transfer needle to inject the medication. This would be painful and could cause skin injury.)
  4. Throw away the transfer needle in the sharps disposal container.

Injecting Hemlibra

When you're ready to inject Hemlibra, follow these steps:

  1. Wipe your chosen injection site with the alcohol wipe and let it air dry for at least 10 seconds.
  2. Attach the injection needle to the syringe by pushing and twisting clockwise until it's fully secure.
  3. Pull the safety shield away from the needle (toward the syringe barrel).
  4. Carefully take the cap off the needle and throw it away in the sharps disposal container. Avoid touching the needle tip, and don't place the needle on any surfaces.
  5. After you remove the cap, you should inject Hemlibra right away. Move the plunger in the syringe to line up with your prescribed dose. The top rim of the plunger should be in line with the mark of your prescribed dose.
  6. Pinch your skin at the injection site you've chosen.
  7. Quickly and firmly, fully insert the needle at a 45-degree or 90-degree angle into the pinched skin. Don't press on the plunger yet.
  8. Once the needle is fully inserted into your skin, let go of the pinched area.
  9. Slowly press the plunger down until you've injected all the medication.
  10. Remove the needle by pulling it out at the same angle you inserted it.

After injecting Hemlibra

Once you've injected Hemlibra, follow these steps:

  1. Lay the needle down on a flat surface. Cover the needle by pressing the safety shield on the syringe forward at a 90-degree angle (away from the barrel). Listen for a click sound. That lets you know that the needle is fully covered in the safety shield.
  2. Keep the needle in the syringe. Don't remove it. And don't replace the injection needle cap.
  3. Throw away the used vial, needles, and syringe in your sharps disposal container.
  4. If you see a few drops of blood at your injection site, press the cotton ball or gauze onto the spot. If the bleeding doesn't stop, call your doctor.
  5. Avoid rubbing the injection site.

Your doctor will tell you how often to take Hemlibra. They may want you to take Hemlibra once a week, once every other week, or once every four weeks.

Take Hemlibra on the same day of the week. For example, if you take Hemlibra once a week, you may choose to take it every Monday.

Medication reminders can help make sure that you don't miss a dose.

There are no known interactions between Hemlibra and alcohol. However, if you have hemophilia A, your blood doesn't clot properly. Drinking alcohol can also prevent your blood from forming clots by reducing the number of clotting factors in your blood. As a result, drinking too much alcohol while taking Hemlibra could reduce how effective Hemlibra will be.

If you drink alcohol, talk with your doctor about whether drinking while taking Hemlibra is safe for you.

Hemlibra can interact with several other medications. It can also interact with certain lab tests.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions increase side effects or make them more severe.

Hemlibra and other medications

Below are medications that may interact with Hemlibra. This list does not contain all drugs that may interact with Hemlibra.

Before taking Hemlibra, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Hemlibra and activated prothrombin complex concentrate (aPCC)

Activated prothrombin complex concentrate (aPCC) is a drug that helps stop bleeding. While Hemlibra may be used with aPCC, taking these drugs together can increase your risk for blood clots. This risk is greatest in people taking Hemlibra who receive more than 100 units/kg of aPCC a day for longer than 24 hours.

If you need aPCC while taking Hemlibra, your doctor will monitor you closely for signs of blood clots. Some blood clots can be serious, and you may need to seek treatment right away. (For more information, see the "Hemlibra side effects" section above.)

If you develop a blood clot while taking these drugs together, your doctor will likely want you to stop taking Hemlibra. They'll decide whether it's safe for you to start taking the drug again.

Hemlibra and other hemophilia A drugs

Taking Hemlibra with certain hemophilia A drugs can increase your risk for blood clots. Specific dosing instructions for using Hemlibra and other hemophilia A drugs include the following:

  • Stop using any bypassing agents (treatments for people with inhibitors) the day before you start taking Hemlibra. Examples of bypassing agents are anti-inhibitor coagulant complex (FEIBA) and recombinant human coagulation Factor VIIa (NovoSeven).
  • If needed, continue factor VIII replacement therapy for up to one week after your first dose of Hemlibra.

If you have questions about how to take other hemophilia treatments with Hemlibra, talk with your doctor.

Hemlibra and certain laboratory tests

Hemlibra may interfere with the results of certain lab tests and give a false reading. These tests include some that look at how long your blood takes to clot. One of these tests is the activated partial thromboplastin time (aPTT) test.

Hemlibra can affect test results for as long as six months after your last dose. When you need to get lab tests, tell your doctor about any current or past Hemlibra treatment so they can order the appropriate tests.

Other treatments are available that can prevent bleeding or reduce the number of bleeds in people with hemophilia A. Some may be better suited for you than others. If you're interested in finding an alternative to Hemlibra, talk with your doctor.

Hemlibra is unique because it:

  • works differently from standard treatment (factor VIII replacement products)
  • works for people with and without factor VIII inhibitors
  • is the first treatment that you can take as a subcutaneous injection (injection under the skin), instead of an intravenous infusion (injection into a vein)
  • stays active in the blood for a long time, so you may be able to take it weekly, once every other week, or once a month
  • isn't created from human plasma or blood
  • doesn't cause factor VIII inhibitors to develop

Other treatments for hemophilia A include anti-inhibitor coagulant complex (FEIBA), which is an activated prothrombin complex concentrate (aPCC).

Many different clotting factor VIII replacement treatments are also available that can be used routinely to help prevent bleeding, including:

  • Adynovate
  • Eloctate
  • Jivi
  • Kovaltry
  • Novoeight

Your doctor will talk with you about the pros and cons of different hemophilia A treatments. They'll work with you to find the treatment that best fits your needs.

Hemophilia A is a bleeding disorder. It's caused by a missing clotting factor called factor VIII (eight). Clotting factors are proteins in the blood that help control bleeding.

Without factor VIII, your blood can't form a clot when you have a bleed or injury. This can lead to dangerous, possibly fatal bleeds.

Hemlibra is a monoclonal antibody, which is an immune system cell that's made in a lab. It's created from animal cells and doesn't contain any human plasma or blood.

Antibodies, which also occur naturally in the body, attach to very specific molecules in the blood. Hemlibra binds to two molecules: activated clotting factor IX (nine) and clotting factor X (ten).

Normally, factor VIII links factor IX and factor X. But in hemophilia A, factor VIII is missing. Hemlibra works by playing the role that factor VIII would have played. It brings the factor IX and factor X together so they can help the blood form clots. This helps reduce the number of potential bleeds.

How does Hemlibra work for people with inhibitors?

For some people with hemophilia, their immune systems form antibodies (immune system proteins) to factor VIII when it's given as a medical treatment. These antibodies attack factor VIII, which prevents factor VIII replacement therapy from working.

Hemlibra works in a different way from factor VIII replacement therapy. Instead of replacing factor VIII, Hemlibra plays the role factor VIII would have played by linking other blood proteins to each other. This enables the blood to clot properly without factor VIII. As a result, Hemlibra works effectively even if there are inhibitors in the blood.

How long does it take to work?

It's not known how quickly you'll begin to see fewer bleeds after starting Hemlibra. Clinical trials showed that people had many fewer bleeds within six months of taking Hemlibra. However, the trial results didn't show when the reduction in bleeds first occurred.

That said, we do know that after an injection, it takes between one and two days for your blood to absorb Hemlibra. And steady levels of the drug are maintained in your blood after the first four weeks of dosing.

If you have questions about when you should see an effect from Hemlibra, talk with your doctor.

It's not known whether Hemlibra is safe to take during pregnancy. There have been no human or animal studies to test the safety of Hemlibra use during pregnancy.

If you take Hemlibra and are considering getting pregnant, talk with your doctor about whether you should keep taking Hemlibra.

Be sure to use birth control while taking Hemlibra if your doctor says it's not safe for you to get pregnant during treatment.

It's not known whether Hemlibra passes into human breast milk. If you're breastfeeding your child and considering taking Hemlibra, talk with your doctor about whether this drug is safe for your child.

Here are answers to some frequently asked questions about Hemlibra.

Can Hemlibra be used in people who don't have inhibitors?

Yes. Hemlibra is FDA-approved for use in people with hemophilia A who don't have inhibitors (as well as people who do). Clinical studies compared Hemlibra to no treatment. They looked at two groups of people without inhibitors: male children ages 12 and older, and male adults. The two groups took the medication for at least 24 weeks and had:

  • 95 percent fewer bleeds when taking 1.5 mg/kg of Hemlibra every week
  • 94 percent fewer bleeds when taking 3 mg/kg of Hemlibra every two weeks

The effectiveness of Hemlibra in the studies was similar between people with inhibitors and without inhibitors.

Is Hemlibra used to treat hemophilia B?

No, Hemlibra isn't used to prevent bleeding in people with hemophilia B.

People with hemophilia B are missing a different clotting factor than people with hemophilia A:

  • hemophilia A: missing clotting factor VIII
  • hemophilia B: missing clotting factor IX

Hemlibra is specifically created to help people who are missing factor VIII. Therefore, it wouldn't work for people missing clotting factor IX.

Does Hemlibra cure hemophilia?

No. There's no cure for hemophilia at this time. Hemlibra works to prevent bleeding episodes, but it doesn't cure the disease.

Is Hemlibra made from blood plasma?

No, Hemlibra isn't made from blood plasma. It's an antibody (immune system protein) made from cells in a lab. There are no human plasma or human blood cells used to make Hemlibra.

Hemlibra is purified and sterilized. It also doesn't contain any viruses that can infect humans.

Does Hemlibra increase my risk for blood clots?

Hemlibra can increase the risk of blood clots if taken with activated prothrombin complex concentrate (aPCC). This is a drug that helps stop bleeding by increasing blood clotting.

Clinical studies looked at people who took Hemlibra and were treated with aPCC. Three people had thrombotic microangiopathy (blood clots in small blood vessels). Two people had thrombotic (blood clot) events in other blood vessels. In each of these cases, the total dose of aPCC was greater than 100 units/kg a day for longer than 24 hours.

If you need treatment with aPCC to stop a bleed while you're taking Hemlibra, talk with your doctor. Together you can discuss your risk for blood clots.

Will this drug cause any issues with my regular lab tests?

It might. Hemlibra can affect results from lab tests that measure how well your blood clots. One of these tests is the activated partial thromboplastin time (aPTT) test. Hemlibra stays in your body for a long time, and can affect test results for up to six months after your last dose. Be sure to tell your doctor about any current or past Hemlibra treatments before taking any lab tests.

This drug comes with a warning from the Food and Drug Administration (FDA).

FDA warning: Thrombotic microangiopathy and thrombotic events

This drug has a boxed warning. This is the most serious warning from the FDA. A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Taking Hemlibra and receiving activated prothrombin complex concentrate (aPCC) for a bleed can increase your risk for serious blood clots. Thrombotic events (blood clots) can occur in major organs or parts of the body, including the lung, head, arms, or legs. They can also occur in small blood vessels in organs such as the kidneys and brain. Blood clots can be dangerous and require immediate medical treatment.

Clinical studies looked at people who took Hemlibra and were treated with aPCC. Three people had thrombotic microangiopathy (blood clots in small blood vessels). Two people had thrombotic (blood clot) events in other blood vessels. In each of these cases, the total dose of aPCC was greater than 100 units/kg a day for longer than 24 hours.

If you develop a blood clot during treatment with Hemlibra and aPCC, your doctor will likely have you stop taking both drugs for a time. Your doctor will decide if it's safe for you to start taking Hemlibra again.

Note: For more information about the potential negative effects of Hemlibra, see the "Hemlibra side effects" section above.

Taking too much Hemlibra can increase your risk for serious side effects.

Overdose symptoms

Symptoms of taking too much Hemlibra can include:

  • headache
  • joint pain

Taking too much Hemlibra can also increase your risk for serious blood clots. In some cases, you may need to seek treatment for blood clots right away. (For more information about potential blood clots, see the "Hemlibra side effects" section above.

What to do in case of overdose

If you think you've taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if you have severe symptoms, call 911 or go to the nearest emergency room right away.

When you get Hemlibra from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date the medication was dispensed.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist. You might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Keep your Hemlibra vials in the refrigerator. Put them in a tightly sealed and light-resistant container. If needed, you can take the vials out of the refrigerator for no longer than seven days. Then you should put them back in the refrigerator. Don't store the vials at temperatures higher than 86°F (30°C) when they're out of the refrigerator.

After opening a vial, use it right away. Throw away any part of the solution that you don't use.

Disposal

If you no longer need to take Hemlibra and have leftover medication, it's important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

After use, be sure to put supplies such as vials, needles with needle caps, and syringes in your sharps disposal container.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Hemlibra (emicizumab-kxwh) is FDA-approved for use as routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients of all ages with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.

Mechanism of action

Hemlibra is a bispecific (contains two different antigen-binding sites) monoclonal antibody that binds to both factor IX and factor X. Binding to both factors restores missing activated factor VIII function by bridging activated factor IX and factor X. This mechanism of action allows the coagulation cascade to continue, increasing clot formation. Hemlibra remains active in the presence of factor VIII inhibitors.

Pharmacokinetics and metabolism

Mean absorption half-life is 1.6 days following subcutaneous absorption. Absolute bioavailability is between 80.4 percent and 93.1 percent.

Mean elimination half-life is 26.9 days.

Contraindications

There are no contraindications to Hemlibra use.

Storage

Hemlibra vials should be stored in the refrigerator at 36°F to 46°F (2°C to 8°C) in the original container, protected from light. Vials should not be frozen or shaken. If needed, unopened vials can be stored out of the refrigerator and then returned to the refrigerator for not longer than seven days at temperatures not exceeding 86° (30°C). Once removed from the vial, discard the unused portion if not used immediately.

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