Hemlibra
Hemlibra (emicizumab or emicizumab-kxwh) is used to prevent or reduce the number of bleeding episodes in people with hemophilia A, a genetic disorder that causes the blood to not clot properly due to a missing clotting factor called factor VIII. It's given as an injection under the skin, so you don't need to infuse it through your veins like some other medications used to treat this condition. It can be given at home, and dosing ranges from once a week to once a month.
What is Hemlibra (emicizumab)?
What is Hemlibra (emicizumab) used for?
- Prevention of bleeding episodes in children and adults with hemophilia A
How Hemlibra (emicizumab) works
People with hemophilia A have either no or a lower amount of a protein called clotting factor VIII, one of the many clotting factors that help control bleeding. When you get injured and start bleeding, clotting factor VIII bridges two other clotting factors together (factor IX and factor X) to help the blood clot in order to stop the bleed. When there's less or factor VIII in the blood, the blood can't clot as well. This puts you at higher risk for bleeds.
Hemlibra (emicizumab) is a monoclonal antibody that does the same job as factor VIII of bringing two important clotting factors together to continue the clotting process in the blood.
Drug facts
Side effects of Hemlibra (emicizumab)
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
- Injection site reaction (bruising, redness, pain, swelling) (22%)
- Headache (15%)
- Joint pain (15%)
- Diarrhea (6%)
- Fever (6%)
Less Common Side Effects
- Muscle pain from rhabdomyolysis (muscle breakdown)
The following Hemlibra (emicizumab) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
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Pros and cons of Hemlibra (emicizumab)
Pros
- Works well to prevent bleeding episodes in people with hemophilia A with or without factor VIII inhibitors
- Stays in your body longer compared to factor VIII treatment
- Can be given once a week to once a month, so flexible dosing schedule
- Can be used in people of all ages
- Injected under the skin instead of infused through the veins, like some other medications used to treat hemophilia A
Cons
- Brand name only, so might be expensive
- Unknown if safe during pregnancy or while breastfeeding
- Can cause unpleasant side effects like headache and joint pain
- Can put you at risk for blood clots or damage to your blood vessels
Pharmacist tips for Hemlibra (emicizumab)
- Before starting Hemlibra (emicizumab), discuss with your provider when you should stop your other medications used for hemophilia A.
- Read the instructions for use and watch this video on how to inject Hemlibra (emicizumab). Your provider will train you on how to inject yourself or your child with Hemlibra (emicizumab). Talk with your provider or pharmacist if you have any questions on how to use this medication.
- Hemlibra (emicizumab) comes in different strengths, and you might need to use more than one to make up your dose. Never combine different vials of different strengths into one injection. You should only use one vial at a time to prevent damaging the medication and giving yourself the wrong dose.
- When you're ready to use Hemlibra (emicizumab), take the vial out of the refrigerator 15 minutes before you prepare your injection to allow it to come to room temperature. This will make it more comfortable when you inject it.
- Check to make sure the color in the Hemlibra (emicizumab) vial is colorless to slightly yellow. If it's cloudy, hazy, colored, contains particles (solid chunks), or if the cap is missing, don't use the vial and contact your provider for further instructions. Never shake Hemlibra (emicizumab) since this can damage the medication.
- You can inject Hemlibra (emicizumab) into your thigh, stomach, or outer upper arm (with help from a caregiver). Discuss the best site to inject yourself with your provider and make sure you're comfortable with the technique.
- Use the syringes, transfer needles, and injection needles only once when giving Hemlibra (emicizumab) to avoid contamination (spreading germs). Once you prepare your dose, give it right away and don't save it for later because it might not work as well anymore.
- Throw the used needles and syringes away in a sharps container or a large, empty, plastic container (such as a laundry detergent container) after your injection to avoid needlestick injuries.
- Store Hemlibra (emicizumab) in the refrigerator in its original carton. It shouldn't be kept out of the refrigerator for more than a total of 7 days or reach a temperature more than 86 degrees F. If this happens, throw the medication away and ask your provider or pharmacist about a replacement.
- Hemlibra (emicizumab) can interfere with certain lab tests, so make sure to tell all of your providers you're taking it.
Common questions about Hemlibra (emicizumab)
In clinical studies, Hemlibra (emicizumab) lowered the number of bleeding episodes that needed treatment in adults and young adults by 68% compared to people who took factor VIII, which is another treatment option for people with hemophilia A. In addition, over 60% of adults and young adults taking Hemlibra (emicizumab) for almost 6 months had zero bleeds that needed treatment during that period of time. Talk with your provider if you have any questions about how well Hemlibra (emicizumab) works.
Yes, Hemlibra (emicizumab) has proven to be safe and work well in people of all ages with hemophilia A. The dose will depend on your child's weight, so make sure to attend all follow-up appointments so the provider can adjust the dose if needed.
Factor VIII inhibitors are antibodies (proteins) that develop in response to a common treatment for hemophilia A known as factor VIII replacement. Your body sees the outside factor VIII as foreign and makes proteins against it. These are called factor VIII inhibitors, because they prevent the factor VIII given to you from working. Since Hemlibra (emicizumab) isn't the same as factor VIII, it won't cause your body to make new factor VIII inhibitors. It will still work regardless if you already have factor VIII inhibitors present.
Talk with your provider if you're currently taking factor VIII and want to start Hemlibra (emicizumab). Typically, you continue to take factor VIII only during the first week of taking Hemlibra (emicizumab). But after that, your provider will have you stop factor VIII because you won't need it anymore. Hemlibra (emicizumab) acts the same way as factor VIII in your body.
There isn't enough information available to know if Hemlibra (emicizumab) is safe to take during pregnancy because there haven't been studies done in pregnant humans or animals. If you're pregnant or planning on becoming pregnant, speak to your provider about the risks and benefits of taking this medication for you and your unborn baby.
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Risks and warnings for Hemlibra (emicizumab)
Hemlibra (emicizumab) 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.
Blood clots and damage to blood vessels
- Risk factors: Taking activated prothrombin complex concentrate (aPCC) together with Hemlibra (emicizumab)
In some people taking Hemlibra (emicizumab) together with aPCC, a medication used to control bleeding in people with hemophilia A and B, blood clots in small blood vessels (thrombotic microangiopathy) and other parts of the body were reported. If this happens, you need to stop aPCC and temporarily stop Hemlibra (emicizumab). You'll typically start to recover in weeks to months after stopping aPCC. Since Hemlibra (emicizumab) stays in your body for a long time, you're at risk for this interaction with aPCC for up to 6 months after your last Hemlibra (emicizumab) dose. Your provider will monitor your blood counts while you're taking both of these medications together. Get medical help right away if you experience symptoms such as swollen leg, pain in your leg, chest pain, difficulty breathing, feeling dizzy, and feeling confused.
Anti-medication antibodies
When you're taking biologic medications like Hemlibra (emicizumab), sometimes your body's immune system can create anti-medication antibodies (proteins) that attack the medication. This can cause your medication to not work a well. If you experience more bleeding episodes or feel like Hemlibra (emicizumab) isn't working well for you, contact your provider.
Hemlibra (emicizumab) dosage
Vial| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 12mg/0.4ml | 1 vial | $3,644.99 | $3,644.99 |
| 300mg/2ml | 2 vials | $36,393.61 | $18,196.81 |
Typical dosage for Hemlibra (emicizumab)
Your dose of Hemlibra (emicizumab) depends on your weight.
The typical starting dose is 3 mg/kg injected under the skin once weekly for the first 4 weeks. Your healthcare provider will have you continue with one of the following maintenance doses, depending on which is best for you:
- 1.5 mg/kg injected under the skin every week, OR
- 3 mg/kg injected under the skin every 2 weeks, OR
- 6 mg/kg injected under the skin every 4 weeks
How much does Hemlibra (emicizumab) cost?
$3,644.99
