Brand Name
Hemlibra
Generic Name
Emicizumab
View Brand Information FDA approval date: November 16, 2017
Form: Injection
What is Hemlibra (Emicizumab)?
HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A with or without factor VIII inhibitors. HEMLIBRA is a bispecific factor IXa- and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A with or without factor VIII inhibitors.
Approved To Treat
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Brand Information
Hemlibra (emicizumab)
WARNING: THROMBOTIC MICROANGIOPATHY AND THROMBOEMBOLISM
Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.
1INDICATIONS AND USAGE
HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.
2DOSAGE FORMS AND STRENGTHS
HEMLIBRA is available as a colorless to slightly yellow solution in single-dose vials.
Injection:
- 12 mg/0.4 mL
- 30 mg/mL
- 60 mg/0.4 mL
- 105 mg/0.7 mL
- 150 mg/mL
- 300 mg/2 mL (150 mg/mL)
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
- Thrombotic Microangiopathy Associated with HEMLIBRA and aPCC
- Thromboembolism Associated with HEMLIBRA and aPCC
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following adverse reactions are based on pooled data from two randomized trials in adult and adolescent patients (HAVEN 1 and HAVEN 3), one single-arm trial in adult and adolescent patients (HAVEN 4), one single-arm trial in pediatric patients (HAVEN 2), and one dose-finding trial, in which a total of 391 male patients with hemophilia A received at least one dose of HEMLIBRA as routine prophylaxis. Two hundred eighty-one patients (72%) were adults (18 years and older), 50 (13%) were adolescents (12 years up to less than 18 years), 55 (14%) were children (2 years up to less than 12 years), and five (1%) were infants (1 month up to less than 2 years). The median duration of exposure across the studies was 34.1 weeks (0.1 to 224.4 weeks).
The most frequently reported adverse reactions observed in ≥ 10% of patients treated with HEMLIBRA were injection site reactions, headache, and arthralgia.
Four patients (1%) in the clinical trials receiving HEMLIBRA prophylaxis withdrew from treatment due to adverse reactions, which were thrombotic microangiopathy, skin necrosis and superficial thrombophlebitis, headache, and injection site reaction.
Adverse reactions observed in patients who received HEMLIBRA are shown in
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of HEMLIBRA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: rash, urticaria, angioedema.
Immune system disorders: hypersensitivity.
5DESCRIPTION
Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) bispecific antibody binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII.
HEMLIBRA (emicizumab-kxwh) injection is a sterile, preservative-free, colorless to slightly yellow solution for subcutaneous injection supplied in single-dose vials containing emicizumab-kxwh at 12 mg/0.4 mL, 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL, or 300 mg/2 mL.
Each single-dose 12 mg vial contains a 0.4 mL solution of emicizumab-kxwh (12 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid.
Each single-dose 30 mg vial contains a 1 mL solution of emicizumab-kxwh (30 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid.
Each single-dose 60 mg vial contains a 0.4 mL solution of emicizumab-kxwh (60 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid.
Each single-dose 105 mg vial contains a 0.7 mL solution of emicizumab-kxwh (105 mg), L-arginine (18.3 mg), L-histidine (2.2 mg), and poloxamer 188 (0.4 mg), adjusted to pH 6.0 with L-aspartic acid.
Each single-dose 150 mg vial contains a 1 mL solution of emicizumab-kxwh (150 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid.
Each single-dose 300 mg vial contains a 2 mL solution of emicizumab-kxwh (300 mg), L-arginine (52.3 mg), L-histidine (6.2 mg), and poloxamer 188 (1 mg), adjusted to pH 6.0 with L-aspartic acid.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
7Instructions for Use HEMLIBRA®(hem-lee-bruh) (emicizumab-kxwh) injection, for subcutaneous use
Be sure that you read, understand, and follow this
Important Information:
- Do not inject yourself or someone else unless you have been shown how to by your healthcare provider.
- Make sure the name HEMLIBRA appears on the box and vial label.
- Before opening the vial, read the vial label to make sure you have the medicine strength(s) needed to give the dose prescribed by your healthcare provider.
- Your healthcare provider will determine your dose in milliliters (mL) that you will need to give based on your body weight.
- HEMLIBRA comes in multiple strengths. Depending on your dose, you may need to use more than one vial to give your total prescribed dose.
- Check the expiration date on the box and vial label.
- Only use the vial one time. After you inject your dose, dispose of (throw away) any unused HEMLIBRA left in the vial. Do not save unused HEMLIBRA in the vial for later use.
- Only use the syringes, transfer needles, and injection needles that your healthcare provider prescribes.
- Only use the syringes, transfer needles and injection needles one time. Dispose of (throw away) any used syringes and needles in a sharps disposal container.
- If your prescribed dose is more than 2 mL, you will need to give more than one injection of HEMLIBRA.
Storing HEMLIBRA:
- Store HEMLIBRA in the refrigerator at 36°F to 46°F (2°C to 8°C).
- Store HEMLIBRA in the original carton to protect the vials from light.
- Do not shake HEMLIBRA.
- Take the vial out of the refrigerator 15 minutes before use and allow it to reach room temperature before preparing an injection.
- Before giving the injection, unopened vials of HEMLIBRA may be stored out of the refrigerator and then returned to the refrigerator. HEMLIBRA should not be stored out of the refrigerator:
Keep HEMLIBRA and all medicines out of the reach of children.
Inspecting the HEMLIBRA vial and your supplies:
- Collect all supplies listed below to prepare and give your injection.
- Check the expiration date on the box, on the vial label, and on the supplies listed below. Do not use if the expiration date has passed.
- Inspect the supplies for damage.
- Place the supplies on a clean, well-lit flat work surface.
HEMLIBRA is colorless to slightly yellow in color. Do not use the vial if:
- the medicine is cloudy, hazy, or colored.
- the medicine contains particles.
- the cap covering the stopper is missing.
Preparing the syringe for injection:
- HEMLIBRA must not be stored
- HEMLIBRA in the syringe must be injected under the skin (subcutaneous injection) immediately.
- Dispose of (throw away) any used vial(s), needles, vial and injection needle caps, and used syringes in a sharps disposal container.
Important information after the injection:
- Do not rub the injection site after an injection.
- If you see drops of blood at the injection site, you can press a sterile cotton ball or gauze over the injection site for at least 10 seconds, until bleeding has stopped.
- If you have bruising (small area of bleeding under the skin), an ice pack can also be applied with gentle pressure to the site. If bleeding does not stop, please contact your healthcare provider.
Disposing of used HEMLIBRA vial(s), needles, and syringes:
- Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not dispose of (throw away) any loose needles and syringes in your household trash.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
- Do not dispose of (throw away) any used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Important: Always keep the sharps disposal container out of reach of children.
1. PREPARATION
Do not use the transfer needle to inject HEMLIBRA as this may cause harm such as pain and bleeding.2. INJECTION
3. DISPOSAL
If you need to use more than one vial to get to your total prescribed dose, follow these steps after you have drawn up HEMLIBRA from the first vial:
Do not use the transfer needle to inject HEMLIBRA as this may cause harm such as pain and bleeding.For more information, go to www.HEMLIBRA.com or call 1-866-HEMLIBRA.
HEMLIBRA
Manufactured by:
HEMLIBRA
U.S. License No. 1048
This
8PRINCIPAL DISPLAY PANEL - 30 mg Vial Carton
NDC 50242-920-01
30 mg/mL
For Subcutaneous Use.
ATTENTION: Dispense the enclosed
Rx only
1 vial
11007739
9PRINCIPAL DISPLAY PANEL - 60 mg Vial Carton
NDC 50242-921-01
60 mg/0.4 mL
For Subcutaneous Use.
ATTENTION: Dispense the enclosed
Rx only
1 vial
11007760
10PRINCIPAL DISPLAY PANEL - 105 mg Vial Carton
NDC 50242-922-01
105 mg/0.7 mL
For Subcutaneous Use.
ATTENTION: Dispense the enclosed
Rx only
1 vial
11007753
11PRINCIPAL DISPLAY PANEL - 150 mg Vial Carton
NDC 50242-923-01
150 mg/mL
For Subcutaneous Use.
ATTENTION: Dispense the enclosed
Rx only
1 vial
11007762
12PRINCIPAL DISPLAY PANEL - 300 mg Vial Carton
NDC 50242-930-01
300 mg/2 mL
For Subcutaneous Use.
ATTENTION: Dispense the enclosed
Rx only
1 vial
11001341
13PRINCIPAL DISPLAY PANEL - 12 mg./0.4 mL Vial Carton
NDC 50242-927-01
Hemlibra
12 mg/0.4 mL
For Subcutaneous Use.
ATTENTION: Dispense the
Rx only
1 vial
11009296
