Medically reviewed by Drugs.com. Last updated on Aug 1, 2019.
(em i SIZ ue mab)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Subcutaneous [preservative free]:
Hemlibra: emicizumab-kxwh 30 mg/1 mL (1 mL); emicizumab-kxwh 150 mg/1 mL (1 mL); emicizumab-kxwh 60 mg/0.4 mL (0.4 mL); emicizumab-kxwh 105 mg/0.7 mL (0.7 mL)
Brand Names: U.S.
- Antihemophilic Agent
- Monoclonal Antibody
Emicizumab, a humanized monoclonal modified immunoglobulin G4 (IgG4) antibody with a bispecific factor IXa- and factor X-directed antibody, bridges activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective hemostasis. Emicizumab has no structural relationship or sequence homology to FVIII and, therefore, does not induce or enhance the development of direct inhibitors to FVIII.
Vd: 10.4 L
26.9 ± 9.1 days
Special Populations Note
Body weight: Clearance and volume of distribution increase with increasing body weight (9 kg to 156 kg). Dosing in mg/kg provides similar emicizumab exposure across body weight range.
Use: Labeled Indications
Hemophilia A, prophylaxis: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors
There are no contraindications listed in the US manufacturer's labeling.
Canadian labeling: Hypersensitivity to emicizumab or any component of the formulation.
Hemophilia A, prophylaxis: SubQ:
Initial: 3 mg/kg once weekly for 4 weeks
Maintenance: 1.5 mg/kg once weekly or 3 mg/kg once every 2 weeks or 6 mg/kg once every 4 weeks
Note: Prophylactic use of bypassing agents should be discontinued the day before starting therapy. Prophylactic use of FVIII may be continued during the first week of therapy.
Refer to adult dosing.
Hemophilia A, prophylaxis: Note: Prophylactic use of bypassing agents should be discontinued the day before starting therapy. Prophylactic use of FVIII may be continued during the first week of therapy.
Infants, Children, and Adolescents:
Initial loading dose: SubQ: 3 mg/kg once weekly for first 4 weeks (4 doses)
Maintenance therapy: Note: Multiple regimens available, and selection should be based on health care provider preferences and increased patient adherence. SubQ: 1.5 mg/kg once weekly or 3 mg/kg once every 2 weeks or 6 mg/kg once every 4 weeks
SubQ: For SubQ administration. Do not shake. Administer immediately after removal from vial. Rotate injection sites (upper outer arms, thighs, or any quadrant of abdomen). Do not inject into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact. Patient may self-inject, or the patient's caregiver may administer; however, only a health care provider should administer in the upper outer arm. Self-administration is not recommended for children <7 years of age.
Refer to product information for preparation and additional administration techniques. Do not use different vials of different concentrations when combining vials to administer prescribed dose.
Store at 2°C to 8°C (36°F to 46°F); protect from light. Do not freeze. May also store unopened vials at <30°C (<86°F) for up to 7 days. Once removed from the vial, discard if not used immediately. Discard unused solution.
Anti-inhibitor Coagulant Complex (Human): Emicizumab may enhance the thrombogenic effect of Anti-inhibitor Coagulant Complex (Human). Monitor therapy
Emicizumab affects intrinsic pathway clotting-based laboratory tests, including activated clotting time (ACT), activated partial thromboplastin time (aPTT), and all assays based on aPTT, such as one-stage factor VIII (FVIII) activity. Do not use intrinsic pathway clotting based laboratory test results to monitor emicizumab.
Central nervous system: Headache (15%)
Local: Injection site reaction (22%), erythema at injection site (11%)
Neuromuscular & skeletal: Arthralgia (15%)
1% to 10%:
Dermatologic: Injection site pruritus (4%)
Gastrointestinal: Diarrhea (6%)
Immunologic: Antibody development (4%; neutralizing: <1%)
Local: Pain at injection site (4%)
Miscellaneous: Fever (6%)
<1%, postmarketing, and/or case reports: Rhabdomyolysis
ALERT: U.S. Boxed WarningThrombotic microangiopathy and thromboembolism:
Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 units/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for 24 hours or more to patients receiving emicizumab prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of emicizumab if symptoms occur.
Concerns related to adverse effects:
• Thrombotic microangiopathy and thromboembolism: [US Boxed Warning]: Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 units/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for ≥24 hours to patients receiving emicizumab prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of emicizumab if symptoms occur. Patients presented with thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury, without severe deficiencies in ADAMTS13 activity; improvement of thrombotic microangiopathy and thromboembolism was seen within 1 week and 1 month, respectively, following discontinuation of aPCC. If these complications occur, discontinue aPCC immediately and interrupt emicizumab; consider benefits vs risks of resuming emicizumab following complete resolution of thrombotic microangiopathy and thrombotic events.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Monitor for thrombotic microangiopathy and thrombotic events if aPCC is administered with emicizumab.
Monitor coagulation parameters using single factor assays utilizing chromogenic or immuno-based methods. Chromogenic FVIII activity tests may be manufactured with either human or bovine coagulation proteins; human coagulation factors assays may overestimate the clinical hemostatic potential of emicizumab; however, bovine coagulation factors assays are insensitive to emicizumab (no activity measured) and can be used to monitor endogenous or infused FVIII activity, or to measure anti-FVIII inhibitors. Emicizumab will produce a false negative result in clotting-based Bethesda assays for functional inhibition of FVIII; a chromogenic Bethesda assay utilizing a bovine-based FVIII chromogenic test that is insensitive to emicizumab may be used. Due to the long half-life of emicizumab, effects on coagulation assays may persist ≤6 months after the last dose.
Animal reproduction studies have not been conducted. Emicizumab is a humanized monoclonal antibody (IgG4). Potential placental transfer of human IgG is dependent upon the IgG subclass and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Females of childbearing potential should use effective contraception during therapy.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience muscle pain, joint pain, or diarrhea. Have patient report immediately to prescriber signs of blood clots (numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain; shortness of breath; tachycardia; or coughing up blood), confusion, passing out, weakness, back pain, abdominal pain, vision changes, chest pain, coughing up blood, eye pain, eye edema, tachycardia, facial numbness, extremity pain, shortness of breath, swelling of the arms or legs, difficult urination, nausea, vomiting, severe headache, jaundice, or severe injection site irritation (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
More about emicizumab
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- Drug class: miscellaneous coagulation modifiers
Other brands: Hemlibra