Hemlibra (emicizumab-kxwh)
Antihemophilic Products Subcutaneous Vial (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Emicizumab is a humanized bispecific monoclonal antibody that binds to human factor IX/IXa and factor X/Xa.
Emicizumab-kxwh is a bispecific monoclonal modified immune globulin G4 (IgG4) that binds to both human factor IXa and factor X. It bridges activated factor IX and factor X restoring the function of activated factor VIII, which is deficient or missing in hemophilia A and necessary for effective hemostasis. It lacks sequence homology and structural relationship with factor VIII, which avoids inducing or enhancing the development of direct inhibitors to factor VIII.
The pharmacokinetics of emicizumab are described as dose proportional over a dose range of 0.3 to 6 mg/kg by subcutaneous injection. Mean trough plasma concentrations of approximately 52.6 mcg/mL are achieved at week 5 following the recommended loading dose subcutaneous regimen of 3 mg/kg once weekly for 4 weeks. The absolute bioavailability of a 1 mg/kg subcutaneous dose ranged from 80.4-93.1%.
Subcutaneous administration into the abdomen, upper arm, or thigh produced similar pharmacokinetic profiles. The mean elimination apparent half-life was approximately 26.9 days. Age (range: 1-77 years), race, factor VIII inhibitor status, mild hepatic impairment, moderate hepatic impairment, mild renal impairment, or moderate renal impairment did not meaningfully alter the pharmacokinetics of emicizumab.
However, the predicted concentrations of emicizumab in patients younger than 6 months of age were 19 to 33% lower compared with older patients, particularly with the every 2 weeks and every 4 weeks maintenance dosage regimens. Increasing body weight (range: 9-156 kg) was associated with an increase in apparent clearance and volume of distribution; emicizumab dosed in mg/kg provides similar exposure across the body weight range.
USES: This medication is used by people with a certain inherited bleeding problem (hemophilia A) to help prevent or lessen how often you have bleeding problems. Emicizumab belongs to a class of medications known as monoclonal antibodies. It works by helping your blood to clot normally, which helps prevent bleeding due to hemophilia A.
Preventing bleeding can lessen symptoms such as painful swellings, joint pain, pain with movement, and difficulty walking far.
Generic name: emicizumab-kxwh
Pronunciation: (EM-i-SIZ-ue-mab)
Drug class: Antihemophilic Products
Therapeutic class: Hematological Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Hemlibra
Indications
The following indications are listed for Hemlibra:
- Bleeding Prevention In Hereditary Factor Viii Deficiency
Also known as: Bleeding Prevention In Classic Hemophilia, Bleeding Prevention In Congenital Factor Viii Deficiency, Bleeding Prevention In Hemophilia A, Bleeding Prophylaxis In Hemophilia A, Hemorrhage Prophylaxis In Hemophilia A, Prevention Of Bleeding Episode In Hemophilia A.
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
No formal drug interaction studies have been conducted to date.
There are no contraindication interactions for this drug.
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Igg Antibodies And Derivatives/Efgartigimod-Alfa
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)
Igg Antibodies And Derivatives/Nipocalimab-Aahu
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)
Moderate Interaction: Assess the risk to the patient and take action as needed.
Igg Antibodies And Derivatives/Rozanolixizumab-Noli
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)
DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)
Contraindications
*None.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
Most common adverse reactions (incidence >=10%) are injection site reactions, headache, and arthralgia.
Less Frequent
- Thromboembolic disorder
Rare or Very Rare
- Angioedema
- Dermal necrosis
- Rhabdomyolysis
- Thrombophlebitis
- Thrombotic thrombocytopenic purpura
More Frequent
- Arthralgia
- Headache disorder
- Injection site sequelae
Less Frequent
- Diarrhea
- Fever
- Injection site erythema
- Injection site pain
Rare or Very Rare
- Hypersensitivity drug reaction
- Myalgia
- Skin rash
- Urticaria
Precautions
No enhanced messaging available.
The clinical efficacy and safety of emicizumab-kxwh have been established in pediatric patients in the HAVEN 1, 2, 3, and 4 trials. Together, these trials included 47 patients 12 years to <18 years of age, 55 patients 2 years to <12 years of age, and 5 patients 1 month to <2 years of age. No differences in efficacy were observed between these age groups.
There are currently limited clinical trial data on the use of emicizumab in infants <6 months of age; however, clinical experience supports the prophylactic efficacy of the drug in infants. The pharmacokinetic exposure in these patients is likely to be less than in older children. Trough plasma concentrations of emicizumab at steady state are comparable between adults and pediatric patients >6 months of age at equivalent weight-based doses. Concentrations of emicizumab in patients <6 months of age are expected to be lower than in older patients.
Adverse effects in emicizumab-treated pediatric patients were generally similar to those observed in adult patients with hemophilia A receiving the drug.
There are no clinical data on use of emicizumab-kxwh in pregnant women. Animal reproductive studies have not been conducted with the drug. Because it is not known whether emicizumab can cause fetal harm or can affect reproduction capacity, use emicizumab during pregnancy only if the potential benefit for the mother outweighs the potential risk to the fetus.
It is not known whether emicizumab is distributed into human milk or if the drug has any effect on milk production or the nursing infant. Since human immune globulin (IgG) is present in human milk, distribution of emicizumab into milk is possible. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for emicizumab and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.
The manufacturer makes no specific dosage recommendations for geriatric patients.
Clinical trials experience in patients >=65 years of age is insufficient to determine whether these patients respond differently to emicizumab than younger patients. Other reported clinical experience has not identified a difference in response between geriatric patients and younger patients.
ICD codes
| Code | Type | Description |
|---|---|---|
| Bleeding prevention in hereditary factor VIII deficiency | ||
| D66 | ICD10CM | Hereditary factor VIII deficiency |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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