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Hemlibra is a brand name for Emicizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency): ● with factor VIII inhibitors ● without factor VIII inhibitors who have: - severe disease (FVIII < 1%) - moderate disease (FVIII ≥ 1% and ≤ 5%) with severe bleeding phenotype. Hemlibra…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders. g. 4). Factor VIII (FVIII) prophylaxis may be continued for the first 7 days of Hemlibra treatment.
5 mg/kg once weekly, 3 mg/kg every two weeks, or 6 mg/kg every four weeks, all doses administered as a subcutaneous injection. The loading dose regimen is the same, irrespective of the maintenance dose regimen. The maintenance dose regimen should be selected based on physician and patient/caregiver dosing regimen preference to support adherence.
5; 3 or 6 mg/kg) = total amount (mg) of emicizumab to be administered The total volume of Hemlibra to be injected subcutaneously is calculated as follows: Total amount (mg) of emicizumab to be administered ÷ vial concentration (mg/mL) = total volume of Hemlibra (mL) to be injected.
Different Hemlibra concentrations (30 mg/mL and 150 mg/mL) should not be combined in the same syringe when making up the total volume to be administered. A volume greater than 2 mL per injection should not be administered. 5 mg/kg once weekly: ● Loading dose (first 4 weeks) example: 16 kg x 3 mg/kg = 48 mg of emicizumab needed for the loading dose.
32 mL of 150 mg/mL Hemlibra concentration to be injected. ● Choose appropriate dose and volume from vial strengths available. 5 mg/kg = 24 mg of emicizumab needed for the maintenance dose. 8 mL of 30 mg/mL Hemlibra concentration to be injected once weekly.
● Choose appropriate dose and volume from vial strengths available. 4 Patient’s bodyweight of 40 kg, under a maintenance dose regimen of 3 mg/kg every two weeks: ● Loading dose (first 4 weeks) example: 40 kg x 3 mg/kg = 120 mg of emicizumab needed for the loading dose.
8 mL of 150 mg/mL Hemlibra concentration to be injected. ● Choose appropriate dose and volume from vial strengths available. ● Maintenance dose (from week 5 on) example: 40 kg x 3 mg/kg = 120 mg of emicizumab needed for the maintenance dose.
8 mL of 150 mg/mL Hemlibra concentration to be injected every two weeks. ● Choose appropriate dose and volume from vial strengths available. Patient’s bodyweight of 60 kg, under a maintenance dose regimen of 6 mg/kg every four weeks: ● Loading dose (first 4 weeks) example: 60 kg x 3 mg/kg = 180 mg of emicizumab needed for the loading dose.
Summary of the safety profile The overall safety profile of Hemlibra is based on data from clinical studies and post-marketing surveillance. 4). 0 %). 7 %) in the clinical studies receiving Hemlibra prophylaxis withdrew from treatment due to ADRs, which were TMA, skin necrosis contemporaneous with superficial thrombophlebitis, and headache.
1). 1 %) were infants and toddlers (1 month to < 2 years). 3 weeks). ADRs from the phase III clinical studies and post-marketing surveillance are listed by MedDRA system organ class (Table 2). The corresponding frequency categories for each ADR are based on the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
11 Table 2 Summary of adverse drug reactions from pooled HAVEN clinical studies and post- marketing surveillance with Hemlibra System Organ Class (SOC) Adverse reactions (preferred term, MedDRA) Frequency Blood and lymphatic system disorders Thrombotic microangiopathy Uncommon Nervous system disorders Headache Very common Vascular disorders Thrombophlebitis superficial Uncommon Cavernous sinus thrombosisa Uncommon Gastrointestinal disorders Diarrhoea Common Skin and subcutaneous tissue disorders Skin necrosis Uncommon Angioedema Uncommon Urticaria Common Rash Common Musculoskeletal and connective tissue disorders Arthralgia Very common Myalgia Common General disorders and administration site conditions Injection site reaction Very common Pyrexia Common Therapeutic response decreasedb Uncommon Immune system disorders Hypersensitivity Uncommon aVascular disorders is a secondary SOC for cavernous sinus thrombosis.
1). 7 % of patients (3/31) who received at least one dose of aPCC while being treated with emicizumab. 4). Patients presented with thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury, without severe deficiencies in ADAMTS13 activity.
4. If FVIII is required in the perioperative period, please refer to section
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20 mL of 150 mg/mL Hemlibra concentration to be injected. ● Choose appropriate dose and volume from vial strengths available. ● Maintenance dose (from week 5 on) example: 60 kg x 6 mg/kg = 360 mg of emicizumab needed for the maintenance dose.
4 mL of 150 mg/mL Hemlibra concentration to be injected every four weeks. ● Choose appropriate dose and volume from vial strengths available. Duration of treatment Hemlibra is intended for long-term prophylactic treatment. Dose adjustments during treatment No dose adjustments of Hemlibra are recommended.
Delayed or missed doses If a patient misses a scheduled subcutaneous injection of Hemlibra, the patient should be instructed to take the missed dose as soon as possible, up to a day before the day of the next scheduled dose. The patient should then administer the next dose on the usual scheduled dosing day.
The patient should not take two doses on the same day to make up for a missed dose. 2). There are no data in patients less than 1 year of age. 2). There are no data in patients over 77 years old. 2). There are limited data available on the use of Hemlibra in patients with moderate renal or hepatic impairment.
Emicizumab has not been studied in patients with severe renal or hepatic impairment Management in the perioperative setting The safety and efficacy of emicizumab have not been formally evaluated in the surgical setting. Patients have had surgical procedures without discontinuing emicizumab prophylaxis in clinical studies.
g. aPCC and rFVIIa) are required in the perioperative period, please refer to the dosing guidance on the use of bypassing agents in section
One patient resumed Hemlibra following resolution of TMA without recurrence. 5 % of patients (2/31) who received at least one dose of aPCC while being treated with emicizumab. Both serious thrombotic events occurred when on average a cumulative amount of > 100 U/Kg/24 hours of aPCC for 24 hours or more was administered during a treatment event.
4). 12 Characterization of the interaction between emicizumab and aPCC treatment in pivotal clinical studies There were 82 instances of aPCC treatment* in patients receiving Hemlibra prophylaxis, of which eight instances (10%) consisted of on average a cumulative amount of 100 U/kg/24 hours of aPCC for 24 hours or more; two of the eight instances were associated with thrombotic events and three of the eight instances were associated with TMA (Table 3).
No TMA or thrombotic events were associated with the remaining instances of aPCC treatment. Of all instances of aPCC treatment, 68 % consisted of only one infusion < 100 U/kg. Table 3 Characterisation of aPCC treatment* in the pooled phase III clinical studies Duration of aPCC treatment Average cumulative amount of aPCC over 24 hours (U/kg/24 hours) <50 50–100 >100 <24 hours 9 47 13 24-48 hours 0 3 1b >48 hours 1 1 7a,a,a,b * An instance of aPCC treatment is defined as all doses of aPCC received by a patient, for any reason, until there was a 36-hour treatment-free break.
Includes all instances of aPCC treatment excluding those in the first 7 days and those that occurred 30 days after the discontinuation of Hemlibra. 4 %) from the pooled phase III clinical studies. All ISRs observed in the Hemlibra clinical studies were reported as being non-serious and mild to […]