Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with:
Hemlibra can be used in all age groups.
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders.
Treatment (including routine prophylaxis) with bypassing agents (e.g. aPCC and rFVIIa) should be discontinued the day before starting Hemlibra therapy (see section 4.4).
Factor VIII (FVIII) prophylaxis may be continued for the first 7 days of Hemlibra treatment.
The recommended dose is 3 mg/kg once weekly for the first 4 weeks (loading dose), followed by maintenance dose of either 1.5 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.
The patient dose (in mg) and volume (in mL) should be calculated as follows:
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.
Examples:
Patient’s bodyweight of 16 kg, under a maintenance dose regimen of 1.5 mg/kg once weekly:
Patient’s bodyweight of 40 kg, under a maintenance dose regimen of 3 mg/kg every two weeks:
Patient’s bodyweight of 60 kg, under a maintenance dose regimen of 6 mg/kg every four weeks:
Hemlibra is intended for long-term prophylactic treatment.
No dosage adjustments of Hemlibra are recommended.
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.
No dose adjustments are recommended in paediatric patients (see section 5.2). There are no data in patients less than 1 year of age.
No dose adjustments are recommended in patients ≥65 years of age (see sections 5.1 and 5.2). There are no data in patients over 77 years old.
No dose adjustments are recommended in patients with mild, renal or hepatic impairment (see section 5.2). 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
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 trials.
If bypassing agents (e.g. aPCC and rFVIIa) are required in the perioperative period, please refer to the dosing guidance on the use of bypassing agents in section 4.4. If FVIII is required in the perioperative period, please refer to section 4.5.
When monitoring a patients underlying hemostatic activity, please refer to section 4.4 for laboratory tests unaffected by emicizumab.
The safety and efficacy of emicizumab in patients receiving ongoing immune tolerance induction have not yet been established. No data are available.
Hemlibra is for subcutaneous use only, and it should be administered using appropriate aseptic technique (see section 6.6).
The injection should be restricted to the recommended injection sites: the abdomen, the upper outer arms and the thighs (see section 5.2).
Administration of Hemlibra subcutaneous injection in the upper outer arm should be performed by a caregiver or healthcare professional.
Alternating the site of injection may help prevent or reduce injection site reactions (see section 4.8). Hemlibra subcutaneous injection should not be administered into areas where the skin is red, bruised, tender or hard, or areas where there are moles or scars.
During treatment with Hemlibra, other medicinal products for subcutaneous administration should, preferably, be injected at different anatomical sites.
Hemlibra is intended for use under the guidance of a healthcare professional. After proper training in subcutaneous injection technique, a patient may self-inject Hemlibra, or the patient’s caregiver may administer it, if their physician determines that it is appropriate.
The physician and the caregiver should determine the appropriateness of the child self-injecting Hemlibra. However, self-administration is not recommended for children below 7 years of age.
For comprehensive instructions on the administration of Hemlibra, see section 6.6 and package leaflet.
There is limited experience with overdose of Hemlibra.
Accidental overdose may result in hypercoagulability.
Patients who receive an accidental overdose should immediately contact their physician and be monitored closely.
Hemlibra 30 mg/mL solution for injection: 30 months.
Hemlibra 150 mg/mL solution for injection: 3 years.
Once removed from the refrigerator, unopened vials can be kept at room temperature (below 30°C) for up to 7 days.
After storage at room temperature, unopened vials may be returned to the refrigerator. If stored out of and then returned to refrigeration, the total combined time out of refrigeration should not exceed 7 days. The vials should never be exposed to temperatures above 30 °C. Vials that have been kept at room temperature for more than 7 days or exposed to temperatures above 30°C should be discarded.
From a microbiological point of view, once transferred from the vial to the syringe, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Store in a refrigerator (2°C to 8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after first opening of the medicinal product, see section 6.3.
Hemlibra 30 mg/mL solution for injection:
3 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and crimped with an aluminium cap fitted with a plastic flip-off disk. Each vial contains 30 mg emicizumab in 1 mL of solution for injection. Each carton contains one vial.
Hemlibra 150 mg/mL solution for injection:
3 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and crimped with an aluminium cap fitted with a plastic flip-off disk. Each vial contains 60 mg emicizumab in 0.4 mL of solution for injection. Each carton contains one vial.
3 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and crimped with an aluminium cap fitted with a plastic flip-off disk. Each vial contains 105 mg emicizumab in 0.7 mL of solution for injection. Each carton contains one vial.
3 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and crimped with an aluminium cap fitted with a plastic flip-off disk. Each vial contains 150 mg emicizumab in 1 mL of solution for injection. Each carton contains one vial.
Not all pack sizes may be marketed.
Hemlibra solution is a sterile, preservative-free, and ready to use solution for subcutaneous injection that does not need to be diluted.
Hemlibra should be inspected visually to ensure there is no particulate matter or discolouration prior to administration. Hemlibra is a colourless to slightly yellow solution. The solution should be discarded if particulate matter is visible or product is discoloured.
Do not shake.
Hemlibra solution for injection vials are for single-use only.
A syringe, a transfer needle (or vial adapter) and an injection needle are needed to withdraw Hemlibra solution from the vial and inject it subcutaneously.
Please see below recommended features:
A 1 mL syringe should be used for an injection up to 1 mL of Hemlibra solution, whereas a 2 to 3 mL syringe should be used for an injection greater than 1 mL and up to 2 mL.
Refer to the Hemlibra “Instructions for Use” for handling instructions when combining vials in a syringe. Different Hemlibra vial concentrations (30 mg/mL and 150 mg/mL) should not be combined in a single injection to administer the prescribed dose.
1 mL syringe:
Criteria: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.01 mL. When used together with a vial adapter, a low dead space plunger 1 mL syringe (transparent polypropylene or polycarbonate syringe with Luer lock tip, graduation 0.01 mL) must be used.
2 to 3 mL syringe:
Criteria: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.1 mL. When used together with a vial adapter, a low dead space plunger 3 mL syringe (transparent polypropylene or polycarbonate syringe with Luer lock tip, graduation 0.1 mL) must be used.
Transfer needle or vial adapter:
Criteria for transfer needle: Stainless steel with Luer-lock connection, gauge 18 G, length 35mm (1 1⁄2"), preferably semi-blunted tip. Criteria for vial adapter: Polycarbonate with Luer-lock connection, sterile, fitting 15 mm vial neck outer diameter, single-use, latex-free and non-pyrogenic.
Injection needle:
Criteria: Stainless steel with Luer-lock connection, gauge 26 G (acceptable range: 25-27 gauge), length preferably 9 mm (3/8") or maximally 13mm (1⁄2"), preferably including needle safety feature.
Please see section 4.2 and package leaflet (section 7 Instructions for Use), for additional information on administration.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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