HEMLIBRA SOLUTION FOR INJECTION 30MG/ML [SIN15577P]

Product Info

HEMLIBRA SOLUTION FOR INJECTION 30MG/ML

[SIN15577P]

2.1 THERAPEUTIC INDICATION(S)
Hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adults and children with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.

Hemlibra can be used in all age groups.

2.2 DOSAGE AND ADMINISTRATION
General
Substitution by any other biological medicinal product requires the consent of the prescribing physician.
Treatment should be initiated under the supervision of a physician experienced in the treatment of hemophilia and/or bleeding disorders.
Treatment with bypassing agents should be discontinued the day before starting Hemlibra therapy (see section 2.4 Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). FVIII prophylaxis may be continued for the first 7 days of Hemlibra treatment.

Recommended dosage (all patients)
The recommended dose is 3 mg/kg administered as a subcutaneous injection once weekly for the first 4 weeks, followed by a maintenance dose of either:

• 1.5 mg/kg once weekly, or

• 3 mg/kg every two weeks, or

• 6 mg/kg every four weeks

The maintenance dose should be selected based on physician and patient/caregiver dosing regimen preference to support adherence.

Method of administration
Hemlibra is for subcutaneous use only. Hemlibra should be administered using appropriate aseptic technique (see section 4.2 Special Instructions for Use, Handling and Disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The injection should be restricted to the recommended injection sites: the abdomen, the upper outer arms and the thighs (see section 3.2 Pharmacokinetic Properties, Absorption – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). No data are available on injection at other sites of the body.

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 2.6 Undesirable Effects, Clinical Trials – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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.

Administration by the patient and/or caregiver
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 Hemlibra, if their physician determines that it is appropriate.

The physician and the caregiver should determine the appropriateness of a child self-injecting Hemlibra. However, self-administration is not recommended for children below 7 years of age.

Duration of treatment
Hemlibra is intended for long-term prophylactic treatment.

Dosage adjustments during treatment
No dosage 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, 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.

2.2.1 SPECIAL DOSAGE INSTRUCTIONS
Pediatric use
No dose adjustments are recommended in pediatric patients. Currently available data are described in sections 3.1.2 Clinical/Efficacy Studies and 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Geriatric use
No dose adjustments are recommended in patients ≥ 65 years of age (see section 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
No dose adjustments are recommended in patients with renal impairment (see section 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hemlibra has not been studied in moderate to severe renal impairment.
Hemlibra is a monoclonal antibody and is cleared by catabolism rather than renal excretion and a change in dose is not expected to be required for patients with renal impairment.

Hepatic impairment
No dose adjustments are recommended in patients with hepatic impairment (see section 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hemlibra has not been studied in moderate to severe hepatic impairment.
Hemlibra is a monoclonal antibody and is cleared by catabolism rather than hepatic excretion and a change in dose is not expected to be required for patients with hepatic impairment.

2.3 CONTRAINDICATIONS
Hemlibra is contraindicated in patients with known hypersensitivity to emicizumab or to any of the excipients.