HYMPAVZI SOLUTION FOR INJECTION IN SINGLE-DOSE PRE-FILLED PEN 150 MG/ML [SIN17187P]

Product Info

HYMPAVZI SOLUTION FOR INJECTION IN SINGLE-DOSE PRE-FILLED PEN 150 MG/ML

[SIN17187P]

4.1. Therapeutic indications

HYMPAVZI is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and paediatric patients 12 years of age and older with:

• severe haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or

• severe haemophilia B (congenital factor IX deficiency) without factor IX inhibitors.

4.2. Posology and method of administration

Treatment should be initiated under the supervision of a physician/healthcare professional experienced in the treatment of haemophilia.

Posology

The recommended dose for patients 12 years of age and older, weighing at least 35 kg, is an initial loading dose of 300 mg by subcutaneous injection followed thereafter by 150 mg by subcutaneous injection once weekly.

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

Dose adjustments during treatment
A dose adjustment to 300 mg subcutaneous injection weekly can be considered in patients weighing ≥50 kg when control of bleeding events is judged to be inadequate by the healthcare professional. There are insufficient data to recommend doses above 300 mg weekly.

Missed dose
If a dose is missed, administer as soon as possible before the day of the next scheduled dose, and then resume usual weekly dosing schedule.

If the missed dose is more than 13 days after the last dose, then a loading dose of 300 mg by subcutaneous injection should be administered followed thereafter by a resumption of 150 mg by subcutaneous injection once weekly.

Switching to HYMPAVZI
Switching from prophylactic factor replacement therapy to HYMPAVZI: Prior to initiation of HYMPAVZI, patients should discontinue treatment with clotting factor concentrates (factor VIII or factor IX concentrates). Patients can initiate HYMPAVZI at any time after discontinuing clotting factor concentrates.

Switching from non-factor-based haemophilia medicinal products to HYMPAVZI: No clinical trial data are available to guide converting patients from non-factor-based medicinal products to HYMPAVZI. Although a washout period has not been studied, one approach is to allow an adequate washout period (at least 5 half-lives) of the prior agent based on labelled half-life before initiating treatment with HYMPAVZI. Haemostatic support with clotting factor concentrates may be needed during the switch from other non-factor-based haemophilia medicinal products to HYMPAVZI.

Special populations

Guidance on use with breakthrough bleed treatments
Factor VIII and factor IX products can be administered for the treatment of breakthrough bleeds in patients receiving HYMPAVZI. Additional doses of HYMPAVZI should not be used to treat breakthrough bleeding events. Healthcare professionals should discuss with all patients and/or caregivers about the dose and schedule of clotting factor concentrates to use, if required, while receiving HYMPAVZI prophylaxis, including using the lowest possible effective dose of clotting factor concentrate (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Please refer to the product information for the clotting factor concentrate being used.

Hepatic impairment
No dose adjustments are recommended in patients with mild hepatic impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Marstacimab has not been studied in patients with moderate or severe hepatic impairment.

Renal impairment
No dose adjustments are recommended in patients with mild renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Marstacimab has not been studied in patients with moderate or severe renal impairment.

Elderly population
No dose adjustments are recommended in patients over 65 years of age. There are limited data in patients over 65 years of age.

Paediatric population
The safety and efficacy of HYMPAVZI in paediatric patients <12 years of age have not yet been established. The safety and efficacy of marstacimab in adolescents with a body weight <35 kg have not been established. No data are available.

Management in the perioperative setting
The safety and efficacy of HYMPAVZI have not been formally evaluated in the surgical setting. Patients have had minor surgical procedures without discontinuing HYMPAVZI prophylaxis in clinical studies.

For major surgery, HYMPAVZI should be discontinued and management initiated per local standard of care with clotting factor concentrate and measures to manage the risk of venous thrombosis which can be elevated in the perioperative period. Consult the product information for the clotting factor concentrate for dosage guidelines in patients with haemophilia undergoing major surgery. Resumption of HYMPAVZI therapy should take into account the overall clinical status of the patient, including the presence of post-surgical thromboembolic risk factors, use of other haemostatic products and other concomitant medications (see Missed dose section above).

Management in patients with acute severe illness
There is limited experience with the use of HYMPAVZI in patients with acute severe illness. Reasons to consider temporary dose interruption of HYMPAVZI include occurrence of acute severe illness (e.g., serious infection, sepsis, trauma) in which there may be increased activation of coagulation and which the physician/healthcare professional considers could increase the risks associated with HYMPAVZI administration. Treatment of acute severe illness should be managed per local standard of care and continued treatment with HYMPAVZI in this situation should be weighed against the potential risks involved. HYMPAVZI therapy can be resumed once the patient has clinically recovered (see Missed dose section above).

Method of administration

HYMPAVZI is for subcutaneous injection only.

HYMPAVZI is intended for use under the guidance of a healthcare professional. After proper training in subcutaneous injection technique, a patient or caregiver may inject with HYMPAVZI if a physician/healthcare professional determines that it is appropriate.

Prior to subcutaneous administration, HYMPAVZI may be removed from the refrigerator and allowed to warm at room temperature in the carton for 15 to 30 minutes protected from direct sunlight. HYMPAVZI should not be warmed by using a heat source such as hot water or a microwave. After removal of HYMPAVZI from the refrigerator, HYMPAVZI must be used within 7 days or discarded (see section 6.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

HYMPAVZI should be administered by subcutaneous injection, once weekly, at any time of day. The recommended injection sites are the abdomen and thigh. Other locations are acceptable if required. Administration of HYMPAVZI in the buttocks (pre-filled pen only) should be performed by a caregiver or healthcare professional only.

For the 300 mg loading dose, each of the two HYMPAVZI 150 mg injections should be administered at different injection sites.

It is recommended to rotate the injection site with each injection. HYMPAVZI should not be administered into bony areas or areas where the skin is bruised, red, tender or hard, or areas where there are scars or stretch marks. HYMPAVZI should not be injected into a vein.

During treatment with HYMPAVZI, other medicinal products for subcutaneous administration should, preferably, be injected at different anatomical sites.

Refer to the Instructions for Use for complete administration instructions.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information