Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Hympavzi is indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older, weighing at least 35 kg, with:
Treatment should be initiated under the supervision of a healthcare professional experienced in the treatment of haemophilia. Treatment should be initiated in a non-bleeding state.
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, at any time of day.
Hympavzi is intended for long-term prophylactic 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. The maximum weekly dose of 300 mg should not be exceeded.
Additional doses of Hympavzi should not be used to treat breakthrough bleeding events. For guidance on treatment in the event of breakthrough bleeds, see section 4.4.
In acute severe illnesses with increased tissue factor expression, such as infection, sepsis, and crush injuries, potentiation of the inflammatory response via concomitant tissue factor pathway inhibitor (TFPI) inhibition could pose a risk of adverse reactions, especially thrombosis (see section 4.4).
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. Additional monitoring for adverse reactions and the development of thromboembolism may be warranted in these patients when marstacimab is administered. Hympavzi should be temporarily interrupted if clinical symptoms, imaging, and/or laboratory findings consistent with thrombotic events occur, and managed as clinically indicated. Hympavzi therapy may be resumed once the patient has clinically recovered at the clinical judgement of the healthcare provider (see Missed dose section below).
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 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 study data are available to guide converting patients from non-factor-based medicinal products to marstacimab. 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.
No dose adjustments are recommended in patients with mild hepatic impairment (see section 5.2). Marstacimab has not been studied in patients with moderate or severe hepatic impairment.
No dose adjustments are recommended in patients with mild renal impairment (see section 5.2). Marstacimab has not been studied in patients with moderate or severe renal impairment.
No dose adjustments are recommended in patients over 65 years of age (see section 5.2).
Hympavzi should not be used in children less than 1 year of age because of potential safety issues. The safety and efficacy of marstacimab 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.
The safety and efficacy of marstacimab 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, it is recommended to discontinue Hympavzi 6 to 12 days prior and initiate management 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. The product information for the clotting factor concentrate should be consulted for dose 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 medicinal products (see Missed dose section above).
Hympavzi is for subcutaneous use 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 the medicinal product if a 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 about 15 to 30 minutes away from direct sunlight (see sections 6.4 and 6.6). The medicinal product should not be warmed by using a heat source such as hot water or a microwave.
The recommended injection sites are the abdomen and thigh. Other locations are acceptable if required. Administration of Hympavzi in the upper arm (pre-filled syringe only) and buttocks (pre-filled pen only) should be performed by a caregiver or healthcare professional only. The medicinal product 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.
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 injected into a vein or muscle.
During treatment with Hympavzi, other medicinal products for subcutaneous administration should, preferably, be injected at different anatomical sites.
For comprehensive instructions on the administration of the medicinal product, see section 6.6 and the ‘Instructions for Use’ provided at the end of the package leaflet.
There is limited experience with overdose of marstacimab.
No serious adverse events occurred in a small number of adult patients weighing ≥ 50 kg who had up to 3 months of exposure to marstacimab at 450 mg administered subcutaneously weekly during early phase studies. However, this was a small group, and the effect of longer-term high exposures is unknown. Receiving higher doses than recommended may result in hypercoagulability.
Patients who receive an accidental overdose should immediately contact their healthcare provider and be monitored closely. In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and/or hypercoagulability and appropriate symptomatic treatment be instituted immediately.
Doses in excess of 150 mg per week for adolescents aged 12 to 17 years weighing < 50 kg have not been studied. No case of overdose has been reported in the paediatric population. The principles described above apply to the management of overdose in the paediatric population.
2 years.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the pre-filled syringe or pre-filled pen in its original carton in order to protect from light.
The medicinal product may be removed from refrigerated storage and stored in its original carton for one single period of maximum 7 days at room temperature (up to 30°C). The medicinal product must not be returned to refrigerated storage. Prior to the end of this period of room temperature storage, the medicinal product must be used or discarded.
Hympavzi 150 mg solution for injection in pre-filled syringe:
Each carton contains one single-dose pre-filled syringe (Type I glass) with a plunger stopper (chlorobutyl elastomer) and a stainless steel 27 gauge, ½ inch staked needle with a needle shield (thermoplastic elastomer).
Each pre-filled syringe contains 1 mL solution for injection.
Hympavzi 150 mg solution for injection in pre-filled pen:
Each carton contains one single-dose pre-filled pen.
The syringe inside the pen is made from Type I glass with a plunger stopper (chlorobutyl elastomer) and a stainless steel 27 gauge, ½ inch staked needle with a needle shield (thermoplastic elastomer).
Each pre-filled pen contains 1 mL solution for injection.
This medicinal product is for single use only.
Do not shake.
For a more comfortable injection, allow the medicinal product to warm up to room temperature in the carton protected from direct sunlight for about 15 to 30 minutes.
Inspect the solution visually prior to use. Hympavzi is a clear and colourless to light yellow solution. Do not use if the medicinal product is cloudy, dark yellow, or contains flakes or particles.
Comprehensive instructions for the preparation and administration of the medicinal product are provided in the package leaflet and ‘Instructions for Use’.
Hympavzi does not contain preservatives; therefore, unused portions should be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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