TAKHZYRO 300 mg solution for injection in pre-filled syringe (lanadelumab) is a new specialty within the TAKHZYRO range, available in town and in hospitals.
In the hospital, it is intended to replace the vial form which, in the meantime, remains on sale to outpatients while stocks last.
Like the vial, TAKHZYRO in pre-filled syringe is a disease-modifying treatment indicated for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
The reimbursement scope is limited, including only patients who have benefited from preventive treatments of 1
re intention well conducted for 3 to 6 months.
The ready-to-use TAKHZYRO pre-filled syringe comes with a needle for subcutaneous injection. It should be stored in the refrigerator, between 2 and 8 ° C.
TAKHZYRO in a pre-filled syringe is for single use and provides a single injection of 300 mg of lanadelumab. The recommended starting dose of anadelumab is 1 injection of 300 mg every 2 weeks.
TAKHZYRO pre-filled syringe is reimbursable at 65%, on hospital prescription, approved for communities and included on the list in addition to GHS.
Its public price (excluding dispensing fees) is 11,853.96 euros (1 pre-filled syringe).
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Edematized right hand during an attack of hereditary angioedema (illustration @LucyHAE on Wikimedia).
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Until now, lanadelumab has only been available as a solution for injection in a vial (TAKHZYRO 300 mg in a 2 mL vial, supplied with an empty syringe) in the hospital, with the possibility of on-lending to outpatients.
TAKHZYRO in a pre-filled syringe is also distributed in hospital but only for internal use (not retrocedable by hospital pharmacies). Ultimately, the pre-filled syringe will replace the vial which, in the meantime, remains retrocedable while stocks last.
TAKHZYRO 300 mg solution for injection in pre-filled syringe and TAKHZYRO 300 mg solution for injection in vial have the same indication: prevention of recurrent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
TAKHZYRO is subject to additional monitoring which will allow rapid identification of new safety information. Healthcare professionals will report any suspected side effects.
A limited scope of coverage compared to the indication in the Marketing Authorization
As for TAKHZYRO in a vial, the Transparency Committee (TC) has attributed a significant actual benefit (SMR) to TAKHZYRO in a pre-filled syringe in the long-term preventive basic treatment in patients aged 12 years and over, presenting severe and recurrent attacks of hereditary angioedema (HAE) and intolerant or insufficiently controlled by preventive treatments of 1re intention well conducted for 3 to 6 months.
On the other hand, the AB is considered insufficient in the other clinical situations provided for by the marketing authorization (MA), such as patients naïve to preventive treatments of 1re intention.
Description of the TAKHZYRO pre-filled syringe
The TAKHZYRO pre-filled syringe is for single use and designed to deliver the drug by subcutaneous injection (SC).
It contains 2 mL of solution, equivalent to 300 mg of lanadelumab (recommended dose every 2 weeks).
The pre-filled syringe is ready to use, fitted with an injection needle (crimped needle 27G x 13 mm) covered by a cap (cf. Figure 1).
–TAKHZYRO pre-filled syringe should be stored in a refrigerator, at 2-8 ° C, in the outer carton, in order to protect from light.
The solution in a pre-filled syringe can be stored at a temperature not exceeding 25 ° C for a single period of 14 days (on a date which must not be later than the expiration date). In this case, the pre-filled syringe should not be placed in the refrigerator.
In practice: dosage and instructions for use of TAKHZYRO pre-filled syringe
TAKHZYRO is not intended for the treatment of acute attacks of HAE. This is a basic treatment.
One injection every 2 weeks
The recommended starting dose is 300 mg of lanadelumab every 2 weeks, equivalent to 1 injection with the TAKHZYRO pre-filled syringe (2 mL) every 2 weeks.
In patients with a stable absence of seizure on treatment, a dose reduction of 300 mg lanadelumab every 4 weeks may be considered, especially in low body weight patients.
SC injection
The solution for injection should only be administered subcutaneously (SC), in abdomen, thighs or upper outer part of the arm. It is recommended to rotate the injection sites.
TAKHZYRO can be self-administered or given by a caregiver only after training in the SC injection technique by a healthcare professional.
It is advisable to remove the pre-filled syringe from the refrigerator 15 to 30 minutes before giving the injection, to allow the solution to come to room temperature.
Administrative identity
Box 1 – Coverage scope for TAKHZYRO pre-filled syringe (reimbursement, approval to communities, GHS)
| Long-term preventive treatment in patients aged 12 years and over with severe and relapsing attacks of hereditary angioedema (HAE) and intolerant or insufficiently controlled by first-line preventive treatments well conducted for 3 to 6 months (corresponding to second-line use). |
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For further
Opinion of the Transparency Commission – TAKHZYRO pre-filled syringe (HAS, September 9, 2020)
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