Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Kyowa Kirin Limited, Tostran (testosterone, 2% gel) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Kyowa Kirin Limited has notified MHRA that the priming instructions in the current Patient Information Leaflet (PIL) for Tostran 2% gel (testosterone) (batch number: 2649810, 2649850, 2649860, 2649820, 2661080, 2661090, 2650030) require updating.
Following a manufacturing change to the Tostran 2% gel dosage pump/dispenser system, the manufacturer has observed that the priming instruction requires changing. Data from the end of shelf life in-use testing has shown that the number of actuations required to prime the device to achieve correct dosing increases over time. This means that more pumps to prime the device being using it for the first time are now required. If these instructions are not followed then a less accurate first dose may be delivered. The PIL and Summary Product Information will be updated to include these the new priming instructions, subject to approval by MHRA.
Healthcare professionals are advised to inform patients that there was a change to the pump/dispenser device supplied with this medicine and the priming instructions prior to use in the current PIL are not accurate. Advise patients that priming should performed before first use as follows:
- With the canister in the upright position, slowly and fully depress and release the actuator until gel is dispensed.
- Slowly depress and release the actuator a further 6 times.
- Discard the gel from the 6 depressions safely in household waste (outside of reach of children or pets).
- Deliver the dose as instructed by a healthcare professional and follow the instructions to prevent accidental transfer to others.
It is only necessary to prime the pump before the first dose. There have been no changes to the content of the canister or the quality of the gel. The device continues to deliver a total of 120 active dose pumps, each dispensing 0.5g of gel (equivalent to 10 mg of testosterone). The storage conditions specified on the pack remain correct.
The change to the priming instruction is considered a low risk to patient safety. To avoid shortages of this medicine, Kyowa Kirin Limited intend to distribute these batches whilst the new PIL is being assessed.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-kyowa-kirin-limited-tostran-testosterone-2-percent-gel-el-23-a-slash-33
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Monday, Sep 4, 2023
Issued at HKT 15:30
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