Direct healthcare professional communication on the importance of following instructions for use of Genotropin (somatropin) to mitigrate potential defect in pre-filled pen device
04.01.2016
Pfizer Croatia d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED), has informed healthcare professionals on the importance of following instructions for use of Genotropin 5,3 mg powder and solvent for solution for injection and Genotropin 12 mg powder and solvent for solution for injection (somatropin) to mitigrate potential defect in pre-filled pen device.
Summary
- The manufacturing defect in the dosing mechanism of some GoQuick pre-filled pens, used for administration of the dose of somatropin, might in some pens lead to the dose being overturned one extra click compared with a preset dose indicated in the memory window, if the dose knob is turned with excessive force.
- In that case the dose knob and the memory window do not show the same dose, i.e. the dose on the dose knob is not in line with the dose shown in the memory window.
- Failure to follow the instructions of GoQuick pen in the Patient Information Leaflet (PIL) may result in a small increase in the dose administered compared to the preset dose: an additional 0,05 mg of Genotropin for the 5,3 mg GoQuick pre-filled pens, and an additional 0,15 mg for the 12 mg GoQuick pre-filled pens.
- This has the potential to affect all patients being treated with Genotropin GoQuick for all approved indications.
- Instructions in the Patient Information Leaflet (PIL) instruct patients how to set the correct dose: the patient has to verify the correct dose has been dialed up before administration (i.e., such that the dose on the dose knob and that shown in the memory window are the same).
- Healthcare professionals should inform patients about the potential manufacturing defect and remind them to follow the instructions in the Patient Information Leaflet and to align the dose settings in order to avoid the potential for an incorrect dose being administered.
- Healthcare professionals should inform the patients to contact their doctor immediately if they notice a defective device.
Further information
Not all Genotropin GoQuick pre-filled pens are affected by this manufacturing defect. When setting the dose the patients generally use the force lower than the force used for the testing in which this manufacturing defect has been detected. The Marketing Authorisation Holder considers the risk of adverse drug reactions arising from administration of the increased dose to be negligible. Based on the analysis of the safety database the Marketing Authorisation Holder has established that no adverse drug reactions arising from this quality defect have been recorded since the marketing of this medicinal product.
Here you may view the direct healthcare professional communication.
The healthcare professionals are being reminded that they report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends the patients to contact their doctor or pharmacist regarding any adverse reaction they may notice.
