Class 4 Medicines Defect Information: Ennogen Healthcare Limited
Class 4 Medicines Defect Information: Ennogen Healthcare Limited, Zoledronic Acid Ennogen 4mg/5ml concentrate for solution for infusion, EL (24)A/53
Ennogen Healthcare Limited has identified that action had not been taken to ensure the Patient Reminder Card (PRC) was distributed alongside the packs of product as part of the approved Additional Risk Minimisation Measures (RMM).
DMRC Number: DMRC-33615243
Company name: Ennogen Healthcare Limited
Product description: Zoledronic Acid Ennogen 4mg/5ml concentrate for solution for infusion, PL 40739/0233
SNOMED Code: 7333011000001103
Details of the affected batch:
| Batch No | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 35000341 | Apr-25 | 1 x 5ml | 01 Sep 2023 |
| 35000387 | Nov-25 | 1 x 5ml | 26 Jan 2024 |
| 35000389 | Nov-25 | 1 x 5ml | 16 Feb 2024 |
| 35000390 | Nov-25 | 1 x 5ml | 16 Feb 2024 |
Active Pharmaceutical Ingredient: zoledronic acid
Brief description of problem:
Ennogen Healthcare Limited has identified that action had not been taken to ensure the Patient Reminder Card (PRC) was distributed alongside the packs of product as part of the approved Additional Risk Minimisation Measures (RMM).
The purpose of the PRC is to alert patients to the risk of osteonecrosis of the jaw (ONJ) and remind them of the precautions to take before and during treatment with zoledronic acid.
This Class 4 Caution in Use notification applies to all batches for PL40739/0233 listed above which were distributed before 17-May-2024.
Ennogen Healthcare Limited has confirmed that all product distributed since 17-May-2024 has been, and shall continue to be, supplied with the PRC.
Advice to Healthcare Professionals:
Ennogen Healthcare Limited confirm that there is sufficient information available to the healthcare professionals administering the medicine via the PIL: Zolendronic Acid Leaflet_08-07-24_v5.cdr (medicines.org.uk) , SmPC: Zoledronic acid Ennogen 4 mg/5 ml concentrate for solution for infusion - Summary of Product Characteristics (SmPC) - print friendly - (emc) (medicines.org.uk) , BNF: Zoledronic acid / Drugs / BNF / NICE to ensure that the relevant cautions whilst taking the medicine and risks associated with ONJ can be discussed during consultation, to make the patient aware of the specific precautions to be taken before and during treatment.
Healthcare professionals can access the electronic versions of the PRC.
Alternatively healthcare professionals may contact Ennogen Healthcare Limited directly to obtain copies of the PRC for distribution to patients via their clinics by e-mailing MedicalInformation@ennogen.com
Patients being administered the product from the above specified batches should either be provided a link to the online copy of the PRC or given a hard copy.
Advice to Patients:
Patients should continue to take medicines from these batches as administered by your healthcare professional. This does not affect the quality of the product.
The Patient Reminder Card is an additional measure to ensure ongoing understanding for the patient of risks associated with osteonecrosis of the jaw during treatment.
If you have any concerns about the information provided with your medicine, please speak to your consultant or GP in the first instance.
Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Company contacts for further information:
For medical information enquiries please contact MedicalInformation@ennogen.com
For stock control enquiries please telephone +44 (0)1322 629220
To access the full recall: