Class 4 Medicines Defect Notification: Baxter Healthcare Corporation, Onkotrone Injection 2 mg/ml concentrate for solution for infusion, EL(26)A/14
Baxter Healthcare Corporation have informed the MHRA that the Patient Information Leaflet (PIL) packed in specified batches does not contain up to date information relating to the duration of contraception required for females after stopping taking this medication.
DMRC reference number
DMRC-38016571
Marketing Authorisation Holder
Baxter Healthcare Corporation
Medicine Details
Onkotrone Injection 2mg/ml concentrate for solution for infusion in 10 ml vials
PL: 00116/0398
Active Ingredient: mitoxantrone hydrochloride
SNOMED code: 4466011000001103
Carton GTIN Number: 55413760208829,
Unit (vial) GTIN Number: 05413760208824
Onkotrone Injection 2mg/ml concentrate for solution for infusion in 12.5 ml vials
PL: 00116/0398
Active Ingredient: mitoxantrone hydrochloride
SNOMED code: 4467411000001109
Carton GTIN Number: 55413760208843
Unit (vial) GTIN Number: 05413760208848
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 3L048A | 30-Nov-2026 | 1 x 10 mL vial | 16-Oct-2024 |
| 3L048I | 30-Nov-2026 | 1 x 10 mL vial | 30-Dec-2024 |
| 4E049Q | 30-Apr-2027 | 1 x 10 mL vial | 20-Feb-2025 |
| 4J050J | 30-Sep-2027 | 1 x 10 mL vial | 14-Apr-2025 |
| 4J050Q | 30-Sep-2027 | 1 x 10 mL vial | 10-Jun-2025 |
| 4J050V | 30-Sep-2027 | 1 x 10 mL vial | 7-Aug-2025 |
| 5B051B | 31-Jan-2028 | 1 x 10 mL vial | 2-Oct-2025 |
| 3C045AA | 28-Feb-2026 | 1 x 12.5 mL vial | 10-Feb-2025 |
| 3C045Y | 28-Feb-2026 | 1 x 12.5 mL vial | 29-Jul-2024 |
| 3C045Z | 28-Feb-2026 | 1 x 12.5 mL vial | 21-Oct-2024 |
| 5B051A | 31-Jan-2028 | 1 x 12.5 mL vial | 12-Jun-2025 |
Background
Baxter Healthcare Corporation have informed the MHRA that the Patient Information Leaflet (PIL) packed in the above batches does not contain up to date information relating to the duration of contraception required for females after stopping taking this medication.
The PIL for Onkotrone Injection 2mg/ml concentrate for solution for infusion, was updated regarding the duration of contraception for females and extended from four to nine months as follows: use effective contraception during therapy and for at least 9 months after cessation of therapy (PIL section 2). The specific batches listed in the table above do not contain this updated information in the PIL.
Future batches will contain the correct PIL.
Advice for Healthcare Professionals:
Inform female patients of the necessity to use contraception and not become pregnant for at least 9 months after stopping this medication.
The updated PIL can be accessed on the Electronic Medicines Compendium (eMC):
Upon request, Baxter Healthcare Corporation will provide hard copies of the updated PIL to wholesalers/pharmacies so that any remaining stock can be supplemented with the correct PIL information. To request hard copies of the PIL, please contact shs_regulatory_uk@baxter.com with your details, i.e. address, product with batch details, required number of leaflets.
Advice for Healthcare Professionals to Provide to Patients:
It is important for female patients to use contraception for a period of at least 9 months after stopping taking this medication. It is important that you do not become pregnant during this period. If you have any questions about this issue, please contact your healthcare professional in the first instance.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Additional information:
For all medical information enquiries regarding this communication, contact Baxter at MedInfo_UKI@baxter.com or telephone 0800 0260516
For stock control enquiries please contact Baxter at servicecs@baxter.com or telephone 0800 028 9881
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
Download document