ADR that result in revision of patient information
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| The United Kingdom: Carfilzomib (Kyprolis▼): risk of reactivation of hepatitis B virus |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that a recent EU review of clinical studies and cases of suspected adverse drug reactions has identified reports of hepatitis B reactivation associated with carfilzomib. Following the review, changes are being made to the Summary of Product Characteristics to recommend screening for hepatitis B virus before a patient starts carfilzomib treatment. Screening is also recommended for patients already under treatment with carfilzomib with unknown hepatitis B virus serology.
The review assessed cases worldwide up to 10 Jul 2019 and identified a total of 23 cases from clinical studies and post-marketing. In clinical studies, 8 serious cases of hepatitis B virus reactivation were identified. Of these, 5 cases had a plausible temporal association and liver function abnormalities and reported an improvement in the patient’s clinical condition once the medicine was stopped (positive dechallenge).
The review also identified 15 cases of hepatitis B virus reactivation in the post-marketing period. Most of these cases (93%; 14 cases) were serious. Reactivation was reported in 12 men and 3 women, with a median patient age of 70 years (range 41 to 78 years). The worldwide cumulative post-marketing exposure for carfilzomib is approximately 108 900 patients (42 200 patient-years) up to 19 Jan 2019.
Of the 13 post-marketing cases in which baseline serology was reported: 3 cases were positive for hepatitis B core antibodies (anti-HBc), 5 cases were negative for hepatitis B surface antigen (HBsAg), 1 case had negative anti-HBc, and 4 had undetected hepatitis B DNA. After diagnosis of hepatitis B virus reactivation, positive HBsAg was reported in 3 cases, with hepatitis B DNA elevated in 4 cases.
Most cases (80%;12) had a plausible temporal association. In 5 cases, the reports indicated the patients’ clinical condition improved once the medicine was stopped, and in 1 case, worsened again once the medicine was restarted. 11 patients received treatment with an anti-hepatitis B medicine. In 5 cases, carfilzomib treatment was continued, and the patient recovered from the hepatitis infection.
Healthcare professionals are advised:
- Hepatitis B virus reactivation has been reported in patients treated with carfilzomib.
- Screen all patients for hepatitis B virus before initiation of carfilzomib; patients with unknown serology who are already on treatment should also be screened.
- Consider prophylaxis with antivirals for patients with positive serology who are treated with carfilzomib.
- Monitor patients with positive serology for clinical and laboratory signs of hepatitis B reactivation during and after treatment.
- Advise patients with positive serology to seek medical help immediately if they experience signs and symptoms suggestive of hepatitis B virus reactivation
-In patients who have hepatitis B reactivation, it is recommended to consult relevant experts when making decisions regarding hepatitis B virus treatment and the continuation, interruption, or resumption of carfilzomib.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/carfilzomib-kyprolis-risk-of-reactivation-of-hepatitis-b-virus
In Hong Kong, there are 2 registered pharmaceutical products containing carfilzomib, namely Kyprolis For Injection 60mg/vial (HK-64828) and Kyprolis For Injection 30mg/vial (HK-65431). Both products are registered by Amgen Hong Kong Limited, and are prescription-only medicines. So far, the Department of Health (DH) has received 16 cases of adverse drug reaction related to carfilzomib, but these cases are not related to HBV reactivation.
Related news was previously issued by the Singapore Health Sciences Authority and was posted on the Drug Office website on 5 Nov 2019. Letters to inform local healthcare professionals were issued by the DH on the same day. In light of the MHRA’s announcement, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Nov 22, 2019
Issued at HKT 17:30
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