引 致 更 改 給 病 人 的 產 品 資 訊 的 藥 物 不 良 反 應 警 示
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| The United Kingdom: Daratumumab (Darzalex▼): risk of reactivation of hepatitis B virus (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that a recent EU cumulative review of worldwide data has identified reports of hepatitis B virus reactivation in patients treated with daratumumab.
There have been 6 cases of hepatitis B virus reactivation observed in clinical trials in patients with multiple myeloma. Most of these cases were considered non-serious, although fatal hepatitis B virus reactivation cases have been reported in clinical trials. There have also been reports from the post-marketing setting. Nearly all cases have been observed in the first 6 months of daratumumab treatment. In some cases, daratumumab has been reinitiated once hepatitis B virus reactivation has been controlled with antiviral medication. No cases of hepatitis B virus reactivation associated with daratumumab have been reported in the UK via the Yellow Card Scheme. Nevertheless, prescribers should be vigilant for the risk in UK patients and ensure serology is established in all patients being treated with daratumumab. In patients on daratumumab who have had hepatitis B virus reactivation, risk factors included previous autologous stem cell transplant (ASCT) and concurrent and/or prior lines of immunosuppressive therapy. Residence in or immigration from regions of high hepatitis B prevalence may also present a higher risk of hepatitis B seropositivity.
Identification of the role of daratumumab therapy in the reported cases of hepatitis B virus reactivation is complicated by the underlying medical condition, given that patients with multiple myeloma are immunosuppressed. In several cases, patients were also receiving concomitant medications associated with viral reactivation. However, because a causal relationship cannot be ruled out, the product information for daratumumab will be updated to reflect the new safety information. A letter has been sent to expected prescribers and dispensers of daratumumab.
Healthcare professionals are advised:
- Hepatitis B virus reactivation has been reported in patients treated with daratumumab, including several fatal cases worldwide.
- Screen all patients for hepatitis B virus before initiation of daratumumab. Patients with unknown serology who are already on treatment should also be screened.
- Monitor patients with positive serology for clinical and laboratory signs of hepatitis B reactivation during treatment, and for at least 6 months following the end of daratumumab treatment.
- Advise patients with positive serology to seek medical help immediately if they experience signs and symptoms suggestive of hepatitis B virus reactivation.
- Stop treatment with daratumumab in patients with hepatitis B virus reactivation and institute appropriate treatment in consultation with experts in the treatment of hepatitis B virus infection; consult with experts before resuming daratumumab in patients with adequately controlled viral reactivation.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/daratumumab-darzalex-risk-of-reactivation-of-hepatitis-b-virus
In Hong Kong, there are 3 registered pharmaceutical products containing daratumumab, namely Darzalex Concentrate For Solution For Infusion 100mg/5ml (Germany) (HK-65066), Darzalex Concentrate For Solution For Infusion 400mg/20ml (HK-65067) and Darzalex Concentrate For Solution For Infusion 100mg/5ml (Switzerland) (HK-65068). All products are registered by Johnson & Johnson (Hong Kong) Ltd, and are prescription-only medicines. So far, the Department of Health (DH) has received 9 cases of adverse drug reaction related to daratumumab, but these cases are not related to hepatitis B virus reactivation. Related news was previously issued by Health Canada and Singapore Health Sciences Authority, and was posted on the Drug Office website on 26 Mar 2019 and 2 Jul 2019 respectively. Letters to inform local healthcare professionals were issued by the DH on 26 Mar 2019. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Tuesday, Aug 20, 2019
Issued at HKT 16:00
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