Cladribine dhpc-01-12
- 1. Direct Healthcare Professional Communication 01 12 2017 Cladribine (Litak and Leustat): risk of progressive multifocal leukoencephalopathy (PML) Dear Healthcare Professional, In agreement with the European Medicine Agency and Medicines and Healthcare products Regulatory Agency, Janssen‐Cilag Limited and Lipomed GmbH, would like to inform you of the ongoing product information changes to reflect the following: Summary Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been reported with cladribine. PML diagnosis has been reported 6 months to several years after treatment with cladribine. An association between cladribine and prolonged lymphopenia was reported in several of these cases. Consider PML in the differential diagnosis for patients with new or worsening neurological, cognitive or behavioural signs or symptoms. If PML is suspected, the patients should not receive further treatment with cladribine. Background on the safety concern Cladribine is a purine nucleoside analogue which acts as an antimetabolite. Medicines containing cladribine authorised for oncology indications are: Litak, which is indicated for hairy cell leukemia (HCL). Leustat, which is indicated for HCL and B‐cell chronic lymphocytic leukemia (CLL). Since cladribine can induce myelosuppression and immunosuppression, as well as lymphopenia that can last several months, it has the potential to increase the risk of PML (a rare, potentially fatal demyelinating disease of the brain caused by reactivation of the JC virus). Cases have been reported of PML associated with cladribine when used in oncology indications. Prolonged cladribine‐induced lymphopenia may be a potential risk factor for PML. The information for healthcare professionals and patients is currently being updated.
- 2. Cladribine is also authorised for the treatment of highly active relapsing multiple sclerosis (MS). The product information for cladribine for the MS indication already includes a warning about the risk of PML. Call for reporting Please continue to report any suspect adverse drug reactions associated with these products in accordance with the national spontaneous reporting system. Suspected adverse reactions should be reported to the MHRA through the Yellow Card Scheme: www.mhra.gov.uk/yellowcard Alternatively, prepaid Yellow Cards for reporting are available: upon request by mail: “FREEPOST YELLOW CARD” (no other address details necessary) by emailing yellowcard@mhra.gov.uk at the back of the British National Formulary (BNF) by telephoning the MHRA Yellow Card free phone reporting line: 0800‐731‐6789 or by electronic download through the Yellow Card section of the MHRA website When reporting please provide as much information as possible, including information about medical history, any concomitant medication, onset dates, treatment dates, product brand name and batch numbers. Suspected adverse reactions should also be reported to the relevant Marketing Authorisation Holder (see contact details below). Company contact point Lipomed GmbH Lipomed GmbH Hegenheimer Strasse 2 D‑79576 Weil/Rhein Germany Janssen‐Cilag Limited Janssen‐Cilag Limited 50‐100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG save@lipomed.com Tel: +41 61 702 02 00 Fax: +41 61 702 02 20 Suspected adverse reactions: e‐mail: dsafety@its.jnj.com Tel: 01494 567447 Fax: 01494 567799 Additional Information: e‐mail: medinfo@its.jnj.com Tel: 0800 7318450 or 01494 567 444 Fax: 01494 567 445 Didier Foechterlen General manager Lipomed GmbH Dr. Frank Wiegand Medical Director Janssen UK & Ireland