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Monitor patients closely for skin cancers. Advise patients to seek urgent attention if they develop signs or symptoms of serious infections.
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Letters were sent about eluxadoline (Truberzi), fingolimod (Gilenya), Bleo-Kyowa (bleomycin sulphate), Buccolam (midazolam), and ERWINASE.
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Letters were sent in September about Dacogen (decitabine), Eperzan▼(albiglutide), ERWINASE, ReoPro (abciximab), and recombinant human erythropoietins.
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Letters were sent about INOmax (nitric oxide) cylinders and triptorelin (Decapeptyl).
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Temporarily discontinue ibrutinib in patients who develop symptoms suggestive of ventricular arrhythmia and assess benefit-risk before restarting therapy. Establish hepatitis B virus status before initiating ibrutinib. Consi…
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Letters were sent about ibrutinib, daclizumab, aflibercept, valproate medicines, and arsenic trioxide.
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Recent clinical trials have shown increased mortality when bendamustine (Levact) was used in combination treatments outside its approved indications. Be aware that the risk of opportunistic infections for all patients receiv…
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There have been reports of rejection of solid organ transplants in patients treated with nivolumab or pembrolizumab. Ipilimumab (Yervoy▼) may also interfere with immunosuppressive therapy, increasing the risk of graft reject…
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Letters were sent about Arsenic Trioxide (Trisenox), Uptravi▼ (selexipag), DepoCyte (cytarabine), Cinryze▼ (C1 esterase inhibitor [human]), and Clexane (enoxaparin sodium).
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Denosumab is associated with a risk of osteonecrosis of the jaw, osteonecrosis of the external auditory canal has also been reported with denosumab.
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Letters were sent about Pharmalgen (Bee Venom and Wasp Venom) Initial kits, bendamustine (Levact), and ERWINASE.
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A summary of letters sent to healthcare professionals, including an important reminder about the withdrawal of retigabine (Trobalt) from the market.
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Prescribers should consider reducing the dose of ponatinib to 15 mg a day for patients with chronic phase chronic myeloid leukaemia (CP-CML) who have achieved a major cytogenetic response.
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A summary of letters sent to relevant healthcare professionals in January 2017.
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A summary of recent letters sent to relevant healthcare professionals, to inform them of updated safety information.
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A summary of recent safety letters sent to relevant healthcare professionals
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Updated advice for healthcare professionals is available, after conclusion of a review of the safety of idelalisib, including the risk of infection.
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A summary of safety letters sent to healthcare professionals in August 2016
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In June 2016, a letter was sent to healthcare professionals about Thalidomide Celgene.
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In May 2016, letters were sent regarding Nexplanon (etonogestrel implant) and ERWINASE.
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Patients should be tested for hepatitis B virus before starting treatment with BCR-ABL tyrosine kinase inhibitors.
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Before starting treatment with pomalidomide, establish hepatitis B virus status in all patients.
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There are new interim treatment recommendations for idelalisib for chronic lymphocytic leukaemia and follicular lymphoma in light of new findings from clinical trials outside its currently authorised drug combinations or ind…
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In April 2016, letters were sent regarding canagliflozin (Invokana▼, Vokanamet▼), BCR-ABL tyrosine kinase inhibitors, pomalidomide (Imnovid▼), and retigabine (Trobalt)
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The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.
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Dental examination and appropriate preventive dentistry should be considered before treatment, especially for patients also treated with an intravenous bisphosphonate.
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In March 2016, letters were sent regarding SGLT2 inhibitors, insulin lispro, natalizumab, noradrenaline, radium-223 dichloride, aflibercept and idelalisib.
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Use trametinib, authorised either as monotherapy or combined with dabrafenib, with caution in patients with risk factors for gastrointestinal perforation.
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In January 2016, letters were sent to healthcare professionals regarding fingolimod (Gilenya▼) and erlotinib (Tarceva)
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Use a lower starting dose of thalidomide in patients with untreated multiple myeloma who are older than age 75 years.
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Osteonecrosis of the external auditory canal has been reported very rarely (fewer than 1 in 10 000 patients) with bisphosphonates, mainly in association with long-term therapy (2 years or longer).
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In November, letters were sent regarding thalidomide, mycophenolate mofetil, nicorandil, InductOs, and dimethyl fumarate
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There have been reports of severe, sometimes fatal, cases of cardiac failure in patients treated with crizotinib.
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Prescribers should be aware of the risk of potentiation of radiation toxicity with vemurafenib when given before, during, or after radiotherapy
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In October 2015, letters were sent to healthcare professionals to provide safety information for the anticancer medicines crizotinib and vemurafenib
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Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced; denosumab 120 mg is now contraindicated in patients with unhealed lesions from dental or oral surgery.
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New monitoring instructions to detect these side effects as soon as possible.
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The new module helps clinicians understand how to identify, manage and avoid side effects when using corticosteroids.
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Since November 2014, letters were sent regarding vismodegib (Erivedge ▼), chlorhexidine solutions, carbocisteine oral liquid (Mucodyne Paediatric 125mg/5ml), regadenoson (Rapiscan), a parenteral nutrition emulsion (Trio…
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Available evidence shows that the risk of blood vessel blockage with ponatinib is likely to be dose-dependent, however the data are insufficient to recommend reducing the ponatinib dose.
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From October 2014 Dexamethasone 4 mg/ml injection (Organon Laboratories Limited) will be replaced by Dexamethasone 3.8 mg/ml solution for injection (Aspen Pharma Trading Limited).
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Minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia.
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Serious and fatal infusion reactions have occurred with ofatumumab and other anti-CD20 monoclonal antibodies. We remind you to always give premedication before each ofatumumab infusion. If a severe reaction occurs, interrupt…
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We remind you to provide clear information to patients and caregivers regarding risk of accidental patch transfer and ingestion of patches, and need for appropriate disposal of patches.
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importance of establishing wild type RAS (KRAS and NRAS) status before treatment of metastatic colorectal cancer
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If thin, translucent or white-to-yellow proteinaceous strands (1–2 mm in length) are visible, filtration is advised.
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Liver function should be tested before and during treatment with temozolomide.
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Patients with active infection with this virus should not be treated with ofatumumab.
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Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with capecitabine.
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Screening for hepatitis B virus is now recommended in all patients (not only those at risk of this infection) before starting treatment for all indications.