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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.
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It is essential that the entire contents of the solvent vial is added to the concentrate vial to produce a concentrate-solvent mixture with the intended concentration of 10 mg/mL cabazitaxel.
It is essential that the enti鈥�
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Capillary leak syndrome (CLS) has been reported in recipients of filgrastim, including patients undergoing chemotherapy and a healthy donor undergoing peripheral blood progenitor-cell mobilisation; it has also been reported 鈥�
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Importance of establishing wildtype RAS (KRAS and NRAS) status before treatment of metastatic colorectal cancer.
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Restricted dose and duration of use.
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New advice on dilution and administration in patients age 65 years or older refers only to the indication for prevention of chemotherapy-induced nausea and vomiting.
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New specific guidance on dose-dependent prolongation of QTc with ondansetron.
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Healthcare professionals should consider this risk when deciding whether to treat patients with thalidomide monitor for the occurrence of these conditions.
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Rare cases of atypical femoral fracture with long-term use.
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Routine monitoring of liver function now recommended.
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The non-identical nature of biological medicines and vaccines means it is very important that safety surveillance is carried out on a brand/product-specific basis.
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A safety review conducted at the end of its routine use during the ongoing human papillomavirus immunisation programme has found that no new risks have been identified for Cervarix, and that the balance of its risks and bene鈥�
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Fatal cases of severe symptomatic hypocalcaemia, and risk of hypocalcaemia at any time during treatment.
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Five cases of necrotising fasciitis have been reported in patients treated with panitumumab in combination with chemotherapy.
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Patients who present with acute or worsening signs and symptoms of keratitis should be referred promptly to an ophthalmology specialist.
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Surgeons reminded to have competent personnel and emergency facilities available for at least 1 hour after administration of the blue dye.
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Healthcare professionals should consider the possibility of second primary malignancy in patients treated with lenalidomide.
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Onsenal鈻� (celecoxib) is no longer approved in Europe for the reduction of intestinal polyps in familial adenomatous polyposis (FAP).
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Use restricted to adults with advanced or metastatic breast cancer only.
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Increased risk of arterial thromboembolism, including myocardial infarction and cerebrovascular events for patients treated with thalidomide.
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Atypical femoral fractures reported rarely with bisphosphonate therapy, mainly in patients receiving long-term treatment for osteoporosis.
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Where possible, use an appropriate alternative therapy for patients at increased risk of thrombosis.
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Patients receiving lenalidomide for management of multiple myeloma should be closely monitored for evidence of arterial and venous thromboembolic events.
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Dental examination and appropriate preventive dentistry should be considered before treatment with bevacizumab or sunitinib.
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Drug interactions involving CYP2D6, genetic variants, and variability in clinical response
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Insufficient evidence to confirm a link between oral bisphosphonate use and an increased risk of oesophageal cancer.
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Prescribers should remain vigilant with regards to the similarity of these 2 drug names.
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Infusion reactions and hypersensitivity reactions have been reported commonly during treatment with Avastin.
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New reports of serious hypersensitivity reactions (including anaphylaxis) in patients receiving panitumumab, some of which were fatal.
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Zoledronic acid is associated with reports of renal impairment and renal failure, especially in patients with pre-existing renal dysfunction or other risk factors. Renal function should be measured before each dose, and pati鈥�
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A case of progressive multifocal leukoencephalopathy (PML) with a fatal outcome was reported in a patient with rheumatoid arthritis who had not previously received treatment with methotrexate or a TNF antagonist.
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Batches of this medicine are being recalled from the market because of low levels of microbial contamination.
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All patients with cancer should have a dental check-up before bisphosphonate treatment.
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Patients with existing meningioma or a history of meningioma must not be prescribed high-dose (鈮�25 mg per day) cyproterone acetate.
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New safety information for intensive monitoring of Erlotinib.
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Continued monitoring of medicines with a black triangle status.
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Spontaneous reporting on the Yellow Card portal has provided important information in the identification of PML associated with some drugs.
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Toremifene (fareston) is associated with a dose-dependent risk of QT prolongation.
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Severe infusion-related hypersensitivity reactions have occurred in patients receiving temsirolimus.
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Patients with cancer who received recombinant human erythropoietins in clinical trials had an increased risk of tumour progression and reduced overall survival compared with study controls.
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Clinical trial results suggest an increased risk of atrial fibrillation for zoledronic acid (Aclasta鈻�), pamidronic acid, and possibly for alendronic acid, although the balance-risk remains favourable for bisphosphonates.
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A similar biological medicinal product (biosimilar) is a new biological product that has been developed to be similar to an existing biological product (鈥渞eference鈥� product).
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Advice for healthcare professionals on potentially fatal outcomes of oral anticancer medicines if they are not prescribed, dispensed or administered properly.
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Over-correction of haemoglobin concentration may increase the risk of death and serious cardiovascular events in patients with chronic kidney disease; it may increase the risk of thrombosis and related complications in patie鈥�
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To avoid the risk of air embolism, these products should not be infused under pressure.
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Risk of early psychiatric side-effects is one of several important safety issues for healthcare professionals to discuss with patients and carers, who should seek urgent medical advice in the event of any worrying symptoms.