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The health care professionals have been informed of the risk of severe cutaneous reactions associated with the use of Capecitabine ( Xeloda ).Xeloda is authorized for the following indications:a) Colo ...


The Food and Drug Administration ( FDA ) has approved Cimzia ( Certolizumab pegol ) for the treatment of adult patients with active psoriatic arthritis ( PsA ).Psoriatic arthritis is a chronic, inflam ...


MHRA ( Medicines and Healthcare Products Regulatory Agency ) previously advised that the contraindications for Dabigatran ( Pradaxa ) had been clarified to include a range of clinical conditions where ...


In the treatment of metastatic colorectal cancer, evidence of wildtype RAS status ( at exons 2, 3, and 4 of KRAS and NRAS ) is required before initiating treatment with Panitumumab ( Vectibix ) alone ...


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; ...


Although the risk of neuropsychiatric side effects with Mefloquine is well-established, a recent review of the prescribing information has led to strengthened warnings and new measures to help minimis ...


The use of short-acting beta2 agonists ( SABAs ) for tocolysis in premature labour has been restricted to 48 hours’ maximum parenteral use under specialist supervision, after a European safety review. ...


There is new evidence on neurodevelopmental delay in children following maternal use of Sodium Valproate. A European review is underway to evaluate all currently available evidence on the association ...


Different antiepileptic drugs ( AEDs ) vary considerably in their characteristics, which influences the risk of whether switching between different manufacturers’products of a particular drug may caus ...


Cases of intraoperative floppy iris syndrome ( IFIS ) during cataract surgery have been reported in patients taking the atypical antipsychotics Risperidone ( Risperdal ) or Paliperidone ( Invega ). IF ...


The use of Codeine for analgesia in children and adolescents under 18 has been restricted after a European safety review. The review was triggered by case reports of children who received Codeine for ...


The risk of foetal malformation with oral retinoids is extremely high, even when used at a low dose or for a short time during pregnancy. All oral retinoids have an associated Pregnancy Prevention Pro ...


Following a Europe-wide review of Cyproterone acetate with Ethinylestradiol ( Co-cyprindiol ), the balance of benefits and risks of Dianette ( brand leader ) and its generics remains positive. To furt ...


Available data indicate that the cardiovascular risk with Diclofenac is similar to that of the selective COX-2 inhibitors. Consistent with COX-2 inhibitors, Diclofenac is now contraindicated in those ...


Patients treated with Thalidomide ( Thalidomide Celgene ) have an increased risk of haematological second primary malignancies ( acute myeloid leukaemia and myelodysplastic syndromes ).Healthcare prof ...


Drug-induced liver injury has been observed in clinical trials investigating potential use in patients with autosomal dominant polycystic kidney disease ( ADPKD, an unlicensed indication ) at higher d ...


A review of available safety data for Strontium ranelate ( Protelos ) has raised concern about its cardiovascular safety beyond the already recognised risk of venous thromboembolism. An analysis of ra ...


Cilostazol ( Pletal ) is restricted to second-line use in patients for whom life-style modifications and other appropriate interventions have failed to sufficiently improve their symptoms.Furthermore, ...


Botulinum toxin type B ( Neurobloc ) is indicated only for the treatment of cervical dystonia ( torticollis ) in adults. MHRA ( Medicines and Healthcare Products Regulatory Agency ) recommends that pr ...


Dabigatran etexilate ( Pradaxa ) is contraindicated in patients with prosthetic heart valves requiring anti-coagulant treatment related to their valve surgery, regardless of the length of time elapsed ...


Atypical femoral fractures have been reported rarely in patients with postmenopausal osteoporosis receiving long-term ( greater than or equal to 2.5 years ) treatment with Denosumab 60 mg ( Prolia ) i ...


Roflumilast ( Daxas ) is a phosphodiesterase-type-4 ( PDE4 ) inhibitor used for maintenance treatment of severe chronic obstructive pulmonary disease ( COPD ) associated with chronic bronchitis. It is ...


Tredaptive is a fixed-dose combination product containing extended-release Nicotinic acid ( 1000 mg ) and Laropiprant ( 20 mg ), which has been indicated for the treatment of dyslipidemia, particularl ...


Elevations of liver enzymes occur in 1-10 patients out of every 100 treated with Lenalidomide ( Revlimid ) for multiple myeloma in clinical trials; the majority of these are non-serious. Serious ( pot ...


Starting Fingolimod ( Gilenya ) treatment, or re-starting Fingolimod after treatment interruption, results in transient decreases in heart rate. In some patients it can also cause transient bradycardi ...


The FDA ( Food and Drug Administration ) has approved Olysio ( Simeprevir ), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen ...


Incivo is a medicine that contains the active substance Telaprevir ; it is used to treat chronic hepatitis C ( a disease of the liver due to infection with the hepatitis C virus [ HCV ] ) in combinati ...


Xofigo is a radiopharmaceutical ( a medicine containing a radioactive substance ) that contains the active substance Radium-223 dichloride. It is used to treat adult men with cancer of the prostate. X ...


Pradaxa is a medicine that contains the active substance Dabigatran etexilate; it is used to prevent the formation of blood clots in the veins in adults who have had an operation to replace a hip or k ...


The FDA ( Food and Drug Administration ) has approved Diclegis ( Doxylamine and Pyridoxine ) to treat pregnant women experiencing nausea and vomiting.Diclegis is a delayed-release tablet intended for ...


The Food and Drug Administration ( FDA ) has approved Procysbi ( Cysteamine bitartrate ) for the management of nephropathic cystinosis in children and adults.Procysbi was granted orphan product design ...


The FDA ( Food and Drug Administration ) has approved Kcentra ( Prothrombin Complex Concentrate, Human ) for the urgent reversal of vitamin K antagonist ( VKA ) anticoagulation in adults with acute ma ...


Bayer HealthCare has announced that the FDA ( Food and Drug Administration ) has approved Xofigo ( Radium 223 dichloride ) for the treatment of patients with castration-resistant prostate cancer ( CRP ...


Eliquis is a medicine that contains the active substance Apixaban; it is used to prevent venous thromboembolism in adults following a hip or knee replacement operation.Eliquis is also used to prevent ...


Stivarga is an anticancer medicine that contains the active substance Regorafenib. It is used to treat metastatic colorectal cancer in adults who have already been treated with, or who cannot be given ...


Xarelto is a medicine that contains the active substance Rivaroxaban; it is used for the following in adults : to prevent venous thromboembolism ( VTE ) in patients who are undergoing surgery to repla ...


Significant liver injury associated with the use of Tolvaptan ( Samsca ) has been reported. In a large double-blind, 3-year, placebo-controlled trial ( TEMPO 3:4 ) in about 1400 patients with autosoma ...


The European Committee for Medicinal Products for Human Use ( CHMP ) has recommended approval of oral anticoagulant Xarelto ( Rivaroxaban ) 2.5 mg twice-daily in combination with standard antiplatelet ...


The Food and Drug Administration ( FDA ) warned the public that Azithromycin ( Zithromax or Zmax ) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fat ...


The FDA ( Food and Drug Administration ) has approved Kadcyla ( Trastuzumab Emtansine ), a new therapy for patients with HER2-positive, late-stage ( metastatic ) breast cancer.HER2 is a protein involv ...


The FDA ( Food and Drug Administration ) has approved a new use of Avastin ( Bevacizumab ) in combination with fluoropyrimidine-based Irinotecan or Oxaliplatin chemotherapy for people with metastatic ...


The Committee for Medicinal Products for Human Use ( CHMP ) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Relvar Ellipta, 184 mcg/22 mcg ...


The investigational compound, Lu AE58054 is a selective 5HT6 receptor antagonist with a different proposed mechanism of action than currently available Alzheimer's medications. Notably, a focus on the ...


Inflectra, a biosimilar medicine to the reference medicinal product, Remicade ( Infliximab ), has been approved for the treatment of inflammatory conditions including rheumatoid arthritis, ankylosing ...


Ruxolitinib ( Jakafi ) is an oral, selective inhibitor of Janus kinases 1 and 2 ( JAK1 and JAK2 ). Ruxolitinib, brand name Jakafi, is indicated for treatment of patients with intermediate or high-risk ...


Denosumab ( Prolia ) is a human monoclonal antibody ( IgG2 ) that targets and binds with high affinity and specificity to RANKL, preventing activation of its receptor, RANK, on the surface of osteocla ...


Melbourne researchers have discovered that anti-cancer compounds currently in clinical trials for some types of leukaemia could offer hope for treating the most common type of breast cancer. The re ...


A second large, prospective study by researchers at Fred Hutchinson Cancer Research Center has confirmed the link between high blood concentrations of Omega-3 fatty acids and an increased risk of pros ...


Pharmacodynamic and safety data from a Phase 2 proof-of-concept study of its investigational factor Xa inhibitor antidote Andexanet alfa ( PRT4445 ) in healthy volunteers who were administered the fac ...


The U.S. Food and Drug Administration ( FDA ) has granted accelerated approval of Iclusig ( Ponatinib ) for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leu ...