Farmacia hospitalaria : órgano oficial de expresión científica de la Sociedad Española de Farmacia Hospitalaria
-
Lenalidomide is an immunomodulatory drug approved by the AEMPS and the EMA, in combination with dexamethasone, for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Moreover, it has recently been approved for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. It has also shown to be active in other hematologic and no hematologic diseases. ⋯ Different clinical practice guidelines and scientific evidence portals consider lenalidomide a valid alternative in the first-line treatment of patients with myelodysplastic syndromes, specially those with the deletion of 5q, and in second line for patients with chronic lymphocytic leukemia. However, the available evidence of lenalidomide in the treatment of patients with primary amyloidosis and primary myelofibrosis is limited, ant thus is not considered as the first choice treatment. In any case, the treatment of choice should consider the safety profile in each patient, the previous treatments that has received and the own therapeutic protocols of each center.
-
Ratiograstim® is the first filgrastim biosimilar approved by EMEA. The reference medicinal product is Neupogen®. The active substance is filgrastim (the manufacturing laboratory, ratiopharm, is using the name XM02). ⋯ Ratiograstim® has the same indications as the reference product: — Cytotoxic chemotherapy induced neutropenia. — Neutropenia caused by myeloablative therapy followed by BMT. — Mobilisation of peripheral blood progenitor cells (PBPC). — Congenital, cyclic or idiopathic neutropenia. — Persistant neutropenia in HIV-patients. Authorisation according to the EMEA guidelines for biosimilars by centralized approval procedure, to demonstrate quality, efficacy and safety compared to the reference product Neupogen®. Comprehensive phase I and phase III clinical studies involving 880 subjects and patients have been completed (table 1).
-
To report and discuss the results of clinical trials published concerning chemotherapy for metastatic colorectal cancer in order to elucidate and define treatment guidelines. ⋯ New drugs for metastatic colorectal cancer open up new therapy lines allowing increasingly improved survival. However, optimal schemes, as well as their order of administration, have yet to be fully devised.
-
The Spanish Pharmacovigilance System for Medicinal Products for Human Use, integrated by regional centers of pharmacovigilance coordinated by the Spanish Agency for Medicines and Health Products, is responsible for developing the Program of Spontaneous Reporting of Suspected Adverse Drug Reactions in our country. Although, until now, reports were only requesting to health professionals, the current understanding of the role of patients in the clinical setting and the experience gained in other countries of our environment, have demonstrated the convenience of developing active participation systems to patients in the reporting of suspected adverse drug reactions. In addition, this is taking into account in the new European legislation on pharmacovigilance.
-
When validating oral chemotherapy, pharmacists should confirm the suitability and correctness of the prescription, applying the same safety standards as those used for parenteral cytostatic drugs. There are an increasing number of cancers for which orally administered drugs are available, which increases patient satisfaction as these drugs can be taken at home without the need to visit a hospital. ⋯ However, the cost of these agents should be below a threshold acceptable for society. As an aid to decision making, pharmacoeconomic tools should be used.