"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
Patients should be informed that VALSTAR (valrubicin) has been shown to induce complete responses in only about 1 in 5 patients, and that delaying cystectomy could lead to development of metastatic bladder cancer, which is lethal. They should discuss with their physician the relative risk of cystectomy versus the risk of metastatic bladder cancer (see Clinical Trials) and be aware that the risk increases the longer cystectomy is delayed in the presence of persisting CIS.
Patients should be informed that the major acute toxicities from VALSTAR (valrubicin) are related to irritable bladder symptoms that may occur during instillation and retention of VALSTAR (valrubicin) and for a limited period following voiding. For the first 24 hours following administration, red-tinged urine is typical. Patients should report prolonged irritable bladder symptoms or prolonged passage of red-colored urine immediately to their physician.
Women of childbearing potential should be advised not to become pregnant during treatment. Men should be advised to refrain from engaging in procreative activities while receiving therapy with VALSTAR (valrubicin) . All patients of reproductive age should be advised to use an effective contraception method during the treatment period.
Last reviewed on RxList: 11/24/2008
This monograph has been modified to include the generic and brand name in many instances.
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