The FDA ( Food and Drug Administration ) has informed the public that the leukemia drug Sprycel ( Dasatinib ) may increase the risk of a rare, but serious condition in which there is abnormally high blood pressure in the arteries of the lungs ( pulmonary arterial hypertension, PAH ). Information about this risk has been added to the Warnings and Precautions section of the Sprycel drug label.
Sprycel is used to treat certain adult patients with Philadelphia chromosome-positive chronic myeloid leukemia ( CML ) or acute lymphoblastic leukemia ( ALL ). It works by blocking the action of an abnormal protein that signals cancer cells to multiply.
The cumulative worldwide exposure to Sprycel is estimated to be 32,882 patients, based on the total sales volume between initial approval in June 2006 and June 2011.
As a result of pulmonary arterial hypertension, the heart must work harder to pump the blood into the lungs. Over time, the overworked heart muscle may become weak and lose its ability to pump enough blood through the lungs. Symptoms of pulmonary arterial hypertension may include shortness of breath, fatigue, and swelling of the body ( such as the ankles and legs ).
In reported cases, patients developed pulmonary arterial hypertension after starting Sprycel, including after more than one year of treatment. Patients with PAH during Sprycel treatment were often taking other medications at the same time or had other co-existing medical conditions. Other medical conditions may also cause symptoms similar to those seen with pulmonary arterial hypertension. Therefore, in symptomatic patients, if other causes have been ruled out, a diagnosis of Sprycel-associated pulmonary arterial hypertension should be considered.
Pulmonary arterial hypertension may be reversible if Sprycel is discontinued.
Healthcare professionals should evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to starting Sprycel and also during treatment. If pulmonary arterial hypertension is confirmed, Sprycel should be permanently discontinued.
Additional information for healthcare professionals
Sprycel may increase the risk of pulmonary arterial hypertension which may occur anytime after initiation, including after more than one year of treatment. Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating Sprycel and during treatment. Patients with PAH during Sprycel treatment were often taking concomitant medications or had co-morbidities. Symptoms of pulmonary arterial hypertension include dyspnea, fatigue, hypoxia, and fluid retention.
Before initiating invasive procedures, more common etiologies of dyspnea associated with Sprycel therapy should be excluded, including pleural effusion, pulmonary edema, anemia, and lung infiltration.
Since pulmonary arterial hypertension may be reversible upon discontinuation of Sprycel, a diagnostic approach of interruption of Sprycel treatment may be considered to observe for improvement.
Right heart catheterization can confirm the diagnosis by showing normal pulmonary capillary wedge pressure ( less than 15 mmHg ) but elevated pulmonary artery ( PA ) pressure ( mean PA pressure greater than 25 mmHg ), indicating that the hypertension is pre-capillary and is not a consequence of left heart failure or chronic lung disease.
If pulmonary arterial hypertension is confirmed, Sprycel should be permanently discontinued.
Source: FDA, 2011
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