FDA Approves Drug for Adults with Rare Form of Bone Marrow Disorder FDA has granted accelerated approval for Vonjo (pacritinib) capsules to treat adults who have a rare form of a bone marrow disorder known as intermediate or high-risk primary or secondary myelofibrosis and who have platelet (blood clotting cells) levels below 50,000/µL. Myelofibrosis is a rare bone marrow disorder that disrupts blood cell production. It causes extensive bone marrow scarring, which can lead to severe anemia (low levels of red blood cells). This scarring can also reduce the number of platelets, which increases the risk of bleeding. The disease often causes an enlarged spleen, the organ that filters red blood cells. Patients must not use Vonjo if they are also taking certain other medicines, such as strong CYP3A4 inhibitors or inducers. Common side effects include diarrhea, low platelet counts, nausea, anemia, and swelling in legs. Because of the risk of major bleeding, patients with active bleeding (blood loss that is quick and difficult to control) should avoid taking Vonjo, and patients should stop Vonjo seven days before any planned surgery. Patients who have bleeding while on Vonjo may need to pause or stop taking the medication, depending on the severity. Another JAK-inhibitor (a similar medication) increased the risk of major adverse cardiac events (such as death, heart attack and stroke) and cancer, particularly in patients with certain risk factors, as well as thrombosis (blood clots that block veins or arteries). Infections can also occur in patients treated with Vonjo. Patients with symptoms of these conditions should be promptly evaluated and treated. Patients should delay starting Vonjo until active serious infections have resolved. More safety information is available in the Vonjo prescribing information. | 
No comments:
Post a Comment