Is Pacritinib approved by the FDA?
Pacritinib, with the generic name pacritinib [pak-RI-ti-nib], is approved by the FDA for the treatment of myelofibrosis in adults. Marketed under the brand name Vonjo, pacritinib is available in the form of oral capsules containing 100 mg of the active ingredient. It belongs to the drug class of multikinase inhibitors.
What is Pacritinib Used For?
Pacritinib is primarily used to treat myelofibrosis in adults. This condition involves the proliferation of fibrous tissue in the bone marrow, leading to the formation of scar tissue and disruption of normal blood cell production.
In clinical practice, pacritinib is prescribed for patients with intermediate or high-risk primary or secondary myelofibrosis (post-polycythemia vera or post-essential thrombocythemia), especially in those with a platelet count less than 50 x 10^9/L.
Pacritinib Side Effects
As with any medication, pacritinib can cause side effects, some of which may be serious. Common side effects include swelling in the ankles, legs, and feet, nausea, vomiting, and pale skin. Serious side effects that require immediate medical attention include:
- Bleeding, bruising, and fever
- Severe or ongoing diarrhea
- Dizziness or feeling light-headed, indicating potential cardiovascular issues
- Symptoms suggestive of a stroke, such as sudden numbness, weakness, severe headache, or speech difficulties
- Signs of a blood clot in the lung or elsewhere in the body, characterized by chest pain, sudden cough, or shortness of breath
- Symptoms resembling a heart attack, such as chest pain or pressure, radiating pain to the jaw or shoulder, nausea, or sweating
- Signs of infection like fever, chills, sore throat, body aches, fatigue, or unusual bruising or bleeding
How to Take Pacritinib
Patients should adhere strictly to their prescribed dosage regimen, typically taking 200 mg of pacritinib orally twice daily. It can be taken with or without food, and the capsules should be swallowed whole, not crushed or opened. Regular blood tests are necessary before and during treatment to monitor its effects.
FDA Approval and Further Information
Pacritinib received FDA approval for its efficacy and safety profile in treating myelofibrosis, especially in patients who have failed other therapies or have specific risk factors associated with their condition. It is crucial for patients to discuss with their healthcare provider any other medications they are taking, as pacritinib may interact with certain drugs, affecting their effectiveness or causing adverse effects.
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