Pacritinib (pa-KRI-ti-nib)

Treats myelofibrosis.

Brand Name(s):

Vonjo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take this medicine about the same time each day.
• Swallow the capsule whole. Do not open, break, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with clarithromycin or rifampin.
• Some medicines can affect how pacritinib works. Tell your doctor if you are using a medicine that weaken your immune system.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, any type of infection, heart or blood vessel disease, diarrhea, active bleeding, or a history of cancer. Tell your doctor if you are a current or past smoker.
• Do not breastfeed during treatment and for 2 weeks after the last dose.
• This medicine may cause the following problems:
  • Serious bleeding problems
  • Heart rhythm problems, including QT prolongation
  • Increased risk of serious heart or blood vessel disease, including heart attack or stroke
  • Increased risk of blood clots, including deep vein thrombosis, pulmonary embolism, arterial thrombosis
  • Increased risk of cancer (including lymphoma, skin cancer)
  • Increased risk of serious infections (bacterial, fungal, viral)
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine 7 days before having surgery or medical tests.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• You may also receive medicines to help prevent nausea and vomiting.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, fainting
• Clumsiness, weakness on one side of your body, trouble speaking, trouble seeing, confusion
• Coughing up blood, numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Diarrhea
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, night sweats, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sores, reddish patch or irritated area, shiny bump, or pink growth on the skin
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Bloody nose

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088