Applies to pacritinib: oral capsule.

Serious side effects of Pacritinib

Along with its needed effects, pacritinib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pacritinib:

More common

• Black, tarry stools
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• body aches or pain
• chills
• cough
• diarrhea
• ear congestion
• fever
• headache
• loss of voice
• pale skin
• pinpoint red spots on the skin
• rapid weight gain
• sneezing
• sore throat
• stuffy or runny nose
• tingling of the hands or feet
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

Less common

• Bloody eye
• lower back or side pain
• painful or difficult urination
• redness of the eye
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising

Incidence not known

• Chest pain or discomfort
• confusion
• coughing up blood
• difficulty in speaking
• dizziness
• double vision
• fainting
• general feeling of illness
• inability to move the arms, legs, or facial muscles
• inability to speak
• increased menstrual flow or vaginal bleeding
• irregular heartbeat recurrent
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• paralysis
• persistent non-healing sore
• pink growth
• prolonged bleeding from cuts
• red or dark brown urine
• reddish patch or irritated area
• shiny bump
• slow speech
• sweating
• swollen glands
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• vomiting
• weight loss
• white, yellow or waxy scar-like area
• yellow skin and eyes

Other side effects of Pacritinib

Some side effects of pacritinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bloody nose
• itching skin

For Healthcare Professionals

Applies to pacritinib: oral capsule.

General

The most commonly reported side effects included diarrhea, thrombocytopenia, and nausea.^[Ref]

Cardiovascular

Very common (10% or more): Peripheral edema (up to 20%), serious hemorrhage (up to 13%)

Common (1% to 10%): Cardiac failure, fatal hemorrhage, QT prolongation

Frequency not reported: Arterial thrombosis, cardiovascular death, deep vein thrombosis, major adverse cardiac events (MACE), myocardial infarction, pulmonary embolism, thrombosis^[Ref]

Dermatologic

Common (1% to 10%): Pruritus^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 48%), nausea (up to 32%), vomiting (up to 19%)^[Ref]

Hematologic

Very common (10% or more): Thrombocytopenia (up to 34%), anemia (up to 24%)

Common (1% to 10%): Neutropenia^[Ref]

Immunologic

Frequency not reported: Risk of infection (e.g., bacterial, fungal, mycobacterial, viral)^[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 15%)

Frequency not reported: Cerebral hemorrhage, meningorrhagia, stroke^[Ref]

Ocular

Common (1% to 10%): Conjunctival hemorrhage^[Ref]

Oncologic

Common (1% to 10%): Squamous cell carcinoma of skin

Frequency not reported: Acute myeloid leukemia, lymphoma, non-melanoma skin cancer (NMSC), secondary malignancies^[Ref]

Other

Very common (10% or more): Pyrexia (up to 15%)

Common (1% to 10%): Disease progression

Frequency not reported: Multiorgan failure^[Ref]

Respiratory

Very common (10% or more): Epistaxis (up to 12%)

Common (1% to 10%): Cough, dyspnea, pneumonia, upper respiratory tract infection^[Ref]