Applies to umbralisib: oral tablet.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• a severe skin rash, or sores on your skin or mouth;

• severe or ongoing diarrhea, stools with mucus or blood, or severe stomach pain;

• liver problems--stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

• low blood cell counts;

• nausea, vomiting, stomach pain, loss of appetite;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• muscle or bone pain;

• feeling tired; or

• abnormal kidney function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to umbralisib: oral tablet.

Hematologic

Very common (10% or more): Decreased neutrophil decreased (33%), decreased hemoglobin (27%), decrease platelets (26%)

Common (1% to 10%): Transaminase elevation, neutropenia

Frequency not reported: Anemia, thrombocytopenia^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (27%)^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (19%), decreased potassium (21%)^[Ref]

Psychiatric

Very common (10% or more): Insomnia (14%)^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection^[Ref]

Hepatic

Very common (10% or more): Increased alanine aminotransferase (33%), increased aspartate aminotransferase (32%)^[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (21%)

Common (1% to 10%): Pneumonia, dyspnea

Rare (less than 0.1%): Pneumonitis^[Ref]

General

Very common (10% or more): Pyrexia (10%)

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

Nervous system

Very common (10% or more): Fatigue (41%)^[Ref]

Renal

Very common (10% or more): Increased creatinine (79%)^[Ref]

Cardiovascular

Very common (10% or more): Edema (14%)^[Ref]

Dermatologic

Very common (10% or more): Rash (18%)

Rare (less than 0.1%): Exfoliative dermatitis^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (58%), nausea (38%), vomiting (21%), abdominal pain (19%)

Common (1% to 10%): diarrhea, colitis^[Ref]