Applies to avatrombopag: oral tablet.

Serious side effects of Avatrombopag

Along with its needed effects, avatrombopag 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 avatrombopag:

Less common

• Bleeding of the gums
• nosebleeds

Less common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• rapid weight gain
• tingling of the hands or feet
• unusual weight gain or loss

Rare

• Confusion
• decreased urine output
• dizziness
• fast or irregular heartbeat
• headache
• increased thirst
• loss of consciousness
• muscle pain or cramps
• nausea
• pale skin
• seizures
• swelling of the face, ankles, or hands
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Incidence not known

• Difficulty breathing
• pain in the chest, groin, or legs, especially the calves
• severe, sudden headache
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• vision changes

Other side effects of Avatrombopag

Some side effects of avatrombopag 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

• Body aches or pain
• bruise
• chills
• cough
• difficulty in moving
• ear congestion
• fever
• joint pain
• loss of voice
• muscle stiffness
• sneezing
• sore throat
• stomach pain
• stuffy or runny nose

For Healthcare Professionals

Applies to avatrombopag: oral tablet.

General

The most common serious adverse reactions were headache and hyponatremia.^[Ref]

Nervous system

Very common (10% or more): Headache (up to 31%)^[Ref]

Other

Very common (10% or more): Fatigue (up to 28%), pyrexia (up to 11%)

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

Cardiovascular

Very common (10% or more): Contusion (26%)

Common (1% to 10%): Thromboembolic events

Respiratory

Very common (10% or more): Epistaxis (19%), upper respiratory tract infection (15%), nasopharyngitis (10%)

Postmarketing reports: Choking sensation, pharyngeal edema

Musculoskeletal

Very common (10% or more): Arthralgia (13%)

Frequency not reported: Myalgia^[Ref]

Gastrointestinal

Very common (10% or more): Gingival bleeding (13%)

Common (1% to 10%): Abdominal pain, nausea^[Ref]

Dermatologic

Very common (10% or more): Petechiae (11%)

Postmarketing reports: Pruritus, rash, erythema, pruritus generalized, rash macular

Metabolic

Uncommon (0.1% to 1%): Hyponatremia^[Ref]

Hematologic

Frequency not reported: Anemia

Immunologic

Postmarketing reports: Hypersensitivity reactions, swelling face, swollen tongue