Avatrombopag (oral route)

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of avatrombopag in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of avatrombopag in the elderly.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Avacopan
• Carbamazepine
• Clarithromycin
• Enzalutamide
• Fedratinib
• Fexinidazole
• Fluconazole
• Itraconazole
• Mavacamten
• Omaveloxolone
• Phenobarbital
• Primidone
• Rifampin
• Tazemetostat

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots, history of—Use with caution. May make these conditions worse.

• Blood clotting disorder (eg, antithrombin deficiency, Factor V Leiden, prothrombin 20210A or, Protein C or S deficiency)—Use with caution. May increase risk for blood clotting problems (eg, thromboembolism).

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

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