Pronunciation:

a-va-TROM-boe-pag

Brand Names:

• Doptelet

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Hematopoietic

Pharmacologic—

Thrombopoietin Receptor Agonist

Uses of This Medicine:

Avatrombopag is used to treat thrombocytopenia (low platelets in the blood) in adults with chronic liver disease who are scheduled to have a medical or dental procedure. It is also used to treat thrombocytopenia in patients with chronic immune thrombocytopenia who have had previous treatment that did not work well. Avatrombopag works by stimulating the bone marrow to produce more platelets.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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.

Children—

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.

Older adults—

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

Breast-feeding—

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.

Other medicines—

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

Other interactions—

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.

Other medical problems—

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).

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine with food.

If you have chronic liver disease, you should begin using this medicine 10 to 13 days before your scheduled procedure. You may have your medical or dental procedure 5 to 8 days after the last dose of avatrombopag.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (tablets):
  • For thrombocytopenia in patients with chronic immune thrombocytopenia:
    • Adults—Dose is based on your platelet count and must be determined by your doctor. At first, 20 milligrams (mg) (1 tablet) once a day. Your doctor may adjust you dose as needed. However, the dose is usually not more than 40 mg (2 tablets) per day.
    • Children—Use and dose must be determined by your doctor.
  • For thrombocytopenia in patients with chronic liver disease:
    • Adults—Dose is based on your platelet count and must be determined by your doctor. The dose is usually 40 (2 tablets) to 60 milligrams (mg) (3 tablets) once a day for 5 days.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will be needed while you are using this medicine.

Blood clotting problems may occur while you are using this medicine. Check with your doctor right away if you have pain, swelling, or tenderness in your leg, or pain in your chest.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

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

Some side effects 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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