【Drug Name】

Name: Acalabrutinib Capsules

Product Name: AKADX

【Specification】

100mg

【Indications】

AKADX is a prescription medicine used to treat adults with:

• Mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer.

• Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

It is not known if AKADX is safe and effective in children.

【Recommended Dosage】

How should I take AKADX?

• Take AKADX exactly as your healthcare provider tells you to take it.

• Do not change your dose or stop taking AKADX unless your healthcare provider tells you to.

• Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking AKADX if you develop certain side effects.

• Do not switch (interchange) your AKADX tablets with AKADX capsules.

• Take AKADX 2 times a day (about 12 hours apart).

• Take AKADX with or without food.

• Swallow AKADX tablets whole with a glass of water. Do not chew, crush, dissolve, or cut ttablets.

• If you miss a dose of AKADX, take it as soon as you remember. If it is more than 3 hours past your usual dosing time, skip the missed dose and take your next dose of AKADX at your regularly scheduled time. Do not take an extra dose to make up for a missed dose.

【Side Effects】

AKADX may cause serious side effects, including:

• Serious infections can happen during treatment with AKADX and may lead to death. Your healthcare provider may prescribe certain medicines if you have an increased risk of getting infections. Tell your healthcare provider right away if you have any signs or symptoms of an infection, including fever, chills, or flu-like symptoms.

• Bleeding problems (hemorrhage) can happen during treatment with AKADX and can be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding,

including:

o blood in your stools or black stools (looks like tar)

o pink or brown urine

o unexpected bleeding, or bleeding that is severe or you cannot control

o vomit blood or vomit that looks like coffee grounds

o cough up blood or blood clots

o dizziness

o weakness

o confusion

o changes in your speech

o headache that lasts a long time

o bruising or red or purple skin marks

• Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with AKADX, but can also be severe. Your healthcare provider should do blood tests to check your blood counts regularly during treatment with AKADX.

• Second primary cancers. New cancers have happened in people during treatment with AKADX, including cancers of the skin or other organs. Your healthcare provider will check you for skin cancers during treatment with AKADX. Use sun protection when you are outside in sunlight.

• Heart rhythm problems (atrial fibrillation and atrial flutter) have happened in people treated with AKADX. Tell your healthcare provider if you have any of the following signs or

symptoms:

o fast or irregular heartbeat

o dizziness

o feeling faint

o chest discomfort

o shortness of breath

The most common side effects of AKADX include:

• headache

• diarrhea

• muscle and joint pain

• upper respiratory tract infection

• bruising

These are not all of the possible side effects of AKADX.

Call your doctor for medical advice about side effects.

【Storage】

• Store at or below 86°F (30°C).

Keep all medicines out of reach of children.