Calquence (acalabrutinib) belongs to a class of medications called kinase inhibitors. Alabrutinib works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Calquence is used to treat people with mantle cell lymphoma (MCL; a fast-growing cancer that begins in the cells of the immune system) who have already been treated with at least one other chemotherapy medication.

Calquence is also used alone or with obinutuzumab (Gazyva) to treat chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) and small lymphocytic lymphoma (SLL: a type of cancer that begins in the white blood cells).

Calquence can make it easier for you to bleed. Contact your doctor or seek emergency medical attention if you have any bleeding that will not stop.

Call your doctor at once if you have signs of bleeding inside your body, such as: dizziness, weakness, confusion, headache, speech problems, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds.

Take Calquence exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Do not switch brand forms without your doctor's advice.

Calquence is usually taken twice per day (about 12 hours apart) with or without food, with a glass of water.

Swallow the tablet or capsule whole and do not crush, chew, break, or dissolve it.

If you need surgery, tell the surgeon ahead of time that you are using Calquence. You may need to stop using the medicine for a short time.

While using Calquence, you may need frequent blood tests.

If you've had hepatitis B, it may come back. You may need liver function tests while using Calquence.

Store at room temperature away from moisture and heat.

Usual Adult Dose of Calquence for Lymphoma:

100 mg orally every 12 hours

Comments:
-Start treatment at cycle 1 (each cycle is 28 days) when use concomitantly with obinutuzumab.
-Start obinutuzumab at Cycle 2 for a total of 6 cycles and refer to the obinutuzumab prescribing information for recommended dosing. Administer Calquence prior to obinutuzumab when given on the same day.
-Treatment should be continued until disease progression or unacceptable toxicity.

Use:
-As monotherapy for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
-As monotherapy or in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

To make sure Calquence is safe for you, tell your doctor if you have ever had:

• an active or chronic infection, including hepatitis B;

• a heart rhythm disorder;

• bleeding problems;

• recent surgery or plan to have surgery, medical or dental procedure; or

• liver disease.

Taking Calquence may increase your risk of developing other cancers. Ask your doctor about this risk.

You may need to have a negative pregnancy test before starting treatment with Calquence.

May cause birth defects. Do not use if you are pregnant. You must use effective birth control while using Calquence and for at least 1 week after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using acalabrutinib and for at least 2 weeks after your last dose.

Take the medicine as soon as you can, but skip the missed dose if you are more than 3 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid taking an antacid such as Tums or calcium carbonate within 2 hours before or after you take Calquence.

Calquence could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction to Calquence: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Acalabrutinib may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Calquence may cause serious side effects. Call your doctor at once if you have:

• unusual bleeding - nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop;

• bleeding inside your body - weakness, dizziness, confusion; problems with speech, prolonged headache, bloody or tarry stools, pink or brown urine; coughing up blood or vomit that looks like coffee grounds;

• heart rhythm disorders - dizziness, chest pain, shortness of breath, fast or irregular heart rate, feeling light-headed;

• 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; or

• signs of infection - fever, chills, tiredness, flu-like symptoms, cough with mucus, chest pain, trouble breathing.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Calquence side effects may include:

• bruising;

• headache, feeling tired;

• muscle or joint pain;

• low blood cell counts;

• diarrhea; or

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

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

If you use a stomach acid reducer such as cimetidine, ranitidine, Tagamet, Pepcid, or Zantac, take Calquence dose 2 hours before taking any of these other medicines.

Tell your doctor about all your current medicines. Many drugs can affect acalabrutinib, especially:

• a blood thinner (warfarin, Coumadin, Jantoven);

• an antibiotic or antifungal medicine (itraconazole, fluconazole, erythromycin, rifampin);

• antiviral medicine to treat hepatitis C or HIV/AIDS;

• heart medication (diltiazem) ; or

• a proton pump inhibitor stomach acid medicine - such as omeprazole, lansoprazole, rabeprazole, Nexium, Prevacid, Prilosec, Protonix, and others.

This list is not complete and many other drugs may interact with acalabrutinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.