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Learn about Adcetris a treatment of Hodgkin Lymphoma

Acalabrutinib (Oral)

a-kal-a-BROO-ti-nib

Medically reviewed on Oct 31, 2018

Commonly used brand name(s)

In the U.S.

  • Calquence

Available Dosage Forms:

  • Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses For acalabrutinib

Acalabrutinib is used to treat mantle cell lymphoma (MCL) in adults who have received at least one previous treatment for their cancer.

Acalabrutinib is available only with your doctor's prescription.

Before Using acalabrutinib

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 acalabrutinib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to acalabrutinib 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.

Pediatric

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

Geriatric

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

Interactions with 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 acalabrutinib, 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 acalabrutinib 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.

  • Aluminum Carbonate, Basic
  • Aluminum Hydroxide
  • Aluminum Phosphate
  • Aprepitant
  • Atazanavir
  • Boceprevir
  • Calcium Carbonate
  • Carbamazepine
  • Cimetidine
  • Ciprofloxacin
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Cyclosporine
  • Dexlansoprazole
  • Dihydroxyaluminum Aminoacetate
  • Dihydroxyaluminum Sodium Carbonate
  • Diltiazem
  • Dronedarone
  • Duvelisib
  • Enzalutamide
  • Erythromycin
  • Esomeprazole
  • Famotidine
  • Fluconazole
  • Fluvoxamine
  • Fosphenytoin
  • Idelalisib
  • Imatinib
  • Indinavir
  • Itraconazole
  • Ivosidenib
  • Ketoconazole
  • Lansoprazole
  • Letermovir
  • Lopinavir
  • Lumacaftor
  • Magaldrate
  • Magnesium Carbonate
  • Magnesium Hydroxide
  • Magnesium Oxide
  • Magnesium Trisilicate
  • Mitotane
  • Nefazodone
  • Nelfinavir
  • Nilotinib
  • Nizatidine
  • Omeprazole
  • Pantoprazole
  • Phenytoin
  • Posaconazole
  • Rabeprazole
  • Ranitidine
  • Rifampin
  • Ritonavir
  • Saquinavir
  • Sodium Bicarbonate
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Verapamil
  • Voriconazole

Interactions with Food/Tobacco/Alcohol

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using acalabrutinib with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use acalabrutinib, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

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

  • Bleeding problems or
  • Heart rhythm problems (eg, atrial fibrillation, atrial flutter)—Use with caution. May make these conditions worse.
  • Infection (eg, hepatitis B)—May decrease your body's ability to fight an infection.

Proper Use of acalabrutinib

Medicines used to treat cancer are very strong and can have many side effects. Before using acalabrutinib, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take acalabrutinib exactly 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.

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

Swallow the capsule whole with a glass of water. Do not open, crush, break, or chew it.

You may take acalabrutinib with or without food.

If you are using an antacid (eg, calcium carbonate), take it at least 2 hours before or after using acalabrutinib.

If you are using an H2 receptor blocker (eg, famotidine, ranitidine), take it 2 hours after using acalabrutinib.

Dosing

The dose of acalabrutinib 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 acalabrutinib. 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 form (capsules):
    • For mantle cell lymphoma:
      • Adults—The usual dose is 100 milligrams (mg) taken two times a day (about every 12 hours). Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of acalabrutinib, 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.

If you miss a dose, and it is less than 3 hours since your usual dosing time, take it as you normally would.

If you miss a dose, and it is more than 3 hours since your usual dosing time, skip the missed dose and take your next dose at your regular schedule. Do not use extra medicine to make up for a missed dose.

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 acalabrutinib

It is very important that your doctor check your progress at regular visits to make sure acalabrutinib is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

Make sure any doctor or dentist who treats you knows that you are using acalabrutinib. You may need to stop using acalabrutinib several days before and after having surgery.

Call your doctor right away if you start to have a cough that would not go away, weight loss, night sweats, fever, chills, flu-like symptoms (such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill), painful or difficult urination, or sores, ulcers, or white spots in the mouth or on the lips. These may be signs that you have an infection.

Acalabrutinib may lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Using acalabrutinib may increase your risk of getting new cancers, including skin cancer. Avoid sun exposure. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Acalabrutinib may cause heart rhythm problems (eg, atrial flutter, atrial fibrillation). Check with your doctor right away if you have a fast or irregular heartbeat, trouble breathing, lightheadedness, dizziness, or fainting.

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.

Acalabrutinib Side Effects

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:

More common

  • Bleeding gums
  • collection of blood under the skin
  • coughing up blood
  • difficulty in breathing or swallowing
  • dizziness
  • headache
  • increased menstrual flow or vaginal bleeding
  • itching, pain, redness, or swelling
  • large, flat, blue or purplish patches in the skin
  • nosebleeds
  • paralysis
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine

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

  • Constipation
  • diarrhea
  • difficulty in moving
  • joint pain or swelling
  • muscle cramp, pain, or stiffness
  • nausea
  • rash
  • stomach pain
  • unusual tiredness or weakness
  • vomiting

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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