Description
Acalabrutinib is used in combination with bendamustine and rituximab to treat mantle cell lymphoma (MCL) in patients who have not received other medicines and who cannot receive autologous hematopoietic stem cell transplant (stem cell transplant that uses your own stem cells). It is also used to treat MCL in adults who have received at least one previous treatment for their cancer. This medicine is also used to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
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.
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.
Breastfeeding
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.
Drug Interactions
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Levoketoconazole
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
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.
- Adagrasib
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Apalutamide
- Aprepitant
- Asciminib
- Atazanavir
- Avacopan
- Belzutifan
- Berotralstat
- Boceprevir
- Calcium Carbonate
- Carbamazepine
- Ceritinib
- Cholera Vaccine
- Cimetidine
- Ciprofloxacin
- Clarithromycin
- Cobicistat
- Conivaptan
- Crizotinib
- Cyclosporine
- Dabrafenib
- Daridorexant
- Dexlansoprazole
- Dihydroxyaluminum Aminoacetate
- Dihydroxyaluminum Sodium Carbonate
- Diltiazem
- Dronedarone
- Duvelisib
- Ebola Zaire Vaccine, Live
- Enasidenib
- Encorafenib
- Enzalutamide
- Erythromycin
- Esomeprazole
- Famotidine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Mavacamten
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. 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 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 this medicine, 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 this medicine. 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.
- Liver disease, severe—Use is not recommended in patients with this condition.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine 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.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Swallow the capsule or tablet whole with a glass of water. Do not open, dissolve, crush, cut, break, or chew it.
You may take this medicine with or without food.
If you are using an antacid (eg, calcium carbonate), take it at least 2 hours before or after using the capsule.
If you are using an H2 receptor blocker (eg, famotidine, ranitidine), take it 2 hours after using the capsule.
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 form (capsules or tablets):
- For mantle cell lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma:
- Adults—100 milligrams (mg) taken 2 times a day (every 12 hours). Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For mantle cell lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma:
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.
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
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 1 week after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
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 this medicine. You may need to stop using this medicine 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 (eg, 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 this medicine may increase your risk of getting new cancers (eg, non-melanoma skin cancer, solid tumors). Tell your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, yellow skin and eyes, persistent non-healing sore, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area on the skin. Avoid sun exposure. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
This medicine 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.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
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
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
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- body aches or pain
- chills
- collection of blood under the skin
- coughing up blood
- diarrhea
- difficulty in breathing or swallowing
- dizziness
- ear congestion
- fever
- headache
- increased menstrual flow or vaginal bleeding
- itching, pain, redness, or swelling
- large, flat, blue or purplish patches in the skin
- loss of voice
- lower back or side pain
- muscle or bone pain
- new loss of taste or smell
- nosebleeds
- painful or difficult urination
- paralysis
- persistent non-healing sore
- pink growth
- pinpoint red spots on the skin
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- reddish patch or irritated area
- shiny bump
- sneezing
- sore throat
- stuffy or runny nose
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- white, yellow, or waxy scar-like area
Incidence not known
- Bloating of the stomach
- fainting
- fast, pounding, or irregular heartbeat or pulse
- light-colored stools
- nausea
- palpitations
- vomiting
- yellow eyes or skin
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
- difficulty in moving
- joint pain or swelling
- muscle cramps or stiffness
- rash
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.
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