What is the most important information I should know about acalabrutinib?
This medicine 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.
What is acalabrutinib?
Acalabrutinib blocks the action of certain enzymes in the body, which can interfere with the growth and spread of cancer cells.
Acalabrutinib is used to treat mantle cell lymphoma (a type of non-Hodgkin lymphoma) in adults. This medicine is given after other treatments have failed.
Acalabrutinib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, patients responded to this medicine. However, further studies are needed.
Acalabrutinib may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking acalabrutinib?
You should not use acalabrutinib if you are allergic to it.
To make sure acalabrutinib is safe for you, tell your doctor if you have ever had:
- an active or chronic infection;
- a heart rhythm disorder;
- bleeding problems; or
- hepatitis B (acalabrutinib can cause this condition to come back or get worse).
Taking acalabrutinib may increase your risk of developing other types of cancer, such as skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether acalabrutinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using acalabrutinib, and for at least 2 weeks after your last dose.
How should I take acalabrutinib?
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Acalabrutinib is usually taken once every 12 hours until your body no longer responds to the medicine.
Take this medicine with a full glass of water.
You may take acalabrutinib with or without food.
Do not chew, break, or open the acalabrutinib capsule. Swallow it whole.
If you need surgery, tell the surgeon ahead of time that you are using acalabrutinib. You may need to stop using the medicine for a short time.
While using acalabrutinib, you may need frequent blood tests.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If you are more than 3 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking acalabrutinib?
If you also take an antacid or stomach acid reducer (such as Zantac), take your acalabrutinib dose at least 2 hours before you take the stomach medicine.
Avoid exposure to sunlight or tanning beds. Acalabrutinib can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
What are the possible side effects of acalabrutinib?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- unusual bleeding (nose, mouth, vagina, or rectum), or any bleeding that will not stop;
- signs of bleeding inside your body --dizziness, weakness, confusion, problems with speech, prolonged headache, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds;
- heart rhythm problems --chest pain, shortness of breath, pounding heartbeats or fluttering in your chest, feeling light-headed;
- low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
- signs of infection --fever, chills, tiredness, flu-like symptoms, cough with mucus, chest pain, trouble breathing; or
- signs of a serious brain infection --any change in your mental state, decreased vision, weakness on one side of your body, or problems with walking (may start gradually and get worse quickly).
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- muscle pain;
- diarrhea; or
- feeling tired.
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.
What other drugs will affect acalabrutinib?
Many drugs can interact with acalabrutinib. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:
- warfarin (Coumadin, Jantoven);
- an antibiotic or antifungal medicine;
- antiviral medicine to treat hepatitis C or HIV/AIDS;
- heart medication; or
- a stomach acid reducer --such as omeprazole, lansoprazole Nexium, Prevacid, Prilosec, Protonix, and others.
This list is not complete and many other drugs can interact with acalabrutinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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