ACALABRUTINIB - ORAL

ACALABRUTINIB - ORAL

PHONETIC PRONUNCIATION: (a-KAL-a-BROO-ti-nib)

COMMON BRAND NAME(S): Calquence

GENERIC NAME(S): acalabrutinib

Uses

USES: This medication is used to treat a certain type of cancer (mantle cell lymphoma-MCL) after previous treatment(s) have not worked well. Acalabrutinib works by slowing or stopping the growth of cancer cells. It belongs to a class of drugs known as kinase inhibitors.


How to use ACALABRUTINIB - ORAL

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using acalabrutinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually two times a day (about 12 hours apart). Swallow the capsule whole with a glass of water. Do not open, break, or chew the capsules. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Medications that decrease stomach acid may make acalabrutinib work less well. If you need to take an antacid, take it either 2 hours before or 2 hours after you take this medication. If you are taking an H2 blocker (such as ranitidine, famotidine), take acalabrutinib at least 2 hours before these medications. Avoid taking proton pump inhibitors (such as omeprazole, pantoprazole). Ask your doctor or pharmacist for more details. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Side Effects

SIDE EFFECTS: Headache, nausea, vomiting, abdominal pain, diarrhea, tiredness, or muscle aches may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: unusual tiredness, easy or unusual bruising or bleeding (such as nose/gum bleeds, pink/dark urine, black/bloody stools, vomit that contains blood or looks like coffee grounds), signs of heart problems (such as fast/irregular heartbeat, dizziness, fainting, shortness of breath, chest discomfort). This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough). Although acalabrutinib is used to treat cancer, it may rarely increase your risk of developing other cancers (such as skin cancer). Tell your doctor right away if you develop unusual growths or lumps, swollen glands, sudden weight loss, night sweats, change in appearance or size of moles, or unusual skin changes/growth (see also Precautions section). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking acalabrutinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood problems (such as ulcers), fast/irregular heartbeat, recent/current infection (including hepatitis, HIV infection). This medication may increase your risk for other cancers, including skin cancer. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Acalabrutinib can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets. Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using acalabrutinib. Acalabrutinib may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for at least 2 weeks after stopping treatment is not recommended. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Other medications can affect the removal of acalabrutinib from your body, which may affect how acalabrutinib works. Examples include azole antifungals (such as ketoconazole, itraconazole, voriconazole), macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as ritonavir, atazanavir, nelfinavir, saquinavir, indinavir), rifamycins (such as rifampin, rifabutin), drugs to treat seizures (such as phenytoin, carbamazepine, phenobarbital), nefazodone, St. John's wort, telithromycin, among others.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
CALQUENCE 100 MG CAPSULE

color
yellow
shape
oblong
imprint
ACA 100mg

Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.