Frequently Asked Questions about CALQUENCE® (acalabrutinib)

Understand the administration, side effects and answers to frequently asked questions about CALQUENCE®

Generic Name: acalabrutinib

Trade Name: CALQUENCE®

For which conditions is CALQUENCE approved for? CALQUENCE is indicated for the treatment of adults with mantle cell lymphoma (MCL) who have received at least one prior therapy.

What is the mechanism of action? CALQUENCE is a tyrosine kinase inhibitor. These drugs work by blocking the action of enzymes called tyrosine kinases, which are involved in many cell functions, including cell signaling, growth, and division. These enzymes may be too active or found at high levels in some types of cancer cells and blocking them may help keep cancer cells from growing. Specifically, CALQUENCE blocks the action of a kinase known as Bruton’s tyrosine kinase, or BTK.

How is CALQUENCE typically given (administered)? CALQUENCE is given every twelve hours, orally. The capsules must be swallowed whole with water and never opened, broken, or chewed.

How are patients typically monitored? Before taking CALQUENCE, discuss any medical conditions with your healthcare provider. This includes: a recent or planned surgery or dental procedure, bleeding problems, heart rhythm problems, liver problems, if you are pregnant or plan to become pregnant, are breast feeding or plan to breast feed. CALQUENCE can harm an unborn baby, so women should not become pregnant while taking this drug. Women who are breastfeeding should not take CALQUENCE because it may cause harm to a newborn baby. Patients taking CALQUENCE should be monitored for bleeding, fever and infection, heart rhythm problems and secondary primary cancers.

What are the most common (occur in 20% or more of patients) side effects of treatment with CALQUENCE?

  • Thrombocytopenia (lower-than-normal number of platelets in the blood)
  • Diarrhea
  • Neutropenia (lower-than-normal number of neutrophils, a type of white blood cell)
  • Anemia
  • Headache
  • Fatigue
  • Muscle pain
  • Bruising

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

Take CALQUENCE exactly as your healthcare provider tells you to take it. If you miss a dose of CALQUENCE by more than 3 hours, then skip the missed dose and take the next dose at its regularly scheduled time. An CALQUENCE capsule should not be taken to make up for a missed dose. Tell your healthcare provider about all the medicines you take, including prescription and over­-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how CALQUENCE works and can cause side effects.

Are there any special precautions patients should be aware of before starting treatment?

Talk to your healthcare provider about any medicines (prescription and over-the-counter), vitamins or herbal supplements that you are taking. It is very important that you tell your healthcare provider if you are taking blood thinner medication. Blood thinners, other medications, vitamins and supplements taken with CALQUENCE can affect how CALQUENCE works and could result in additional side effects. Talk to your doctor about how to appropriately use gastric acid reducing agents when you are taking CALQUENCE.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. This includes persistent diarrhea, heart rhythm problems and signs of bleeding, such as blood in stools or urine and prolonged or uncontrolled bleeding.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONNECT SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN. CANCERCONNECT DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

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