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Acalabrutinib (Calquence)

Acalabrutinib (Calquence)

What Is Acalabrutinib?

Acalabrutinib (pronounced [a KAL a broo ti nib]) is also known by the brand name, Calquence. It is a targeted anticancer therapy (an antineoplastic drug) that belongs to a class called Bruton’s tyrosine kinase (BTK) inhibitors. BTK inhibitors work by blocking Bruton’s tyrosine kinase (BTK), a protein involved in signaling pathways that help certain B-cells survive and grow. Follow your clinic/pharmacy’s handling instructions for antineoplastic medications. Wash hands after handling and keep tablets out of reach of children and pets.

What Is Targeted Therapy?

Targeted therapy is a cancer treatment that blocks specific proteins or signals that help cancer cells grow and survive. Unlike traditional chemotherapy, many targeted therapies are not broadly cytotoxic to rapidly dividing cells, though they can still cause significant side effects.

How Is Calquence Used?

Calquence is FDA-approved to treat certain B-cell blood cancers, including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL) in specific settings. Calquence may be used alone or in combination with other anticancer medicines (for example, with obinutuzumab for CLL/SLL, or with bendamustine and rituximab for certain patients with previously untreated MCL).

Available Formulations

Calquence is available as oral tablets. The tablets are available in a 100 mg strength. The tablets are orange, oval, film-coated, and debossed with “ACA 100” on one side. Calquence is dosed twice a day, and the dose is dependent on the cancer type or severity and other factors. Verify the correct dose and frequency with your provider.

Directions for Use

Calquence may be taken with or without food, but it should be taken with water. When taking the tablet, swallow it whole with water; do not break, crush, or chew it. If taken in combination with obinutuzumab (Gazyva), which is given intravenously, it is best to take Calquence at least one hour prior to the infusion.

Missed Dose

If you accidentally miss a dose, and it has been more than 3 hours, skip the missed dose and continue with the next scheduled dose. Do not take extra doses to make up for a missed dose.

Storage

Store capsules in a cool, dry place at room temperature and ensure the bottle is tightly closed.

What To Avoid While Taking Calquence?

While on Calquence therapy, you must follow some precautions. Always tell your physician about any medications you are already taking. Do not take any drug or medicine (even herbals or over-the-counter medications) without prior consent from your physician or pharmacist, as they may have significant interactions with Calquence. 

Do not receive any vaccinations (especially live vaccines) without first discussing it with your oncology team. They can advise you on timing and which vaccines are appropriate during treatment. Minimize sun exposure and use sunblock while outside. Tell your care team if you take acid-reducing medicines (antacids, H2 blockers like famotidine, or proton pump inhibitors/PPIs like omeprazole). Your pharmacist or oncology team will advise you on the best way to take Calquence with these medicines, if needed.

Avoid grapefruit, grapefruit juice, and any foods or supplements containing grapefruit or grapefruit juice throughout therapy as they may also interact with the medication. Ask your care team about alcohol use during treatment, especially if you have bleeding risk, liver problems, or are taking other medicines that increase bleeding. It may be necessary to discontinue Calquence 3 to 7 days before any scheduled surgeries.

Pregnancy and Calquence

Pregnancy status must be checked prior to starting treatment in women of childbearing age. Effective contraception must be used during treatment and for 1 week after the last dose. Calquence may cause fetal harm and is therefore not recommended for women who are breastfeeding during therapy. Breastfeeding should also be avoided for at least 2 weeks after the last dose.

Side Effects

As with any other medication, you may encounter many side effects while taking Calquence. A few things to keep in mind are:

  • You may not have all the side effects listed below. Many people may experience little to no side effects.
  • The severity of side effects may vary from person to person, so don’t compare your side effects with other people’s experiences.
  • Most of the side effects will improve when therapy is discontinued.
  • These side effects are easily manageable most of the time either by readjusting the dose of Calquence or using additional medications to treat the symptoms. Consult with your physician or pharmacist to explore available options.
  • Do not hide any symptoms; when you feel any discomfort, do not hesitate to tell your physician or pharmacist about it. 

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions. 

Some of the most common side effects of Calquence are: 

Nausea and Vomiting

You may experience nausea and vomiting after starting treatment. These symptoms usually disappear after a few hours or days after starting therapy. If nausea or vomiting is severe, contact your physician to see if they can add an antiemetic medication to the regimen. Eating habits should consist of small amounts of food 4 to 6 times a day. Try to avoid eating too much at once. Maintain proper body hydration and drink fluids throughout the day. Nausea and vomiting may result in abdominal pain and can also cause a decrease in appetite, leading to weight loss.

Diarrhea or Abdominal Pain

If you have watery stools more than four times a day or frequent loose, watery stools, you may have diarrhea. This is one of the most common side effects of Calquence. Abdominal pain may be associated with diarrhea. Stay hydrated and take plenty of fluids to maintain the water balance of your body. If you have diarrhea, choose bland, low-fiber foods and avoid foods that commonly worsen diarrhea (such as greasy/fried foods, spicy foods, high-fiber foods, and dairy if it bothers you). As symptoms improve, gradually return to your usual diet based on your tolerance. Examples of foods that are often easier to tolerate include bananas, rice, applesauce, toast, plain pasta, and baked/boiled lean proteins. In rare cases, diarrhea may get severe. If that happens, consult your doctor immediately. Patients 60 years or older may experience a greater incidence of these side effects.

Bleeding Complications

Bleeding problems may occur including bruising; black, tarry, or bloody stools; bleeding gums; blood in the urine; coughing up blood; cuts that take a long time to stop bleeding; feeling dizzy, tired, or weak; nosebleeds; pain or swelling; increased menstrual flow; throwing up blood; vomit that looks like coffee grounds; or a very bad headache. These side effects can potentially lead to serious hemorrhagic events; therefore, inform your physician if any of these bleeding complications appear. It may be necessary to discontinue Calquence 3 to 7 days before any scheduled surgeries. 

Infection Risk

There may be a high chance of acquiring an infection while on Calquence therapy. Infections may include fungal, bacterial (like pneumonia), or viral infections (like hepatitis B). If previously infected with hepatitis B, using Calquence may lead to the reactivation of the viral infection. In order to minimize the risk of infection, it is important to avoid crowds, unhygienic street foods, certain vaccines, etc. Early symptoms of infection may include cough, chills, fever, flu, or trouble breathing. If you acquire any infection, immediately seek advice from your physician. 

Blood Count Changes

Your care team may monitor your blood counts with periodic labs (such as a complete blood count/CBC). Calquence can sometimes cause decreases in blood cells, including leukopenia (low white blood cells), neutropenia (low neutrophils), thrombocytopenia (low platelets), and anemia (low red blood cells).

Heart Rhythm Complications

There is a risk that Calquence may cause heart rhythm complications like atrial fibrillation or atrial flutter. Symptoms may present as shortness of breath, irregular heartbeat, chest discomfort, or dizziness. Risk is higher in patients with a history of high blood pressure or arrhythmias. 

Secondary Malignancies

It is possible that Calquence can give rise to a secondary type of cancer during treatment. The most common cancer is skin cancer, which is why it is essential to avoid the sun during therapy and use sunscreen while outdoors. If any new lumps or moles appear on the skin, consult your physician immediately. 

Other common side effects may include:

  • Muscle tenderness or pain
  • Fatigue
  • Skin rash 
  • Bruising
  • Neck, joint, or bone pain

Precautions

Unless approved by your physician, Calquence is generally not recommended in: 

  • Patients who have an allergy to Calquence. Allergic reactions can cause a rash over the whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, trouble breathing, and sweating. If you have any of these symptoms, stop using Calquence and call your doctor or get emergency help right away.
  • Patients with a risk of high blood pressure or a history of arrhythmias. Blood pressure should be monitored regularly.
  • Patients undergoing elective surgery. Calquence may need to be discontinued 3 to 7 days before and after scheduled surgeries.

FAQs

Is Calquence a chemo agent?

Calquence (acalabrutinib) is generally considered a targeted therapy (a BTK inhibitor), not traditional chemotherapy. It works by blocking BTK signaling that can help certain cancerous B-cells survive and grow.

What is the best time to take Calquence?

Calquence may be taken with or without food, but should be taken with water. When taking the tablet, swallow it whole with water; do not break, crush, or chew it. If taken in combination with obinutuzumab (Gazyva), which is given intravenously, it is best to take Calquence at least 1 hour prior to the infusion.

Is Acalanritinib available as a generic?

Currently, acalabrutinib is not available as a generic. It is only available as the brand, Calquence.

REFERENCES:

Abbas, H. A., & Wierda, W. G. (2021). Acalabrutinib: A Selective Bruton Tyrosine Kinase Inhibitor for the Treatment of B-Cell Malignancies. Frontiers in Oncology, 11, 1620.

Acalabrutinib. In: Lexi-drugs online [database on the Internet]. Hudson (OH): Lexicomp, Inc.; 2016 [updated 6 Nov 2021; cited 9 Nov 2021]. Available from: http://online.lexi.com

Acalabrutinib. In: In Depth Answers [database on the Internet]. Greenwood Village (CO): IBM Corporation; 2017 [cited 2021 Nov 9]. Available from: www.micromedexsolutions.com.

Byrd, J. C., Harrington, B., O’Brien, S., Jones, J. A., Schuh, A., Devereux, S., … & Furman, R. R. (2016). Acalabrutinib (ACP-196) in relapsed chronic lymphocytic leukemia. New England Journal of Medicine, 374(4), 323-332.

Calquence: Uses, dosage, side effects, warnings. Drugs.com. (n.d.). Retrieved November 9, 2021, from https://www.drugs.com/Calquence.html.

Ghia, P., Pluta, A., Wach, M., Lysak, D., Kozak, T., Simkovic, M., … & Jurczak, W. (2020). ASCEND: phase III, randomized trial of acalabrutinib versus idelalisib plus rituximab or bendamustine plus rituximab in relapsed or refractory chronic lymphocytic leukemia. Journal of Clinical Oncology, 38(25), 2849-2861.

Luttwak, E., Gurevich-Shapiro, A., Azem, F., Lishner, M., Klieger, C., Herishanu, Y., … & Avivi, I. (2021). Novel agents for the treatment of lymphomas during pregnancy: A comprehensive literature review. Blood Reviews, 100831

Sharman, J. P., Banerji, V., Fogliatto, L. M., Herishanu, Y., Munir, T., Walewska, R., … & Byrd, J. C. (2019). ELEVATE TN: Phase 3 study of acalabrutinib combined with obinutuzumab (O) or alone vs O plus chlorambucil (Clb) in patients (Pts) with treatment-naive chronic lymphocytic leukemia (CLL).

Singh, S. P., Dammeijer, F., & Hendriks, R. W. (2018). Role of Bruton’s tyrosine kinase in B cells and malignancies. Molecular cancer, 17(1), 1-23.

Wang, M., Rule, S., Zinzani, P. L., Goy, A., Casasnovas, O., Smith, S. D., … & Jurczak, W. (2018). Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. The Lancet, 391(10121), 659-667.

Wu, J., Zhang, M., & Liu, D. (2016). Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. Journal of hematology & oncology, 9(1), 1-4.

This information is not a substitute for medical advice or treatment. Talk to your doctor or healthcare provider about your medical condition prior to starting any new treatment. AmeriPharma® Specialty Care assumes no liability whatsoever for the information provided or for any diagnosis or treatment made as a result, nor is it responsible for the reliability of the content. AmeriPharma® Specialty Care does not operate all the websites/organizations listed here, nor is it responsible for the availability or reliability of their content. These listings do not imply or constitute an endorsement, sponsorship, or recommendation by AmeriPharma® Specialty Care. This webpage may contain references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with AmeriPharma® Specialty Care.
Portrait of Dania J., a healthcare professional at AmeriPharma.
MEDICALLY REVIEWED BY Dr. Dania Jaradat, PharmD

Dr. Dania Jaradat, PharmD was born and raised in Torrance, California. She graduated from Marshall B. Ketchum University. The most rewarding part of her job is to keep the line between pharmacist and patient open and to educate patients on medication management. In her free time, she enjoys traveling to different countries, spending time with her husband and son, and reading. See Author Biography