Question 1

What is Calquence?

Accepted Answer

Calquence is a prescription medication that belongs to a class of drugs called Bruton's tyrosine kinase (BTK) inhibitors. It works by blocking the action of a specific protein that signals certain cells to multiply and survive.

By inhibiting this protein, the medication helps control the development of abnormal cells. This targeted approach focuses on the underlying biological pathways involved in specific medical conditions.

Question 2

What is Calquence used for?

Accepted Answer

Calquence is used to treat the following conditions:

mantle cell lymphoma

chronic lymphocytic leukemia

small lymphocytic lymphoma

Question 3

How does Calquence work?

Accepted Answer

Mechanism of Action

Calquence belongs to a class of medications called kinase inhibitors. It works by targeting and blocking a protein in the body known as Bruton's tyrosine kinase (BTK).

BTK is a signaling protein found in B-cells, which are a type of white blood cell. In certain types of blood and lymph node cancers, BTK sends signals that cause these B-cells to grow, multiply, and spread uncontrollably. By inhibiting this protein, Calquence helps to:

Interrupt the signals that allow cancer cells to survive.

Prevent the cancer cells from multiplying.

Slow the progression of the disease.

Because it specifically targets the BTK protein, Calquence is considered a targeted therapy. This means it is designed to interfere with specific molecules involved in the growth of cancer cells rather than affecting all rapidly dividing cells in the body.

Question 4

What are the active ingredients in Calquence?

Accepted Answer

The active ingredient in Calquence is acalabrutinib .

Question 5

What are the side effects of Calquence?

Accepted Answer

Common side effects of Calquence may include:

headache

diarrhea

fatigue

and others

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Calquence?

Accepted Answer

Calquence belongs to the Bruton's tyrosine kinase inhibitor drug class.

Question 7

What is the dosage of Calquence and how do I take it?

Accepted Answer

How to take Calquence

Calquence is available as a capsule or tablet to be taken by mouth. It is usually taken twice a day, approximately 12 hours apart. You can take this medication with or without food.

When taking Calquence, follow these instructions:

Swallow the capsule or tablet whole with a glass of water.

Do not crush, chew, break, or open the capsules or tablets.

Try to take your doses at the same time each day to maintain a steady level of medicine in your body.

Missed doses

If you miss a dose, take it as soon as you remember. However, if too much time has passed since the scheduled dose, skip the missed dose and take your next dose at the regular time. Do not take two doses at once to make up for a missed one.

Special considerations

Certain medications that reduce stomach acid, such as proton pump inhibitors, may affect how Calquence capsules work. If you take antacids or other acid-reducing medicines, your healthcare provider may advise you to take them at a different time than your Calquence dose.

Question 8

Is Calquence safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

Calquence can cause harm to a fetus if taken during pregnancy. Based on findings from animal studies, the medication may lead to decreased fetal weight and other developmental issues. Healthcare providers typically advise the following:

Pregnancy testing: A pregnancy test is often recommended for individuals of reproductive potential before starting treatment to ensure they are not pregnant.

Contraception: Effective birth control should be used during treatment and for at least one week after the last dose of Calquence.

Communication: If you become pregnant or think you might be pregnant while taking this medication, contact your healthcare provider to discuss the potential risks to the fetus.

Breastfeeding

It is not known whether Calquence passes into human breast milk or how it might affect a nursing infant. Because of the potential for serious adverse reactions in a breastfed child, it is recommended to avoid breastfeeding during treatment and for at least two weeks after the final dose.

Question 9

What forms and strengths does Calquence come in?

Accepted Answer

Calquence is available in the following oral formulations:

Capsules

Tablets

The tablet formulation was developed to allow for administration with or without food and to be compatible with certain medications that reduce stomach acid. Both the capsules and tablets should be swallowed whole and not crushed, chewed, or dissolved.

Question 10

What is the FDA approval status of Calquence?

Accepted Answer

FDA Approval History

Calquence was first approved by the U.S. Food and Drug Administration (FDA) in October 2017. The initial approval was granted under the accelerated approval pathway for the treatment of adults with mantle cell lymphoma (MCL) who had received at least one prior therapy. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.

In November 2019, the FDA expanded the approval of Calquence to include the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Recent Regulatory Updates

In 2024, the FDA approved Calquence in combination with bendamustine and rituximab for the treatment of adults with previously untreated mantle cell lymphoma. This expanded the drug's use to include first-line treatment for this specific condition.

Current Approved Indications

Calquence is currently FDA-approved for the following uses:

Chronic Lymphocytic Leukemia (CLL): For the treatment of adult patients.

Small Lymphocytic Lymphoma (SLL): For the treatment of adult patients.

Mantle Cell Lymphoma (MCL): For adult patients who have received at least one prior therapy, or in combination with other medications for previously untreated patients.

Safety and Monitoring

There are currently no boxed warnings or Risk Evaluation and Mitigation Strategy (REMS) programs required for Calquence. The medication is available by prescription only and its safety continues to be monitored through post-marketing surveillance and clinical trial data.

Question 11

What should I know about Calquence and cost?

Accepted Answer

Estimated Retail Price

Calquence is a high-cost specialty medication. The retail price for a 30-day supply, which typically consists of 60 capsules or tablets (100 mg), is approximately $16,500 to $17,000. Most patients do not pay this full amount out of pocket, as costs are often offset by insurance or assistance programs.

Factors Influencing Cost

Insurance and Medicare: Most commercial insurance plans and Medicare Part D provide coverage for Calquence. However, because it is a specialty drug, it is often placed on a higher formulary tier, which may require a significant co-pay or coinsurance payment.

Generic Availability: There is currently no generic version of acalabrutinib available. Brand-name medications typically remain at a higher price point until generic alternatives are approved and released.

Pharmacy Selection: Prices can vary between specialty pharmacies. Some insurance providers may require the use of a specific specialty pharmacy to manage the distribution of this medication.

Financial Assistance Programs

The manufacturer of Calquence offers support programs to help manage costs for eligible patients. These may include co-pay cards for those with commercial insurance to reduce out-of-pocket expenses, or patient assistance programs for individuals who are uninsured or underinsured and meet specific income requirements.

Calquence

Medication Quick Facts

📋Overview

What It's Used For

How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

Forms & Strengths

FDA / Regulatory Status

Price Information

FAQ

Additional Resources

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