Calquence

(Acalabrutinib)

The active ingredient in Calquence is acalabrutinib, which is a Bruton tyrosine kinase (BTK) inhibitor. By blocking BTK, this medication stops cancer cells from growing and spreading.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Calquence. However, the following is a synopsis of the general guidelines for the use of Calquence:

• Calquence tablets and capsules are typically taken twice daily (approximately 12 hours apart) with or without food and a glass of water. Swallow the tablet and capsule whole; don't crush, chew, break, open, or dissolve them.
• If you need to take an antacid, do so two hours before or after taking Calquence. Take Calquence two hours before taking any other acid reducers (H-2 receptor blockers).
• If you need surgery, inform the surgeon that you are receiving this medication. You may need to stop taking the medication for a brief period.

The most common side effects of Calquence seen in clinical trials as compared to placebo include:

• Low red blood cells (anemia).
• Low white blood cells (neutropenia).
• Low platelets.
• Tiredness.
• Headache.
• Muscle or joint pain.
• Respiratory tract infection.
• Constipation.
• Increased risk of bleeding.

Some individuals may experience serious side effects while using Calquence. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Serious infections include body aches, chills, fever, headaches, a new cough, a sore throat, and fatigue.
• Serious bleeding includes persistent bleeding or bruising, substantial amounts of bleeding, vomiting blood, blood in the urine, and bloody or black, tarry faeces.
• Heart rhythm issues include rapid heartbeat, chest discomfort, atrial fibrillation, fainting, dizziness, and shortness of breath.
• Allergic reaction to the medication.

These are not all of the possible side effects of Calquence. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Calquence, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• An active or chronic infection, such as hepatitis B.
• Heart rhythm problems.
• Bleeding problems or signs of bleeding (hemorrhage).
• Recently underwent surgery or have scheduled surgery.
• Liver problems.
• Change in blood test results. It can result in low amounts of red blood cells (anaemia), white blood cells (leukopenia), and platelets (thrombocytopenia). You will receive complete blood counts regularly and will request tests to monitor your liver function.
• Using this medicine may increase your risk of getting new cancers (eg, non-melanoma skin cancer, solid tumors).
• Liver toxicity, which may be severe or fatal, has been reported with Bruton tyrosine kinase inhibitors.

It is contraindicated in people with a known hypersensitivity to acalabrutinib or any of its components.

Calquence begins working as soon as you take it. However, laboratory or imaging testing can take some time to get results. You'll probably keep using Calquence for as long as it works against your cancer without causing serious adverse effects.

When Calquence is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• A blood thinner (warfarin, Coumadin, or Jantoven).
• An antibiotic or antifungal medication (itraconazole, fluconazole, erythromycin, rifampin).
• Antiviral medications are used to treat hepatitis C and HIV/AIDS.
• Heart medicine (diltiazem).
• Proton pump inhibitor stomach acid medicines include omeprazole, lansoprazole, rabeprazole, Nexium, Prevacid, Prilosec, Protonix, and others.

The typical initial dose of Calquence is 100 mg taken orally twice a day (approximately 12 hours apart).

If you encounter certain adverse effects, your dose may be adjusted accordingly. It may also alter if you are taking any medications that could interact with Calquence.

If you miss a dose, and it is more than 3 hours since your usual dosing time, skip the missed dose and take your next dose at your regular schedule. Do not use extra medicine to make up for a missed dose.

Store at room temperature and keep out of reach of children.

AstraZeneca Pharmaceuticals LP is the company that manufactures Calquence.

There are no generic versions available of Calquence.

Do not modify your dose or stop taking your medicine unless your healthcare professional instructs you to.

Tell your doctor if you are pregnant or plan to become pregnant, as Calquence might harm your unborn child and cause complications during childbirth. If you can conceive, your doctor may perform a pregnancy test before you begin therapy.

Females who can conceive should use effective birth control (contraception) while taking this medication and for at least one week following the final dosage.

Inform your healthcare professional if you are nursing or want to breastfeed. Calquence is not known to enter into breast milk. Do not breastfeed while taking this medication or for at least two weeks following the last dosage.