Calquence

Generic name: acalabrutinib (a KAL a BROO ti nib)
Brand name: Calquence
Drug class: BTK inhibitors

Calquence (acalabrutinib) blocks the action of certain enzymes in the body, which can interfere with the growth and spread of cancer cells.

Calquence is used to treat mantle cell lymphoma (a type of non-Hodgkin lymphoma) in adults. This medicine is given after other treatments have failed.

Calquence was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, patients responded to this medicine. However, further studies are needed.

Calquence is also used to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults.

Warnings

Calquence can make it easier for you to bleed. Contact your doctor or seek emergency medical attention if you have any bleeding that will not stop.

Call your doctor at once if you have signs of bleeding inside your body, such as: dizziness, weakness, confusion, headache, speech problems, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds.

Before taking this medicine

You should not use Calquence if you are allergic to acalabrutinib.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • an active or chronic infection;
  • a heart rhythm disorder;
  • bleeding problems; or
  • hepatitis B (acalabrutinib can cause this condition to come back or get worse).

Taking Calquence may increase your risk of developing other types of cancer, such as skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether acalabrutinib will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether acalabrutinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Calquence, and for at least 2 weeks after your last dose.

How should I take Calquence?

Take Calquence exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Calquence is usually taken once every 12 hours until your body no longer responds to the medicine.

Take this medicine with a full glass of water.

You may take this medicine with or without food.

Do not chew, break, or open the Calquence capsule. Swallow the capsule whole.

If you need surgery, tell the surgeon ahead of time that you are using acalabrutinib. You may need to stop using the medicine for a short time.

While using Calquence, you may need frequent blood tests.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Mantle Cell Lymphoma:

100 mg orally approximately every 12 hours
Duration of Therapy: Until disease progression or unacceptable toxicity

Use: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Usual Adult Dose for Leukemia :

Monotherapy:
100 mg orally every 12 hours until disease progression or unacceptable toxicity

In Combination With Obinutuzumab:
100 mg orally every 12 hours until disease progression or unacceptable toxicity; start this drug at Cycle 1 (each cycle is 28 days); start obinutuzumab at Cycle 2 for a total of 6 cycles and refer to the obinutuzumab prescribing information for recommended dosing; administer this drug prior to obinutuzumab when given on the same day

Use: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you are more than 3 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

If you also take an antacid or stomach acid reducer (such as Zantac), take your Calquence dose at least 2 hours before you take the stomach medicine.

Avoid exposure to sunlight or tanning beds. Acalabrutinib can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Calquence side effects

Get emergency medical help if you have signs of an allergic reaction to Calquence: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • unusual bleeding (nose, mouth, vagina, or rectum), or any bleeding that will not stop;
  • signs of bleeding inside your body - dizziness, weakness, confusion, problems with speech, prolonged headache, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds;
  • heart rhythm problems - chest pain, shortness of breath, pounding heartbeats or fluttering in your chest, feeling light-headed;
  • low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
  • signs of infection - fever, chills, tiredness, flu-like symptoms, cough with mucus, chest pain, trouble breathing; or
  • signs of a serious brain infection - any change in your mental state, decreased vision, weakness on one side of your body, or problems with walking (may start gradually and get worse quickly).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Calquence side effects may include:

  • bruising;
  • headache;
  • muscle pain;
  • diarrhea; or
  • feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Calquence?

Many drugs can interact with acalabrutinib. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • warfarin (Coumadin, Jantoven);
  • an antibiotic or antifungal medicine;
  • antiviral medicine to treat hepatitis C or HIV/AIDS;
  • heart medication; or
  • a stomach acid reducer - such as omeprazole, lansoprazole Nexium, Prevacid, Prilosec, Protonix, and others.

This list is not complete and many other drugs can interact with acalabrutinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.