Taking CALQUENCE

Dosing Information to Help You Stay on Track With Taking Your Medication

Take CALQUENCE twice daily, about every 12 hours,

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1 capsule in the morning and 1 at night.

It’s important that you take CALQUENCE as directed, so you always have the proper amount of medicine in your body to help manage your MCL.

Important Information

Here are a few more things you should know about taking CALQUENCE:

  • Take CALQUENCE exactly as your healthcare provider tells you to take it
  • Do not change your dose or stop taking CALQUENCE unless your healthcare provider tells you to
  • Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking CALQUENCE if you develop certain side effects
  • Swallow CALQUENCE capsules whole with a glass of water. Do not open, break, or chew capsules
  • If you need to take an antacid medicine, take it either 2 hours before or 2 hours after you take CALQUENCE
  • If you need to take certain other medicines called acid reducers (H2-receptor blockers), take CALQUENCE 2 hours before the acid reducer medicine

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If you take too much CALQUENCE, call your healthcare provider or go to the nearest hospital or emergency room right away.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking CALQUENCE with certain other medications may affect how CALQUENCE works and can cause side effects. Especially tell your healthcare provider if you take a blood thinner medicine.

Please see Important Safety Information and Patient Information.

Dosage Information

Take CALQUENCE twice daily, about every 12 hours, 1 capsule in the morning and 1 at night.

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CALQUENCE can be taken with or without food.

 

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Swallow CALQUENCE capsules whole with a glass of water. Do not open, break, or chew capsules.

If you miss a dose of CALQUENCE, take it as soon as you remember.

If it is more than 3 hours past your usual dosing time, skip the missed dose and take your next dose of CALQUENCE at your regularly scheduled time.

Do not take an extra dose of CALQUENCE to make up for a missed dose.

What You Should Know About Side Effects

CALQUENCE can cause side effects. The most common side effects include:

  • Headache
  • Diarrhea
  • Tiredness
  • Muscle aches
  • Bruising

Other serious side effects may occur. See below.

In the CALQUENCE clinical study:

  • 1.6% had to reduce their dose because of side effects
  • 6.5% stopped taking it entirely because of side effects

In the CALQUENCE clinical study:

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Tell your healthcare provider if you have any side effect that bothers you or does not go away while taking CALQUENCE.

CALQUENCE may cause serious side effects, including:

  • Bleeding problems (hemorrhage) may happen during treatment with CALQUENCE, and can be serious. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:
    • blood in your stools or black stools (looks like tar)
    • pink or brown urine
    • unexpected bleeding, or bleeding that is severe or you cannot control
    • vomit blood or vomit that looks like coffee grounds
    • cough up blood or blood clots
    • dizziness
    • weakness
    • confusion
    • change in your speech
    • headache that lasts a long time
  • Infections. Infections can happen during treatment with CALQUENCE. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, or flu-like symptoms.
  • Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with CALQUENCE, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
  • Second primary cancers. New (second) cancers have happened in patients who received CALQUENCE, including cancers of the skin. Use sun protection when you are outside in sunlight.
  • Heart rhythm problems (atrial fibrillation and atrial flutter) have happened in people treated with CALQUENCE. Tell your healthcare provider if you have any of the following signs or symptoms:
    • your heartbeat is fast or irregular
    • feel lightheaded or dizzy
    • pass out (faint)
    • shortness of breath
    • chest discomfort

Call your healthcare provider for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more details about side effects, please read Important Safety Information.

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IMPORTANT SAFETY INFORMATION

CALQUENCE may cause serious side effects, including:

  • Bleeding problems (hemorrhage) may happen during treatment with CALQUENCE, and can be serious. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:
    • blood in your stools or black stools (looks like tar)
    • pink or brown urine
    • unexpected bleeding, or bleeding that is severe or you cannot control
    • vomit blood or vomit that looks like coffee grounds
    • cough up blood or blood clots
    • dizziness
    • weakness
    • confusion
    • change in your speech
    • headache that lasts a long time
  • Infections. Infections can happen during treatment with CALQUENCE. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, or flu-like symptoms.
  • Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with CALQUENCE, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
  • Second primary cancers. New cancers have happened in people during treatment with CALQUENCE, including cancers of the skin. Use sun protection when you are outside in sunlight.
  • Heart rhythm problems (atrial fibrillation and atrial flutter) have happened in people treated with CALQUENCE. Tell your healthcare provider if you have any of the following signs or symptoms:
    • your heartbeat is fast or irregular
    • feel lightheaded or dizzy
    • pass out (faint)
    • shortness of breath
    • chest discomfort

The most common side effects of CALQUENCE include:

  • headache
  • diarrhea
  • tiredness
  • muscle aches
  • bruising

These are not all the possible side effects of CALQUENCE. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is CALQUENCE?

CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer.

It is not known if CALQUENCE is safe and effective in children.

Please see complete Prescribing Information including Patient Information.