WHAT ARE THE SIDE EFFECTS?

SIDE EFFECTS MAY HAPPEN

Side effects may occur with CALQUENCE, but learning about them early may help you identify and manage some of them at home. Preventing and managing side effects from treatment may help you stay on treatment. Remember to always tell your doctor about any side effects you experience, especially if side effects are severe, or if they don't go away or get worse.

The most common side effects of CALQUENCE are listed below, along with tips from leading sources on how to help manage them. This information is not provided by AstraZeneca and is not meant to replace directions from your own doctor. It's important to talk to your doctor before implementing tips on how to manage side effects.

Headache Icon MCL

Headache

  • Can usually occur within 30 minutes of dosing and typically can be managed with acetaminophen (like Tylenol®) or caffeine
  • Typically resolves over a period of 4 weeks
Diarrhea Icon MCL

Diarrhea

  • Drink more fluids, eat smaller, more frequent, and easier-to-digest meals, and avoid spicy foods
  • Your doctor may recommend taking an anti-diarrheal medication (like Imodium®)
Muscle and Joint Pain MCL

Muscle and joint pain

  • Take the time to stretch in order to relax and ease aches
  • Take pain medication as prescribed and discuss other treatments, such as massage or physical therapy, with your doctor
Upper Respiratory Tract Infection MCL

Upper respiratory tract infection

  • Minimize the chance of catching or spreading an infection by washing your hands with soap and water thoroughly and often
  • Tell your doctor right away if you have any signs or symptoms of an infection, including fever, chills, or flu-like symptoms
Bruising Icon MCL

Bruising

  • Elevate and ice the affected area to reduce swelling and ease tenderness
Fatigue Icon MCL

Fatigue

  • Ensure adequate nighttime sleep and take short naps early in the day if needed
  • Meditate, read, or listen to music to help relieve stress
  • Engage in moderate exercise, such as walking or stretching (consult your doctor before starting any exercise plan)

Always tell your doctor about any side effects you experience, especially if side effects are severe, or if they don't go away or get worse.

SERIOUS SIDE EFFECTS

There are also more serious side effects that can occur:

  • Serious infections can happen during treatment with CALQUENCE and may lead to death. Your doctor may prescribe certain medicines if you have an increased risk of getting infections. You should tell your doctor right away if you have any signs or symptoms of an infection, including fever, chills, or flu-like symptoms
  • Bleeding problems (hemorrhage) can happen during treatment with CALQUENCE and can be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. You should tell your doctor if you have any signs or symptoms of bleeding, including:
    • blood in the stools or black stools (looks like tar)
    • pink or brown urine
    • unexpected bleeding, or bleeding that is severe or cannot be controlled
    • vomit blood or vomit that looks like coffee grounds
    • cough up blood or blood clots
    • dizziness
    • weakness
    • confusion
    • changes in speech
    • headache that lasts a long time
    • bruising or red or purple skin marks
  • 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 doctor should do blood tests to check your blood counts regularly during treatment with CALQUENCE
  • Second primary cancers. New cancers have happened during treatment with CALQUENCE, including cancers of the skin or other organs. Your doctor will check for skin cancers during treatment with CALQUENCE. You should use sun protection when outside in sunlight
  • Heart rhythm problems (cardiac arrhythmias) have happened in treatment with CALQUENCE, which may be serious or lead to death. You should tell your doctor if you have any of the following signs or symptoms:
    • fast or irregular heartbeat
    • dizziness
    • feeling faint
    • chest discomfort
    • shortness of breath
  • Liver problems. Liver problems can happen during treatment with CALQUENCE, which may be severe or life-threatening, or lead to death. Contact your healthcare provider if you experience stomach pain or discomfort, urine of dark color, or yellowing of your skin. Your healthcare provider will request tests to monitor your liver function during treatment with CALQUENCE.

These are not all of the possible side effects of CALQUENCE. You should call your doctor for medical advice about side effects. Side effects may be reported to FDA at 1-800-FDA-1088.1-800-FDA-1088.

ARE THERE ANY SIDE EFFECTS ASSOCIATED WITH HEART HEALTH?

Information collected from a clinical trial in previously treated MCL patients who had received CALQUENCE showed there were low rates of hypertension (4%, or 5 out of 124 patients) and heart rhythm issues, such as atrial fibrillation (1.6%, or 2 out of 124 patients). Overall, 16 out of 124 patients in the clinical trial had cardiac adverse events; 11 of these 16 patients had prior cardiac risk factors.

Heart rhythm problems (cardiac arrhythmias) experienced during treatment with CALQUENCE may be serious or lead to death. Signs or symptoms of heart rhythm problems include fast or irregular heartbeat, dizziness, feeling faint, chest discomfort, or shortness of breath.

Adults with MCL and other health conditions should talk to their doctor about the right therapy for them. High blood pressure, or hypertension, is a condition where over time the force of your blood against the artery walls is hard enough that it may cause health problems, such as heart disease. Adults over 65 are more likely to have cardiovascular disease (problems with the heart, blood vessels, or both).

HOW MANY PEOPLE STOP TREATMENT DUE TO SIDE EFFECTS?

In an initial analysis from a clinical trial of patients with previously treated MCL, after approximately 15 months of median* follow-up, 7% of patients (8 out of 124) had to stop treatment due to side effects.

In the same clinical trial, after 38 months of median* follow-up, 11% of patients (14 out of 124) had to stop treatment due to side effects.

*Median is the middle number in a group of numbers that are arranged from lowest
to highest.