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
- 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:
- muscle aches
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.