FDA approves Calquence

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Calquence (acalabrutinib), an oral kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

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 this medicine is safe and effective in children.

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

have had recent surgery or plan to have surgery. Your healthcare provider may stop Calquence for any planned medical, surgical, or dental procedure.

have bleeding problems.

have or had heart rhythm problems.

have an infection.

have or had hepatitis B virus (HBV) infection.

are pregnant or plan to become pregnant. Calquence may harm your unborn baby.

are breastfeeding or plan to breastfeed. It is not known if Calquence passes into your breast milk. Do not breastfeed during treatment, and for two weeks after your final dose.

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

Take Calquence exactly as your healthcare provider tells you to take it.

Do not change your dose or stop taking this medicine unless your healthcare provider tells you to.

Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop treatment if you develop certain side effects.

Take Calquence two times a day (about 12 hours apart).

Take the capsules with or without food.

Swallow the 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 two hours before or two hours after you take Calquence.

If you need to take certain other medicines called acid reducers (H-2 receptor blockers), take Calquence two hours before the acid reducer medicine.

If you miss a dose, take it as soon as you remember. If it is more than three hours past your usual dosing time, skip the missed dose and take your next dose at your regularly scheduled time. Do not take an extra dose to make up for a missed dose.

Calquence side effects

Calquence may cause serious side effects, including:

Bleeding problems (hemorrhage) may happen during treatment, 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

changes in your speech

headache that lasts a long time

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 include:

headache

diarrhea

tiredness

muscle aches

bruising

These are not all the possible side effects.

 

 

FDA approves Calquence

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Calquence (acalabrutinib), an oral kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. 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 this medicine is safe and effective in children. Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you: have had recent surgery or plan to have surgery. Your healthcare provider may stop Calquence for any planned medical, surgical, or dental procedure. have bleeding problems. have or had heart rhythm problems. have an infection. have or had hepatitis B virus (HBV) infection. are pregnant or plan to become pregnant. Calquence may harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Calquence passes into your breast milk. Do not breastfeed during treatment, and for two weeks after your final dose. Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements. Taking this mecidine with certain other medications may affect how it works and can cause side effects. Especially tell your healthcare provider if you take a blood thinner medicine. Take Calquence exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking this medicine unless your healthcare provider tells you to. Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop treatment if you develop certain side effects. Take Calquence two times a day (about 12 hours apart). Take the capsules with or without food. Swallow the 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 two hours before or two hours after you take Calquence. If you need to take certain other medicines called acid reducers (H-2 receptor blockers), take Calquence two hours before the acid reducer medicine. If you miss a dose, take it as soon as you remember. If it is more than three hours past your usual dosing time, skip the missed dose and take your next dose at your regularly scheduled time. Do not take an extra dose to make up for a missed dose. Calquence side effects Calquence may cause serious side effects, including: Bleeding problems (hemorrhage) may happen during treatment, 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 changes in your speech headache that lasts a long time 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 include: headache diarrhea tiredness muscle aches bruising These are not all the possible side effects.