Imbruvica is a type of cancer treatment called a kinase inhibitor. Imbruvica is a new oral medicine developed to treat a type of leukemia: chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Imbruvica can be given alone or in combination with immunotherapy medicines used to treat leukemia called rituximab or obinutuzumab. It can also be used in combination with rituximab and a chemotherapy medicine called bendamustine. Below you’ll find common questions and answers about Imbruvica to help decide whether it’s right for you.
How Does Imbruvica Work to Treat CLL/SLL?
Imbruvica is a type of medicine called a kinase inhibitor. Kinases are enzymes on a cell that help the cell grow and divide. Imbruvica links to a kinase on leukemia cells called Bruton's tyrosine kinase (BTK). When it links to BTK, it stops the leukemia cells from growing and causes them to die.
How Will I Get Imbruvica?
Imbruvica is taken as a tablet, capsule, or liquid suspension that you swallow. The typical dosage is 420 milligrams of Imbruvica once a day. You should take your dose around the same time every day. If you miss a dose, you should take it as soon as you remember. Imbruvica tablets or capsules should be taken whole with a full glass of water. You should not open, cut, crush, break, or chew them. Do not take your tablets or capsules if they are broken or crushed, or if the carton the liquid comes in has a broken or damaged seal. You should avoid drinking grapefruit juice or eating grapefruits or Seville oranges while you are taking Imbruvica since this could increase the levels of the drug in your body.
You will take Imbruvica for as long as possible. This means you will take it until your cancer grows (progresses) or until you have side effects that prevent you from tolerating the medicine. Your doctor may choose to decrease your dose, hold, or stop Imbruvica completely if you have severe side effects.
Your dose of Imbruvica may need to be lowered if you are taking certain medications. You should tell your health care provider about all of the medications or supplements that you are taking.
You may need a lower dose of Imbruvica if you have problems with your liver. Talk to your health care provider about all of your medical history so they can decide what dose of Imbruvica is right for you.
How Well Does Imbruvica Work for CLL and SLL?
Imbruvica was studied in people with CLL or SLL who were 65 and older and did not receive any prior treatment for their leukemia. People in this study got either Imbruvica or chemotherapy. This study looked at progression-free survival (PFS), which measured how long people lived without progression of their cancer or death. It also looked at overall survival (OS), which measured how long people lived, and overall response rate (ORR), which measured the amount of people who had a complete or partial response. There were 269 patients in this study. The median age was 73 and most of the people were at least 70 years old (70%). Sixty-five percent of people in the Imbruvica group were male and 61% in the chemotherapy group were male. The PFS rate at 18 months was 90% in the Imbruvica group and 52% in the chemotherapy group. This means that people taking Imbruvica lived significantly longer without progression than those in the chemotherapy group. OS was also significantly improved in the Imbruvica group with 98% of people still alive at 24 months versus 85% in the chemotherapy group. People in the Imbruvica group had an ORR of 86% and people in the chemotherapy group had an ORR of 35%.
Imbruvica was also studied in combination with a chemotherapy medicine called bendamustine, plus rituximab for people with CLL and SLL. People in this study either got Imbruvica plus bendamustine and rituximab (BR) or placebo plus BR. People in this study had relapsed or refractory CLL or SLL that had been treated with at least one other treatment for their cancer. The study looked at PFS, as well as OS and ORR. There were 578 people in this study. Ages ranged from 31 to 86, and the median age was 64. Sixty-seven percent of people in the Imbruvica/BR group were male, and 65% of people in the BR group were male. Most of the people in both groups had CLL (89%). After 60 months, the PFS in the Imbruvica/BR group was 52.7% versus 8.2% in the BR group. At 5 years, the median PFS was significantly longer in the Imbruvica/BR group at 65.1 versus 14.3 in the BR group. This means that half the people in the Imbruvica/BR group lived at least 65.1 months and half the people in the BR group lived at least 14.3 months without their cancers progressing. The OS rate was 75.7% for the Imbruvica/BR group versus 61.2% for the BR group. This means that people that received Imbruvica plus BR lived longer than those that got BR alone. The ORR was also longer in the Imbruvica/BR group (87.2%) versus the BR group (66.1%).
Another study looked at Imbruvica in combination with obinutuzumab. People in this study got Imbruvica plus obinutuzumab or chemotherapy plus obinutuzumab. People were included in this study if they had CLL or SLL that was never treated before and were 65 or older. Some people that were less than 65 were included if they had other coexisting conditions. This study measured PFS as well as ORR. There were 229 people in this study and they were evenly split between the two groups. The median age was 71, ranging from 40 to 87, with most patients (80%) being 65 or older. Fifty-nine percent in the Imbruvica group and 68% in the chemotherapy group were men. Ninety-six percent of people in this study were white, 2% were Black or African American, 1% were Asian, and 1% were Native Hawaiian or other Pacific Islander. The median PFS at 42 months was 74% in the Imbruvica group versus 33% in the chemotherapy group. This means that people in the Imbruvica group lived significantly longer without disease progression than people in the chemotherapy group. The ORR was also better in the Imbruvica group at 91% versus the chemotherapy group at 81%.
Imbruvica was also studied in combination with rituximab. People were included in this trial if they had CLL or SLL that had never been treated and if they were 70 years old or less. People got either rituximab plus Imbruvica or rituximab plus chemotherapy. This study looked at PFS as well as OS. There were 529 people in this trial; 354 people were in the Imbruvica group and 175 people were in the chemotherapy group. The median age for this study was 57 and the ages ranged from 49 to 64. About 67% of the people were male. At three years, the PFS for the Imbruvica was 89.4% as compared to 72.9% in the chemotherapy group. The OS was also higher in the Imbruvica group versus the chemotherapy group at 98.8% versus 91.5%. This shows that Imbruvica given with rituximab improved both PFS and OS in CLL and SLL patients without prior treatment.
What Are Other Unique Considerations to Be Aware Of?
Imbruvica can cause harm to a fetus. Your health care provider will discuss options for contraception while you take Imbruvica. You should use an effective method of birth control while you are receiving Imbruvica and for 1 month after your last dose. If you and your partner are or are planning to become pregnant, talk with your health care provider about your options. Imbruvica may pass into your breast milk if you are breastfeeding. You should not breastfeed while you are getting Imbruvica and for one month after your last dose.
Imbruvica may cause other severe side effects such as bleeding problems and heart problems. Contact your health care provider right away if you experience signs or symptoms of bleeding such as dark urine or tarry stool, coughing or vomiting up blood, or confusion, dizziness or severe headache, or signs and symptoms of heart problems such as fast heartbeat, pain in your chest, or feeling short of breath.
What Are the Side Effects of Imbruvica, and How Can I Prevent or Manage Them?
Imbruvica can cause low blood counts, including low platelets (thrombocytopenia), low white blood cells (neutropenia), and low red blood cells (anemia). Thrombocytopenia can cause you to bruise or bleed easier than normal. Things you can do to prevent this include using an electric shaver instead of a razor, using a soft bristled toothbrush to brush your teeth, and avoiding contact sports. Neutropenia can cause severe infections. You can help reduce your risk of developing an infection by washing your hands often and staying away from people with infections, colds, or the flu. If you are at high risk for getting an infection, your health care provider may prescribe a medicine to help prevent infections. You should contact your health care provider right away if you develop a fever or any other signs of an infection such as a sore throat or cough. They may prescribe you medicine to treat your infection. Anemia can make you feel more tired than usual and have shortness of breath. Eating foods rich in iron such as spinach and red meat may help boost your energy. You should contact your health care provider if you have these symptoms so your blood counts can be monitored.
Imbruvica may cause gastrointestinal (GI) side effects such as nausea and diarrhea. Your health care provider may give you certain medicines to prevent these side effects from happening, as well as medicines to treat them if they occur. Eating bland food and smaller meals throughout the day can help with symptoms of nausea. If you experience diarrhea, your health care provider may recommend that you take diarrhea medicine and drink more fluids to avoid dehydration.
Skin reactions are a common side effect of Imbruvica. If you develop a rash, you should contact your health care provider. They may recommend creams or antihistamines to help with your rash and itchiness. You may also be given a corticosteroid to treat your rash.
You may also experience muscle, bone, or joint pain while taking Imbruvica. Your health care provider may recommend that you use over-the-counter pain relievers such as ibuprofen or Tylenol. You should contact your health care provider if you have pain that does not go away with over-the-counter medicines.
If you have certain side effects while you take Imbruvica, your health care provider may need to change how often you get your medicine, pause your medicine, or even stop your medicine altogether. This will depend on how severe the side effect is that you have and what type of treatment it requires.
These are not all the possible side effects of Imbruvica. Contact your health care provider for medical advice about side effects if you are having symptoms that bother you. You can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
How Do I Know If Imbruvica Is Working?
Your health care provider will regularly check how well Imbruvica is working for your cancer through looking at results of tests such as blood tests, CT scans, or MRI scans. You may notice improvements within a few weeks to months after starting Imbruvica. The complete therapeutic effect can take longer, depending on individual factors and disease progression.
Is There a Cost Savings Program?
There is a copay savings program available from the drugmaker that may cost you as little as $0 for your monthly copay for your Imbruvica prescription. Whether or not you are eligible depends on your insurance coverage. You can find out more by visiting www.imbruvica.com/imbruvica-by-your-side-copay-card or by calling 888-968-7743.
