
Imbruvica
Imbruvica (ibrutinib) is a type of targeted therapy called a kinase inhibitor. It's used to treat adults with certain blood cancers. These are chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) and Waldenström's macroglobulinemia (WM). This medication can also treat chronic graft-versus-host disease (cGVHD) in people ages 1 year and older. Imbruvica (ibrutinib) comes as tablets, capsules, and a liquid. The dose is taken by mouth once a day. Common side effects are diarrhea, nausea, and rash.
What is Imbruvica (ibrutinib)?
What is Imbruvica (ibrutinib) used for?
- Chronic lymphocytic leukemia and small lymphocytic leukemia (CLL/SLL) in adults
- Waldenström's macroglobulinemia (WM) in adults
- Chronic graft-versus-host disease (cGVHD) in people 1 year and older
How Imbruvica (ibrutinib) works
Imbruvica (ibrutinib) is a type of kinase inhibitor. It's called a Bruton's tyrosine kinase (BTK) inhibitor. It works by blocking a protein called BTK. This protein helps certain immune cells grow and work.
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For CLL/SLL and WM: Blocking BTK helps stop abnormal immune cells from growing. This helps slow the cancer.
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For chronic graft-vs-host-disease (cGVHD): Imbruvica (ibrutinib) helps calm down your immune system. After a bone marrow or stem cell transplant, donor immune cells can cause your own immune system to attack your healthy tissues and organs. Blocking BTK helps stop your immune cells from attacking your body.
Drug facts
| Common Brands | Imbruvica |
|---|---|
| Drug Class | BTK inhibitor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
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Side effects of Imbruvica (ibrutinib)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Low platelets (52%)
- Low white blood cells (51%)
- Diarrhea (48%)
- Lower hemoglobin levels (36%)
- Muscle or bone pain (28%)
- Nausea (26%)
- Rash (24%)
- Fever (24%)
- Cough (19%)
- Mouth sores (17%)
- Joint pain (17%)
- Upper respiratory tract infection (16%)
- Pneumonia (15%)
- Constipation (15%)
Less Common Side Effects
- Vomiting
- Small, flat red, purple, or brown pinpoint spots on the skin
- Bruising
- Headache
- Dizziness
- Muscle spasms
- Shortness of breath
- Sinus infection
- Urinary tract infection (UTI)
- Blurry vision
- High blood pressure
Note: Side effects were from adults with CLL/SLL. Side effects might differ for people taking Imbruvica (ibrutinib) for other conditions.
Imbruvica (ibrutinib) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious bleeding: bloody vomit or vomit that looks like coffee grounds, bloody or black stools, pink or brown urine, bleeding that's hard to stop, dizziness, weakness, confusion, sudden and severe headache
- Infection: fever, chills, weakness, cough, extreme tiredness, trouble breathing, confusion
- Heart problems: fast or irregular heartbeat, lightheadedness, fainting, trouble breathing, chest pain, swelling of your arms or legs, sudden weight gain
- New or worsening high blood pressure: higher blood pressure than usual, severe headache, confusion, chest pain, nausea, anxiety, trouble breathing
- Liver problems: yellowing of your skin or eyes, stomach pain, nausea, low appetite, clay-colored stools
- Tumor lysis syndrome: nausea, vomiting, low appetite, side pain, muscle cramps, numbness, dark urine, less urination, fast heartbeat
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The following Imbruvica (ibrutinib) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
- Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- Increase in blood pressure
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Bone, joint, or muscle pain
- Diarrhea
- Nausea
- Pain, redness, or swelling with sores inside the mouth or throat
Pros and cons of Imbruvica (ibrutinib)
Pros
- Taken by mouth once a day
- Can take at home
- A recommended option for CLL
- An option for cGVHD that doesn't respond well to steroids
Cons
- Can cause nausea and diarrhea
- Can raise your blood pressure
- Has a risk of infection and bleeding
- Not recommended for people with severe liver problems because of safety risks
Pharmacist tips for Imbruvica (ibrutinib)
- Take Imbruvica (ibrutinib) once a day at around the same time each day. This helps the medication work consistently. You can pair it with your daily routine, like taking it after dinner, to help you remember.
- If you miss a dose of Imbruvica (ibrutinib), take it as soon as you remember that same day. Then, you can continue with your usual schedule (take the medication as usual the next day). Never double up to make up for a missed dose since this could lead to more side effects.
- For Imbruvica (ibrutinib) capsules or tablets: Swallow the pill whole with a glass of water. Don't open, break, cut, crush, or chew the pill. If you have trouble swallowing it whole, ask your prescriber about your options.
- For the Imbruvica (ibrutinib) oral suspension: Follow the instructions to measure and give the right dose. Shake the bottle well each time. Use the oral syringes to measure out the liquid. Then, place the syringe tip along the inside of the cheek and slowly push the plunger down to give the full dose. Don't save the medication in the syringe for later. After opening the bottle, the medication is good for 60 days — write this date on the bottle so you know when it expires. Store between 36ºF and 77ºF.
- Imbruvica (ibrutinib) can often cause nausea and diarrhea. If this happens, drink plenty of fluids to stay hydrated. Also try eating simple foods, like bananas or toast, and avoid spicy or greasy foods to help calm your stomach. Talk to your care team about more ways to manage these side effects. Your prescriber might suggest medications if you need more help.
- Check your blood pressure regularly while taking Imbruvica (ibrutinib). This medication can raise your blood pressure. If it stays higher than usual, tell your prescriber. You might need blood pressure medications to help control it.
- Avoid grapefruit and Seville oranges (often found in marmalades) while taking Imbruvica (ibrutinib). They can raise the level of the medication in your body. This can raise your risk of side effects.
- Talk to your prescriber about your drinking habits. It might be a good idea to limit or avoid alcohol while taking Imbruvica (ibrutinib). Alcohol can make some side effects like nausea, headache, and dizziness worse. Heavy drinking can also damage the liver. Since the medication itself might have a risk of harming the liver, drinking alcohol might raise this risk even more.
- Wash your hands well with soap and warm water often while taking Imbruvica (ibrutinib). Also stay away from large crowds and people who are sick. This medication can raise your risk of infection. Reach out to your care team about any signs of infection, like fever, chills, cough, or sore throat.
- Tell your prescriber if you have any surgeries or procedures planned. Imbruvica (ibrutinib) can raise your risk of bleeding. Your prescriber might ask you to stop taking it for a few days before your procedure and wait a few days after to take it again. Follow their instructions to help prevent serious bleeding problems.
- Get any blood tests or lab testing done on time as your prescriber tells you. These tests help check for side effects and make sure Imbruvica (ibrutinib) is still safe for you. For example, you'll need blood tests every month to check your blood cell counts. This medication can cause anemia, low platelets, and low white blood cells. Your care team can explain your results and what they mean.
- Give your care team a list of all the medications and supplements you take or plan to take. Imbruvica (ibrutinib) can interact with many medications. Some, like blood thinners or certain antifungals, can raise your risk of side effects. Others, like some seizure medications, can make Imbruvica (ibrutinib) work less well. Your care team can make sure your medications are safe to take together. They might adjust your medications, including Imbruvica (ibrutinib), to keep you safe.
- If you or your partner can become pregnant: Use reliable birth control and condoms while taking Imbruvica (ibrutinib). Continue for 1 month after your last dose. Preventing pregnancy is important because the medication can harm an unborn baby. Tell your prescriber right away if you or your partner gets pregnant during treatment.
- If you plan to breastfeed: Don't breastfeed while taking Imbruvica (ibrutinib) and for 1 week after your last dose. We don't know if the medication can pass into breast milk. We also don't know if it can affect your milk supply or cause side effects in your baby. But there's a risk that it can. Speak to your prescriber or a lactation expert about safer feeding options.
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Risks and warnings for Imbruvica (ibrutinib)
Imbruvica (ibrutinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk of bleeding
- Risk factors: Taking blood thinners | Recent surgery
Some people taking Imbruvica (ibrutinib) have had bleeding episodes. This can include bleeding, bruising, or small red spots on the skin. In rare cases, bleeding can be serious or life-threatening. Examples include serious brain and stomach bleeds and blood in the urine.
In general, the risk of serious bleeding is higher if you also take any blood thinners. Tell your care team about all the medications you take so they can check your risk.
Because of the risk of serious bleeding, tell your care team about any planned procedures. Your prescriber might tell you to stop Imbruvica (ibrutinib) for a few days before and after the surgery. This depends on the type of surgery and your risk of bleeding.
Watch for unusual bleeding or bruising while taking Imbruvica (ibrutinib). If this happens, tell your care team. Get medical help right away if you see blood in your vomit, urine, or stool or have a sudden severe headache. These can be signs of serious bleeding.
Infections
Some people taking Imbruvica (ibrutinib) have had infections, which can sometimes be very serious. If you have a high risk, your prescriber might give you other medications to take with Imbruvica (ibrutinib) to help prevent infections.
Call your care team about any signs of infection while taking Imbruvica (ibrutinib). This includes fever, chills, cough, and sore throat.
Risk of heart rhythm problems and heart failure
- Risk factors: High blood pressure | History of irregular heartbeat | Diabetes | Infection
In rare cases, some people taking Imbruvica (ibrutinib) have had serious heart problems. These included abnormal heart rhythm (arrhythmia) and heart failure. Some cases were fatal and sudden deaths have also rarely happened.
Before starting Imbruvica (ibrutinib), tell your care team about your medical history, especially any heart problems. Your prescriber might order heart scans or tests before treatment to check your risk.
Let your care team know if you feel your heart racing, feel lightheaded, or faint. Also tell them if you have chest pain or trouble breathing. These can be signs of heart problems. Your prescriber can check your heart and decide if you need a lower dose of Imbruvica (ibrutinib). If you develop heart problems, your prescriber can weigh the risks and benefits of continuing the medication.
High blood pressure
Some people who take Imbruvica (ibrutinib) can have high blood pressure. This can start in the months after beginning treatment.
Get your blood pressure checked regularly while taking Imbruvica (ibrutinib). Also check at home. If your blood pressure stays higher than usual, tell your prescriber. They can start blood pressure medications and lower your dose of Imbruvica (ibrutinib).
Call for medical help right away if you have signs of very high blood pressure. Watch for severe headache, confusion, chest pain, nausea, anxiety, or trouble breathing. Very high blood pressure can be serious and needs medical care.
Risk of new cancers
Some people who took Imbruvica (ibrutinib) developed other cancers. The most common type of cancer reported was non-melanoma skin cancer. Wear protective clothing and sunscreen if you're going outside. Talk to your prescriber if you're worried about this risk.
Liver problems
Some people taking medications like Imbruvica (ibrutinib) have had liver problems. These can sometimes be severe or life-threatening.
Before starting Imbruvica (ibrutinib), let your prescriber know if you have any liver problems. Your prescriber will also check your liver with blood tests. People with severe liver problems should avoid taking this medication.
During treatment, your prescriber will keep checking your liver with blood tests periodically. Watch for symptoms like yellowing of your skin or eyes, stomach pain, nausea, and low appetite. Tell your care team if you notice these symptoms during treatment. If needed, your prescriber might pause or stop Imbruvica (ibrutinib) to keep you safe.
Tumor lysis syndrome (TLS)
- Risk factors: Higher tumor burden | Dehydration | Kidney damage
Rarely, some people taking Imbruvica (ibrutinib) have had tumor lysis syndrome (TLS). This happens when cancer cells break down very fast in the body. It can cause changes in the levels of potassium, phosphorus, calcium, and uric acid in your blood. This can lead to muscle cramps, irregular heartbeat, kidney problems, or other organ issues if not treated.
Your prescriber will check your risk for TLS. The risk is higher if you have a lot of cancer cells in your body or cancer with very fast-growing cells. You're also at risk if you're dehydrated or have kidney damage.
Your care team will watch you closely for TLS during treatment. Call them right away if you have nausea, vomiting, low appetite, side pain, dark urine, or less urination. Also call if you have numbness, muscle cramps, or heart palpitations. These could be signs of TLS, which should get treated to prevent serious problems.
Harm to an unborn baby
Based on animal studies, Imbruvica (ibrutinib) might harm an unborn baby if taken during pregnancy. If you can become pregnant, your prescriber might have you take a pregnancy test before starting treatment. This helps them make sure the medication is safe to start.
If you can become pregnant, use effective birth control while taking Imbruvica (ibrutinib) and for 1 month after your last dose. If your partner can become pregnant, also use birth control like condoms during this time. Tell your prescriber right away if you or your partner becomes pregnant.
Imbruvica (ibrutinib) dosage
Typical dosage for Imbruvica (ibrutinib)
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CLL/SLL or WM
- Adults: The typical dose is 420 mg by mouth once daily.
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cGVHD
- People 12 years and older: The typical dose is 420 mg by mouth once daily.
- Children 1 to under 12 years of age: The dose is based on your child's body size, also called body surface area (BSA). It's calculated in m² units and uses your child's height and weight. The typical dose is 240 mg/m² of BSA (up to a total of 420 mg), taken by mouth once daily.
Your dose might differ depending on a few things. This includes if you have liver problems and if you have side effects. Your prescriber might also adjust the dose to keep you safe from interactions with certain medications.
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