Imbruvica

(Ibrutinib)

The active ingredient in Imbruvica is ibrutinib. It works by targeting and blocking the enzyme Bruton tyrosine kinase (BTK). BTK signals certain cancer cells to grow and divide. By blocking BTK, Imbruvica stops the cancer cells from multiplying and causes them to die.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Imbruvica. However, the following is a synopsis of the general guidelines for the use of Imbruvica:

• Take Imbruvica capsules or tablets whole with a glass of water, with or without meals. Avoid opening, breaking, cutting, crushing, or chewing the capsules or tablets.
• If you are using Imbruvica oral suspension, read the instructions carefully to ensure that your child receives the proper dose. If you have any further questions, please contact your child's provider. Do not use it if the carton's seal is broken or missing.
• Drink plenty of fluids to stay hydrated while taking Imbruvica (ibrutinib). This medication's most common side effect is diarrhoea, which can cause dehydration and increase your risk of serious consequences.
• Follow up with your doctor for monthly blood testing.

The most common side effects of Imbruvica seen in clinical trials include:

• Fatigue.
• Constipation.
• Diarrhea.
• Bruising.
• Upper respiratory tract infection.
• Nausea.
• Headache.
• Fever.
• Mouth sores.
• Musculoskeletal pain (bone, muscle, or joint pain).
• Low platelet count (thrombocytopenia).
• Low red blood cells (anemia).
• Muscle spasms.
• Stomach pain.
• Low white blood cells (neutropenia).

Some individuals may experience serious side effects while using Imbruvica. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Increased risk of bleeding, which includes blood in vomit, vomit that resembles coffee grounds, blood in your stool or black faeces, unexpected bleeding, severe or uncontrollable bleeding, dizziness, weakness, disorientation, speech change, sudden and severe headache, and headache that lasts for a long period.
• Infections include fever, chills, lethargy, and disorientation.
• Heart disorders include palpitations, dizziness, lightheadedness, fainting, difficulty breathing, chest pain, and swelling of the arms and legs.
• New or increasing high blood pressure (hypertension) symptoms include headaches, visual problems, flushing, shortness of breath, and chest pain.
• Symptoms of low blood cell counts include infections, fever, disorientation, weakness, and difficulty breathing.
• Cancers, including skin cancer. Symptoms include new moles or spots on the skin, changes in existing moles, and skin bleeding or itching.
• Tumor lysis syndrome symptoms include dark urine, decreased urination, pain on either side of the lower back, a racing heart, muscle cramps or spasms, numbness, nausea, vomiting, and convulsions.

These are not all of the possible side effects of Imbruvica. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Imbruvica, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• A skin infection.
• Bleeding problems (hemorrhage).
• Take a blood thinner like warfarin.
• A heart rhythm abnormality (atrial fibrillation)
• Heart failure or heart problems.
• Cardiovascular disease risk factors include diabetes, smoking, obesity, high blood pressure, and low blood cell counts.
• If you have recently had or plan to have surgery, medical, or dental procedures, you may develop liver disease.

There are no contraindications with Imbruvica.

Imbruvica (ibrutinib) often produces a response within a few months, with some patients achieving very good partial responses within three to six months.

When Imbruvica is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Moderate to powerful CYP3A inhibitors include clarithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, ritonavir, grapefruit juice, seville oranges, erythromycin, and verapamil.
• Moderate to severe CYP3A inducers include glucocorticoids, rifampin, carbamazepine, phenobarbital, and phenytoin. Avoid co-administration.
• Chlorambucil.

The normal dose is 420 mg taken orally once daily.

If you have liver problems or are taking other medications that potentially interfere with Imbruvica, your dose may change.

If you miss a dose of Imbruvica, take it as soon as you remember on the same day. Then take your next dose at its normal time the next day. Do not take extra doses to make up for a missed dose.

Store at room temperature and keep out of reach of children.

Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie Company, are the companies that manufacture Imbruvica.

There are no lower-cost generic medications available for Imbruvica.

It is not advised to stop taking the medication suddenly. Speak to your healthcare provider first.

If you are a woman, you may need to take a pregnancy test to ensure you are not pregnant. Use birth control while using Imbruvica and for at least one month following your last dose. If you are a male and your sexual partner is capable of becoming pregnant, use an effective form of birth control like condoms while on Imbruvica and for 1 month after your last dose. If you become pregnant, tell your doctor straight away.

Do not breastfeed while taking Imbruvica and for at least one week following your final dosage.