Bosulif

The active ingredient in Bosulif is bosutinib monohydrate. Bosulif is a targeted medication that works by suppressing the function of BCR-ABL kinase, a protein (enzyme) that CML cells normally overproduce, thereby preventing or delaying their growth and spread. In addition to targeting BCR-ABL, it inhibits Src, Lyn, and Hck, all of which belong to the Src family of kinases. Bosulif belongs to a class of drugs known as tyrosine kinase inhibitors. Other examples of this class include dasatinib, imatinib, and nilotinib.

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 Bosulif. However, the following is a synopsis of the general guidelines for the use of Bosulif:

• Take it with food.
• Swallow the tablet whole; do not chew, crush, or break it. If a crushed or broken pill comes into contact with your skin, the medication can be hazardous. If this happens, cleanse your skin with soap and water. Ask your chemist how to properly dispose of a broken pill.
• If you are unable to swallow the capsules whole, put on gloves, open the appropriate number of Bosulif capsules, and mix them with room-temperature applesauce or yoghurt. Do not combine Bosulif with other meals. Swallow the entire combination immediately, without chewing; do not reserve it for later use. Take it with a complete meal.
• If you are administering Bosulif capsules/tablets to a child, wear gloves when removing them from the container and placing them in their mouth.
• Take Bosulif at least two hours after taking an antacid or H2 blocker. If you are taking a proton pump inhibitor (PPI), consult your doctor or pharmacist. During Bosulif treatment, avoid eating grapefruit, drinking grapefruit juice, and taking grapefruit extract supplements.
• The dosage may need to be adjusted due to toxicity, kidney, or liver damage.

Some mild or common side effects of Bosulif include:

• Fatigue.
• Diarrhea.
• Nausea.
• Vomiting.
• Rash.
• Stomach pain.
• Decreased appetite.
• Respiratory tract infection.
• Constipation.
• Joint pain.
• Low red blood cell counts (anemia).
• Low white blood cell counts (neutropenia)
• Low platelet counts (thrombocytopenia).
• High creatinine levels in the blood.

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

• Severe or persistent nausea, vomiting, stomach discomfort, or diarrhea.
• Symptoms of kidney damage like urinating less and blood in your urine.
• Symptoms of heart problems include swelling, rapid weight gain, chest pain, and shortness of breath.
• Low blood cell count symptoms include fever, chills, fatigue, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale complexion, and cold hands and feet.
• Fluid retention, swelling in the arms or legs (peripheral edema), and fluid buildup in the heart (pericardial effusion) or lungs (pleural effusion).
• Symptoms of liver disease include upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), and swelling or fluid build-up in the lungs.
• Allergic reaction to the medication, such as hives, skin rash, or swelling (edema).

These are not all of the possible side effects of Bosulif. 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 Bosulif, 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:

• Heart disease.
• High blood pressure.
• Diabetes.
• Liver problems or liver injury. Your doctor must do blood tests to check your liver function regularly during your treatment with Bosulif.
• Kidney disease.

A history of hypersensitivity to bosutinib.

The time it takes Bosulif to work will vary. Some people notice an improvement in their cancer as soon as three months after starting Bosulif.

Once you've taken Bosulif, your doctor will order lab testing. These tests will help you determine whether Bosulif is working for you. Clinical trials showed that people who took Bosulif had fewer cancer cells at 24 weeks, 48 weeks, and 12 months.

When Bosulif 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:

• Antacids or stomach acid reducers (such as famotidine or cimetidine).
• Proton pump inhibitors (such as omeprazole).
• Strong and moderate CYP3A inhibitors such as clarithromycin, diltiazem, erythromycin, itraconazole, ketoconazole, ritonavir, and verapamil.
• Strong CYP3A inducers such as glucocorticoids, rifampin, carbamazepine, phenobarbital, St. John’s Wort, and phenytoin.

Bosulif is available in the following dosage forms and strengths:

• 100 mg, 400 mg, and 500 mg oral tablets
• 50 mg and 100 mg oral capsules

The standard dose for adults is 400 mg once daily for newly diagnosed patients and 500 mg once daily for those in the chronic, blast, or accelerated phases.

For children, the average dose is 300 mg/m² once daily when first diagnosed, and 400 mg/m² once daily if in the chronic phase with resistance or intolerance to previous therapy.

If you miss a dose and it is more than 12 hours until the next scheduled dose, you should skip the missed dose and resume the medication with the next scheduled dose.

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

Pfizer Pharmaceuticals is the company that manufactures Bosulif.

There are several generic versions available of Bosulif.

Do not stop taking Bosulif without speaking to your healthcare provider first.

Bosulif can harm an unborn baby. Females who are capable of becoming pregnant should have a pregnancy test before beginning therapy and take effective birth control (contraception) during treatment and for two weeks after the final dosage. Consult your doctor about effective birth control options. If you become pregnant accidentally while undergoing treatment, notify your doctor immediately.

It is not known whether Bosulif can pass into breast milk, but it may cause serious harm if it does. You should not breastfeed during treatment with Bosulif and for 2 weeks after your last dose, just to be safe.