Sprycel

(Dasatinib)

The active ingredient in Sprycel is dasatinib, which is a tyrosine kinase inhibitor (TKI). It inhibits an enzyme in your body called BCR-ABL tyrosine kinase. This protein is present on cancer cells, such as CML and ALL, but not on normal, healthy cells. It encourages cancer cells to expand and reproduce. Sprycel kills and prevents the spread of cancer cells by inhibiting this protein.

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

• You can take Sprycel with or without food. Take your medicine at the same time every day.
• Do not chew, crush, or break a Sprycel pill. Swallow the tablet whole. If your kid is unable to swallow the tablet whole, consult with a healthcare expert.
• Avoid taking a tablet that has been accidentally shattered. A crushed or fractured pill might be hazardous if it gets into your eyes, mouth, nose, or skin. If this happens, clean your skin with soap and water or rinse your eyes with water. When working with a broken tablet or capsule, always wear rubber gloves. Ask your doctor or chemist how to safely dispose of a broken tablet. Pregnant women should not handle broken pills.
• Sprycel can reduce the number of blood cells that aid in infection resistance and blood clotting. Your blood will need to be tested frequently. Your cancer treatments may be postponed depending on the results of these tests.
• If you take an antacid medicine, take it 2 hours before or 2 hours after your dose of Sprycel.

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

• Constipation.
• Abdominal pain.
• Weight gain.
• Vomiting.
• Trouble breathing.
• Fluid retention (edema).
• Low platelet count (thrombocytopenia).
• Low white blood cells (neutropenia) and low red blood cell counts (anemia).
• Musculoskeletal pain.
• High blood pressure.

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

• Infection symptoms include persistent fevers, chills, coughing, difficulty breathing, severe diarrhoea, vomiting, and painful or frequent urination.
• Serious hemorrhage includes persistent bleeding or bruising, a substantial amount of bleeding, blood in the urine, vomiting blood, and bloody or black and tarry faeces.
• Heart difficulties and cardiac dysfunction include chest pain, rapid heartbeat, shortness of breath, leg or foot swelling, unexpected weight gain, weariness, dizziness, weakness on one side of the body, and vision or speech impairments.
• Abnormal electrolyte levels and kidney problems include dark urine, decreased urination, pain on either side of the lower back, a racing heart, muscle cramps or spasms, numbness, nausea, and vomiting.
• Pulmonary arterial hypertension (PAH), which is high blood pressure in the vessels of your lungs. Symptoms include shortness of breath, fatigue, and swelling.
• Allergic reaction to the medication, such as swelling and skin rash.
• Tumor lysis syndrome. Symptoms include nausea, vomiting, weakness, shortness of breath, swelling, and muscle cramps.
• Pleural effusion (fluid around the lungs).

These are not all of the possible side effects of Sprycel. You should always consult 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 Sprycel, 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 weakened immune system (due to sickness or the use of certain medications).
• Stomach or intestinal haemorrhage.
• Heart problems.
• Heart failure.
• Liver problems.
• Heart disease.
• Your blood contains low quantities of potassium and magnesium.
• Long QT syndrome or QT prolongation (in you or a family member).
• Lung disease.
• Lactose intolerance.
• Grapefruit, grapefruit juice, and St. John’s Wort may interact with dasatinib, resulting in undesirable side effects. Avoid using these products while taking Sprycel.

There are no contraindications with Sprycel.

Sprycel starts working soon after you take it. Within a month or two, your body may begin to respond to the medicine. Some people who used Sprycel experienced a full response (no cancer cells detected with two bone marrow tests) after around three months of medication.

When Sprycel 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:

• Strong CYP3A4 Inhibitors
• Strong CYP3A4 Inducers
• Antacids
• H2 Antagonists and Proton Pump Inhibitors

Dosing for adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib, is determined by the phase of the disease. The normal dose is 100 mg or 140 mg Sprycel tablets taken orally once a day.

Adults with Ph+ ALL (Philadelphia chromosome-positive acute lymphoblastic leukemia): The average dose is 140 mg taken orally once daily.

Children with Ph+CML or Ph+ALL: The child's weight will determine the appropriate dosage. Dosage ranges from 40 mg to 100 mg taken orally once per day.

If you are using drugs that interact with Sprycel, your dose may differ. Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Store this medication at room temperature and keep it out of the reach of children.

Bristol-Myers Squibb Company (BMS) is the company that manufactures Sprycel.

There are several lower-cost generic versions of Sprycel available.

Do not discontinue Sprycel without first visiting your doctor. It is a medicine used to treat specific types of leukaemia, and it's critical to follow your doctor's instructions for dosage and cessation. The effect of discontinuing therapy after complete cytogenetic response is achieved has not been investigated.

Dasatinib could harm an unborn baby. You may require a pregnancy test to ensure you are not pregnant. Use effective contraception while using Sprycel and for at least 30 days after your final dosage. Please notify your doctor if you become pregnant. You should use effective birth control (contraception) during treatment and for 30 days after your last dose of Sprycel.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.