• Sprycel is a brand (trade) name for dasatinib which may be used to treat newly diagnosed chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL).
• Sprycel works by inhibiting multiple conformations of the ABL kinase which is an abnormal enzyme involved in the development of blood cancers such as Ph+ CML and Ph+ALL. At nanomolar concentrations, Sprycel inhibits BCR-ABL, SCF (stem cell factor) (SRC, LCK, YES, FYN), the KIT protein (c-KIT), EPHA2, and PDGFR-B. By targeting these enzymes, Sprycel stops the overproduction of leukemic cells in the bone marrow of patients with CML and ALL, while allowing normal red cell, white cell, and blood platelet production to resume.
• Sprycel belongs to the class of medicines known as BCR-ABL tyrosine kinase inhibitors (TKIs).

• May be used for the treatment of newly diagnosed Philadelphia-positive CML (Ph+ CML) in adults and Ph+CML in children aged 1 year and older in the chronic phase.
• Can be used to treat Ph+CML in blast crisis, accelerated, myeloid, or chronic phase with resistance or intolerance to prior treatment including imatinib (Gleevec).
• Consider for adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior treatment or for children with newly diagnosed Ph+ ALL in combination with chemotherapy.
• Sprycel allows normal red cell, white cell, and blood platelet production to resume while blocking the overproduction of leukemic cells in the bone marrow.
• May be available for other conditions as part of a clinical trial.
• Sprycel is a targeted treatment and is not chemotherapy. It may also be called a cancer growth inhibitor.
• Was approved by the FDA in 2006 and provides a treatment option for patients who are resistant or intolerant to other treatments.
• Available as 20mg, 50mg, 70mg, 80mg, 100mg and 140mg tablets.
• Inhibits multiple conformations of the ABL kinase.
• Generally, rates of adverse effects are lower with Sprycel than they are with imatinib (Gleevec).

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Fluid retention, pleural effusion, superficial edema, diarrhea, muscle and joint pain, rash, headache, abdominal pain, fatigue, and nausea are the most common side effects reported. Weigh and monitor patients regularly for signs of fluid retention and investigate rapid weight gain carefully.
• May increase the risk of infection, such as upper respiratory tract infections or the flu because it can reduce the number of white blood cells in your blood (called neutropenia). Regular blood cell counts are required.
• May increase the risk of bleeding and bruising because it can reduce the number of platelets in the blood. Monitor for any unexplained bruising or bleeding and consider a platelet transfusion if necessary. Serious bleeding has also been reported.
• Can also cause anemia (low number of red blood cells) and a blood transfusion may be needed.
• May cause visual disturbances or blurred vision which may affect a person's ability to drive or operate machinery.
• Few studies have been conducted in patients with decreased renal function (many studies excluded patients with serum creatinine concentration > 1.5 to 3 times the upper limit of normal). Postmarketing studies have suggested that hemodialysis patients are potentially vulnerable to the cardiotoxic effects of dasatinib and cardiac function and plasma drug concentration should be monitored.
• Mild elevations in serum aminotransferase levels have been reported in up to 50% of patients receiving dasatinib therapy but these usually resolve themselves. Elevations above 5 times the upper limit of normal (ULN) occurred in 1% to 9% of patients and generally responded to dose adjustment or temporary discontinuation and restarting at a lower dose, which is recommended if liver test results are markedly elevated (ALT or AST persistently greater than 5 times ULN or bilirubin more than 3 times ULN). Patients with mild, moderate, or severe hepatic impairment may receive the recommended starting dose with monitoring.
• May also cause growth retardation in children and adolescents and growth should be monitored. May also cause bone pain or gynecomastia in children.
• Tumor lysis syndrome has been reported in people receiving Sprycel. Those at higher risk include people with resistance to prior imatinib (Gleevec) treatment. Correct dehydration and treat high uric acid levels before Sprycel initiation.
• May affect the heart and cause heart failure or left ventricular dysfunction. Other adverse effects include numbness or tingling in the hands or feet.
• Requires ongoing blood monitoring every 2 to 3 months. Sprycel treatment may be associated with anemia, neutropenia, and thrombocytopenia.
• May cause hepatitis B reactivation. Ensure a person's vaccination status is up to date before administering Sprycel. Do not administer any live vaccines during treatment.
• Sprycel may harm a developing fetus and should not be given to pregnant women. Females of reproductive potential should use effective contraception during treatment with Sprycel and for at least 30 days after the last dose. Breastfeeding is not advised during treatment with Sprycel and for 2 weeks after the final dose.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Sprycel may be taken once daily with or without food, either in the morning or at night. Do not stop taking Sprycel without talking to your doctor.
• The recommended dose for children is based on body weight. This should be recalculated by your doctor every 3 months based on changes in body weight as your child grows.
• Do not take Sprycel with grapefruit or grapefruit juice or products because this may increase its side effects.
• Swallow Sprycel tablets whole with a glass of water. They should not be chewed, cut, or crushed. Take them at the same time every day. If you find it hard to swallow the tablets tell your doctor, nurse, or pharmacist.
• If you are a caregiver administering Sprycel tablets to a child or somebody who needs your help, wear latex or nitrile gloves when handling the tablets if they have been accidentally crushed or broken.
• If you have a child or an adult who cannot swallow Sprycel tablets, you can disperse the tablets as follows.

• Wash hands and put on gloves.
• Fill a drinking glass with 1 ounce or 30 ml of chilled orange juice or apple juice (without preservatives). Place the number of tablets required for the dose into the glass of juice.
• Let the tablets sit in the water for 5 minutes, then stir gently. Stir until all tablets are dissolved which may take up to 20 minutes.
• Administer the dissolved tablets in the juice immediately. Make sure your child takes all of the liquid and when the glass is empty, rinse it with 15 mL of juice and administer it to your child. Throw away the mixture if it is not given within 60 minutes.
• Wash all dishes used right after use. Discard the gloves.

• If you miss a dose of Sprycel, take it as soon as you remember. If a full day has gone by, let your doctor or nurse know. If you vomit just after taking the capsules or tablets, contact the hospital. Do not take a double dose unless your doctor tells you to.
• During treatment, you will regularly see a hematologist (a doctor who treats blood cancers) or a cancer doctor, a specialist nurse, or a specialist pharmacist, and have your blood monitored regularly. Keep these appointments.
• Sprycel can increase your risk of developing an infection that may become serious. Contact the hospital straight away on the 24-hour contact number you have been given if your temperature goes over 37.5°C (99.5°F), you suddenly feel unwell, even with a normal temperature, you have symptoms of an infection (fever, pain, difficulty breathing, feeling shivery and shaking, a sore throat, a cough, diarrhea, needing to pee a lot, or pain while peeing), or your temperature goes below 36°C (96.8°F).
• Sprycel can make you bruise or bleed more easily. Talk to your doctor if you have any unexplained bruising or bleeding including nosebleeds, bleeding gums, heavy periods, blood in your urine (pee) or stools (poo), or tiny red or purple spots on the skin that may look like a rash.
• Sprycel can also make you anemic. Symptoms include pale skin, lack of energy, and feeling breathless, dizzy, or light-headed. Tell your doctor or nurse if you have these symptoms.
• If Sprycel makes you feel sick or vomit, your doctor can prescribe anti-sickness (anti-emetic) drugs to prevent or reduce sickness and vomiting.
• If you develop diarrhea while taking Sprycel, try to drink at least 2 liters (3½ pints) of fluids each day; avoid alcohol, caffeine, milk products, high-fat foods, and high-fiber foods; and talk to your doctor about medications to help reduce it.
• Tell your doctor if you develop any other side effects of concern, including rapid weight gain. This may indicate fluid build-up. If you have a severe rash or any blistering or peeling contact your doctor immediately.
• If you lose your appetite try to eat smaller meals more often. Talk to a dietician if you find it difficult to eat enough. They can give you advice on getting more calories and protein in your diet and possibly supplement drinks to try or you can buy these from your drugstore.
• Sprycel can cause visual defects or blurred vision which may affect your ability to drive or operate machinery.
• Talk to your doctor or pharmacist before taking any other medicines with Sprycel including vitamins, herbal drugs, or complementary therapies.
• All your vaccinations should be up to date before starting Sprycel. While taking Sprycel you will not be allowed to have any live vaccines. Doctors usually recommend that people with cancer have a flu vaccination and a coronavirus vaccination. These are both inactivated vaccinations that can help reduce the risk of infection. If you have had Hepatitis B (a liver infection) in the past, this treatment can make it active again.
• Tell your doctor if you are pregnant, intending to become pregnant, or breastfeeding because Sprycel may not be suitable for you.

• Research has shown that in patients with newly diagnosed chronic phase CML, the primary endpoint was the rate of confirmed complete cytogenetic response (CCyR) within 12 months was 76.8% with Sprycel and 66.2% with imatinib. 52.1% reported a major molecular response with Sprycel and 33.8% with imatinib.
• The effectiveness of Sprycel in adults with imatinib-resistant or intolerant chronic phase CML at a minimum of 24 months follow up was 92% hematologic clinical response after 4 weeks, and a cytogenetic response rate of MCyR of 63% and CCyR of 50% with Sprycel 100mg once daily.
• See the product information for a full list of clinical trials associated with Sprycel.
• Continue treatment for as long as there is no evidence of progressive disease or unacceptable toxicity. * Well tolerated. With a minimum of 24 months follow-up, 77% of patients randomized to Sprycel and 75% of patients randomized to imatinib (Gleevec) were still in the study, and after at least 60 months of follow-up, 61% of patients taking Sprycel and 62% of patients taking Gleevec were still on treatment.

Medicines that interact with Sprycel may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Sprycel. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Sprycel interacts with over 690 drugs. Most of these interactions are considered major or moderate. Common medications that may interact with Sprycel include:

• antiandrogens, such as apalutamide and enzalutamide
• antipsychotics, such as clozapine
• azathioprine
• benzodiazepines, such as alprazolam, oxazepam, or temazepam
• brewer's yeast, or ginseng
• chemotherapy agents such as mitotane
• cisapride
• colchicine
• corticosteroids, such as dexamethasone
• CYP450 3A4 inducers, such as carbamazepine, fosphenytoin, phenobarbital, phenytoin, and rifampin (may reduce the effectiveness of Sprycel)
• CYP450 3A4 inhibitors, such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, and grapefruit (may increase plasma concentrations of Sprycel)
• CYP450 3A4 substrates such as triazolam, nifedipine, statins, warfarin, etc (may increase blood concentrations of these agents)
• etanercept
• fentanyl, hydrocodone, or oxycodone
• fingolimod
• grapefruit juice
• griseofulvin
• high cholesterol treatments such as simvastatin
• infliximab
• ketoconazole
• live vaccines and some other vaccines, such as BCG, cholera, Covid-19 vaccines, measles, hepatitis b vaccines, yellow fever, or live influenza vaccines (Sprycel reduces the immune response to vaccination. Administer live or live-attenuated vaccines at least 4 weeks before Sprycel initiation, and non-live vaccines at least 2 weeks before)
• NSAIDs such as diclofenac or ibuprofen
• rifampin or rifabutin
• SSRIs such as fluoxetine, paroxetine, or sertraline
• St. John's Wort
• targeted treatments such as brigatinib and dabrafenib
• TNF inhibitors such as adalimumab
• tramadol
• warfarin
• zolpidem.

Note that this list is not all-inclusive and includes only common medications that may interact with Sprycel. You should refer to the prescribing information for Sprycel for a complete list of interactions.