Description and Brand NamesBefore UsingProper UsePrecautionsSide Effects Brand Name : Sprycel Descriptions Dasatinib is used to treat different types of leukemia. Leukemia is a type of cancer where the body makes too many abnormal white blood cells. It belongs to the general group of medicines known as antineoplastics or cancer medicines. Dasatinib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by dasatinib, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Before you begin treatment with dasatinib, you and your doctor should talk about the benefits this medicine will do as well as the possible risks of using it. This medicine is available only with your doctor’s prescription. This product is available in the following dosage forms: Tablet In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Appropriate studies have not been performed on the relationship of age to the effects of dasatinib in the pediatric population. Safety and efficacy have not been established. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dasatinib in the elderly. However, some elderly patients may be more sensitive than younger adults to the effects of dasatinib. Pregnancy Information about this dasatinib-oral-route Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breastfeeding There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Drug Interactions Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Amifampridine Cisapride Dronedarone Fluconazole Mesoridazine Nelfinavir Pimozide Piperaquine Posaconazole Saquinavir Sparfloxacin Thioridazine Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Alfuzosin Amiodarone Amitriptyline Amoxapine Anagrelide Apomorphine Aprepitant Aripiprazole Arsenic Trioxide Asenapine Astemizole Atazanavir Azithromycin Buserelin Carbamazepine Ceritinib Chloroquine Chlorpromazine Cimetidine Ciprofloxacin Citalopram Clarithromycin Clomipramine Clozapine Cobicistat Crizotinib Dabrafenib Delamanid Desipramine Deslorelin Dexamethasone Disopyramide Dofetilide Dolasetron Domperidone Droperidol Erythromycin Escitalopram Eslicarbazepine Acetate Esomeprazole Famotidine Fingolimod Flecainide Fluoxetine Fosaprepitant Fosphenytoin Gatifloxacin Gemifloxacin Gonadorelin Goserelin Granisetron Halofantrine Haloperidol Histrelin Ibutilide Idelalisib Iloperidone Imipramine Indinavir Itraconazole Ivabradine Ketoconazole Lansoprazole Lapatinib Leuprolide Levofloxacin Lopinavir Lumefantrine Mefloquine Methadone Metronidazole Mifepristone Mitotane Moxifloxacin Nafarelin Nefazodone Nilotinib Nizatidine Norfloxacin Nortriptyline Octreotide Ofloxacin Omeprazole Ondansetron Paliperidone Pantoprazole Pazopanib Perflutren Lipid Microsphere Phenobarbital Phenytoin Primidone Procainamide Prochlorperazine Promethazine Propafenone Protriptyline Quetiapine Quinidine Quinine Rabeprazole Ranitidine Ranolazine Rifabutin Rifampin Ritonavir Salmeterol Sevoflurane Siltuximab Sodium Phosphate Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Solifenacin Sorafenib Sotalol St John’s Wort Sunitinib Telithromycin Terfenadine Tetrabenazine Topotecan Toremifene Trazodone Trifluoperazine Trimipramine Triptorelin Vandetanib Vardenafil Vemurafenib Vinflunine Voriconazole Ziprasidone Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Aluminum Carbonate, Basic Aluminum Hydroxide Aluminum Phosphate Calcium Calcium Carbonate Dihydroxyaluminum Aminoacetate Dihydroxyaluminum Sodium Carbonate Magaldrate Magnesium Carbonate Magnesium Hydroxide Magnesium Oxide Magnesium Trisilicate Simvastatin Sodium Bicarbonate Other Interactions Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. Grapefruit Juice Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Bleeding problems (e.g., stomach bleeding) or Blood or bone marrow problems (e.g., anemia, neutropenia, thrombocytopenia) or Congestive heart failure or Edema (fluid retention or swelling) or Heart attack, history of or Heart disease (e.g., cardiomyopathy) or Heart rhythm problems (e.g., congenital long QT syndrome, QTc prolongation)—Use with caution. May make these conditions worse. Hypokalemia (low potassium in the blood) or Hypomagnesemia (low magnesium in the blood)—These conditions should be treated first before taking dasatinib. Infection—Dasatinib may decrease your body’s ability to fight infection. Lactose intolerance—Use with caution. This medicine contains lactose. Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment. This medicine comes with a patient information insert. Read the information carefully and make sure you understand them before taking this medicine. Ask your doctor if you have any questions. Keep using this medicine for as long as your doctor has told you to. Do not change your dose or stop taking this medicine without first talking with your doctor. You may take this medicine with or without food. Swallow the tablet whole. Do not crush, break, or chew it. Dasatinib tablets should be handled with care and people (especially pregnant personnel) who are not taking this medicine should avoid handling crushed or broken tablets. If tablets are broken or crushed, it is advisable to wear disposable chemotherapy gloves to avoid exposure to the medicine. If you are taking antacids (e.g., aluminum hydroxide, magnesium hydroxide, Maalox®, Rolaids®, or Tums®), take it at least 2 hours before or 2 hours after you take dasatinib. Dosing The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For oral dosage form (tablets): For the treatment of chronic phase CML: Adults—At first, 100 milligrams (mg) once a day given either in the morning or in the evening. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor. For the treatment of accelerated or blast crisis CML or Ph+ ALL: Adults—At first, 140 milligrams (mg) per day given in two divided doses (70 mg two times a day, one in the morning and one in the evening). Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor. Missed Dose If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests will be needed to check for unwanted effects. Be sure to keep all appointments. Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Use an effective form of birth control to keep from getting pregnant. Some forms of birth control include condoms, diaphragms, or birth control pills. Men using this medicine should use a condom to avoid pregnancy in their partner. Dasatinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding: If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination. Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin. Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done. Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime. Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur. Dasatinib may cause fluid retention. Check with your doctor right away if you have a decrease in amount of urine; noisy or rattling breathing; shortness of breath; swelling of the fingers, hands, feet, or lower legs; troubled breathing at rest; or weight gain. This medicine can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Check with your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats. Check with your doctor right away if you have the following symptoms while taking this medicine: chest discomfort or pain; decreased urine output; fast, irregular or pounding heartbeat; shortness of breath; swelling of the feet or lower legs; troubled breathing; or unusual tiredness or weakness. These could be symptoms of a serious heart problem. Using this medicine may cause headache, muscle or joint pain, skin rash, or unusual tiredness or weakness. If these symptoms persist and become worse, check with your doctor. This medicine may increase your risk of having a condition called pulmonary arterial hypertension (high blood pressure in the vessels of your lungs). This may occur at anytime during treatment with this medicine. Check with your doctor right away if you have the following symptoms: shortness of breath, troubled breathing, tiredness, or swelling all over your body (fluid retention). Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John’s wort) or vitamin supplements. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: More common Bloody or black, tarry stools body aches or pain burning, tingling, numbness or pain in the hands, arms, feet, or legs chest pain constipation cough or hoarseness coughing up blood decrease in the amount of urine difficulty with breathing dizziness ear congestion fainting fast, slow, or irregular heartbeat fever or chills full or bloated feeling headache loss of voice lower back or side pain nasal congestion noisy or rattling breathing painful or difficult urination pale skin paralysis pressure in the stomach runny nose sensation of pins and needles severe stomach pain shortness of breath sneezing sore throat stabbing pain swelling of the abdominal or stomach area swelling of the face, fingers, hands, feet, or lower legs tightness in the chest troubled breathing ulcers, sores, or white spots in the mouth unsteadiness or awkwardness unusual bleeding or bruising unusual tiredness or weakness vomiting of blood or material that looks like coffee grounds weakness in the arms, hands, legs, or feet weight gain wheezing Less common Bloating blue lips and fingernails chest discomfort coughing that sometimes produces a pink frothy sputum decreased urine output difficult or fast breathing dilated neck veins increased sweating irregular breathing irregular heartbeat nausea swelling swelling in the legs and ankles Incidence not known Anxiety pain, redness, or swelling in the arm or leg sudden shortness of breath or troubled breathing tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: More common Abdominal or stomach pain bleeding gums cracked lips diarrhea difficulty with moving difficulty with swallowing increased menstrual flow or vaginal bleeding itching skin lack or loss of strength loss of appetite muscle aching or cramping muscle or bone pain muscle stiffness nose bleeds pain pain in the joints prolonged bleeding from cuts red or dark brown urine skin rash swelling or inflammation of the mouth swollen joints vomiting weight loss Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.