Pronunciation:

da-SA-ti-nib

Brand Names:

• Sprycel
• APO-daSATinib
• Reddy-daSATinib
• Taro-daSATinib
• Teva-daSATinib

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Dasatinib is used to treat Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in adults and children. It is also used to treat Ph+ CML and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in adults after other medicines (eg, imatinib) or treatments did not work well. Dasatinib is also used in combination with chemotherapy to treat newly diagnosed Ph+ ALL in children 1 year of age and older. 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. It interferes with the growth of cancer cells, which are eventually destroyed by the body.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dasatinib in children 1 year of age and older. However, it may cause slowed growth and development in children. Safety and efficacy have been established.

Older adults—

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 unwanted effects of dasatinib.

Breast-feeding—

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.

Other medicines—

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.

• Bepridil
• Dronedarone
• Fluconazole
• Lefamulin
• Levoketoconazole
• Measles Virus Vaccine, Live
• Mesoridazine
• Mumps Virus Vaccine, Live
• Nelfinavir
• Piperaquine
• Posaconazole
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Varicella Virus Vaccine, Live
• Ziprasidone
• Zoster Vaccine, Live

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.

• Adagrasib
• Adenovirus Vaccine
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bacillus of Calmette and Guerin Vaccine, Live
• Bedaquiline
• Belzutifan
• Boceprevir
• Buprenorphine
• Buserelin
• Carbamazepine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Cimetidine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Darunavir
• Degarelix
• Delamanid
• Dengue Tetravalent Vaccine, Live
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexlansoprazole
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Duvelisib
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Esomeprazole
• Famotidine
• Fedratinib
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indinavir
• Influenza Virus Vaccine, Live
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lansoprazole
• Lapatinib
• Larotrectinib
• Lenacapavir
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lopinavir
• Lorlatinib
• Lumacaftor
• Lumefantrine
• Macimorelin
• Mavacamten
• Mefloquine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Mirtazapine
• Mitotane
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nafarelin
• Nefazodone
• Netupitant
• Nilotinib
• Nirmatrelvir
• Nizatidine
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Olutasidenib
• Omaveloxolone
• Omeprazole
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Pantoprazole
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pipamperone
• Pirtobrutinib
• Pitolisant
• Poliovirus Vaccine, Live
• Ponesimod
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Rabeprazole
• Ranitidine
• Ranolazine
• Relugolix
• Ribociclib
• Rifampin
• Risperidone
• Ritlecitinib
• Ritonavir
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Smallpox Vaccine
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tocilizumab
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Trofinetide
• Typhoid Vaccine, Live
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Yellow Fever Vaccine
• Zotepine
• Zuclopenthixol

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:

• Anemia or
• Arrhythmia (heart rhythm problem) or
• Bleeding problems or
• Congenital long QT syndrome (heart rhythm problem) or
• Edema (fluid retention or swelling) or
• Lung or breathing problems or
• Neutropenia (low white blood cells) or
• Palpitations (fast heart rate) or
• Stomach bleeding or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

• Hypokalemia (low potassium levels in the blood) or
• Hypomagnesemia (low magnesium levels in the blood)—Use with caution. May cause side effects to become worse.

• Infection—Dasatinib may decrease your body's ability to fight an infection.

• Lactose intolerance—Use with caution. This medicine contains lactose.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of unwanted effects.

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all of 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 leaflet. Follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food. Swallow the tablet whole. Do not break, cut, crush, or chew it.

Pregnant women should avoid handling crushed or broken tablets. If a tablet is broken or crushed, wear disposable gloves to avoid exposure to the medicine.

If you are taking an antacid (eg, aluminum hydroxide, magnesium hydroxide, Maalox®, Rolaids®, or Tums®), take it at least 2 hours before or after you take dasatinib.

Do not drink grapefruit juice while you are using this medicine. Grapefruit juice may change the amount of medicine that is absorbed in the body.

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 1 year of age and older—Dose is based on body weight and must be determined by your doctor.
      • Weighs 45 kilograms (kg) or more—At first, 100 mg once a day, given either in the morning or in the evening. Your doctor may adjust your dose as needed.
      • Weighs 30 kg to less than 45 kg—At first, 70 mg once a day, given either in the morning or in the evening. Your doctor may adjust your dose as needed.
      • Weighs 20 kg to less than 30 kg—At first, 60 mg once a day, given either in the morning or in the evening. Your doctor may adjust your dose as needed.
      • Weighs 10 kg to less than 20 kg—At first, 40 mg once a day, given either in the morning or in the evening. Your doctor may adjust your dose as needed.
    • Children younger than 1 year of age and weigh less than 10 kg—Use is not recommended.
  • For the treatment of accelerated or blast crisis CML or Ph+ ALL:
    • Adults—At first, 140 milligrams (mg) once a day, given either in the morning or in the evening. Your doctor may adjust your dose as needed.
    • Children 1 year of age and older—Dose is based on body weight and must be determined by your doctor.
      • Weighs 45 kilograms (kg) or more—At first, 100 mg once a day, given either in the morning or in the evening. Your doctor may adjust your dose as needed.
      • Weighs 30 kg to less than 45 kg—At first, 70 mg once a day, given either in the morning or in the evening. Your doctor may adjust your dose as needed.
      • Weighs 20 kg to less than 30 kg—At first, 60 mg once a day, given either in the morning or in the evening. Your doctor may adjust your dose as needed.
      • Weighs 10 kg to less than 20 kg—At first, 40 mg once a day, given either in the morning or in the evening. Your doctor may adjust your dose as needed.
    • Children younger than 1 year of age and weigh less than 10 kg—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, 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.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's 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. Female patients should use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 30 days after your last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 30 days after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

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 right away 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 right away 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, including pleural effusion (fluid build-up around your lungs). Check with your doctor right away if you have a decrease in the amount of urine, noisy or rattling breathing, difficulty breathing, swelling of the fingers, hands, feet, or lower legs, trouble breathing, or weight gain.

This medicine can cause changes in heart rhythm, including 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, including a fast, pounding, or irregular heartbeat.

Check with your doctor right away if you have chest discomfort or pain, decreased urine output, fast, irregular, or pounding heartbeat, swelling of the feet or lower legs, trouble breathing, or unusual tiredness or weakness. These could be symptoms of a serious heart or blood vessel problem (eg, heart attack, stroke).

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 lungs). This may occur at anytime during treatment with this medicine. Check with your doctor right away if you have trouble breathing, tiredness, or swelling all over your body (fluid retention).

Serious skin reactions (eg, Stevens-Johnson syndrome, erythema multiforme) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, red irritated eyes, red skin lesions, often with a purple center, severe acne or skin rash, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while you are using this medicine.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

This medicine may cause slowed growth and development in children. Your child's doctor may want to monitor their weight and growth regularly. Talk to your child's doctor if you have concerns.

Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).

This medicine may cause serious liver problems. Check with your doctor right away if you have dark urine, loss of appetite, nausea or vomiting, stomach pain, sever, or yellow eyes or skin.

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 (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

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

Bleeding gums

bloody or black, tarry stools

body aches or pain

burning, tingling, numbness, or pain in the hands, arms, feet, or legs

chest pain or tightness

chills

constipation

cough

coughing up blood

decrease in the amount of urine

dizziness

ear congestion

fainting

fast, slow, or irregular heartbeat

fever

full or bloated feeling

headache

hoarseness

increased menstrual flow or vaginal bleeding

loss of voice

lower back or side pain

noisy or rattling breathing

nosebleeds

painful or difficult urination

pale skin

paralysis

pressure in the stomach

prolonged bleeding from cuts

red or dark brown urine

runny or stuffy nose

sensation of pins and needles

severe stomach pain

sneezing

sore throat

stabbing pain

swelling of the stomach area

swelling of the face, fingers, hands, feet, or lower legs

trouble 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

Less common

Blue lips and fingernails

chest discomfort

coughing that sometimes produces a pink frothy sputum

difficult or fast breathing

dilated neck veins

increased sweating

irregular breathing

loss of appetite

nausea

stomach pain, severe

swelling in the legs and ankles

vomiting

yellow eyes or skin

Incidence not known

Anxiety

blistering, peeling, or loosening of the skin

blurred vision

cloudy or bloody urine

diarrhea

itching

joint or muscle pain

nervousness

pain, redness, or swelling in the arm or leg

pounding in the ears

red skin lesions, often with a purple center

red, irritated eyes

sudden weakness in the arms or legs

sudden, severe chest pain

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

Bone pain

cracked lips

difficulty with moving

difficulty with swallowing

lack or loss of strength

loss of appetite

muscle aching, cramping, or stiffness

pain

skin rash

stomach pain

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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.