Pronunciation:

da-SA-ti-nib

Brand Names:

• Sprycel

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Dasatinib is used to prevent and stop the growth of cancer cells in patients with chronic myeloid leukemia (CML). CML is a disease in which your body makes too many abnormal white blood cells, which can cause you to become sick more often and to feel weak or tired. Dasatinib helps your body stop making these abnormal white blood cells .

Dasatinib is also used to treat other conditions such as Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) .

Before you begin treatment with dasatinib, you and your doctor should talk about the good this medicine will do as well as the possible risks of using it. This medicine is usually used in patients who have already taken other cancer medicines .

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 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 .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-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—

	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.

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—

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.

• Atazanavir
• Carbamazepine
• Cimetidine
• Clarithromycin
• Dexamethasone
• Esomeprazole
• Famotidine
• Indinavir
• Itraconazole
• Ketoconazole
• Lansoprazole
• Nefazodone
• Nelfinavir
• Nizatidine
• Omeprazole
• Pantoprazole
• Phenobarbital
• Phenytoin
• Rabeprazole
• Ranitidine
• Rifabutin
• Rifampin
• Ritonavir
• Saquinavir
• St John's Wort
• Telithromycin
• Voriconazole

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
• Bleeding problems or
• Edema (fluid retention or swelling) or
• Heart rhythm problems (e.g., 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 .

• Liver disease—Drug effects may be increased because of slower removal of dasatinib from the body .

Proper Use of This Medicine:

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 .

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—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—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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not keep outdated medicine or medicine no longer needed.

Keep out of the reach of children.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects .

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 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 .

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 or vitamin supplements .

Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments .

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 fingers, hands, feet, or lower legs; troubled breathing at rest; or weight gain .

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

Bloody or black, tarry stools

body aches or pain

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

chest pain

constipation

coughing up blood

cough or hoarseness

decrease in amount of urine

difficulty in 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 orrattling 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 abdominal or stomach area

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

tightness in chest

troubled breathing

ulcers, sores, or white spots in mouth

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

weakness in 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 legs and ankles

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 pain

bleeding gums

cracked lips

diarrhea

difficulty in moving

difficulty in 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 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.