Sprycel

DRUG DESCRIPTION

SPRYCEL (dasatinib) is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2- [ [6- [4-(2-hydroxyethyl)-1 -piperazinyl] -2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26C1N7O2SH2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure:

SPRYCEL (dasatinib) - Structural Formula Illustration

Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. SPRYCEL tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The tablet coating consists of hypromellose, titanium dioxide, and polyethylene glycol.

What are the possible side effects of dasatinib (Sprycel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • pale skin, weakness;
  • easy bruising or bleeding (nosebleeds, bleeding gums);
  • fever, chills, body aches, flu symptoms;
  • black, bloody, or tarry stools;
  • vomit that looks like blood or coffee grounds;
  • sudden numbness or weakness, especially on one...

Read All Potential Side Effects and See Pictures of Sprycel

What are the precautions when taking dasatinib (Sprycel)?

Before taking dasatinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as lactose), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, heart problems (e.g., irregular heartbeat), liver problems.

Dasatinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have...

Read All Potential Precautions of Sprycel


Sprycel Consumer (continued)

SIDE EFFECTS: Upset stomach, nausea, vomiting, diarrhea, headache, tiredness, and loss of appetite may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: dry cough, swelling (especially of lower legs/the area around eyes), sudden/unexplained weight gain, increasing trouble breathing (shortness of breath).

Tell your doctor immediately if any of these rare but very serious side effects occur: black/bloody stools, dark urine, stomach/abdominal pain, vomit that looks like coffee grounds, yellowing eyes/skin.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/slow/irregular heartbeat, chest pain, confusion, weakness on one side of the body.

This medication may cause very serious blood disorders (low number of blood cells such as red cells, white cells, and platelets). This effect can cause anemia, decrease your body's ability to fight an infection, or cause your body to bruise or bleed more easily. Tell your doctor immediately if you develop any of the following symptoms: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, unusual tiredness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking dasatinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as lactose), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, heart problems (e.g., irregular heartbeat), liver problems.

Dasatinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using dasatinib, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using dasatinib safely.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Older adults may be more sensitive to the effects of this drug, especially swelling of the lower legs, sudden/unexplained weight gain, and shortness of breath.

This drug is not recommended for use during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. To avoid pregnancy, both males and females must use reliable form(s) of birth control (e.g., condoms, birth control pills) during treatment with this drug. Talk with your doctor about effective forms of birth control.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Sprycel Patient Information Including Side Effects

Brand Names: Sprycel

Generic Name: dasatinib (Pronunciation: da SAT in ib)

  • What is dasatinib (Sprycel)?
  • What are the possible side effects of dasatinib (Sprycel)?
  • What is the most important information I should know about dasatinib (Sprycel)?
  • What should I discuss with my health care provider before taking dasatinib (Sprycel)?
  • How should I take dasatinib (Sprycel)?
  • What happens if I miss a dose (Sprycel)?
  • What happens if I overdose (Sprycel)?
  • What should I avoid while taking dasatinib (Sprycel)?
  • What other drugs will affect dasatinib (Sprycel)?
  • Where can I get more information?

What is dasatinib (Sprycel)?

Dasatinib is a cancer medication that slows the growth and spread of cancer cells in the body.

Dasatinib is used to treat chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) when other cancer treatments have not been effective.

Dasatinib may also be used for other purposes not listed in this medication guide.

What are the possible side effects of dasatinib (Sprycel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • pale skin, weakness;
  • easy bruising or bleeding (nosebleeds, bleeding gums);
  • fever, chills, body aches, flu symptoms;
  • black, bloody, or tarry stools;
  • vomit that looks like blood or coffee grounds;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • swelling in your hands, ankles, or feet; or
  • uneven heartbeats.

Less serious side effects may include:

  • headache, tiredness;
  • mild skin rash;
  • nausea, vomiting, stomach pain, diarrhea; or
  • muscle or joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dasatinib (Sprycel)?

Do not use this medication without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Before using dasatinib, tell your doctor if you have liver disease, low levels of potassium or magnesium in your blood, heart disease or a heart rhythm disorder, or if you have a personal or family history of "Long QT syndrome."

Do not crush, chew, or break a dasatinib tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

There are many other medicines that can interact with dasatinib. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Dasatinib can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

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