Sprycel 100mg Tablets

Dasatinib is a small molecule kinase inhibitor that inhibits multiple tyrosine kinases, including BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. It binds to both the active and inactive conformations of the BCR-ABL kinase, making it effective against imatinib-resistant CML and Ph+ ALL, including those with BCR-ABL mutations (except T315I). By inhibiting these kinases, dasatinib blocks proliferation and induces apoptosis in BCR-ABL expressing leukemia cells.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Infections: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum, painful urination, mouth sores, or wounds that won't heal.
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises or bruising that worsens, or uncontrollable bleeding.
Electrolyte imbalances: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance problems, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
Blood pressure changes: Severe headaches, dizziness, fainting, or vision changes.
Numbness or tingling: In the hands or feet.
Seizures: Convulsions or loss of consciousness.
Fluid retention: Swelling, weight gain, or breathing difficulties.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or other severe skin reactions, which may be life-threatening. Seek help if you experience red, swollen, blistered, or peeling skin; skin irritation with or without fever; red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
Tumor lysis syndrome (TLS): A potentially life-threatening condition that may occur in cancer patients. Seek help if you experience a rapid or abnormal heartbeat, fainting, difficulty urinating, muscle weakness or cramps, nausea, vomiting, diarrhea, loss of appetite, or fatigue.
Heart problems: Abnormal heartbeat (including prolonged QT interval), heart attack, or small strokes (TIAs). Seek help if you experience chest pain, rapid or abnormal heartbeat, shortness of breath, sudden weight gain, swelling in the arms or legs, weakness on one side of the body, confusion, slurred speech, balance problems, drooping on one side of the face, vision changes, severe dizziness, or fainting.
Liver problems: Dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin and eyes.

Common Side Effects

Most people experience no side effects or only mild side effects. However, if you notice any of the following, contact your doctor or seek medical attention if they bother you or persist:

Constipation
Stomach pain
Headache
Fatigue or weakness
Muscle or joint pain
Pain in the arms or legs
* Diarrhea, nausea, vomiting, or decreased appetite (common side effects that can be managed with your doctor's guidance)

Reporting Side Effects

If you experience any side effects, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including low levels of potassium or magnesium in your blood.
If you are taking any of the following medications:
+ Cimetidine
+ Dexlansoprazole
+ Esomeprazole
+ Famotidine
+ Lansoprazole
+ Nizatidine
+ Omeprazole
+ Pantoprazole
+ Rabeprazole
+ Ranitidine
Any other medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This medication can interact with various drugs, such as those used to treat HIV, infections, or seizures.
* If you are breast-feeding. You should not breast-feed while taking this medication and for 2 weeks after your last dose.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to inform your doctor and pharmacist about all your medications, health problems, and any other relevant information. Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.

Important Warnings and Cautions for Patients Taking This Medication

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular monitoring of your blood work, heart function, and lung function is crucial, as directed by your doctor.

If you follow a lactose-free diet, consult your doctor, as some products may contain lactose. Additionally, avoid consuming grapefruit and grapefruit juice while taking this medication.

Blood-Related Risks

This medication may decrease the bone marrow's ability to produce necessary blood cells, increasing the risk of bleeding problems, infections, or anemia. If you have concerns, discuss them with your doctor. To minimize the risk of infection, practice good hygiene by washing your hands frequently and avoiding close contact with people who have infections, colds, or flu.

You may experience easier bleeding, so it is crucial to be cautious and avoid injuries. Use a soft toothbrush and an electric razor to reduce the risk of bleeding. In rare cases, bleeding problems can be life-threatening.

Respiratory Risks

This medication may increase the risk of developing a severe lung condition called pulmonary arterial hypertension, which can occur at any time during treatment, even after more than a year. Discuss this risk with your doctor.

Special Considerations

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

This medication has been shown to cause fertility problems in animal studies, which may affect your ability to conceive or father a child. Pregnant individuals should not handle crushed or broken tablets, and if they come into contact with them, they should immediately wash the area with soap and water.

Pregnancy and Birth Control

This medication may harm the unborn baby if taken during pregnancy. If you may become pregnant, use birth control while taking this medication and for 30 days after your last dose, unless otherwise instructed by your doctor. If you become pregnant, notify your doctor immediately.

If your partner may become pregnant, use birth control while taking this medication and for 30 days after your last dose, unless otherwise instructed by your doctor. If your partner becomes pregnant, notify the doctor right away.

Pediatric Considerations

If you are giving this medication to a child and their weight changes, consult your doctor, as the dosage may need to be adjusted. This medication may affect growth in children and teenagers in some cases, and regular growth checks may be necessary. Discuss this with your doctor.

• Strong CYP3A4 inducers (e.g., carbamazepine, dexamethasone, phenobarbital, phenytoin, rifabutin, rifampin, St. John's Wort)
• Proton Pump Inhibitors (PPIs) (e.g., omeprazole, lansoprazole, pantoprazole, esomeprazole, rabeprazole)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) - coadministration requires dose reduction of dasatinib.
• H2-receptor antagonists (e.g., famotidine, cimetidine, ranitidine) - avoid coadministration or separate administration by at least 2 hours.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil, grapefruit juice) - use with caution, consider dose reduction.
• Antacids (e.g., aluminum hydroxide/magnesium hydroxide) - separate administration by at least 2 hours.

• Not available

• Fever, chills, signs of infection (due to myelosuppression)
• Unusual bleeding or bruising (due to thrombocytopenia)
• Fatigue, pallor, shortness of breath (due to anemia)
• Shortness of breath, cough, chest pain, swelling in ankles/legs, rapid weight gain (signs of fluid retention, pleural/pericardial effusion, pulmonary hypertension)
• Nausea, vomiting, diarrhea, abdominal pain
• Muscle pain, joint pain
• Skin rash
• Headache
• Dizziness, lightheadedness, palpitations, fainting (signs of cardiac issues, including QTc prolongation)

Dasatinib can cause fetal harm when administered to a pregnant woman. Based on animal studies and its mechanism of action, dasatinib is expected to cause serious birth defects. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 30 days after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 90 days after the last dose.

It is not known whether dasatinib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with dasatinib and for 2 weeks after the last dose.

Dasatinib is approved for pediatric patients 1 year of age and older with chronic phase Ph+ CML and for pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL. Dosing is based on body surface area. Close monitoring for growth and development, as well as adverse effects, is crucial.

No specific dose adjustment is required based on age. However, elderly patients may be more susceptible to certain adverse reactions, such as fluid retention and cardiovascular events. Monitor closely for adverse effects.

• Dasatinib is effective in patients resistant or intolerant to imatinib, including those with BCR-ABL mutations (except T315I).
• Fluid retention, particularly pleural effusion, is a common and potentially serious side effect. Patients should be educated on symptoms and monitored closely.
• Myelosuppression is dose-limiting; frequent CBC monitoring and dose adjustments are often necessary.
• Avoid concomitant use with proton pump inhibitors (PPIs) and H2-receptor antagonists due to pH-dependent solubility. Antacids should be separated by at least 2 hours.
• Strong CYP3A4 inhibitors require dasatinib dose reduction, and strong CYP3A4 inducers are contraindicated.
• Patients should be advised to avoid grapefruit products.
• Monitor for QTc prolongation, especially in patients with pre-existing cardiac conditions or those on other QTc-prolonging medications. Correct hypokalemia/hypomagnesemia.
• Pulmonary arterial hypertension (PAH) is a rare but serious adverse event; patients presenting with new or worsening dyspnea should be evaluated for PAH.

• Other BCR-ABL tyrosine kinase inhibitors (TKIs) for CML/Ph+ ALL: Imatinib (Gleevec), Nilotinib (Tasigna), Bosutinib (Bosulif), Ponatinib (Iclusig), Asciminib (Scemblix)
• Chemotherapy (for ALL, or in combination with TKIs)
• Allogeneic hematopoietic stem cell transplantation (HSCT)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more details. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.