Sprycel 140mg Tablets

Dasatinib is a small-molecule tyrosine kinase inhibitor that inhibits the activity of BCR-ABL kinase at concentrations of 0.6-0.8 nM. It is active against 33 of 34 imatinib-resistant BCR-ABL mutations in vitro. Dasatinib also inhibits other oncogenic kinases, including SRC family kinases (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ.

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 immediate medical attention:

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty 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 discolored sputum, painful urination, mouth sores, or unhealing wounds.
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in the 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 or dizziness, fainting, or changes in vision.
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. Symptoms include red, swollen, blistered, or peeling skin; skin irritation (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
Tumor lysis syndrome (TLS): A potentially life-threatening condition that may occur in cancer patients. Symptoms include rapid or abnormal heartbeat, fainting, difficulty urinating, muscle weakness or cramps, nausea, vomiting, diarrhea, loss of appetite, or feeling sluggish.
Heart problems: Abnormal heartbeat (including prolonged QT interval), heart attack, or small strokes (TIAs). Symptoms include 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, changes in vision, 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 symptoms, 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, vomiting, nausea, or decreased appetite (common side effects that may be managed with medical guidance)

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. 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. Be sure to describe the symptoms you experienced.
Certain health conditions, including low levels of potassium or magnesium in your blood.

Additionally, tell your doctor about all the medications you are currently taking, including:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Specifically, inform your doctor if you are taking any of the following medications: cimetidine, dexlansoprazole, esomeprazole, famotidine, lansoprazole, nizatidine, omeprazole, pantoprazole, rabeprazole, or ranitidine
* Certain medications used to treat HIV, infections, or seizures, as they may interact with this medication

Also, inform your doctor if you are breast-feeding. It is recommended that you do 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 discuss all your medications and health conditions with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

Important Information for Patients Taking This Medication

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

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

Blood-Related Risks

This medication may suppress the bone marrow's ability to produce essential blood cells, potentially leading to 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 avoid close contact with individuals who have infections, colds, or flu.

You may experience an increased risk of bleeding, so it is essential to be cautious and avoid injuries. Use a soft toothbrush and an electric razor to reduce the risk of bleeding. Although rare, some bleeding complications can be life-threatening.

Respiratory Risks

This drug 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 of use. Consult with your doctor if you have any concerns.

Special Considerations

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

This drug has been shown to cause fertility problems in animal studies, which may affect your ability to conceive or father a child. If you are pregnant or may become pregnant, it is essential to handle this medication carefully. Pregnant individuals should not handle crushed or broken tablets, and if accidental contact occurs, wash the area with soap and water immediately.

Pregnancy and Contraception

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

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

Pediatric Patients

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

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

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit juice) - reduce dasatinib dose or avoid.
• H2-receptor antagonists (e.g., famotidine, ranitidine, cimetidine) - separate administration by at least 2 hours.
• Antacids (e.g., aluminum hydroxide/magnesium hydroxide) - separate administration by at least 2 hours.
• QT-prolonging drugs (e.g., quinidine, procainamide, disopyramide, amiodarone, sotalol, dofetilide, cisapride, pimozide, thioridazine, moxifloxacin, halofantrine) - use with caution, monitor ECG.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, fluconazole) - use with caution, consider dose reduction.
• Moderate CYP3A4 inducers (e.g., efavirenz, modafinil) - use with caution, consider dose increase.

• Not typically clinically significant interactions reported for minor severity.

• Fever
• Chills
• Unusual bleeding or bruising
• Fatigue
• Shortness of breath
• Cough
• Chest pain
• Swelling (especially in ankles, feet, face)
• Rapid heartbeat
• Dizziness
• Nausea
• Vomiting
• Diarrhea
• Abdominal pain
• Rash
• Muscle pain
• Headache
• Yellowing of skin or eyes (jaundice)

Dasatinib can cause fetal harm when administered to a pregnant woman. Based on animal studies and its mechanism of action, dasatinib is contraindicated during pregnancy. Women of reproductive potential should be advised to use effective contraception during treatment and for 30 days after the last dose.

It is unknown if dasatinib is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment with dasatinib and for 2 weeks after the last dose.

Dasatinib is approved for pediatric patients with newly diagnosed chronic phase Ph+ CML. Dosing is based on body surface area. Safety and efficacy in other pediatric indications are not established. Pediatric patients may experience similar adverse events as adults, including myelosuppression and fluid retention.

No significant differences in efficacy were observed between older and younger patients. However, patients ≥65 years of age may have an increased incidence of fluid retention (e.g., pleural effusion, pericardial effusion) and cardiac events compared to younger patients. Close monitoring is recommended.

• Dasatinib's absorption is pH-dependent; avoid concomitant use with PPIs. If antacids are needed, separate administration by at least 2 hours.
• Fluid retention, particularly pleural effusion, is a common and potentially serious side effect. Monitor patients closely for symptoms (e.g., dyspnea, cough, chest pain) and consider chest X-ray or echocardiogram if suspected.
• Myelosuppression (neutropenia, thrombocytopenia, anemia) is frequent and may require dose interruptions or reductions. Monitor CBCs regularly.
• Dasatinib can prolong the QTc interval. Correct hypokalemia and hypomagnesemia prior to and during therapy. Use with caution in patients with pre-existing cardiac conditions or on other QT-prolonging medications.
• Patients should be advised to report any signs of bleeding, infection, or cardiac symptoms immediately.

• Imatinib (Gleevec)
• Nilotinib (Tasigna)
• Bosutinib (Bosulif)
• Ponatinib (Iclusig)
• Olverembatinib (Olinvo - approved in some regions, e.g., China)

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