Sprycel 20mg Tablets

Dasatinib is a small-molecule tyrosine kinase inhibitor that inhibits multiple tyrosine kinases, including BCR-ABL, SRC family kinases (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).

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 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 enlarging bruises, or uncontrollable bleeding.
Electrolyte problems: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance changes, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
High or low blood pressure: Severe headache 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 can 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 can 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 (such as 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 changes, 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.

Other Side Effects

Most people experience no side effects or only mild side effects. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not improve:

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 can be managed with medical guidance)

Reporting Side Effects

If you have questions about side effects or experience any side effects not listed here, 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.
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 is crucial because many drugs can interact with this medication, such as those used to treat HIV, infections, or seizures.
* If you are breastfeeding. It is recommended that you do not breastfeed 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 or health problems that may affect your ability to take this medication safely. Therefore, it is vital to discuss all your medications (prescription and OTC), natural products, vitamins, and health problems with your doctor and pharmacist to ensure it is safe for you to take this medication. 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 medication. 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 medication.

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 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. If you are pregnant or may become pregnant, it is essential to handle this medication with care. Pregnant individuals should not handle crushed or broken tablets, and if accidental contact occurs, the area should be washed immediately with soap and water.

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 medication and for 30 days after the 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 the last dose, unless otherwise instructed by your doctor. If your partner becomes pregnant, inform the doctor immediately.

Pediatric Considerations

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

• Strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) - may significantly decrease dasatinib plasma concentrations.
• Proton Pump Inhibitors (PPIs) (e.g., omeprazole, esomeprazole, lansoprazole) - significantly decrease dasatinib solubility and absorption due to pH-dependent solubility.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, telithromycin, nefazodone) - may significantly increase dasatinib plasma concentrations, increasing toxicity risk. Consider alternative agents or dose reduction of dasatinib.
• H2-receptor antagonists (e.g., ranitidine, famotidine) - may decrease dasatinib absorption. Separate administration by at least 2 hours or consider alternative agents.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, grapefruit juice) - may increase dasatinib concentrations. Monitor for toxicity.
• Moderate CYP3A4 inducers (e.g., efavirenz, bosentan) - may decrease dasatinib concentrations. Monitor for efficacy.

• Antacids (e.g., aluminum hydroxide/magnesium hydroxide) - may decrease dasatinib absorption. Administer dasatinib at least 2 hours before or 2 hours after antacids.

• Signs of bleeding (e.g., bruising, petechiae, melena, hematuria)
• Signs of infection (e.g., fever, chills, sore throat)
• Symptoms of fluid retention (e.g., shortness of breath, cough, swelling in ankles/feet, rapid weight gain)
• Cardiac symptoms (e.g., chest pain, palpitations, dizziness, syncope)
• Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, abdominal pain)
• Skin rash or other dermatologic reactions
• Fatigue, muscle pain, headache

Dasatinib can cause fetal harm when administered to a pregnant woman. Based on animal studies and its mechanism of action, dasatinib is teratogenic and embryotoxic. It should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Women of reproductive potential should be advised to avoid becoming pregnant during treatment and for 30 days after the last dose.

It is not known whether dasatinib is excreted in human milk. However, due to the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated during treatment with dasatinib and for 2 weeks after the last dose.

Dasatinib is approved for pediatric patients with chronic phase CML and Ph+ ALL. Dosing is based on body surface area. Safety and efficacy in pediatric patients younger than 1 year have not been established. Close monitoring for growth and development is recommended.

No specific dose adjustment is required based on age. However, elderly patients (≥65 years) may have an increased incidence of certain adverse reactions, particularly fluid retention (e.g., pleural effusion, pericardial effusion), and should be monitored closely.

• Dasatinib is effective in patients with imatinib resistance or intolerance, including those with BCR-ABL mutations, except T315I.
• Fluid retention, particularly pleural effusion, is a common and potentially serious side effect. Monitor for dyspnea, cough, and weight gain. May require diuretics or dose modification.
• Myelosuppression (neutropenia, thrombocytopenia, anemia) is dose-limiting. Frequent CBC monitoring is crucial, especially during the initial months.
• Dasatinib absorption is pH-dependent. Avoid concomitant use with PPIs and H2-receptor antagonists. Separate antacid administration.
• Significant drug interactions exist with strong CYP3A4 inhibitors and inducers. Review concomitant medications carefully.
• QTc prolongation can occur; monitor ECG and electrolytes, especially in patients with pre-existing cardiac conditions or on other QT-prolonging drugs.
• Pulmonary arterial hypertension (PAH) is a rare but serious adverse event. Patients developing new or worsening dyspnea should be evaluated for PAH and dasatinib should be discontinued if diagnosed.

• Imatinib (Gleevec)
• Nilotinib (Tasigna)
• Bosutinib (Bosulif)
• Ponatinib (Iclusig)
• Omacetaxine mepesuccinate (Synribo) - for CML with T315I mutation

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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 medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.