Dasatinib 20mg Tablets

Dasatinib is a small-molecule tyrosine kinase inhibitor (TKI) 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 ABL kinase domain, making it effective against imatinib-resistant CML and Ph+ ALL, particularly those with BCR-ABL mutations (except T315I). By inhibiting these kinases, dasatinib blocks proliferation and induces apoptosis in CML and Ph+ ALL cell lines overexpressing BCR-ABL.

WHAT ARE SOME SIDE EFFECTS THAT I NEED TO CALL MY DOCTOR ABOUT RIGHT AWAY? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:Signs of an allergic reaction, like 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.Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.Signs of electrolyte problems like mood changes; confusion; muscle pain, cramps, or spasms; weakness; shakiness; change in balance; an abnormal heartbeat; seizures; loss of appetite; or severe upset stomach or throwing up.Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.Numbness or tingling in the hands or feet.Seizures.This drug may cause you to swell or keep fluid in your body. Tell your doctor if you have swelling, weight gain, or trouble breathing.Severe skin reactions have happened with this drug. These have included Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe skin reactions. Sometimes these have been deadly. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin; other skin irritation (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.Patients with cancer who take this drug may be at a greater risk of getting a severe health problem called tumor lysis syndrome (TLS). This may lead to death. Call your doctor right away if you have a fast or abnormal heartbeat; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, diarrhea, or not able to eat; or feel sluggish.Heart problems have happened with this drug. These include abnormal heartbeat (like prolonged QT interval), heart attack, or small strokes (TIAs). Call your doctor right away if you have chest pain; fast or abnormal heartbeat; shortness of breath; a big weight gain; swelling in the arms or legs; weakness on 1 side of the body; confusion; slurred speech; change in balance; drooping on one side of the face; change in eyesight; very bad dizziness; or passing out.Liver problems have happened with drugs like this one. The risk of liver problems may be higher if you already have liver problems. Call your doctor right away if you have signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes. WHAT ARE SOME OTHER SIDE EFFECTS OF THIS DRUG? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:Constipation.Stomach pain.Headache.Feeling tired or weak.Muscle or joint pain.Pain in arms or legs.Diarrhea, throwing up, upset stomach, and decreased appetite are common with this drug. If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not get better, or are severe.These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.You may report side effects to the FDA at 1-800-332-1088. You may also report side effects 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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, such as low potassium or magnesium levels, which may affect your ability to take this medication safely.
If you are currently taking any of the following medications: cimetidine, dexlansoprazole, esomeprazole, famotidine, lansoprazole, nizatidine, omeprazole, pantoprazole, rabeprazole, or ranitidine.
Any other prescription or over-the-counter (OTC) medications, natural products, or vitamins you are taking, as this medication can interact with various drugs, including those used to treat HIV, infections, or seizures.
* If you are breast-feeding, as 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 or health problems that may be relevant to your treatment with this medication. Therefore, it is crucial to inform your doctor and pharmacist about all your medications, health conditions, and any other relevant information to ensure your safety while taking 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 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 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 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 avoid close contact with individuals who have infections, colds, or flu.

You may also 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. Although rare, some 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. 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, 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 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 administering this medication to a child, consult 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, so regular growth checks may be necessary. Discuss this 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, telithromycin, nefazodone, ritonavir, atazanavir, indinavir, nelfinavir, saquinavir, tipranavir): May significantly increase dasatinib exposure. Consider alternative agents or dasatinib dose reduction.
• H2-receptor antagonists (e.g., famotidine, ranitidine, cimetidine): May decrease dasatinib absorption. Avoid or separate administration by at least 2 hours.
• Antacids (e.g., aluminum hydroxide/magnesium hydroxide): May decrease dasatinib absorption. Separate administration by at least 2 hours.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, fluconazole, grapefruit juice): May increase dasatinib exposure. Monitor for adverse effects.
• Warfarin and other anticoagulants: Increased risk of bleeding due to dasatinib's potential to cause platelet dysfunction and hemorrhage. Monitor INR/bleeding parameters closely.
• Drugs that prolong QT interval (e.g., antiarrhythmics, antipsychotics, macrolide antibiotics, fluoroquinolones): Additive risk of QT prolongation. Use with caution and monitor ECG.

• Not specifically categorized as minor, but any drug affecting gastric pH or CYP3A4 activity should be considered.

• Fever, chills, signs of infection (due to myelosuppression)
• Unusual bleeding or bruising (due to thrombocytopenia or hemorrhage risk)
• Shortness of breath, cough, chest pain, swelling in ankles/legs, rapid weight gain (signs of fluid retention or PAH)
• Fatigue, weakness, dizziness (due to anemia or other adverse effects)
• Nausea, vomiting, diarrhea, abdominal pain
• Muscle pain, joint pain
• Skin rash
• Headache

Dasatinib is classified as Pregnancy Category D, meaning there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. It can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with dasatinib 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. However, due to the potential for serious adverse reactions in a breastfed infant, breastfeeding is not recommended 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. Safety and efficacy have been established. Dosing is typically based on body surface area. Close monitoring for growth and development, as well as long-term adverse effects, is important.

No significant differences in safety or efficacy were observed between older and younger patients. However, patients 65 years of age and older may be more susceptible to fluid retention events, including pleural effusion, and should be monitored closely.

• Dasatinib is a potent multi-targeted TKI effective in imatinib-resistant CML and Ph+ ALL, but requires careful management of side effects.
• Fluid retention, particularly pleural effusion, is a common and potentially serious side effect. Monitor patients closely for weight gain, dyspnea, and other signs. Diuretics may be used, and dose reduction or interruption may be necessary.
• Myelosuppression (neutropenia, thrombocytopenia, anemia) is frequent. Regular CBC monitoring is crucial, and dose adjustments or growth factor support may be needed.
• Pulmonary arterial hypertension (PAH) is a rare but serious and potentially irreversible adverse event. Patients presenting with new or worsening dyspnea should be evaluated for PAH, and dasatinib should be discontinued if confirmed.
• Strict adherence to drug interaction guidelines is essential, especially regarding CYP3A4 inhibitors/inducers and gastric pH-altering agents (PPIs, H2 blockers, antacids).
• Patients should be educated on the importance of reporting any new or worsening symptoms promptly.

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

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 information. 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 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.