Dasatinib 100mg Tablets

Dasatinib is a small molecule 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 active and inactive conformations of the BCR-ABL kinase, making it effective against imatinib-resistant CML and Ph+ ALL.

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, such as foods or drugs. Be sure to describe the allergic reaction 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 medications can interact with this drug, particularly those used to treat HIV, infections, or seizures.
* If you are breast-feeding. Please note that you should not breast-feed while taking this medication and for 2 weeks after your last dose.

This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe use. Do not start, stop, or change the dose of any medication without consulting your doctor first.

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 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, 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 individuals who have infections, colds, or flu.

You may experience easier bleeding, so it is crucial to be cautious and avoid injury. 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.

Age-Related Considerations

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

Reproductive Considerations

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 accidental contact occurs, the area should be washed immediately 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 effective birth control while taking this medication and for 30 days after the last dose, unless otherwise advised 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 advised by your doctor. If your partner becomes pregnant, inform the doctor immediately.

Pediatric Considerations

If you are giving 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, 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)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice) - require dasatinib dose reduction
• Antacids (e.g., aluminum hydroxide/magnesium hydroxide) - separate administration by at least 2 hours
• H2-receptor antagonists (e.g., famotidine, ranitidine) - avoid concomitant use
• Proton pump inhibitors (e.g., omeprazole, pantoprazole) - avoid concomitant use
• QT prolonging drugs (e.g., quinidine, procainamide, amiodarone, sotalol, cisapride, pimozide, thioridazine, moxifloxacin, halofantrine) - use with caution
• Warfarin and other anticoagulants (increased bleeding risk)

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

• Not specifically listed as minor, but any drug affecting gastric pH or CYP3A4 could have some interaction.

• Signs of infection (fever, chills, sore throat)
• Unusual bleeding or bruising (petechiae, epistaxis, GI bleeding)
• Signs of fluid retention (shortness of breath, cough, swelling in ankles/feet, rapid weight gain, chest pain)
• Cardiac symptoms (palpitations, dizziness, syncope)
• Signs of pulmonary arterial hypertension (dyspnea, fatigue, peripheral edema)
• Signs of hepatotoxicity (jaundice, dark urine, severe nausea/vomiting, abdominal pain)
• Fatigue, headache, rash, diarrhea, nausea, musculoskeletal pain

Dasatinib can cause fetal harm when administered to a pregnant woman based on animal studies and its mechanism of action. Advise pregnant women of the potential risk to the fetus. Females of reproductive potential should use effective contraception during treatment and for 30 days after the last dose. Males with female partners of reproductive potential should use effective contraception during treatment and for 90 days after the last dose.

There are no data on the presence of dasatinib in human milk, the effects on the breastfed infant, or the effects on milk production. Due to the potential for serious adverse reactions in a breastfed infant, advise women not to breastfeed during treatment with Sprycel and for 2 weeks after the last dose.

Approved for pediatric patients with chronic phase CML and Ph+ ALL. Dosing is based on body surface area (BSA). Pediatric patients may experience similar adverse reactions as adults, with some differences in incidence (e.g., musculoskeletal pain, growth retardation). Close monitoring is required.

No specific dose adjustment is required based on age. However, elderly patients (≥65 years) may have an increased incidence of certain adverse events, including fluid retention (e.g., pleural effusion, pericardial effusion) and cardiac events. Close monitoring for these events is recommended.

• Dasatinib is a potent TKI effective against imatinib-resistant CML and Ph+ ALL.
• Fluid retention, particularly pleural effusion, is a common and important adverse event. Monitor patients closely for signs and symptoms, and manage with diuretics or dose modification.
• Myelosuppression (neutropenia, thrombocytopenia, anemia) is frequent and requires regular CBC monitoring and dose adjustments.
• Pulmonary arterial hypertension (PAH) is a rare but serious adverse event. Patients presenting with new or worsening dyspnea should be evaluated for PAH.
• QT prolongation can occur; monitor ECG and electrolytes, especially in patients with pre-existing cardiac conditions or on concomitant QT-prolonging medications.
• Strict adherence to drug interaction guidelines, especially regarding gastric pH-altering agents and CYP3A4 inhibitors/inducers, is crucial for efficacy and safety.
• Patients should be educated on the importance of reporting any new or worsening symptoms promptly.

• Imatinib (Gleevec)
• Nilotinib (Tasigna)
• Bosutinib (Bosulif)
• Ponatinib (Iclusig)
• Asciminib (Scemblix)

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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.