Sprycel 80mg Tablets

Dasatinib is a small molecule kinase inhibitor. It inhibits multiple tyrosine kinases, including BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. By inhibiting BCR-ABL, it prevents the proliferation of Philadelphia chromosome-positive (Ph+) leukemia cells.

Important Side Effects to Report to Your Doctor Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention right away:

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 production, painful urination, mouth sores, or wounds that won't heal.
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 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 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 (such as prolonged QT interval), heart attack, or small strokes (TIAs). Symptoms include chest pain, rapid or abnormal heartbeat, shortness of breath, significant 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 Possible Side Effects

Most people experience no side effects or only mild side effects while taking this medication. However, if you experience any of the following side effects, consult your doctor:

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 may be managed with your doctor's guidance)

If any of these side effects bother you, do not improve, or are severe, seek medical attention. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.

Reporting Side Effects

You can 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 medication can interact with various drugs, such as those used to treat HIV, infections, or seizures.
* If you are breastfeeding. You should 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. To ensure your safety, it is crucial to inform your doctor and pharmacist about all your medications and health conditions. Before starting, stopping, or changing the dose of any medication, consult with your doctor to verify that it is safe to do so in conjunction with this medication.

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 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 avoid close contact with individuals 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. 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 medication and for 30 days after your 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 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 your doctor, 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)
• Proton Pump Inhibitors (PPIs) (e.g., omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, atazanavir, indinavir, nefazodone, telithromycin, voriconazole, grapefruit juice) - reduce dasatinib dose or avoid.
• H2-receptor antagonists (e.g., famotidine, ranitidine, cimetidine) - separate administration by at least 2 hours or avoid if possible.
• Antacids (e.g., aluminum hydroxide/magnesium hydroxide) - separate administration by at least 2 hours.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, fluconazole) - monitor for increased dasatinib effects.
• Moderate CYP3A4 inducers (e.g., efavirenz, modafinil) - monitor for decreased dasatinib efficacy.

• Drugs that prolong QT interval (e.g., antiarrhythmics, antipsychotics, macrolides) - use with caution, monitor ECG.

• Fever, chills, signs of infection
• Unusual bleeding or bruising
• Shortness of breath, cough, chest pain (especially new or worsening)
• Swelling in ankles, feet, hands, or abdomen
• Rapid weight gain
• Fatigue, weakness
• Nausea, vomiting, diarrhea
• Muscle pain or cramps
• Skin rash
• Headache, dizziness

Dasatinib can cause fetal harm when administered to a pregnant woman. Based on animal studies and its mechanism of action, it is classified as Pregnancy Category D. Avoid use during pregnancy.

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

Dasatinib is approved for pediatric patients with Ph+ CML (chronic phase) and Ph+ ALL. Dosing is weight-based. Close monitoring for growth and development, as well as adverse effects, is crucial.

No significant differences in efficacy or safety were observed between older and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use with caution, monitor for age-related comorbidities and potential for increased adverse effects (e.g., fluid retention).

• Dasatinib absorption is pH-dependent; avoid concomitant use with PPIs. Separate administration from H2-receptor antagonists and antacids.
• Significant fluid retention, particularly pleural effusion, is a common and important adverse effect. Monitor for symptoms and manage proactively with diuretics or dose modification.
• Pulmonary arterial hypertension (PAH) is a rare but serious adverse effect. Patients presenting with new or worsening dyspnea should be evaluated for PAH.
• Myelosuppression is common and often requires dose interruptions or reductions. Frequent CBC monitoring is essential.
• Dasatinib can prolong the QT interval; use with caution in patients with pre-existing cardiac conditions or those taking other QT-prolonging drugs.
• Grapefruit juice and St. John's Wort should be avoided due to significant drug interactions.

• 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 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 your 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.