Generic Dasatinib

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What is Dasatinib?

Dasatinib is a targeted cancer therapy used to treat Philadelphia chromosome-positive chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL). It belongs to a class of drugs called tyrosine kinase inhibitors. The abnormal BCR-ABL protein produced by the Philadelphia chromosome tells white blood cells to multiply without stopping. Dasatinib binds to that protein and shuts it off. The overproduction of abnormal cells halts, and the disease goes into remission. It is used both in newly diagnosed patients and in those who have become resistant or intolerant to imatinib (Gleevec).

Dasatinib does not cure these leukemias in most cases, but it can keep them under control for many years. It is taken as a daily oral tablet. The usual dose for chronic phase CML is 100 mg once daily. For advanced phase CML or Philadelphia chromosome-positive ALL, the dose is 140 mg once daily. The 50 mg tablet is used for patients who need a lower dose due to side effects, blood count issues, or when combined with other medications that affect drug levels. It is also used in some pediatric dosing regimens. The effect is usually seen within weeks to months as blood counts normalize and the abnormal cells disappear from the bone marrow.

Mechanism and Pharmacology

Dasatinib is a second-generation BCR-ABL tyrosine kinase inhibitor. It binds to the ATP-binding site of the BCR-ABL protein, preventing it from adding phosphate groups to other proteins. This blocks the downstream signals that drive the uncontrolled growth of leukemia cells. Dasatinib is more potent than imatinib and is effective against many imatinib-resistant mutations. It also inhibits the SRC family of kinases, which may contribute to its activity. The result is apoptosis, programmed cell death, of the abnormal cells, allowing normal blood cell production to recover.

After oral administration, dasatinib is well absorbed, with peak plasma levels reached in about 0.5 to 3 hours. Food does not significantly affect the total amount absorbed, but a high-fat meal can delay the peak. The drug is extensively metabolized in the liver, primarily by CYP3A4. The half-life is about 3 to 5 hours, but the active effect lasts much longer due to irreversible binding to the target. Dasatinib is eliminated mainly in the feces. Dose adjustment is not required for kidney impairment, but caution is advised in severe renal disease. Liver impairment may require dose reduction. Dasatinib can cause fluid retention, including pleural effusion, and can prolong the QT interval on the electrocardiogram.

How to Use Dasatinib

Take Dasatinib once daily, with or without food, at the same time each day. Swallow the tablet whole with water. Do not crush, chew, or split the tablet. If you miss a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed one. Do not double up. Do not take extra tablets if you vomit. Continue with the next scheduled dose.

The 50 mg tablet is often used when your doctor reduces the dose because of side effects, particularly low blood counts, fluid retention, or heart rhythm concerns. Some patients are started on a lower dose if they have liver problems or are taking certain interacting medications. The dose may be adjusted based on your response and laboratory results. Never change the dose on your own. Blood counts, liver enzymes, and electrolytes are checked regularly. An ECG may be done before starting and periodically during treatment, especially if you have heart disease or take other QT-prolonging drugs. Do not stop Dasatinib without talking to your oncologist. Stopping suddenly can allow the leukemia to return.

Side Effects of Dasatinib

The most common and serious side effect is myelosuppression, meaning low blood counts. Neutropenia, low white blood cells, increases the risk of infections. Thrombocytopenia, low platelets, increases the risk of bleeding and bruising. Anemia, low red blood cells, causes fatigue and shortness of breath. Blood counts are monitored frequently, especially in the first months. The dose may be held or reduced if counts drop too low.

Fluid retention is another major concern. It can appear as swelling in the ankles, around the eyes, or in the abdomen. The most serious form is pleural effusion, fluid accumulating around the lungs, which causes shortness of breath, chest pain, and a dry cough. This occurs in a significant minority of patients, more often with dasatinib than with nilotinib or imatinib. If you develop new shortness of breath or swelling, tell your oncologist immediately. The dose may be reduced or a diuretic prescribed.

Other common side effects include diarrhea, nausea, headache, fatigue, muscle and joint pain, and skin rash. Bleeding is a risk because of low platelets and the drug's effect on platelet function. Watch for easy bruising, nosebleeds, or blood in the stool. Pulmonary arterial hypertension, high blood pressure in the lungs, is a rare but serious complication. Symptoms include progressive shortness of breath, fatigue, and swelling. If this develops, the drug must be stopped. QT interval prolongation can occur, leading to arrhythmias. Electrolytes, especially potassium and magnesium, must be kept normal. Avoid other QT-prolonging drugs. Liver enzyme elevations are common and usually mild, but severe hepatitis is possible. Yellowing of the skin or eyes, dark urine, or severe abdominal pain should be reported immediately.

High-Risk Groups (Elderly, Pregnancy)

Pregnancy. Dasatinib is pregnancy category D. It can cause serious birth defects and fetal loss. It should not be used during pregnancy. Women of childbearing age must use effective contraception during treatment and for at least 30 days after the last dose. Men taking dasatinib should also use contraception, as the drug may be present in semen. If pregnancy occurs, the patient must be informed of the risk. Breastfeeding is not recommended while taking Dasatinib.

Elderly patients can use dasatinib without dose adjustment for age alone. However, older adults are more likely to have heart disease, kidney or liver problems, and are at higher risk of fluid retention, bleeding, and infections. The 50 mg dose may be used more frequently in this population to reduce side effects. Patients with moderate to severe liver impairment may require a lower dose. Kidney function does not significantly affect drug levels, but the drug can worsen renal function, so serum creatinine is monitored. Patients with a history of heart rhythm problems, uncontrolled hypertension, or pleural effusion need careful evaluation before starting. Those taking anticoagulants or antiplatelet drugs have an increased bleeding risk. A complete medication review is essential.

Interaction With Activities (Driving, Alcohol)

Dasatinib can cause fatigue, dizziness, and visual changes. If you feel tired or lightheaded, don't drive. The fatigue can come on suddenly and be severe, especially early in treatment. Alcohol should be limited or avoided. Alcohol can worsen liver irritation, add to the fatigue, and increase the risk of stomach bleeding when combined with dasatinib. Heavy drinking is strongly discouraged. If you drink, keep it light and tell your oncologist honestly.

Drug Interactions

Dasatinib is metabolized by CYP3A4. Strong CYP3A4 inhibitors, like ketoconazole, itraconazole, clarithromycin, and ritonavir, can increase dasatinib levels and the risk of side effects. Strong CYP3A4 inducers, like rifampin, phenytoin, carbamazepine, and St. John's Wort, can lower dasatinib levels and reduce its effectiveness. These combinations should be avoided if possible. Grapefruit and grapefruit juice must be avoided entirely, as they inhibit CYP3A4 and can cause dangerous spikes in drug levels.

Dasatinib absorption is reduced by gastric acid suppression. Antacids, H2 blockers like famotidine, and proton pump inhibitors like omeprazole can significantly lower dasatinib blood levels, making the treatment less effective. If you need an antacid, take it at least 2 hours before or 2 hours after dasatinib. H2 blockers and proton pump inhibitors should be avoided if possible, or the dasatinib dose may need adjustment. Dasatinib itself can increase levels of drugs metabolized by CYP3A4, such as simvastatin, cyclosporine, and warfarin. Doses may need adjustment. Warfarin and other anticoagulants increase the risk of bleeding, and INR should be monitored closely. Drugs that prolong the QT interval, such as certain antiarrhythmics, antipsychotics, and macrolide antibiotics, must be avoided because of additive risk. Always tell your oncologist about every medication, supplement, and herbal product you take before starting Dasatinib.

Alternative Options

For chronic myeloid leukemia, the treatment landscape includes several tyrosine kinase inhibitors. Imatinib (Gleevec) is the first-generation drug and remains a standard first-line option. Nilotinib (Tasigna) is another second-generation drug with a higher risk of cardiovascular events. Bosutinib (Bosulif) is used for patients who cannot tolerate other drugs. Ponatinib (Iclusig) is used for the T315I mutation, which is resistant to dasatinib, nilotinib, and imatinib. Asciminib (Scemblix) is a newer drug that targets a different site on the BCR-ABL protein and is used for resistant disease. The choice depends on the specific BCR-ABL mutation, the patient's other health conditions, and side effect tolerance. Dasatinib is particularly useful for patients who need rapid responses and for those with certain mutations that are less responsive to nilotinib. However, its higher risk of pleural effusion makes it less suitable for patients with pre-existing lung or heart disease.

INN, Brand Names, and Classification in Canada

INN (International Nonproprietary Name): Dasatinib
Available brand names in Canada: Sprycel, and generic dasatinib
ATC code: L01EA02
Forms and strengths: Tablets 50 mg, 70 mg, 100 mg, 140 mg. The 50 mg tablet is used for reduced dosing and pediatric regimens.
Manufacturers: Bristol-Myers Squibb Canada (Sprycel), and generic manufacturers including Apotex Inc. and Teva Canada Limited.
Registration status in Canada: Registered
Classification: Prescription (Rx)

Frequently Asked Questions

Why might I be prescribed the 50 mg tablet?
The 50 mg strength is used when your doctor reduces the dose because of side effects, particularly low blood counts, fluid retention, or heart rhythm concerns. It may also be used if you have liver problems or are taking medications that increase dasatinib levels.

Can I take Dasatinib with food?
Yes. Dasatinib can be taken with or without food, but it is best to be consistent. A high-fat meal may delay absorption slightly, but it does not significantly reduce the total amount. Avoid grapefruit and grapefruit juice entirely.

What should I do if I develop shortness of breath?
Shortness of breath can be a sign of pleural effusion or pulmonary arterial hypertension, both serious side effects. Stop taking Dasatinib and contact your oncologist immediately or go to the emergency room. Do not ignore new respiratory symptoms.

How long will I need to take Dasatinib?
Usually for as long as it keeps the leukemia under control and you can tolerate the side effects. This can be many years. Some patients in deep molecular remission may be able to stop under strict medical supervision, but never stop on your own.

Can I take antacids with Dasatinib?
Antacids can reduce the absorption of dasatinib. If you need them, take them at least 2 hours before or 2 hours after your Dasatinib dose. Avoid H2 blockers and proton pump inhibitors if possible, or discuss alternatives with your oncologist.

Delivery Information Across Canada

We ship Dasatinib to all provinces and territories. Delivery times vary depending on how remote your location is:

• Ontario (Toronto, Ottawa, Mississauga): 5 to 7 days
• Quebec (Montreal, Quebec City, Laval): 5 to 7 days
• British Columbia (Vancouver, Victoria, Burnaby): 5 to 9 days
• Alberta (Calgary, Edmonton, Red Deer): 5 to 9 days
• Manitoba (Winnipeg, Brandon): 5 to 9 days
• Saskatchewan (Saskatoon, Regina): 5 to 9 days
• Nova Scotia (Halifax, Sydney): 5 to 9 days
• New Brunswick (Moncton, Fredericton): 5 to 9 days
• Newfoundland and Labrador (St. John's, Corner Brook): 7 to 14 days
• Prince Edward Island (Charlottetown): 7 to 14 days
• Yukon, Northwest Territories, Nunavut: 7 to 14 days

All shipments are packed discreetly with no branding or indication of contents on the outside.

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