Dasatinib Sandoz
Dasatinib Sandoz treats certain types of blood cancer (leukemia) in adults and children aged 1 year and older by stopping the growth of cancer cells.
Form
tabletti, kalvopäällysteinen
Strength
20 mg
Active Ingredient
Dasatinib
Manufacturer
Sandoz A/S
How to Use
Dosage
For adults with chronic phase CML, the usual starting dose is 100 mg once a day. For adults with accelerated or blast phase CML or Ph+ ALL, the usual starting dose is 140 mg once a day. For children aged 1 year and older, the dose depends on their body weight: 10-<20 kg, 40 mg daily; 20-<30 kg, 60 mg daily; 30-<45 kg, 70 mg daily; ≥45 kg, 100 mg daily.
Method
Take tablets whole by mouth once a day at the same time each day. Do not crush, split, or chew them. You can take Dasatinib Sandoz with or without food.
Important
Your doctor will determine your maximum daily dose, which may be adjusted based on your response to treatment.
Possible Side Effects
COMMON
- •Infections (bacterial, viral, and fungal)
- •Shortness of breath
- •Diarrhea, nausea, vomiting
- •Rash, fever, swelling (face, hands, feet), headache, fatigue or weakness, bleeding
- •Muscle pain, stomach pain
- •Low platelet count, low white blood cells (neutropenia), anemia, fluid around lungs
- •Pneumonia, herpes virus infection (including CMV), upper respiratory tract infection, severe blood or tissue infection (in some cases fatal)
- •Palpitations, irregular heartbeats, congestive heart failure, weakening of heart muscle, high blood pressure, increased blood pressure in lung arteries, cough
- •Appetite changes, taste changes, swollen or distended stomach, colon inflammation, constipation, heartburn, mouth ulcers, weight gain or loss, gastritis
- •Skin tingling, itching, dry skin, acne, skin inflammation, ringing in ears, hair loss, excessive sweating, vision problems (blurred vision), dry eyes, bruises, depression, insomnia, flushing, dizziness, appetite loss, drowsiness, generalized swelling
- •Joint pain, muscle weakness, chest pain, pain in hands and feet, chills, muscle and joint stiffness, muscle cramps
- •Fluid around the heart, fluid in lungs, irregular heart rhythm, febrile neutropenia, gastrointestinal bleeding, high uric acid levels in blood
RARE
- •Heart attack (can be fatal), inflammation of the sac around the heart, chest pain due to insufficient oxygen to the heart (angina), low blood pressure, narrowed airways causing breathing difficulties, asthma, increased blood pressure in lung arteries
- •Pancreatitis, stomach ulcer, esophageal inflammation, abdominal swelling, anal fissure, difficulty swallowing, gallbladder inflammation, bile duct blockage, acid reflux
- •Allergic reaction including tender, red skin bumps (erythema nodosum), anxiety, confusion, mood swings, decreased libido, fainting, tremors, red or painful eye inflammation, skin disease with tender, red patches and fever (neutrophilic dermatosis), hearing loss, photosensitivity, vision impairment, increased tear production, skin pigmentation changes, inflammation of subcutaneous fat, skin ulcer, skin blistering, nail/hair disorders, hand-foot syndrome, kidney failure, frequent urination, male breast enlargement, menstrual disorders, general weakness and malaise, underactive thyroid, loss of balance, bone necrosis, arthritis, swelling of skin
- •Vein inflammation (phlebitis) causing redness, tenderness, and swelling, tendinitis
- •Memory loss
- •Abnormal blood test results and possible kidney impairment due to tumor breakdown products (tumor lysis syndrome), low albumin/lymphocyte/high cholesterol levels in blood, swollen lymph nodes, brain hemorrhage, irregular electrical activity of the heart, enlarged heart muscle, liver inflammation, protein in urine, increased levels of creatine kinase/troponin/gamma-glutamyltransferase, milky fluid around the lungs (chylothorax)
- •Enlarged right heart ventricle, inflammation of heart muscle, heart problems due to reduced blood flow (coronary artery events), cardiac arrest, coronary artery disease, inflammation of heart and lung lining, blood clots, pulmonary embolism
- •Loss of essential nutrients (like protein) from digestive tract, bowel obstruction, anal fistula, kidney impairment, diabetes
- •Seizures, optic nerve inflammation (can cause vision loss), blue-purple skin discoloration (livedo reticularis), overactive thyroid, thyroid inflammation, ataxia (lack of muscle coordination), difficulty walking, miscarriage, skin vasculitis, skin fibrosis
- •Stroke, temporary nerve dysfunction due to reduced blood flow (TIA), facial nerve paralysis, dementia
- •Severe allergic reaction
- •Slowed bone formation in the rounded ends of bones (epiphyses); slowed or delayed growth
- •Life-threatening stomach or intestinal bleeding
- •Reactivation of hepatitis B infection in patients who previously had hepatitis B (liver inflammation)
- •Fever-inducing reaction, skin blisters, and mucous membrane ulcers
- •Kidney disease with symptoms such as swelling and abnormal lab test results (e.g., protein in urine, low blood protein)
- •Blood vessel damage called thrombotic microangiopathy (TMA), involving reduced red blood cells, reduced platelets, and blood clot formation
Important Warnings
- Do not take if you are allergic to dasatinib or any other ingredient in this medicine.
- Tell your doctor if you take medicines that thin your blood or prevent blood clots.
- Tell your doctor if you have or have had liver or heart disease.
- Inform your doctor if you have or have had hepatitis B, as Dasatinib Sandoz can reactivate the infection.
- Do not take antacids (like aluminum or magnesium hydroxide) 2 hours before or 2 hours after taking Dasatinib Sandoz.
Show 4 more warnings
- Do not eat grapefruit or drink grapefruit juice while taking Dasatinib Sandoz.
- Do not use if you are pregnant or breastfeeding, unless specifically instructed by your doctor. Use effective contraception during treatment.
- Be careful when driving or operating machines if you experience dizziness or blurred vision.
- Seek immediate medical attention if you experience severe chest pain, breathing difficulties, cough, fainting, unexplained bleeding or bruising, blood in vomit/stool/urine, black stools, signs of infection (fever, severe chills), fever with sore mouth/throat, or blistering/peeling skin.