Dasatinib Stada
Dasatinib Stada contains dasatinib and is used to treat chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) in adults and children aged 1 year and older by stopping the growth of cancer cells.
Form
tabletti, kalvopäällysteinen
Strength
140 mg
Active Ingredient
Dasatinib
Manufacturer
STADA Arzneimittel AG
How to Use
Dosage
For adults, the usual starting dose is 100 mg once daily for chronic phase CML, or 140 mg once daily for accelerated phase CML, blast phase CML, or Ph+ ALL. For children, the dose depends on their body weight, usually 40-100 mg once daily.
Method
Take the tablets whole, at the same time each day, with or without food. Do not crush, divide, or chew them.
Important
The maximum daily dose prescribed by your doctor is typically 140 mg, but your doctor may adjust it based on your condition.
Possible Side Effects
COMMON
- •Infections (bacterial, viral, fungal)
- •Shortness of breath
- •Diarrhea, feeling sick (nausea), being sick (vomiting)
- •Rash, fever, swelling of face, hands and feet, headache, feeling tired or weak, bleeding
- •Muscle pain (during or after treatment), stomach pain (abdominal pain)
- •Low platelet count, low white blood cell count (neutropenia), anemia, fluid around the lungs
- •Pneumonia, herpes virus infection (including CMV), upper respiratory tract infection, severe blood or tissue infection (rarely fatal)
- •Palpitations, irregular heartbeats, narrowing of heart failure, weak heart muscle, high blood pressure, high blood pressure in the lungs, cough
- •Appetite changes, taste changes, swollen or bloated stomach, colon inflammation, constipation, heartburn, mouth ulcers, weight gain, weight loss, gastritis
- •Skin tingling, itching, dry skin, acne, skin inflammation, persistent ringing in ears, hair loss, excessive sweating, vision problems (blurred vision, reduced vision), dry eyes, bleeding under skin, depression, insomnia, flushing, dizziness, bruises, loss of appetite, drowsiness, general 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 the lungs, irregular heart rhythm, febrile neutropenia, bleeding in the digestive tract, high uric acid levels in blood
RARE
- •Heart attack (may lead to death), inflammation of the heart sac, irregular heartbeats, chest pain due to insufficient oxygen supply to the heart (angina pectoris), low blood pressure, narrowed airways causing breathing difficulties, asthma, high blood pressure in lung arteries
- •Pancreatitis, stomach ulcer, esophageal inflammation, stomach swelling, anal skin tear, difficulty swallowing, gallbladder inflammation, bile duct blockage, acid reflux (stomach acid and contents return to esophagus)
- •Allergic reaction including tender, red skin lumps (erythema nodosum), anxiety, confusion, mood swings, decreased sex drive, fainting, tremor, red or painful eye inflammation, skin disease with tender, red, sharp-edged patches, sudden fever and increased white blood cell count (neutrophilic dermatosis), hearing loss, light sensitivity, impaired vision, increased tear production, pigment disorder, inflammation of subcutaneous fat, skin ulcer, blistering of skin, nail disorder, hair disorder, hand-foot syndrome, kidney failure, frequent urination, male breast enlargement, menstrual disorders, general weakness and discomfort, underactive thyroid, loss of balance when walking, bone necrosis (bone loss due to reduced blood supply), arthritis, skin swelling anywhere on the body
- •Vein inflammation causing redness, tenderness and swelling, tendon inflammation
- •Memory loss
- •Abnormal blood test results and possible kidney function impairment due to waste products from destroyed tumor (tumor lysis syndrome), low albumin levels in blood, low lymphocyte count (a type of white blood cell), high cholesterol levels in blood, swollen lymph nodes, cerebral hemorrhage, irregular electrical activity of the heart, enlarged heart, liver inflammation, protein in urine, increased creatine kinase levels (an enzyme found mainly in heart, brain and skeletal muscles), increased troponin levels (an enzyme found mainly in heart and skeletal muscles), increased gamma-glutamyl transferase levels (an enzyme found mainly in liver), milky fluid around the lungs (chylothorax)
- •Enlarged right heart ventricle, heart muscle inflammation, various conditions due to impaired heart blood circulation (coronary artery disease events), cardiac arrest (cessation of blood flow from the heart), coronary artery disease, inflammation of heart and lung lining, blood clots, pulmonary embolism
- •Loss of vital nutrients (like protein) from the digestive tract, bowel obstruction, anal fistula (abnormal opening between anus and surrounding skin), kidney function impairment, diabetes
- •Seizures, optic nerve inflammation (can cause complete or partial vision loss), blue-violet skin spots (lividity), overactive thyroid, thyroid inflammation, ataxia (muscle coordination disorder), difficulty walking, miscarriage, skin blood vessel inflammation, skin fibrosis. Brain: stroke, temporary nervous system dysfunction caused by reduced blood flow (transient ischemic attack), facial paralysis, dementia. Immune system: severe allergic reaction. Bones, muscles, connective tissue: delayed bone fusion at round ends of bones (epiphyses), slowed or delayed growth.
- •Lung inflammation, life-threatening stomach or intestinal bleeding, reactivation of Hepatitis B infection (liver inflammation) if previously had it, fever-raising reaction, skin blisters and mucous membrane ulcers, kidney disease (symptoms like swelling, abnormal lab tests like protein in urine or low blood protein), blood vessel damage (thrombotic microangiopathy (TMA)) including 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 the medicine.
- Tell your doctor if you are taking medicines that thin the blood or prevent blood clots.
- Tell your doctor if you have or have had liver or heart disease.
- Tell your doctor if you have or have had Hepatitis B, as this medicine can reactivate it.
- Do not take with certain medicines like antifungals (ketoconazole, itraconazole), antibiotics (erythromycin, clarithromycin, telithromycin), antivirals (ritonavir), epilepsy medicines (phenytoin, carbamazepine, phenobarbital), tuberculosis medicines (rifampicin), stomach acid reducers (famotidine, omeprazole), or St. John's Wort.
Show 5 more warnings
- Do not take antacids (medicines that neutralize stomach acid) 2 hours before or 2 hours after taking Dasatinib Stada.
- Do not eat grapefruit or drink grapefruit juice while taking this medicine.
- If you are pregnant or think you might be pregnant, tell your doctor immediately. This medicine should not be used during pregnancy unless absolutely necessary.
- If you are breastfeeding, tell your doctor. You must stop breastfeeding while using Dasatinib Stada.
- Do not give this medicine to children younger than 1 year old.