Fludarabine Accord
This medicine stops cancer cells from growing and is used to treat a type of blood cancer called chronic lymphocytic leukemia (CLL).
Form
injektio-/infuusiokonsentraatti, liuosta varten
Strength
25 mg/ml
Active Ingredient
Fludarabine fosfate
Manufacturer
Accord Healthcare B.V.
How to Use
Dosage
Your doctor will determine your dose based on your body size, usually 25 mg per square meter of body surface.
Method
This medicine is given as an injection or, more commonly, as an infusion (a slow drip into your vein), usually lasting about 30 minutes.
Important
You will receive one dose daily for 5 days in a row. This 5-day treatment cycle is repeated every 28 days, typically for about six cycles.
Possible Side Effects
COMMON
- •Infections (some serious)
- •Infections due to a weakened immune system
- •Pneumonia, which may cause difficulty breathing and/or a feverish cough
- •Low platelet count (thrombocytopenia), which can cause bruising and bleeding
- •Low white blood cell count (neutropenia)
- •Low red blood cell count (anemia)
- •Cough
- •Vomiting
- •Diarrhea
- •Nausea
- •Fever
- •Fatigue
- •Weakness
- •Other blood-related cancers (e.g., myelodysplastic syndrome, acute myeloid leukemia)
- •Bone marrow suppression
- •Severe loss of appetite and weight loss
- •Numbness or weakness in arms and legs (peripheral neuropathy)
- •Vision problems
- •Mouth inflammation (stomatitis)
- •Rash
- •Swelling due to excessive fluid retention (edema)
- •Mucosal inflammation in the digestive tract (mucositis)
- •Chills
- •General feeling of unwellness
RARE
- •Autoimmune disorders
- •Tumor lysis syndrome (a problem caused by breakdown of cancer cells)
- •Confusion
- •Lung problems such as scarring (pulmonary fibrosis), inflammation (pneumonitis), shortness of breath
- •Stomach or intestinal bleeding
- •Abnormal liver or pancreas enzyme levels
- •Lymph system disorders caused by viral infections (EBV-associated lymphoproliferative disorder)
- •Coma
- •Seizures
- •Agitation
- •Blindness
- •Optic nerve inflammation or damage (optic neuritis, optic neuropathy)
- •Heart failure
- •Irregular heartbeats
- •Skin cancer
- •Skin and/or mucosal reactions with redness, inflammation, blistering, and tissue breakdown (e.g., Lyell's syndrome, Stevens-Johnson syndrome)
- •Bladder inflammation causing painful urination and blood in urine
- •Brain hemorrhage
- •Lung hemorrhage
- •Neurological disorders such as headache, nausea, vomiting, seizures, vision problems, vision loss, mental changes (confusion), and muscle weakness in limbs (paralysis)
Important Warnings
- Do not use if you are allergic to fludarabine phosphate or any other ingredients in this medicine.
- Do not breastfeed, as this medicine can harm your baby.
- Do not use if you have severe kidney problems. Your doctor will regularly check your kidney function.
- Do not use if you have a certain severe lack of red blood cells (uncompensated hemolytic anemia).
- Tell your doctor if your bone marrow is not working well, your immune system is weak, or you have had serious infections in the past.
Show 9 more warnings
- Seek immediate medical attention if you feel very ill, notice unusual bruising, excessive bleeding, or get frequent infections. These can be signs of reduced blood cell counts.
- Tell your doctor if your urine turns red or brownish, you have side pain, blood in your urine, reduced urine output, or a rash or blisters on your skin. These can be signs of serious reactions.
- Seek immediate medical attention if you notice unusual nervous system symptoms, such as vision problems, headache, confusion, or seizures.
- If you need a blood transfusion, your doctor will make sure you receive irradiated blood to prevent serious complications.
- Tell your doctor if you have or have had skin cancer, or if you notice any skin changes during or after treatment.
- Men and women who can have children must use effective contraception during treatment and for at least 6 months after treatment ends.
- Discuss vaccinations with your doctor. Avoid live vaccines during and after using this medicine.
- This medicine is not recommended for children under 18 years old as its safety and effectiveness have not been confirmed.
- Do not drive or operate machinery if you experience fatigue, weakness, vision problems, confusion, agitation, or seizures while taking this medicine.