Fludara; Fludarabine Phosphate for Injection; Fludarabine Phosphate for Injection, USP; Fludarabine Phosphate Injection, PPC STD.
- This drug may have unsafe effects on the bone marrow. The bone marrow may not be able to make cells found in the blood as well as it used to.
- This drug may sometimes cause deadly autoimmune diseases. Talk with the doctor.
- This drug may cause anemia and low platelet counts.
- This drug may cause very bad and sometimes deadly nerve problems like blindness, confusion, and seizures. Talk with the doctor.
- Do not take this drug with pentostatin. Very bad and sometimes deadly lung problems may happen. Talk with the doctor.
- It is used to treat leukemia.
- It may be given to your child for other reasons. Talk with the doctor.
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If your child has kidney disease.
- If your child has a type of anemia called hemolytic anemia.
- Tell dentists, surgeons, and other doctors that your child is using this drug.
- Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
- This drug may add to your child’s chance of getting lymphoma or other cancers.
- Skin cancer has happened in people taking this drug for a long time. Talk with the doctor.
- Your child may have more chance of getting infections. Avoid crowds and people with infections, colds, or flu.
- Your child may bleed more easily. Make sure your child is careful and avoids injury. Be sure your child has a soft toothbrush.
- If your child has an upset stomach or loose stools (diarrhea), is throwing up, or is not hungry, talk with the doctor. There may be ways to lower these side effects.
- Have your child’s blood work checked often. Talk with your child’s doctor.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- Talk with the doctor before your child gets any vaccines. Use with this drug may either raise the chance of very bad infection or make the vaccine not work as well.
If your child is or may be sexually active:
- Have your child use birth control to prevent pregnancy during care and for some time after care ends. Talk with the doctor to see how long your child needs to use birth control after stopping this drug.
- If your child is a male and has sex with a female who could get pregnant, they must prevent pregnancy during care and for some time after care ends. Talk with the doctor to see how long they must use birth control after your child stops this drug.
If your child is pregnant or breast-feeding a baby:
- This drug may cause harm to the unborn baby if your child takes it during pregnancy.
- Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks of using this drug.
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
- Shortness of breath.
- Chest pain or pressure.
- Mood changes.
- Loss of eyesight.
- Change in eyesight.
- A burning, numbness, or tingling feeling that is not normal.
- Change in thinking clearly and with logic.
- Very upset stomach or throwing up.
- Not able to eat.
- Cough that does not go away.
- Very loose stools (diarrhea).
- Not able to pass urine.
- Feeling very tired or weak.
- Yellow skin or eyes.
- A skin lump or growth.
- Swelling in the arms or legs.
- Patients with cancer who take this drug may be at greater risk of getting a bad and sometimes deadly health problem called tumor lysis syndrome (TLS). Call your child’s doctor right away if your child has a fast heartbeat; a heartbeat that does not feel normal; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, loose stools, or not able to eat; or feel sluggish.
- A very bad brain problem called progressive multifocal leukoencephalopathy (PML) may happen with this drug. It may cause disability or death. Tell the doctor right away if your child has signs like confusion, memory problems, low mood (depression), change in the way your child acts, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
- Feeling tired or weak.
- Upset stomach or throwing up.
- Not hungry.
- Loose stools (diarrhea).
- Sweating a lot.
- Muscle pain.
- Give this drug with or without food.
- Have your child swallow whole. Do not let your child chew, break, or crush.
- Give this drug with a full glass of water.
- It is given as an infusion into a vein over a period of time.
- Call your child’s doctor to find out what to do.
- Store in the original container at room temperature.
- Do not freeze.
- This drug will be given to your child in a hospital or doctor’s office. You will not store it at home.
- Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
If you have any questions or concerns, talk with a member of your healthcare team. You can reach them Monday through Friday from 9:00 am to 5:00 pm at ____________________. After 5:00 pm, during the weekend, and on holidays, please call____________________. If there’s no number listed, or you’re not sure, call 212-639-2000.