Oforta Oral Warnings
This medication may cause certain severe blood and bone marrow problems (low red blood cells/white blood cells/platelets, hemolytic anemia). These problems can decrease your body's ability to prevent/stop bleeding, fight infection, or carry enough oxygen in your blood. Tell your doctor immediately if you develop easy bleeding/bruising, unusual tiredness, fast/pounding heartbeat, yellowing eyes/skin, red/brown urine, pale/bluish skin, or signs of infection (e.g., fever, chills, persistent sore throat).
Fludarabine may rarely cause severe (sometimes fatal) central nervous system problems. Symptoms may not occur until weeks after your last treatment. Tell your doctor immediately if you notice any vision changes, seizures, agitation, confusion, or numbness/tingling.
Do not use fludarabine with pentostatin (deoxycoformycin). Use of these 2 medications together has caused fatal lung problems.
Oforta Oral Uses
This medicine comes with a Patient Information Leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.
Take this medication by mouth with or without food, usually once a day for 5 days in a row or as directed by your doctor. This 5-day cycle may be repeated after 28 days, usually for up to 6 cycles. Swallow the tablet(s) whole with a glass of water. Do not break, crush, or chew the tablets.
Dosage is based on your medical condition, body size, and response to treatment. Your doctor will check your blood counts to make sure you can receive your next cycle. Keep all medical/lab appointments.
Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.
Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.
Oforta Oral Side Effects
See also Warning section.
Nausea, vomiting, diarrhea, tiredness, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.
Many people using this medication may have serious side effects. However, your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. To lower your risk of serious side effects, your doctor will follow your condition closely and order lab tests.
Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.
This medication affects your blood cells, reducing your ability to fight infections. Although fever and chills are common side effects of fludarabine, they may also be signs of an infection. Tell your doctor if you develop chills or fever.
Fludarabine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, drink plenty of fluids unless your doctor directs you otherwise. Tell your doctor immediately if you experience symptoms such as low back/side pain (flank pain), red/pinkish urine, painful urination, or muscle spasms/weakness.
Seek immediate medical attention if any of these rare but very serious side effects occur: bloody/black/tarry stool, persistent cough, coughing up blood, painful/difficult breathing, chest pain, seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Oforta Oral Precautions
Before using fludarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: hemolytic anemia, severe kidney disease.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: current infections, certain infections (opportunistic infections such as fungal infections), certain virus conditions (herpes, chickenpox), blood disorders (e.g., anemia, clotting problems), immune system problems, kidney problems, liver disease, skin cancer.
Wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).
To lower your chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
Before having surgery, tell your doctor or dentist that you are taking this medication. Before receiving any blood transfusions, tell your doctor that you are taking/have taken fludarabine.
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects (e.g., infection, bleeding) while using this drug.
This drug is not recommended for use during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment and for 6 months after treatment has ended. Consult your doctor for details and to discuss effective forms of birth control.
It is not known whether this medication passes into breast milk. However, it may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.
Oforta Oral Interactions
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medications because very serious interactions may occur: live vaccines (e.g., flu vaccine inhaled through the nose, typhoid/polio vaccine taken by mouth), pentostatin, other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).
If you are currently using any of these medications listed above or planning any vaccinations, tell your doctor or pharmacist before starting fludarabine.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin, enoxaparin), dipyridamole, salicylates/NSAIDs (e.g., aspirin, ibuprofen, naproxen).
Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, and aspirin) that can increase your risk of bleeding. Low-dose aspirin should be continued if prescribed by your doctor for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day). Consult your doctor or pharmacist for more details.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
Oforta Oral Overdose
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.NOTES:
Do not share this medication with others.
Laboratory and/or medical tests (e.g., complete blood count, kidney function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.MISSED DOSE:
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.STORAGE:
Store medication in the original package at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not open protective package until ready to use. Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.