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Fludara

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Fludara

Fludara Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Fludara (fludarabine) is a cancer medication used to treat B-cell chronic lymphocytic leukemia (CLL). It is usually given after other cancer medications have been tried without successful response to treatment. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include nausea or vomiting (may be severe), diarrhea, headache, muscle aches, tiredness, loss of appetite, sores in the mouth, and pain/redness at the injection site

The recommended adult dose of Fludara for Injection is 25 mg/mē administered intravenously over a period of approximately 30 minutes daily for five consecutive days. Each 5-day course of treatment should commence every 28 days. Fludara may interact with pentostatin. Tell your doctor all medications and supplements you use. Fludara is not recommended for use during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. Both males and females using this drug should use birth control (e.g., birth control pills, condoms) during treatment and for 6 months after treatment has ended. Consult your doctor to discuss birth control. It is unknown if this drug passes into breast milk. However, it may have undesirable effects on a nursing infant. Breastfeeding while using this medication is not recommended.

Our Fludara (fludarabine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Fludara in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness;
  • pale or yellowed skin, dark colored urine;
  • cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
  • black, bloody, or tarry stools;
  • coughing up blood;
  • lower back pain, blood in your urine;
  • urinating less than usual or not at all;
  • numbness or tingly feeling around your mouth, fast or slow heart rate, weak pulse, fainting;
  • muscle weakness, tightness, or contraction, overactive reflexes;
  • drowsiness, mood changes, increased thirst, swelling, rapid weight gain;
  • vision problems, headache or pain behind your eyes, changes in behavior, confusion, agitation, seizure (convulsions); or
  • severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • mild nausea, loss of appetite, diarrhea;
  • mild itching or skin rash;
  • headache;
  • muscle pain; or
  • tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Fludara (Fludarabine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Fludara Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, diarrhea, headache, muscle aches, tiredness, loss of appetite, and pain/redness at the injection site 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.

Tell your doctor right away if you have any serious side effects, including: fast/irregular heartbeat, swelling ankles/feet.

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. Also, your doctor may prescribe an additional medication. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), pink/bloody urine, change in the amount of urine, painful urination, muscle spasms/weakness.

Get medical help right away 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, get medical help right away 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.

Read the entire patient information overview for Fludara (Fludarabine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Fludara FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Very common adverse events include myelosuppression (neutropenia, thrombocytopenia and anemia), fever and chills, fatigue, weakness, infection, pneumonia, cough, nausea, vomiting, and diarrhea. Other commonly reported events include malaise, mucositis and anorexia. Serious opportunistic infections (such as latent viral reactivation, herpes zoster virus, Epstein-Barr virus, and progressive multifocal leukoencephalopathy) have occurred in CLL patients treated with FLUDARA (fludarabine) FOR INJECTION. Adverse events and those reactions which are more clearly related to the drug are arranged below according to body system.

Hematopoietic Systems

Hematologic events (neutropenia, thrombocytopenia, and/or anemia) were reported in the majority of CLL patients treated with FLUDARA (fludarabine) FOR INJECTION. During FLUDARA (fludarabine) FOR INJECTION treatment of 133 patients with CLL, the absolute neutrophil count decreased to less than 500/mm³ in 59% of patients, hemoglobin decreased from pretreatment values by at least 2 grams percent in 60%, and platelet count decreased from pretreatment values by at least 50% in 55%. Myelosuppression may be severe, cumulative, and may affect multiple cell lines. Bone marrow fibrosis occurred in one CLL patient treated with FLUDARA (fludarabine) FOR INJECTION.

Several instances of trilineage bone marrow hypoplasia or aplasia resulting in pancytopenia, sometimes resulting in death, have been reported in post-marketing surveillance. The duration of clinically significant cytopenia in the reported cases has ranged from approximately 2 months to approximately 1 year. These episodes have occurred both in previously treated or untreated patients.

Life-threatening and sometimes fatal autoimmune phenomena such as hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evans syndrome, and acquired hemophilia have been reported to occur in patients receiving FLUDARA FOR INJECTION (see WARNINGS section). The majority of patients rechallenged with FLUDARA (fludarabine) FOR INJECTION developed a recurrence in the hemolytic process.

In post-marketing experience, cases of myelodysplastic syndrome and acute myeloid leukemia, mainly associated with prior, concomitant or subsequent treatment with alkylating agents, topoisomerase inhibitors, or irradiation have been reported.

Infections

Serious and sometimes fatal infections, including opportunistic infections and reactivations of latent viral infections such as VZV (herpes zoster), Epstein-Barr virus and JC virus (progressive multifocal leukoencephalopathy) have been reported in patients treated with FLUDARA (fludarabine) FOR INJECTION.

Rare cases of Epstein-Barr virus (EBV) associated lymphoproliferative disorders have been reported in patients treated with FLUDARA (fludarabine) FOR INJECTION.

In post-marketing experience, cases of progressive multifocal leukoencephalopathy have been reported. Most cases had a fatal outcome. Many of these cases were confounded by prior and/or concurrent chemotherapy. The time to onset has ranged from a few weeks to approximately one year after initiating treatment.

Of the 133 adult CLL patients in the two trials, there were 29 fatalities during study, approximately 50% of which were due to infection.

Metabolic

Tumor lysis syndrome has been reported in CLL patients treated with FLUDARA (fludarabine) FOR INJECTION. This complication may include hyperuricemia, hyperphosphatemia, hypocalcemia, metabolic acidosis, hyperkalemia, hematuria, urate crystalluria, and renal failure. The onset of this syndrome may be heralded by flank pain and hematuria.

Nervous System (see WARNINGS section)

Objective weakness, agitation, confusion, seizures, visual disturbances, optic neuritis, optic neuropathy, blindness and coma have occurred in CLL patients treated with FLUDARA (fludarabine) FOR INJECTION at the recommended dose. Peripheral neuropathy has been observed in patients treated with FLUDARA (fludarabine) FOR INJECTION and one case of wrist-drop was reported. There have been additional reports of cerebral hemorrhage though the frequency is not known.

Pulmonary System

Pneumonia, a frequent manifestation of infection in CLL patients, occurred in 16% and 22% of those treated with FLUDARA (fludarabine) FOR INJECTION in the MDAH and SWOG studies, respectively. Pulmonary hypersensitivity reactions to FLUDARA (fludarabine) FOR INJECTION characterized by dyspnea, cough and interstitial pulmonary infiltrate have been observed.

In post-marketing experience, cases of severe pulmonary toxicity have been observed with FLUDARA (fludarabine) FOR INJECTION use which resulted in ARDS, respiratory distress, pulmonary hemorrhage, pulmonary fibrosis, pneumonitis and respiratory failure. After an infectious origin has been excluded, some patients experienced symptom improvement with corticosteroids.

Gastrointestinal System

Gastrointestinal disturbances such as nausea and vomiting, anorexia, diarrhea, stomatitis and gastrointestinal bleeding and hemorrhage have been reported in patients treated with FLUDARA (fludarabine) FOR INJECTION. Elevations of pancreatic enzyme levels have also been reported.

Cardiovascular

Edema has been frequently reported. One patient developed a pericardial effusion possibly related to treatment with FLUDARA (fludarabine) FOR INJECTION. There have been additional reports of heart failure and arrhythmia though the frequency is rare. No other severe cardiovascular events were considered to be drug related.

Genitourinary System

Rare cases of hemorrhagic cystitis have been reported in patients treated with FLUDARA (fludarabine) FOR INJECTION.

Skin

Skin toxicity, consisting primarily of skin rashes, has been reported in patients treated with FLUDARA (fludarabine) FOR INJECTION. Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and pemphigus have been reported, with fatal outcomes in some cases.

Neoplasms

Worsening or flare-up of pre-existing skin cancer lesions, as well as new onset of skin cancer, has been reported in patients during or after treatment with FLUDARA (fludarabine) FOR INJECTION.

Hepatobiliary Disorders

Elevations of hepatic enzyme levels have been reported.

Data in the following table are derived from the 133 patients with CLL who received FLUDARA (fludarabine) FOR INJECTION in the MDAH and SWOG studies.

PERCENT OF CLL PATIENTS REPORTING NONHEMATOLOGIC ADVERSE EVENTS

ADVERSE EVENTS MDAH (N=101) SWOG (N=32)
ANY ADVERSE EVENT 88% 91%
BODY AS A WHOLE 72 84
  FEVER 60 69
  CHILLS 11 19
  FATIGUE 10 38
  INFECTION 33 44
  PAIN 20 22
  MALAISE 8 6
  DIAPHORESIS 1 13
  ALOPECIA 0 3
  ANAPHYLAXIS 1 0
  HEMORRHAGE 1 0
  HYPERGLYCEMIA 1 6
  DEHYDRATION 1 0
NEUROLOGICAL 21 69
  WEAKNESS 9 65
  PARESTHESIA 4 12
  HEADACHE 3 0
  VISUAL DISTURBANCE 3 15
  HEARING LOSS 2 6
  SLEEP DISORDER 1 3
  DEPRESSION 1 0
  CEREBELLAR SYNDROME 1 0
  IMPAIRED MENTATION 1 0
PULMONARY 35 69
  COUGH 10 44
  PNEUMONIA 16 22
  DYSPNEA 9 22
  SINUSITIS 5 0
  PHARYNGITIS 0 9
  UPPER RESPIRATORY INFECTION 2 16
  ALLERGIC PNEUMONITIS 0 6
  EPISTAXIS 1 0
  HEMOPTYSIS 1 6
  BRONCHITIS 1 0
  HYPOXIA 1 0
GASTROINTESTINAL 46 63
  NAUSEAA/OMITING 36 31
  DIARRHEA 15 13
  ANOREXIA 7 34
  STOMATITIS 9 0
  GI BLEEDING 3 13
  ESOPHAGITIS 3 0
  MUCOSITIS 2 0
  LIVER FAILURE 1 0
  ABNORMAL LIVER FUNCTION TEST 1 3
  CHOLELITHIASIS 0 3
  CONSTIPATION 1 3
  DYSPHAGIA 1 0
  CUTANEOUS 17 18
  RASH 15 15
  PRURITUS 1 3
  SEBORRHEA 1 0
GENITOURINARY 12 22
  DYSURIA 4 3
  URINARY INFECTION 2 15
  HEMATURIA 2 3
  RENAL FAILURE 1 0
  ABNORMAL RENAL FUNCTION TEST 1 0
  PROTEINURIA 1 0
  HESITANCY 0 3
CARDIOVASCULAR 12 38
  EDEMA 8 19
  ANGINA 0 6
  CONGESTIVE HEART FAILURE 0 3
  ARRHYTHMIA 0 3
  SUPRAVENTRICULAR TACHYCARDIA 0 3
  MYOCARDIAL INFARCTION 0 3
  DEEP VENOUS THROMBOSIS 1 3
  PHLEBITIS 1 3
  TRANSIENT ISCHEMIC ATTACK 1 0
  ANEURYSM 1 0
  CEREBROVASCULAR ACCIDENT 0 3
MUSCULOSKELETAL 7 16
  MYALGIA 4 16
  OSTEOPOROSIS 2 0
  ARTHRALGIA 1 0
  TUMOR LYSIS SYNDROME 1 0

More than 3000 adult patients received FLUDARA (fludarabine) FOR INJECTION in studies of other leukemias, lymphomas, and other solid tumors. The spectrum of adverse effects reported in these studies was consistent with the data presented above.

Read the entire FDA prescribing information for Fludara (Fludarabine) »

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Fludara - User Reviews

Fludara User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Fludara sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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