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Oforta Side Effects

Generic Name: fludarabine

Note: This document contains side effect information about fludarabine. Some of the dosage forms listed on this page may not apply to the brand name Oforta.

For the Consumer

Applies to fludarabine: intravenous powder for solution, intravenous solution

Warning

Intravenous route (Powder for Solution; Solution)

Fludarabine can severely suppress bone marrow function when used at high doses. In dose-ranging studies in patients with acute leukemia, fludarabine was associated with severe neurologic effects, including blindness, coma, and death. Life-threatening and sometimes fatal autoimmune hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evan's syndrome, and acquired hemophilia has been reported to occur after one or more cycles of treatment. Closely monitor patients for hemolysis. In a clinical investigation using fludarabine for injection in combination with pentostatin (deoxycoformycin) for the treatment of refractory CLL, there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of fludarabine for injection in combination with pentostatin is not recommended.

Side effects requiring immediate medical attention

Along with its needed effects, fludarabine (the active ingredient contained in Oforta) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking fludarabine:

More common

  • Arm, back, or jaw pain
  • black, tarry stools
  • blood in the urine or stools
  • chest pain or discomfort
  • chest tightness or heaviness
  • constipation
  • cough or hoarseness
  • coughing or spitting up blood
  • fast or irregular heartbeat
  • fever or chills
  • general feeling of discomfort or illness
  • lower back or side pain
  • nausea
  • pain
  • painful, burning, or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • shortness of breath
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain, severe
  • sweating
  • swelling
  • tender, swollen glands in the neck
  • thickening of bronchial secretions
  • troubled breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • wheezing

Less common

  • Agitation
  • aneurysm
  • bleeding gums
  • blurred vision
  • confusion
  • decreased urine output
  • difficulty in breathing or swallowing
  • dilated neck veins
  • dizziness
  • extreme fatigue
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • headache
  • increased menstrual flow or vaginal bleeding
  • irregular breathing
  • loss of hearing
  • nosebleeds
  • numbness or tingling in the fingers, toes, or face
  • pain, redness, or swelling in the arm or leg
  • paralysis
  • prolonged bleeding from cuts
  • seizures
  • slurred speech
  • sudden and severe inability to speak
  • temporary blindness
  • weakness in the arm or leg on one side of the body, sudden and severe
  • weight gain

Rare

  • Blindness
  • continuing vomiting
  • dark-colored urine
  • drowsiness
  • frequent urination
  • hives
  • itching
  • light-colored stools
  • loss of appetite
  • loss of consciousness
  • lower abdominal cramping
  • muscle tremors
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid, deep breathing
  • restlessness
  • skin rash
  • stomach pain
  • trouble speaking, thinking, or walking
  • yellow eyes or skin

Side effects not requiring immediate medical attention

Some side effects of fludarabine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Abdominal pain
  • bladder pain
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • cloudy urine
  • congestion
  • diarrhea
  • difficulty in moving
  • dry mouth or throat
  • flushed, dry skin
  • frequent urge to urinate
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • runny nose
  • swollen joints
  • trouble in swallowing
  • voice changes
  • weight loss

Less common

  • Abdominal fullness
  • bluish color of skin
  • changes in skin color
  • cracked lips
  • dandruff
  • decrease in height
  • decreased urination
  • difficulty in sleeping
  • discouragement
  • feeling sad or empty
  • gaseous abdominal pain
  • heartburn
  • irritability
  • loss of interest or pleasure
  • lightheadedness
  • oily skin
  • pain or tenderness around the eyes and cheekbones
  • rapid breathing
  • recurrent fever
  • stuffy nose
  • sunken eye
  • trouble concentrating
  • wrinkled skin

For Healthcare Professionals

Applies to fludarabine: intravenous powder for injection, intravenous solution, oral tablet

Hematologic

Very common (10% or more): Neutropenia, anemia, thrombocytopenia

Common (1% to 10%): Hemorrhage, myelosuppression[Ref]

Immunologic

Very common (10% or more): Opportunistic infection (e.g., latent viral reactivation, progressive multifocal leukoencephalopathy, Herpes zoster virus, Epstein-Barr-virus) (44%)

Uncommon (0.1% to 1%): Autoimmune disorder (e.g., autoimmune hemolytic anemia, Evans syndrome, thrombocytopenic purpura, acquired hemophilia, pemphigus)

Rare (less than 0.1%): Lymphoproliferative disorder (EBV-associated)[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting (36%), anorexia (34%), diarrhea (15%)

Common (1% to 10%): Dehydration, stomatitis, GI hemorrhage, esophagitis, mucositis, constipation, dysphagia[Ref]

Nervous system

Very common (10% or more): Weakness (69%), paresthesia (12%)

Common (1% to 10%): Headache, cerebellar syndrome, impaired mentation, peripheral neuropathy

Rare (less than 0.1%): Coma, seizures

Frequency not reported: Cerebral hemorrhage[Ref]

Respiratory

Very common (10% or more): Cough (69%), pneumonia (22%), dyspnea (22%), upper respiratory tract infection (16%)

Common (1% to 10%): Sinusitis, pharyngitis, allergic pneumonitis, epistaxis, hemoptysis, bronchitis, hypoxia

Uncommon (0.1% to 1%): Pulmonary toxicity (e.g., pulmonary fibrosis, pneumonitis, dyspnea)

Frequency not reported: Pulmonary hemorrhage[Ref]

Cardiovascular

Very common (10% or more): Edema (19%)

Common (1% to 10%): Angina, congestive heart failure arrhythmia, supraventricular tachycardia, myocardial infarction, deep venous thrombosis, phlebitis, transient ischemic attack, aneurysm, cerebrovascular accident[Ref]

Genitourinary

Common (1% to 10%): Dysuria, urinary tract infection, hematuria, proteinuria, urinary hesitancy[Ref]

Renal

Common (1% to 10%): Renal failure, abnormal renal function tests

Frequency not reported: Hemorrhagic cystitis[Ref]

Hypersensitivity

Common (1% to 10%): Anaphylaxis[Ref]

Metabolic

Very common (10% or more):

Common (1% to 10%): Hyperglycemia, tumor lysis syndrome (TLS), anorexia

Uncommon (0.1% to 1%): Tumor lysis syndrome (including renal failure, metabolic acidosis, hyperkalemia, hypocalcemia, hyperuricemia, hematuria, urate crystalluria, hyperphosphatemia)[Ref]

Dermatologic

Very common (10% or more): Rash (15%), diaphoresis (13%)

Common (1% to 10%): Alopecia, pruritus, seborrhea

Rare (less than 0.1%): Skin cancer, necrolysis epidermal toxic (Lyell type) , Stevens-Johnson syndrome[Ref]

Oncologic

Common (1% to 10%): Myelodysplastic syndrome, acute myeloid leukemia (mainly associated with prior, concomitant or subsequent treatment with alkylating agents, topoisomerase inhibitors, or irradiation)[Ref]

Hepatic

Common (1% to 10%): Hepatic failure, abnormal liver function tests, cholelithiasis[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (16%)

Common (1% to 10%): Osteoporosis, arthralgia[Ref]

Ocular

Common (1% to 10%): Visual disturbance

Rare (less than 0.1%): Blindness, optic neuritis, optic neuropathy[Ref]

Psychiatric

Common (1% to 10%): Sleep disorder, depression

Uncommon (0.1% to 1%): Confusion

Rare (less than 0.1%): Agitation[Ref]

Other

Very common (10% or more): Fever (69%), chills (19%), fatigue (38%), pain (22%)

Common (1% to 10%): Malaise, hearing loss, chills, mucositis, edema[Ref]

References

1. "Product Information. Fludarabine Phosphate (fludarabine)." Hospira Inc, Lake Forest, IL.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.