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Ifex

Last reviewed on RxList: 8/13/2018
Ifex Side Effects Center

Last reviewed on RxList 8/13/2018

Ifex (ifosfamide) is a cancer (antineoplastic) medication used to treat testicular cancer. Ifex is available in generic form. Common side effects of Ifex include:

  • nausea or vomiting (may be severe),
  • diarrhea,
  • stomach/abdominal pain,
  • loss of appetite,
  • injection site reactions (redness, pain, or swelling),
  • mouth sores, or
  • temporary hair loss.

Severe nausea, vomiting, and diarrhea may result in dehydration. See your doctor if you have symptoms of dehydration such as unusual decreased urination, unusual dry mouth/increased thirst, lack of tears, dizziness, lightheadedness, or pale/wrinkled skin. Tell your doctor if you have any serious side effects of Ifex including:

Ifex is administered intravenously at a dose of 1.2 g/m² per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity. Ifex may interact with "live" vaccines. Tell your doctor all medications and supplements you use. Ifex 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. Consult your doctor to discuss birth control. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug.

Our Ifex (ifosfamide) 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.

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Ifex Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

  • fever, chills, flu symptoms;
  • mouth and throat ulcers;
  • skin sores, pale skin, cold hands and feet;
  • easy bruising, unusual bleeding;
  • rapid heart rate, shallow breathing; or
  • feeling light-headed or short of breath.

Call your doctor at once if you have any of these side effects:

  • confusion, unusual thoughts or behavior, hallucinations, seizure (convulsions);
  • little or no urination, painful or difficult urination, blood in your urine;
  • loss of bladder control;
  • a seizure;
  • muscle movements you cannot control;
  • problems with your hearing or vision, ringing in your ears;
  • sudden chest pain, wheezing, dry cough;
  • dark urine, jaundice (yellowing of the skin or eyes); or
  • a wound that will not heal.

Common side effects may include:

  • nausea and vomiting;
  • confusion, vision problems, thinking problems;
  • numbness, tingling, burning pain;
  • infections;
  • urination problems; or
  • hair loss.

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 Ifex (Ifosfamide)

Ifex Professional Information

SIDE EFFECTS

Adverse Reactions From Clinical Trials

Because clinical trials are conducted from widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse reactions and frequencies below are based on 30 publications describing clinical experience with fractionated administration of ifosfamide as monotherapy with a total dose of 4 to 12 g/m² per course.

System Organ Class (SOC) Adverse Reaction Percentage (Ratio)
INFECTIONS AND INFESTATIONS Infection 9.9% (112/1128)
BLOOD AND LYMPHATIC SYSTEM DISORDERS Leukopenia1 (any)
Leukopenia <1 x 103/μL 43.5% (267/614)
Thrombocytopenia2 (any)
Thrombocytopenia, 50 x 103/μL 4.8% (35/729)
Anemia3 37.9% (202/533)
METABOLISM AND NUTRITION DISORDERS Anorexia 1.1% (15/1317)
NERVOUS SYSTEM DISORDERS Central nervous system toxicity4,5 15.4% (154/1001)
Peripheral neuropathy 0.4% (5/1317)
CARDIAC DISORDERS Cardiotoxicity6 0.5% (7/1317)
VASCULAR DISORDERS Hypotension7 0.3% (4/1317)
GASTROINTESTINAL DISORDERS Nausea/Vomiting 46.8% (443/964)
Diarrhea 0.7% (9/1317)
Stomatitis 0.3% (4/1317)
HEPATOBILIARY DISORDERS Hepatotoxicity8 1.8% (22/1190)
SKIN AND SUBCUTANEOUS TISSUES DISORDERS Alopecia 89.6% (540/603)
Dermatitis 0.08% (1/1317)
Papular rash 0.08% (1/1317)
RENAL AND URINARY DISORDERS Hemorrhagic cystitis9
Hematuria
- without mesna 44.1% (282/640)
- with mesna 21.3% (33/155)
Macrohematuria
- without mesna 11.1% (66/594)
- with mesna 5.2% (5/97)
Renal dysfunction10 --
Renal structural damage --
GENERAL DISORDERS AND ADMINISTRATIVE SITE CONDITIONS Phlebitis11 2.8% (37/1317)
Neutropenic fever12 1.0% (13/1317)
Fatigue 0.3% (4/1317)
Malaise Unable to calculate
1 The following adverse reaction terms have been reported for leukopenia: neutropenia, granulocytopenia, lymphopenia, and pancytopenia. For neutropenic fever, see below.
2 Thrombocytopenia may also be complicated by bleeding. Bleeding with fatal outcome has been reported.
3 Includes cases reported as anemia and decrease in hemoglobin/hematocrit.
4 Encephalopathy with coma and death has been reported.
5 Central nervous system toxicity was reported to be manifested by the following signs and symptoms: Abnormal behavior, Affect lability Aggression, Agitation, Anxiety, Aphasia, Asthenia, Ataxia, Cerebellar syndrome, Cerebral function deficiency, Cognitive disorder, Coma, Confusional state, Convulsions, Cranial nerve dysfunction, Depressed state of consciousness, Depression, Disorientation, Dizziness, Electroencephalogram abnormal, Encephalopathy, Flat affect. Hallucinations, Headache, Ideation, Lethargy, Memory impairment, Mood change, Motor dysfunction, Muscle spasms, Myoclonus, Progressive loss of brainstem reflexes, Psychotic reaction, Restlessness, Somnolence, Tremor, Urinary incontinence.
6 Cardiotoxicity was reported as congestive heart failure, tachycardia, pulmonary edema. Fatal outcome has been reported.
7 Hypotension leading to shock and fatal outcome has been reported.
8 Hepatotoxicity was reported as increases in liver enzymes, i.e., serum alanine aminotransferase, serum aspartate aminotransferase, alkaline phosphatase, gamma-glutamyltransferase and lactate dehydrogenase, increased bilirubin, jaundice, hepatorenal syndrome.
9 Reported symptoms of hemorrhagic cystitis included dysuria and pollakiuria. See also Post-marketing ADVERSE REACTIONS.
10 Renal dysfunction was reported to be manifested as: Renal failure (including acute renal failure, irreversible renal failure; fatal outcomes have been reported), Serum creatinine increased, BUN increased, Creatinine clearance decreased, Metabolic acidosis, Anuria, Oliguria, Glycosuria, Hyponatremia, Uremia, Creatinine clearance increased. Renal structural damage was reported to be manifested as: Acute tubular necrosis, renal parenchymal damage, Enzymuria, Cylindruria, Proteinuria.
11 Includes cases reported as phlebitis and irritation of the venous walls.
12 Includes cases reported as granulocytopenic fever.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Ifex. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections And Infestations

The following manifestations have been associated with myelosuppression and immunosuppression caused by ifosfamide: increased risk for and severity of infections†, pneumonias†, sepsis and septic shock (including fatal outcomes), as well as reactivation of latent infections, including viral hepatitis†, Pneumocystis jiroveci†, herpes zoster, Strongyloides, progressive multifocal leukoencephalopathy†, and other viral and fungal infections.

† Severe immunosuppression has led to serious, sometimes fatal, infections.

Neoplasms, Benign And Malignant And Unspecified (Incl Cysts And Polyps)

As treatment-related secondary malignancy*, Acute leukemia* (Acute myeloid leukemia)*, Acute promyelocytic leukemia*, Acute lymphocytic leukemia*, Myelodysplastic syndrome, Lymphoma (Non-Hodgkin’s lymphoma), Sarcomas*, Renal cell carcinoma, Thyroid cancer

Blood And Lymphatic System Disorders

Hematotoxicity*, Myelosuppression manifested as Bone marrow failure, Agranulocytosis; Febrile bone marrow aplasia; Disseminated intravascular coagulation, Hemolytic uremic syndrome, Hemolytic anemia, Neonatal anemia, Methemoglobinemia

Immune System Disorders

Angioedema*, Anaphylactic reaction, Immunosuppression, Urticaria, Hypersensitivity reaction

Endocrine Disorders

Syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Metabolism And Nutrition Disorders

Tumor lysis syndrome, Metabolic acidosis, Hypokalemia, Hypocalcemia, Hypophosphatemia, Hyperglycemia, Polydipsia

Psychiatric Disorders

Panic attack, Catatonia, Mania, Paranoia, Delusion, Delirium, Bradyphrenia, Mutism, Mental status change, Echolalia, Logorrhea, Perseveration, Amnesia

Nervous System Disorders

Convulsion*, Status epilepticus (convulsive and nonconvulsive), reversible posterior leukoencephalopathy syndrome, Leukoencephalopathy, Extrapyramidal disorder, Asterixis, Movement disorder, Polyneuropathy, Dysesthesia, Hypothesia, Paresthesia, Neuralgia, Gait disturbance, Fecal incontinence, Dysarthria

Ifosfamide has been reintroduced after neurotoxicity. While some patients did not experience neurotoxicity, others had recurrent, including fatal, events.

Eye Disorders

Visual impairment, Vision blurred, Conjunctivitis, Eye irritation

Ear And Labyrinth Disorders

Deafness, Hypoacusis, Vertigo, Tinnitus

Cardiac Disorders

Cardiotoxicity*, Cardiac arrest*, Ventricular fibrillation*, Ventricular tachycardia*, Cardiogenic shock*, Myocardial infarction*, Cardiac failure*, Bundle branch block left, Bundle branch block right, Pericardial effusion, Myocardial hemorrhage, Angina pectoris, Left ventricular failure, Cardiomyopathy*, Congestive cardiomyopathy, Myocarditis*, Arrhythmia*, Pericarditis, Atrial fibrillation, Atrial flutter, Bradycardia, Supraventricular extrasystoles, Premature atrial contractions, Ventricular extrasystoles, Myocardial depression, Palpitations, Ejection fraction decreased*, Electrocardiogram ST-segment abnormal, Electrocardiogram T-wave inversion, Electrocardiogram QRS complex abnormal

Vascular Disorders

Pulmonary embolism, Deep vein thrombosis, Capillary leak syndrome, Vasculitis, Hypertension, Flushing, Blood pressure decreased

Respiratory, Thoracic, And Mediastinal Disorders

Respiratory failure*, Acute respiratory distress syndrome*, Pulmonary hypertension*, Interstitial lung disease* as manifested by Pulmonary fibrosis*, Alveolitis allergic, Interstitial pneumonitis, Pneumonitis*, Pulmonary edema*, Pleural effusion, Bronchospasm, Dyspnea, Hypoxia, Cough

Gastrointestinal Disorders

Cecitis, Colitis, Enterocolitis, Pancreatitis, Ileus, Gastrointestinal hemorrhage, Mucosal ulceration, Constipation, Abdominal pain, Salivary hypersecretion

Hepatobiliary Disorders

Hepatic failure*, Hepatitis fulminant*, Veno-occlusive liver disease, Portal vein thrombosis, Cytolytic hepatitis, Cholestasis

Skin And Subcutaneous Tissue Disorders

Toxic epidermal necrolysis, Stevens-Johnson syndrome, Palmar-plantar erythrodysesthesia syndrome, Radiation recall dermatitis, Skin necrosis, Facial swelling, Petechiae, Macular rash, Rash, Pruritus, Erythema, Skin hyperpigmentation, Hyperhidrosis, nail disorder

Musculoskeletal And Connective Tissue Disorder

Rhabdomyolysis, Osteomalacia, Rickets, Growth retardation, Myalgia, Arthralgia, Pain in extremity, Muscle twitching

Renal And Urinary Disorders

Fanconi syndrome, Tubulointerstitial nephritis, Nephrogenic diabetes insipidus, Phosphaturia, Aminoaciduria, Polyuria, Enuresis, Feeling of residual urine Fatal outcomes from acute and chronic renal failure have been documented.

Reproductive System And Breast Disorders

Infertility, Ovarian failure, Premature menopause, Amenorrhea, Ovarian disorder, Ovulation disorder, Azoospermia, Oligospermia, Impairment of spermatogenesis, Blood estrogen decreased, Blood gonadotrophin increased

Congenital, Familial And Genetic Disorders

Fetal growth retardation

General Disorders And Administrative Site Conditions

Multi-organ failure*, General physical deterioration, Injection/Infusion site reactions including swelling, inflammation, pain, erythema, tenderness, pruritus; Chest pain, Edema, Mucosal inflammation, Pain, Pyrexia, Chills

* Including fatal outcomes

Read the entire FDA prescribing information for Ifex (Ifosfamide)

Related Resources for Ifex

Related Health

Read the Ifex User Reviews »

© Ifex Patient Information is supplied by Cerner Multum, Inc. and Ifex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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