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CYCLOPHOSPHAMIDE FOR is a brand name for Cyclophosphamide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Cyclophosphamide for Injection, used alone or as a component of combination therapy is indicated in adults for: A: Frequently responsive myeloproliferative and lymphoproliferative disorders 1. Malignant lymphomas (See also 4 DOSAGE AND ADMINISTRATION) a) Hodgkin's disease [Cotswold stages II & III (massive mediastinal…
Verbatim from this product's HC label. Tap a section to expand.
) a) Hodgkin's disease [Cotswold stages II & III (massive mediastinal disease) and IIIA1,2 - IV E] Non-Hodgkin's lymphomas (Working Formulation. Low Grade A,B,C; Intermediate Grade D,E,F,G; High Grade H,I,J) b) Follicular lymphoma (B,C,D) c) Lymphocytic lymphoma (A,B,E; mixed histiocytic, C,F) ** Note: Type A, small diffuse and well differentiated malignant lymphocytic lymphoma is consistent with chronic lymphocytic leukemia, to be considered a heterogenous group of chronic B-cell disorders.
d) Diffuse histiocytic lymphoma (G,H) e) Lymphoblastic lymphoma (I) f) Burkitt's lymphoma (J) 2. Multiple Myelomas (Myeloma stages II, IIIA, IIIB) (See also 4 DOSAGE AND ADMINISTRATION) 3. Leukemias (See also 4 DOSAGE AND ADMINISTRATION) a) Chronic Lymphocytic Leukemia (CLL) (Rai Stages II, III, IV) (Binet Stages B, C) NOTE: Chronic lymphocytic leukemias are considered to be a heterogenous group of chronic B-cell disorders.
b) Chronic Myelogenous Leukemia (CML) (Ineffective in acute blastic crises) c) Acute Myelogenous Leukemia (AML) (M0-M7) (Also called acute nonlymphocytic leukemia) Acute Myelomonocytic Leukemia (AMML) (Type M4) PrCyclophosphamide for Injection Page 5 of 59 Protected B / Protégé B 4.
Mycosis Fungoides (Advanced disease) (Stages III, IVA, IVB) (See also 4 DOSAGE AND ADMINISTRATION) B: Frequently responsive solid malignancies (See also 4 DOSAGE AND ADMINISTRATION) 1. Neuroblastoma (in patients with disseminated disease, Stage IV) 2.
Carcinoma of the Breast (Stages II-IV) 3. 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (> 65 years of age): In elderly patients, monitoring for toxicities and the need for dose adjustment should reflect the higher frequency of decreased hepatic, renal, cardiac, or other organ function, and concomitant diseases or other drug therapy in this population.
2 CONTRAINDICATIONS Cyclophosphamide is contraindicated in: • Patients who are hypersensitive to this drug or its metabolites, alone or as part of combination chemotherapy or to any ingredient in the formulation, including any non-medical ingredient, or component of the container.
For a complete listing, See
1 Adverse Reaction Overview Increased risk for and severity of pneumonias (including fatal outcomes), reactivation of latent infections, malignant and benign neoplasms, progression of underlying malignancies (including fatal outcomes), different degrees of myelosuppression (sometimes with life threatening infections), leucopenia, anemia, thrombocytopenia, fulminating anaphylaxis (with fatal outcome), hypersensitivity reactions, syndrome of inappropriate antidiuretic hormone secretion, tumor lysis syndrome, hematuria, confusion, neurotoxicity (both the central and peripheral nervous system), cardiotoxicity (with fatal outcomes), hearing disorders, arterial and venous occlusive disorders with and without embolization, gastrointestinal hemorrhages, acute pancreatitis, hepatotoxicity, hepatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, skin eruption, hemorrhagic cystitis, rhabdomyolysis, sterility in both sexes, fetal malformation and toxicity (including intra-uterine death), multiorgan failure, general physical deterioration, increased lactate dehydrogenase and C-reactive protein.
NOTE:
Many side effects of cancer chemotherapy are unavoidable, since they represent the drug's pharmacologic action. Leukopenia and thrombocytopenia are used as guidelines, among others, to aid in individual dosage titration. 2 Clinical Trial Adverse Reactions The list of adverse reactions to cyclophosphamide in this document is based on postmarketing data.
5 Post-Market Adverse Reactions The following is a summary of adverse reactions reported with cyclophosphamide either alone or in combination with other chemotherapeutic agents in the post marketing experience, listed by MedDRA system Organ Class (SOC), then by Preferred Term in order of severity, where feasible.
In the case of a polychemotherapy regimen, the adverse reaction profile of each drug component should be reviewed.
General Risk factors for cyclophosphamide toxicities and their sequelae described here and in other sections may constitute contraindications if cyclophosphamide is not used for the treatment of a life-threatening condition. In such situations, individual assessment of risk and expected benefits is necessary.
Prior to initiating treatment with Cyclophosphamide for Injection, it is necessary to exclude or correct any electrolyte imbalances. PrCyclophosphamide for Injection Page 25 of 59 Protected B / Protégé B Each individual component of a cyclophosphamide-containing poly-chemotherapy regimen must have its precaution profile reviewed.
Since cyclophosphamide is highly toxic with a relatively low therapeutic index, and a therapeutic response is not likely to occur without some evidence of toxicity, the drug must only be used under constant supervision of the attending physician.
Alopecia occurs commonly in patients treated with even low doses of cyclophosphamide. With large parenteral doses, considerable hair loss (5-30%, with possible total alopecia) is to be expected. The hair can be expected to grow back after or even during continued treatment; it may, however be different in texture and / or colour.
If a patient who is to undergo surgery is receiving cyclophosphamide or has been treated with cyclophosphamide within 10 days of general anesthesia, the anesthetist should be so advised prior to surgery (See also 9 Drug-Drug Interactions section).
In case of accidental paravenous administration of cyclophosphamide, the infusion should be stopped immediately, the extravascular cyclophosphamide solution should be aspirated with the cannula in place, and other measures should be instituted as appropriate.
Carcinogenesis and Mutagenesis As with cytotoxic therapy in general, treatment with cyclophosphamide involves the risk of secondary tumours and their precursors as late sequelae. The risk of developing urinary tract cancer as well as myelodysplastic alterations partly progressing to acute leukemias, or non-malignant disease in which immune processes are believed to be involved pathologically is increased.
Cyclophosphamide is contraindicated in: • Patients who are hypersensitive to this drug or its metabolites, alone or as part of combination chemotherapy or to any ingredient in the formulation, including any non-medical ingredient, or component of the container.
For a complete listing, See 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Patients with urinary outflow obstructions • Patients with severe myelosuppression • Patients with severe renal impairment • Patients with severe hepatic impairment • Patients with an active infection, particularly varicella zoster infection • Patients with severe immunosuppression • Pediatric population (<18 years of age) • Pregnant women • Breast feeding women PrCyclophosphamide for Injection Page 6 of 59 Protected B / Protégé B • Asian patients with ALDH2 mutation In combined chemotherapy regimen, the contraindications for each individual drug must be identified.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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INFECTIONS AND INFESTATIONS:
The following manifestations have been associated with myelosuppression and immunosuppression caused by cyclophosphamide: increased risk for and severity of pneumonias (including fatal outcomes), other bacterial, fungal, viral, protozoal, parasitic infections; reactivation of latent infections, including viral hepatitis, tuberculosis, JC virus with progressive multifocal leukoencephalopathy (including fatal outcomes), Pneumocystis jiroveci, herpes zoster, Strongyloides, Sepsis and Septic shock (including fatal outcomes) NEOPLASMS, BENIGN AND MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS): Acute leukemia (Acute myeloid leukemia, Acute promyelocytic leukemia), Myelodysplastic syndrome, Lymphoma (Non-Hodgkin’s lymphoma), Sarcomas, Renal cell carcinoma, Renal pelvis cancer, Bladder cancer, Ureteric cancer, Thyroid cancer, Treatment related PrCyclophosphamide for Injection Page 34 of 59 Protected B / Protégé B secondary malignancy, Carcinogenic effect in offspring, Tumor lysis syndrome.
Additionally, progression of underlying malignancies, including fatal outcomes, have been reported.
BLOOD AND LYMPHATIC SYSTEM DISORDERS:
Myelosuppression manifested as Bone marrow failure, Pancytopenia, Neutropenia, Agranulocytosis, Granulocytopenia, Thrombocytopenia (complicated by bleeding), Leukopenia, Anemia; Febrile neutropenia, Lymphopenia, Disseminated intravascular coagulation, Hemolytic uremic syndrome (with thrombotic microangiopathy), Hemoglobin decreased IMMUNE SYSTEM DISORDERS: Immunosuppression, Anaphylactic shock, Anaphylactic / Anaphylactoid reaction (including fatal outcomes), Hypersensitivity reaction ENDOCRINE DISORDERS: Water intoxication, Syndrome of inappropriate antidiuretic hormone secretion (SIADH) with fatal outcomes.
METABOLISM AND NUTRITION DISORDERS:
Hyponatremia with fatal outcomes, Fluid retention, Anorexia, Blood glucose increased, Blood glucose decreased, tumor lysis manifested by hyperkalemia, hyperuricemia PSYCHIATRIC DISORDERS: Confusional state NERVOUS SYSTEM DISORDERS: Encephalopathy, Convulsion, Dizziness, Neurotoxicity has been reported and manifested as Reversible posterior leukoencephalopathy syndrome, Myelopathy, Peripheral neuropathy, Polyneuropathy, Neuralgia, Dysesthesia, Hypoesthesia, Paresthesia, Tremor, Dysgeusia, Hypogeusia, Parosmia EYE DISORDERS: Blurring of Vision, Myopia, Visual impairment, Conjunctivitis, Lacrimation increased EAR AND LABYRINTH DISORDERS: Deafness, Hearing impaired, Tinnitus CARDIAC DISORDERS: Cardiac arrest, Ventricular fibrillation, Ventricular tachycardia, Cardiogenic shock, Pericardial effusion (progressing to cardiac tamponade), Myocardial hemorrhage, Myocardial infarction, Cardiac failure congestive (including fatal outcomes), Cardiac failure (including fatal outcomes), Left ventricular failure, Left ventricular dysfunction, Cardiomyopathy, Myocarditis, Pericarditis, Carditis, Atrial fibrillation, Supraventricular arrhythmia, Ventricular arrhythmia, Bradycardia, Tachycardia, Palpitations, Electrocardiogram QT prolonged, Ejection fraction decreased PrCyclophosphamide for Injection Page 35 of 59 Protected B / Protégé B VASCULAR DISORDERS: Pulmonary embolism, Venous thrombosis, Vasculitis, Peripheral ischemia, Hypertension, Hypotension, Flushing, Hot flush, Blood pressure decreased.
RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS:
Pulmonary veno-occlusive disease, Acute respiratory distress syndrome, Interstitial lung disease as manifested by Pulmonary fibrosis, Respiratory failure (including fatal outcomes), Obliterative bronchiolitis, Organizing pneumonia, Alveolitis allergic, Pneumonitis; Respiratory distress, Pulmonary hypertension, Pulmonary edema, Pleural effusion, Bronchospasm, Dyspnea, Hypoxia, Cough, Nasal congestion, Nasal discomfort, Oropharyngeal pain, Rhinorrhea, Sneezing GASTROINTESTINAL DISORDERS: Enterocolitis hemorrhagic, Gastrointestinal hemorrhage, Acute pancreatitis, Colitis, Enteritis, Cecitis, Mucosal ulceration, Stomatitis, Diarrhea, Vomiting, Constipation (sometimes severe), Nausea, […]
Other malignancies reported after use of cyclophosphamide or regimens with cyclophosphamide include lymphoma, thyroid cancer, and sarcomas. In some cases, the second malignancy developed several years after cyclophosphamide treatment had been discontinued.
Malignancy has also been reported after in utero exposure. Urinary bladder malignancies have usually occurred in patients who previously had hemorrhagic cystitis. Animal studies demonstrate that the risk of bladder cancer can be markedly reduced by an adequate administration of mesna.
Cardiovascular Myocarditis and myopericarditis, which may be accompanied by significant pericardial effusion and cardiac tamponade, have been reported with cyclophosphamide therapy and have led to severe, sometimes fatal congestive heart failure.
Histopathologic examination has primarily shown hemorrhagic myocarditis. Hemopericardium has occurred secondary to hemorrhagic myocarditis and myocardial necrosis. PrCyclophosphamide for Injection Page 26 of 59 Protected B / Protégé B Acute cardiac toxicity has been reported with a single dose of less than 20 mg/kg cyclophosphamide.
Following exposure to treatment regimens that included cyclophosphamide, supraventricular arrhythmias (including atrial fibrillation and flutter) as well as ventricular arrhythmias (including severe QT prolongation associated with ventricular tachyarrhythmia) have been reported in patients with and without other signs of cardiotoxicity.
The risk of cyclophosphamide cardiotoxicity may be increased following high doses of cyclophosphamide, in patients with advanced age, and in patients with previous radiation treatment of the cardiac region and/or previous or concomitant treatment with other cardiotoxic agents.
Particular caution is necessary in patients with risk factors for cardiotoxicity and in patients with pre-existing cardiac disease. Driving and Operating Machinery Due to potential adverse effects of cyclophosphamide such as dizziness, blurred vision, visual impairment, nausea and vomiting which could be symptoms of vasomotor ataxia, caution should be advised when driving or operating machinery.
5 mg of ethanol anhydrous. The alcohol content in a dose of cyclophosphamide regimen may affect the central nervous system and should be taken into account for patients in whom alcohol intake should be avoided or minimized, including high-risk groups such as patients with hepatic impairment or epilepsy.
Some medications, such as CNS depressants, pain relievers and sleep aids may interact with the alcohol in the cyclophosphamide infusion and exacerbate depression or worsen the intoxicating effects. Product may also interact with the other alcohol containing chemotherapy drugs which could be administered concomitantly with cyclophosphamide.
Patients are advised to avoid driving, operating machinery, or performing other activities that are dangerous for one to two hours after the infusion of Cyclophosphamide for Injection. Health care professionals should consider the alcohol content of Cyclophosphamide for Injection when prescribing or administering the drug to patients when using it in conjunction with other medications.
Endocrine and Metabolism Cyclophosphamide has been shown to be more toxic in adrenalectomized dogs. Dose adjustments of Cyclophosphamide for Injection may be necessary for adrenalectomized patients. PrCyclophosphamide for Injection Page 27 of 59 Protected B / Protégé B Gastrointestinal Administration of cyclophosphamide may cause nausea and vomiting.
Current guidelines on the use of antiemetics for prevention and amelioration of nausea and vomiting should be considered. Alcohol consumption may increase cyclophosphamide-induced vomiting and nausea. Administration of cyclophosphamide may cause stomatitis […]