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PROCYTOX TAB is a brand name for Cyclophosphamide, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................5 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Cyclophosphamide is contraindicated in: Patients who have demonstrated hypersensitivity to this drug or its metabolites, alone or as part of combination chemotherapy 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 In combined chemotherapy regimen, the contraindications for each individual drug must be identified.
WARNINGS AND PRECAUTIONS 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 Serious Warnings and Precautions PROCYTOX (Cyclophosphamide) is a potent drug and should be used only by physicians experienced with cancer chemotherapeutic drugs.
Secondary Malignancy (see Warnings and Precautions). The patient's hematologic, hepatic and urinary profile must regularly be monitored. Acute cardiac toxicity after a single dose of cyclophosphamide (see Warnings and Precautions).
Severe QT prolongation associated with ventricular tachyarrhythmia (see Warnings and Precautions). Hepatotoxicity(see Warnings and Precautions). Severe myelosuppression: Cyclophosphamide should not be administered to patients with a leukocyte count below 2500 cells/microliter (cells/ mm3) and/or a platelet count below 50,000 cells/microliter (cells/mm3) (see Warnings and Precautions).
Urotoxicity (see Warnings and Precautions). Patients with renal impairment (see Warnings and Precautions). Acute pulmonary toxicity after a single dose of cyclophosphamide (see Warnings and Precautions). Fulminating anaphylaxis (with fatal outcome) (see Warnings and Precautions).
Drug-drug interaction with depolarizing muscle relaxants causes inhibition of cholinesterase activity (see Drug-Drug Interactions section). Live vaccines may lead to vaccine-induced infection in patients on cyclophosphamide PROCYTOX (Cyclophosphamide) Page 6 of 65 life-threatening condition.
In such situations, individual assessment of risk and expected benefits is necessary. Prior to initiating treatment with PROCYTOX, it is necessary to exclude or correct any electrolyte imbalances. Each individual component of a cyclophosphamide-containing poly-chemotherapy regimen must have its precaution profile reviewed.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
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.
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 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.
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.
PROCYTOX (Cyclophosphamide) Page 7 of 65 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. 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 […]