Endoxan Injection
Cyclophosphamide
500mg
Synovia Pharma PLC
| Pack size | 1's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 521.76 AED |
Available as:
Indications
Endoxan Injection is used for:
Malignant lymphomas, hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of the ovary, retinoblastoma, breast carcinoma
Adult Dose
Intravenous
Malignant Diseases
IV: initial course, 40-50 mg/kg divided over 2-5 days;
OR 10-15 mg/kg every 7-10 days;
OR 3-5 mg/kg twice weekly
Adjust dosage based on specific regimen administered, response to treatment, myelosuppression or other adverse reactions, and patient risk factors
IV (continuous daily therapy): 60-120 mg/m2/day (1-2.5 mg/kg/day)
Non-Hodgkin Lymphoma
600-1500 mg/m² IV with other antineoplastics (part of CHOP regimen); dose intensification possible
Breast Cancer
600 mg/m² IV with other antineoplastics; dose intensification possible
Oral
Malignant Diseases
PO (intermittent therapy): 400-1000 mg/m² divided over 4-5 days
PO (continuous daily therapy): 50-100 mg/m²/day or 1-5 mg/kg/day
Nephrotic Syndrome
2-3 mg/kg/day for up to 12 weeks when corticosteroids are unsuccessful
Child Dose
Intravenous
Malignant Diseases
IV (intermittent therapy): 40-50 mg/kg (400-1800 mg/m²) divided over 2-5 days; may be repeated at intervals of 2-4 weeks
IV (continuous daily therapy): 60-120 mg/m²/day (1-2.5 mg/kg/day)
Oral
(Intermittent therapy): 400-1000 mg/m² divided over 4-5 days
(Continuous daily therapy): 50-100 mg/m²/day
Usually 1 mg per kg per day to 5 mg per kg per day for both initial and maintenance dosing.
Juvenile Idiopathic Arthritis/Vasculitis
10 mg/kg IV every 2 weeks
Nephrotic Syndrome
2-3 mg/kg/day for up to 12 weeks when corticosteroids are unsuccessful
Systemic Lupus Erythematosus
500-750 mg/m² IV monthly; not to exceed 1 g/m²
Renal Dose
Renal Impairment
Dose adjustments
Reduce dose if serum creatinine concentration greater than 120 micromol/litre.
Monitor for toxicity in patients with moderate and severe renal impairment.
Administration
Should be taken on an empty stomach. Preferably taken on an empty stomach, but may be taken w/ meals to minimise GI irritation. Ensure adequate fluid intake. Swallow whole.
IV Preparation
Maximum concentration of cyclophosphamide is limited to 20 mg/mL because of solubility
IV push: Reconstitute with NS (do not use SWI, because it is hypotonic)
Infusion: Reconstitute with SWI to concentration of 20 mg/mL
May dilute further with D5W, NS, lactated Ringer solution, or other compatible fluids
IV Administration
Infusions may be administered over 1-2 hours
Doses >500 mg up to ~1 g may be administered over 20-30 minutes
To minimize bladder toxicity, increase normal fluid intake during and for 1-2 days after cyclophosphamide therapy; most adult patients will require fluid intake of at least 2 L/day; high-dose regimens should be accompanied by vigorous hydration with or without mesna therapy
Contra Indications
Bladder haemorrhage. Patients with bone-marrow aplasia, acute infection, drug- or radiation-induced urothelial toxicity. Porphyria. Pregnancy and lactation.
Precautions
Myelosuppression, Immunosuppression, Bone Marrow Failure and Infections – Severe immunosuppression may lead to serious and sometimes fatal infections. Close hematological monitoring is required.
Urinary Tract and Renal Toxicity – Hemorrhagic cystitis, pyelitis, ureteritis, and hematuria can occur. Exclude or correct any urinary tract obstructions prior to treatment.
Cardiotoxicity – Myocarditis, myopericarditis, pericardial effusion arrhythmias and congestive heart failure, which may be fatal, have been reported.
Pulmonary Toxicity – Pneumonitis, pulmonary fibrosis and pulmonary venoocclusive disease leading to respiratory failure may occur.
Secondary malignancies - Have been reported in patients treated with cyclophosphamide-containing regimens.
Veno-occlusive Liver Disease - Fatal outcome can occur.
Alcohol content - The alcohol content in a dose of Cyclophosphamide Injection may affect the central nervous system. This may include impairment of a patient’s ability to drive or use machines immediately after infusion.
Embryo-Fetal Toxicity - Can cause fetal harm. Advise patients of the reproductive potential of the potential risk to a fetus and to use effective contraception
Monitoring Parameters
Monitor haematological profile and presence of RBCs in urine regularly.
Maintain adequate hydration and frequent micturition to reduce the risk of cystitis.
Monitor patients for signs and symptoms of pulmonary toxicity.
Monitor patients, especially those with risk factors for cardiotoxicity or pre-existing cardiac disease.
Pregnancy-Lactation
Pregnancy
Based on mechanism of action and published reports of effects in pregnant patients or animals, drug can cause fetal harm when administered to pregnant woman; exposure to cyclophosphamide during pregnancy may cause fetal malformations, miscarriage, fetal growth retardation, and toxic effects in the newborn; drug is teratogenic and embryo-fetal toxic in mice, rats, rabbits and monkeys; advise pregnant women and females of reproductive potential of the potential risk to the fetus
Verify the pregnancy status of females of reproductive potential prior to the initiation of therapy
Contraception
Therapy can cause fetal harm; advise females of reproductive potential to use effective contraception during treatment for up to 1 year after completion of therapy
Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after completion of therapy
Infertility
Amenorrhea, transient or permanent, associated with decreased estrogen and increased gonadotropin secretion develops in a proportion of women treated with cyclophosphamide
Affected patients generally resume regular menses within a few months after cessation of therapy; risk of premature menopause with cyclophosphamide increases with age
Oligomenorrhea has also been reported in association with cyclophosphamide treatment
Men treated with cyclophosphamide may develop oligospermia or azoospermia, which are normally associated with increased gonadotropin but normal testosterone
Lactation
Drug is present in breast milk; neutropenia, thrombocytopenia, low hemoglobin, and diarrhea have been reported in infants breast fed by women treated with cyclophosphamide; because of potential for serious adverse reactions in a breastfed child from therapy, advise lactating women not to breastfeed during treatment and for 1 week after last dose
Interactions
Increased risk of cardiotoxicity w/ doxorubicin or other cardiotoxic drugs.
May increase incidence of mucositis w/ protease inhibitors.
May increase haematotoxicity and/or immunosuppression w/ ACE inhibitors, natalizumab, paclitaxel, thiazide diuretics, zidovudine.
May increase pulmonary toxicity w/ amiodarone.
May increase nephrotoxicity w/ amphotericin B.
May result to acute water intoxication w/ indometacin.
May increase risk of hepatotoxicity w/ azathioprine.
May increase incidence of hepatic veno-occlusive disease and mucositis w/ busulfan.
May increase risk of haemorrhagic cystitis w/ previous or concomitant radiotherapy.
May result to acute encephalopathy w/ metronidazole.
May increase risk of thromboembolic complications.
May alter the effect of warfarin.
May increase immunosuppressive effect of cyclosporin.
May result to prolonged apnoea w/ depolarising muscle relaxants (e.g. suxamethonium).
Contraindicated (0)
Serious (22)
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Adverse Effects
Side effects of Cyclophosphamide :
Frequency Not Defined
Neutropenia
Fever
Nausea
Vomiting
Anorexia
Abdominal discomfort or pain
Diarrhea
Hemorrhagic colitis
Oral mucosal ulceration
Jaundice
Alopecia
Skin rash
Pigmentation of skin and changes in nails
Potentially Fatal: Anaphylactic reactions, bone marrow failure, severe immunosuppression, urotoxicity, cardiotoxicity, hyponatraemia, haemorrhagic cystitis.
Mechanism of Action
Cyclophosphamide is a prodrug which is converted in the body to the active metabolites. It acts at any stage of the cell cycle but its main action is blockage at the G2 stage. It arrests cell division by alkylating the DNA in a dose-dependent manner. It also exerts immunosuppressive effects possibly due to a cytotoxic effect on lymphocytes.
Note
Endoxan 500mg Injection manufactured by Synovia Pharma PLC. Its generic name is Cyclophosphamide. Endoxan is availble in Bangladesh.
Farmaco BD drug index information on Endoxan Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.