Medicinal Products

ENDOXAN 1,000 mg

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Cyclophosphamide
laboratory: Baxter

Powder for solution for injection
Box of 1 bottle of 1000 mg
All forms

Indication

- Adjuvant and metastatic treatment of mammary adenocarcinoma.
- Treatment of ovarian cancers, bronchial cancers including small cells, testicular seminomas and carcinomas, bladder cancer, sarcomas, neuroblastomas, Hodgkin's and non-Hodgkin's lymphomas, multiple myeloma, acute lymphoid leukemia .
- In high doses, conditioning of allo- and spinal cord autografts.
- Low dose, treatment of rheumatoid arthritis, Wegener's granulomatosis, some severe forms of acute lupus erythematosus disseminated, auto-immune nephropathies corticoresistant.

Dosage ENDOXAN 1000 mg Powder for solution for injection Box of 1 vial of 1000 mg

Dosage:
- The dosage of cyclophosphamide depends on the therapeutic indication (antitumor or immunosuppressive treatment, type and location of the tumor, initial treatment or maintenance) and the place of the drug in the treatment undertaken (used alone or in combination with other cytostatic drugs). It is individual and must take into account the clinical and hematological status of the patient (see precautions for use).
- Injectable cyclophosphamide is usually used at average doses of 150 to 1200 mg / m² in children and 500 to 4000 mg / m² in adults, every 3 to 4 weeks, administered:
. 1 to 3 days at each cycle,
. in two injections 7 days apart.
Administration mode :
In order to prepare a ready-to-use isotonic solution, the powder must be dissolved in a solution of sodium chloride 0.9% so as to bring the concentration to 1 g per 50 ml. If necessary, it can also be dissolved in a solution of Ringer, in water for injection or glucose solution. The reconstituted solution should not be stored beyond 48 hours and should not exceed a concentration of 2%.
- The usual route of administration is the venous route with short infusion (30 minutes to 2 hours). 24-hour infusion is also possible. The drug previously reconstituted in 0.9% sodium chloride solution is introduced into the infusion fluid (isotonic solution of glucose or sodium chloride solution).
- It is recommended to combine the administration of UROMITEXAN from 600 mg / m² / day and / or to ensure sufficient hydration.
- In some cases (altered venous capital), the intramuscular route can be used without exceeding the dose of 500 mg per injection for reasons of volume.
- In case of extravasation, the administration will be interrupted immediately (see overdose).
How to handle:
The preparation of injectable cytotoxic solutions must be carried out by specialized and trained personnel with knowledge of the drugs used, under conditions ensuring the protection of the environment and especially the protection of the personnel handling. It requires a preparation room reserved for this purpose. It is forbidden to smoke, eat, drink in this room. Manipulators must have a set of equipment suitable for handling, including long-sleeved gowns, face shields, caps, safety goggles, sterile disposable gloves, worktop protection fields, containers and collection bags. waste. Excreta and vomit must be handled with care. Pregnant women should be warned and avoid manipulation of cytotoxics. Any broken container must be treated with the same precautions and be considered a contaminated waste. Disposal of contaminated waste is by incineration in rigid containers labeled for this purpose .
These provisions can be envisaged within the framework of the oncology network (circular DGS / DH / 98 n ° 98/188 of March 24, 1998) in collaboration with any suitable structure and fulfilling the required conditions.

Against indications

CONTRAINDICATED:
This medicine is contraindicated in the following cases:
- known allergy to cyclophosphamide;
- severe bone marrow failure;
- acute urinary tract infection, pre-existing haemorrhagic cystitis;
- women of childbearing potential not using effective contraception (see warnings and precautions for use and pregnancy and lactation);
- Pregnancy: In the clinic, some cases of malformations (limb abnormalities, craniostenosis, facial dysmorphia) have been reported after exposure to the 1st trimester, even when cyclophosphamide was used as an immunosuppressant. In late pregnancy, some cases of anemia or even pancytopenia have been reported. There is also a theoretical risk of cardiac toxicity (rhythm disorders, heart failure). It is therefore advisable, whenever possible, to schedule the birth, at least 3 weeks after the last treatment, and to carry out a neonatal surveillance (in particular hematological and cardiac).
- Breastfeeding: Because of the passage of cyclophosphamide in breast milk and the possible occurrence of serious adverse effects on the newborn, breastfeeding is contraindicated.
- in combination with the yellow fever vaccine.
NOT RECOMMENDED :
This drug is generally not recommended in combination with:
- live attenuated vaccines (except yellow fever),
- phenytoin.

Endoxan side effects

- The general and local tolerance of cyclophosphamide is good.
- Neutropenia and rarely moderate thrombocytopenia or anemia may be observed: they are always spontaneously reversible after a decrease in dosage or when treatment is stopped. In general, the nadir of leukocytes and platelets occurs during the first and second weeks of treatment; these effects are usually reversible after three to four weeks. Anemia usually develops only after several cycles of treatment.
- Some patients may experience nausea with or without vomiting that is easily prevented or suppressed by anti-emetics.
- Alopecia is inconstant, transient and reversible. Changes in pigmentation of hands, nails and soles have been reported.
- In rare cases, an increase in transaminases, jaundice and hepatitis has been observed.
- Amenorrhea or azoospermia are possible, even definitive.
- As with any high cumulative dose cytotoxic therapy, cyclophosphamide therapy may be responsible for secondary tumors. The risk of developing a tumor of the urinary tract, such as a myelodysplastic syndrome that can progress to acute leukemia, is increased.
- Other undesirable effects:
. cases of inappropriate pseudo-secretions of antidiuretic hormone (SIADH) have been described with possible acute intoxication by water;
. hypersensitivity reactions to cyclophosphamide, possibly accompanied by fever, are possible and may progress in isolated cases to shock;
. dizziness associated with transient vision disturbances has been reported;
. isolated cases of acute pancreatitis;
. very rare cases of Stevens-Johnson syndrome and necrotizing toxidermia have been reported.
SPECIAL TOXICITY TO HIGH DOSES :
in high doses (800 to 1600 mg / m²):
. gastrointestinal toxicity such as mucositis and / or diarrhea can also be observed.
. risk of haemorrhagic cystitis and a possibility of renal damage especially in case of pre-existing lesions. Edema of the bladder wall, sub-urethral bleeding, interstitial inflammation with fibrosis, and possible sclerosis of the bladder wall were observed.
. cases of interstitial pneumonitis or pulmonary fibrosis may occur. The risk of pulmonary fibrosis is potentiated by anterior or associated radiotherapy.
- at very high doses (> 1600 mg / m²):
there is a risk of cardiotoxicity (acute cardiomyopathy, myocardial ischemia), potentiated by previous irradiation of the heart area or the use of anthracyclines and / or pentostatin.
- Approximately 15-50% of patients receiving high-dose cyclophosphamide in combination with busulfan or total body radiotherapy for allogeneic bone marrow transplantation experienced veno-occlusive liver disease (VWD) . On the other hand, MVO is only rarely observed in patients with arterenative anemia treated as monotherapy with a high dose of cyclophosphamide. The syndrome typically develops 1 to 3 weeks after transplantation and is characterized by sudden weight gain, hepatomegaly, ascites and hyperbilirubinemia, or even liver failure.
- Predisposing factors for the development of MVO are pre-existing functional liver disorders, a hepatotoxic drug associated with high-dose chemotherapy, particularly when busulfan is used as an alkylating agent in the conditioning protocol.

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