Medicinal Products

ENDOXAN 50 mg

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

Coated tablet
Box of 50
All forms

Indication

- Adjuvant and metastatic treatment of mammary adenocarcinoma.
- Treatment of ovarian cancers, bronchial cancers, especially small cell cancers, seminomas and testicular embryonic carcinomas, bladder cancers, sarcomas, neuroblastomas, Hodgkin's and non-Hodgkin's malignant lymphomas, multiple myeloma, acute leukemias, especially lymphoid.
- Low dose, treatment of rheumatoid arthritis, Wegener's granulomatosis, some severe forms of acute lupus erythematosus disseminated, auto-immune nephropathies corticoresistant.

Dosage ENDOXAN 50 mg Coated Tablet Box of 50

- Oral cyclophosphamide is mainly indicated for autoimmune disorders. However, tablets are included in some antineoplastic chemotherapy regimens.
- The usual dosage for adults and children is 100 to 200 mg / m² / day (2.5 to 5 mg / kg / day) in short cycles of 1 to 14 days. Administration is repeated every 2 to 4 weeks. Lower dosages of 40 to 100 mg / m² / day (ie 1 to 2.5 mg / kg / day) can be used, without interruption, as long-term treatments.
- Tablets should be administered in the morning on an empty stomach by combining sufficient absorption of the drink at the time of taking and immediately afterwards.

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, craniosynostosis, facial dysmorphism) have been reported after 1st trimester exposure, 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: Due to the passage of cyclophosphamide in breast milk and the possible occurrence of serious adverse events for the newborn, breastfeeding is contraindicated.
. in combination with the yellow fever vaccine.
- Due to the presence of lactose and sucrose, this drug is contraindicated in case of congenital galactosemia, fructose intolerance, glucose-galactose malabsorption syndrome or lactase or sucrase-isomaltase deficiency.
NOT RECOMMENDED :
This drug is generally not recommended in combination:
- with live attenuated vaccines (except yellow fever),
- with 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.
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 rarely seen in patients with arterenative anemia treated with high-dose cyclophosphamide monotherapy. 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.
Factors predisposing to 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.
- 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.

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