Medicinal Products

ELSEP 2 mg / mL

Generic Drug Therapeutic Class: Neurology-Psychiatry
Active ingredients: Mitoxantrone
laboratory: Meda Pharma

Solution for solution for IV infusion
Bottle of 10 ml
All forms

Indication

- This treatment should be used only after evaluation of the benefit / risk and in particular the hematological and cardiac risk.
- ELSEP is indicated for aggressive forms of relapsing-remitting or relapsing-type multiple sclerosis.
Aggressiveness is defined by:
. 2 relapses each with sequelae in the last 12 months and 1 new lesion raised by gadolinium on an MRI less than 3 months old.
. or by a 2-point increase in EDSS over the previous 12 months and 1 new gadolinium-enhanced lesion on an MRI less than 3 months old.
- ELSEP is not indicated for first-line treatment.
- ELSEP is not indicated in progressive primary forms of multiple sclerosis.

Dosage ELSEP 2 mg / mL Concentrate for solution for IV infusion 10 ml vial

Dosage:
Treatment should not be instituted in patients who have previously been treated with mitoxantrone.
The recommended dose of ELSEP is 12 mg / m 2 once a month, not exceeding 20 mg infusion, over a 6-month period (for a maximum of 6 infusions in total) with a cumulative maximum dose limited to 72 mg / m 2 and at a cumulative total dose of 120 mg.
Treatment must be limited to a maximum of 6 infusions per patient; under no circumstances should this medication be re-administered to the same patient.
It has not been demonstrated that continued treatment beyond 3 monthly infusions in non-responder patients is effective.
It is therefore recommended to reassess the benefit / risk of continuing treatment after the 3rd infusion.
Administration mode :
The solution will be diluted in at least 50 ml of 0.9% sodium chloride solution or 5% glucose.
This solution will be slowly introduced into the tubing of an ongoing infusion (0.9% sodium chloride or 5% glucose solution) in a minimum of 5 to 15 minutes. The solution is stable for at least 48 hours.
In case of injection out of the vein, the infusion will be stopped immediately and replaced elsewhere.
Mitoxantrone should never be administered subcutaneously, intramuscularly, intraarterially or intrathecally.
Caution, intrathecal administration can be fatal.
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 materials suitable for handling, including long-sleeved gowns, face masks, hood, goggles, sterile disposable gloves, worktop protection fields, containers and collection bags. garbage. 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 considered as contaminated waste. Disposal of contaminated waste is by incineration in rigid containers labeled for this purpose.

Against indications

CONTRAINDICATED:
- Hypersensitivity to mitoxantrone or to any of the constituents of the drug.
- Patients who previously received mitoxantrone or anthracyclines.
- Heart disease.
Myelodysplasia.
- Abnormalities of the Blood Formula Count (below the usual values ​​of the patient).
- History of hematological malignancy.
- Pregnancy or breastfeeding, women of childbearing potential not using effective contraception (see warnings and precautions for use and pregnancy and lactation): because of the mechanism of action of mitoxantrone, there is potential risk of fetal DNA damage.
- In combination with the yellow fever vaccine, (see interactions).
- Hepatic insufficiency.
Perform TP, albuminemia, alkaline phosphatase, bilirubin, transaminases before treatment.
In the case of increased transaminases, initiation of ELSEP therapy is not recommended until the origin of this increase has been determined.
Mitoxantrone should never be administered subcutaneously, intramuscularly, intraarterially or intrathecally.
NOT RECOMMENDED :
This drug is generally not recommended in combination with live attenuated vaccines (except yellow fever), phenytoin and fosphenytoin (see interactions).

Elsep side effects

- Hematological toxicity: Leukopenia may occur after each administration. It is usually transient with the lowest number of leukocytes by the 10th day and spontaneous recovery by the 20th day.
Thrombocytopenia may also be reversible.
Monitoring of hematological variables should be performed regularly during treatment (see warnings and precautions for use).
- Acute myeloid leukemias, in some fatal cases, have been reported with mitoxantrone. As with other topoisomerase II inhibitors, a high incidence of secondary leukemias is found, presenting as de novo leukemias LAM2, LAM3, LAM4 and LAM5. These AML are characterized by a short onset of onset, on average 2 years and often less than 5 years, (but may occur beyond), sudden onset and no myelodysplastic phase. They are of very fast evolution (see warnings and precautions of use).
- Cardiac toxicity: abnormalities of the ECG have been observed. Congestive heart failure with left ventricular ejection function has been reported below the 50% low limit value. Monitoring of cardiac function should be performed regularly (see warnings and precautions for use).
- Amenorrhea and menorrhagia have been observed (see warnings and precautions for use).
- Digestive toxicity: nausea and vomiting are of low intensity and transient.
Alopecia: Alopecia, if it occurs, is usually mild and reversible upon discontinuation of treatment.
- Other undesirable effects have been reported: anorexia, diarrhea, dyspnea, infections including urinary tract infections, fatigue, febrile seizures, allergic manifestations, rare reversible increases in transaminases, creatinine and blood urea, gastrointestinal haemorrhage, stomatitis.
- Due to the presence of sodium metabisulfite, risk of allergic reactions including anaphylactic reactions and bronchospasm.
- A blue-green coloration of urine and / or sclera may occur during treatment.

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