Medicinal Products

ELDISINE 5 mg

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Vindesine
laboratory: EG Labo

Powder for solution for injection
Box of 1 vial of 5 mg
All forms

Indication

Acute lymphoblastic leukemia and lymphoma refractory to chemotherapy (other cytostatic agents).

Some solid tumors: breast, esophagus, upper aerodigestive tract, bronchopulmonary cancer.

Dosage ELDISINE 5 mg Powder for solution for injection Box of 1 vial of 5 mg

Dosage

ELDISINE IS USED STRICT INTRAVENOUSLY, at minimum intervals of 7 days or more, under control of the hemogram.

If the neutrophils are not raised to 2000 elements per mm 3, delay the injection until normalization.

· In monochemotherapy:

Adult: 3 mg / m 2 every 7 to 10 days for one month, then every 15 days thereafter;

Children: 4 mg / m 2 every 7 to 10 days.

· In combination with other antineoplastics:

Some protocols recommend doses of 2 to 4 mg / m 2 every 3 to 4 weeks; the importance of the unit dose and the timing of the injections depend on the indication and the hematological tolerance of the associated drugs.

· The dosage should be adjusted in case of hepatocellular insufficiency or elevation of bilirubinemia (see section Warnings and Precautions for Use ).

Administration mode

Preparation of the solution:

Dissolve the contents of the 5 mg vial in 5 ml of water for injection or saline or glucose solution. This gives a solution dosed at 1 mg / ml of vindesine.

After reconstitution, unused solutions should not be stored.

Route of administration

This medicine is only used by INTRAVENOUS STRICT

It is recommended to dilute vindesine in 50 to 100 ml bags and administer as a fast intravenous infusion for 5 to 10 minutes, monitoring the absence of extravasation. (This reconstitution is intended to avoid errors in the route of administration).

Eldisine should not be mixed with other chemotherapies in the same syringe or vial.

Vindesine should be administered by experienced people.

Caution: Intrathecal administration causes fatal ascending paralysis.

CAUTION: It is extremely important to make sure the needle is properly inserted into the vein before starting the injection. In case of extravasation, may occur cellulitis or necrosis. It is then necessary to stop the injection immediately and to suck up the maximum extravasated product, the remaining quantity must be administered by another vein. The local injection of hyaluronidase, the application of moderate heat facilitate the diffusion of the product and seem to reduce the risk of cellulite.

Handling modalities

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 masks, protective cap, safety 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.

These provisions may be envisaged within the framework of the oncology network (circular DGS / DH / 98 N ° 98/188 of 24 March 1998) in collaboration with any suitable and qualified structure.

Against indications

This medicine is contraindicated in the following cases:

· Pregnancy, breastfeeding,

· Severe neutropenia or thrombocytopenia induced by chemotherapy,

· Infections,

· Severe peripheral neuropathy,

· Dyspnea or severe bronchospasm that occurred during a previous administration of vindesine,

· In combination with the yellow fever vaccine.
(see section Interactions with other medicines and other forms of interaction ).

This drug is generally not recommended in combination with live attenuated vaccines and with itraconazole, phenytoin and fosphenytoin.

Eldisine side effects

They depend on the dose administered.

Hematological effects

Leukopenia is an expected effect of vindesine, it is the dose-limiting factor. It will be all the more severe in nature and duration that the dose administered will be higher. The nadir usually occurs between the 3rd and 5th day after the administration of vindesine with return to normal between the 7th and the 10th day.

Cases of thrombocytopenia (less than 150, 000 platelets per mm 3 ) have been reported, particularly in patients with bone marrow depression due to radiotherapy or prior chemotherapy. Their occurrence is rarer if the recommended regimen (direct route IV once a week) is followed.

Gastrointestinal effects

Cases of nausea, vomiting, diarrhea, anorexia, stomatitis have been observed as well as cases of constipation and abdominal pain related to neurological involvement (see Warnings and Precautions for Use Precautions).

Neurological effects

The neurotoxicity of vindesine is generally less severe than that observed with vincristine.

The involvement of the neuro-vegetative nervous system is manifested by the appearance of constipation accompanied by abdominal pains that can progress to paralytic ileus.

Peripheral neuropathies may occur, indicated by a decrease or abolition of osteotendinous reflexes and paresthesia.

Headaches and sometimes seizures have been observed.

Rare cases of cortical blindness have been reported in patients treated with multidrug therapy including vindesine without clear responsibility for the drug.

Some cranial pals have been reported (auditory and vestibular disorders). Caution is therefore recommended when combining vindesine with ototoxic substances such as cisplatin.

Broncho-pulmonary effects

Cases of dyspnea and severe bronchospasm have been reported with vinca alkaloids, some of which are associated with mitomycin C. These reactions occur within minutes or hours after the injection of vinca alkaloids and may occur two weeks after administration of a dose of mitomycin C. Persistent dyspnea requiring long-term treatment has already been reported.

Faced with these manifestations, vindesine should not be re-administered.

Cardiac effects

A few rare cases of myocardial ischemia (myocardial infarction, angina and / or transient changes in the electrocardiogram) have been reported (see Warnings and Precautions for Use section) .

Various

Reversible alopecia (reversibility may sometimes be observed before the end of treatment), myalgia, jaw pain, pain at the tumor site, rash, chills, fever, weight loss, asthenia, necrosis and cellulitis at the injection site in case accidental extravasation.

As with any oncolytic, the risk of amenorrhea and azoospermia can not be ruled out.

The occurrence of hyponatraemia due to inappropriate secretion of antidiuretic hormone (SIHAD) has been reported in high doses.

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