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Dacarbazine.

Structure

- 200mg - Dacarbazine;

Without a Prescription

Dacarbazine is prescribed for the treatment of patients with metastatic malignant melanoma.

Further indications for Dacarbazine as part of combination chemotherapy are:

Hodgkin`s disease
Advanced adult soft tissue sarcomas (except mesothelioma, Kaposi sarcoma)

Dosage

Malignant Melanoma
Dacarbazine can be administered as single agent in doses of 200 to 250 mg/m 2 body surface area/day as an I.V. injection for 5 days every 3 weeks.

As an alternative to an intravenous bolus injection Dacarbazine can be administered as a short-term infusion (over 15-30 minutes)

Dacarbazine is possible to give 850 mg/m 2 body surface area on day 1 and then once every 3 weeks as intravenous infusion.

Hodgkin`s Disease
Dacarbazine is administered in a daily dose of 375 mg/m 2 body surface area I.V. on day 1 and day 15 in combination with doxorubicin, bleomycin and vinblastine for each cycle of ABVD regimen.

Adult soft tissue sarcoma
For adult soft tissue sarcomas Dacarbazine is given in daily doses of 250 mg/m 2 body surface area I.V. (days 1-5) in combination with doxorubicin every 3 weeks (ADIC regimen).

Restriction of food intake for 4-6 hours prior to treatment may reduce the severity of the nausea and vomiting which occurs in most patients particularly during the first two days of treatment.

Because severe gastrointestinal and haematological disturbances can occur an extremely careful benefit-risk analysis has to be made before every course of therapy with Dacarbazine.

Elderly patients:
As limited experience in elderly patients is available no special instructions for use in elderly patients can be given.

Patients with kidney/liver insufficiency:
If there is mild to moderate renal or hepatic insufficiency alone, a dose reduction is not usually required. In patients with combined renal and hepatic impairment elimination of Dacarbazine is prolonged. However, no validated recommendations on dose reductions can be given currently.

Duration of therapy:
The treating physician should individually decide about the duration of therapy taking into account the type and stage of the underlying disease, the combination therapy administered and the response to adverse effects of Dacarbazine. In Hodgkin`s disease, the recommended cycles for administration of ABVD combination therapy ranges between 3 to 8 cycles of therapy based on the stage of disease and the treatment response. In metastasised malignant melanoma and in advanced tissue sarcoma, the duration of treatment depends on the efficacy and tolerability in the individual patient.

Administration:
If extravasation occurs, the injection should be discontinued immediately.

Dacarbazine is sensitive to light exposure. All reconstituted solutions should be suitably protected from light during administration (light-resistant infusion set).

Administration is by the intravenous route only.

Dacarbazine 100 mg and 200 mg vials should be reconstituted with 9.9 ml and 19.7 ml respectively, with Water for Injections BP. The resulting solutions contain the equivalent of 10 mg/ml of Dacarbazine and have a pH of 3 to 4. The resultant solution is hypo-osmolar and therefore should be given by slow intravenous injection over one to two minutes.

If desired the reconstituted solution can be further diluted with 125-250 ml of Dextrose Injection BP 5% or Sodium Chloride Injection BP 0.9% and administered by intravenous infusion over 15-30 minutes.

Doses up to 200 mg/m 2 may be given as slow intravenous injection. Larger doses (ranging from 200 to 850 mg/m 2 ) should be administered as an I.V. infusion over 15-30 minutes.

Instructions for handling:
The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicines used, in conditions that guarantee the protection of the environment and, in particular, the protection of the personnel handling the medicines. It requires a preparation area reserved for this purpose. It is forbidden to smoke, eat or drink in this area.

Personnel must be provided with appropriate handling materials, notably long sleeved gowns, protection masks, caps, protective goggles, sterile single-use gloves, protective covers for the work area and collection bags for waste.

Excreta and vomit must be handled with care.

Pregnant women must be warned to avoid handling cytotoxic agents.

Any broken container must be treated with the same precautions and considered as contaminated waste. Contaminated waste should be incinerated in suitably labelled rigid containers.

Special precautions for disposal and other handling:

Preparation Guidelines:
All operations such as reconstitution should be carried out only under aseptic conditions in a suite or cabinet dedicated for the assembly of cytotoxics.

Dacarbazine solutions should be prepared immediately before use. Before being administered, injectable solution should be visually inspected in order to detect possible presence of particles of discolouration. Dacarbazine is photosensitive, with exposure to light causing a colour change from pale yellow to pink. The product should not be used if it appears pink in colour.

Aseptically transfer the required amount of water for injections into the vial and shake until a solution is obtained. The solution should be clear, colourless and free from visible particles. The resultant solution should be injected intravenously over one to two minutes.

If desired the reconstituted solution can be further diluted with 125-250ml of Dextrose Injection 5% or Sodium Chloride Injection 0.9% and administered by intravenous infusion over 15-30 minutes. During administration, the infusion set should be protected from exposure to daylight e.g. by using light-resistant PVC infusion sets. If normal infusion sets are used, then these should be covered to protect from light.

Disposal
Vials, materials that have been utilised for dilution, and any other contaminated material should be placed in a thick plastic bag or other impervious container and incinerated.

Cytotoxic Handling Guidelines
The handling of this cytotoxic agent by nursing or medical personnel requires every precaution to guarantee the protection of the handler and their surroundings.

In case of contact of the drug with the eye, wash the eye thoroughly with water. If the substance is splashed accidentally onto the skin, wash the skin with large amounts of water and then with a soft soap. Rinse thoroughly.

Before being administered, injectable solution should be visually inspected in order to detect possible presence of particles of discolouration.

Contraindications

Dacarbazine is contraindicated in cases of:
- Pregnancy and lactation;
- Patients with severe liver or kidney diseases;
- Patients who have demonstrated a hypersensitivity to Dacarbazine in the past;
- In combination with yellow fever vaccine phenytoin in prophylactic use and live attenuated vaccines;

Form

Vial of 20 ml.

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2004 - 2017