Medicinal Products

DACARBAZINE LIPOMED 200 mg

Generic drug of the therapeutic class: Oncology and Hematology
Active ingredients: Dacarbazine
laboratory: Lipomed Gmbh

Powder for solution for injection IV or infusion
Box of 10 single-dose vials of 200 mg
All forms

Indication

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

Other indications for dacarbazine in the context of a multidrug therapy are:

· Advanced Hodgkin's disease.

· Advanced soft tissue sarcomas (except mesothelioma and Kaposi's sarcoma).

Dosage DACARBAZINE LIPOMED 200 mg Powder for solution for injection IV or for infusion Box of 10 Single-dose vials of 200 mg

The use of Dacarbazine Lipomed should be reserved for experienced physicians in oncology or hematology.

Dacarbazine is sensitive to light. Reconstituted solutions should be protected from light, including during administration (opaque infusion).

Administration of the injection should be done with care to avoid extravasation in tissues because it would cause localized pain and tissue damage. In case of extravasation, the injection must be stopped immediately and the rest of the dose must be introduced into another vein.

Food absorption prior to administration of dacarbazine should be avoided to limit the severity of nausea and vomiting. Excreta and vomit should be handled with care.

The following dosages may be used. For more details, see current scientific publications.

Malignant melanoma

Dacarbazine can be used as monotherapy at doses of 200 to 250 mg / m 2 body surface area / day IV injection for 5 days every 3 weeks. Dacarbazine can be administered either by intravenous bolus injection or by short infusion (over 15-30 minutes).

It is also possible to administer 850 mg / m 2 of body surface area on day 1 and then once every 3 weeks as an intravenous infusion.

Hodgkin's disease

Dacarbazine should be administered IV at a daily dose of 375 mg / m 2 body surface area every 15 days in combination with doxorubicin, bleomycin and vinblastine (ABVD therapy).

Sarcoma of soft tissues

For adult soft tissue sarcomas, dacarbazine should be administered IV at daily doses of 250 mg / m 2 body surface area (Days 1-5) in combination with doxorubicin every 3 weeks (ADIC treatment) .

During treatment with dacarbazine, blood counts, as well as liver and kidney function, should be monitored frequently. As severe gastrointestinal reactions are common, it is advisable to use anti-emetics and symptomatic management measures.

As severe gastrointestinal and hematologic disturbances are possible, an extremely careful evaluation of the benefit / risk ratio is necessary before each treatment with Dacarbazine Lipomed.

Duration of treatment

The attending physician should decide on the duration of each patient's individual treatment, taking into account the type and stage of the underlying disease, the associated chemotherapy used, the response to dacarbazine and its adverse effects.

In the treatment of advanced Hodgkin's disease, it is usually recommended to administer 6 cycles of ABVD combination therapy.

In the treatment of metastatic malignant melanoma and advanced soft tissue sarcoma, the duration of treatment depends on the efficacy and safety observed in each patient.

Rate of administration of the injection / infusion

Doses up to 200 mg / m 2 can be administered by slow intravenous injection over about 1 minute. Higher doses (200 to 850 mg / m 2 ) should be administered as an intravenous infusion over 15 to 30 minutes.

It is recommended to first test vein permeability with 5 to 10 ml of isotonic solution for infusion based on sodium chloride or 5% glucose. The same solution should be used after the infusion to purge the drug residues in the tubing.

After reconstitution with water for injections and without further dilution with isotonic sodium chloride or 5% glucose solution, Dacarbazine Lipomed 100 preparations are hypo osmolar (approximately 100%). mOsmol / kg) and must therefore be administered by slow intravenous injection, e.g. 1 minute, not IV bolus injection over a few seconds.

Special populations

Patients with renal / hepatic impairment

In patients with mild to moderate renal or hepatic impairment, it is not usually necessary to reduce the dose. In patients with combined renal and hepatic impairment, elimination of dacarbazine is slower. However, no validated recommendations for dose reduction can currently be provided.

Elderly patients

Since experience in elderly patients is limited, no specific instructions can be provided regarding the use of dacarbazine in this population.

children

No specific recommendations can be made regarding the use of dacarbazine in children until additional data are available.

For preparation and reconstitution instructions, see the Instructions for Use, Handling and Disposal section .

Against indications

Dacarbazine Lipomed is contraindicated in the following cases:

· Hypersensitivity to dacarbazine or any of the excipients.

· Pregnancy or breastfeeding

· Leukopenia and / or thrombocytopenia.

· Severe hepatic or renal disease.

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

Side effects Dacarbazine Lipomed

Frequency

Very common (≥ 1/10)

Frequent (≥ 1/100 to <1/10)

Uncommon (≥ 1/1000 to <1/100)

Rare (≥ 1/10 000 to <1/1000)

Very rare (≥ 1/10 000)

Not known (can not be estimated from the available data)

Hematological and systemic disorders

Frequent

lymphatic

Anemia, leukopenia, thrombocytopenia, medullary insufficiency.

Rare

Pancytopenia, agranulocytosis.

Immune system disorders

Rare

Anaphylaxis, hypersensitivity reactions.

Psychiatric disorders

Rare

Confusion.

Nervous system disorders

Rare

Headache, lethargy, convulsions, facial paresthesia.

Eye disorders

Rare

Blurry vision.

Rare

impaired vision.

Vascular disorders

Rare

Facial flushing.

Gastrointestinal disorders

Frequent

Anorexia, nausea, vomiting.

Rare

Diarrhea.

Hepatobiliary disorders

Rare

Elevation of transaminases (ASAT, ALT), elevation of alkaline phosphatase, elevation of lactic dehydrogenase (LDH). Hepatotoxicity, hepatic venous thrombosis, hepatic necrosis, Budd-Chiari syndrome of potentially fatal evolution.

Skin and tissue disorders

Rare

subcutaneous

Alopecia, hyperpigmentation, photosensitivity, rash

transient.

Rare

Erythema, maculopapular exanthema, urticaria.

Renal and urinary disorders

Rare

Alteration of renal function with elevated creatinine

blood and blood urea.

General disorders and site abnormalities

Rare

administration

Flu-like symptoms, malaise.

Rare

Irritation at the injection site.

Digestive disorders such as anorexia, nausea and vomiting are common and severe. Rare cases of diarrhea have been observed.

Frequently observed changes in blood counts (anemia, leukopenia, thrombocytopenia) are dose-dependent and delayed, with nadirs often not reached until 3-4 weeks later. Rare cases of pancytopenia and agranulocytosis have been described.

Flu-like symptoms of exhaustion, chills, fever and muscle aches are occasionally observed during or often a few days after administration of dacarbazine. These disorders may reappear during the next infusion.

Elevations of hepatic enzymes (transaminases (ASAT, ALAT), alkaline phosphatase, lactic dehydrogenase (LDH), for example) have been observed infrequently.

Uncommon cases of hepatic necrosis following intrahepatic vein occlusion (veno-occlusive disease) have been observed following dacarbazine monotherapy or multidrug therapy. The syndrome usually occurred during the second treatment cycle. Symptoms included fever, eosinophilia, abdominal pain, increased liver volume, jaundice, and rapidly worsening shock within hours or days. Since fatal changes have been reported, it is particularly important to frequently check liver size, liver function, and blood counts (especially eosinophils) during treatment. In specific cases of suspicion of veno-occlusive disease, rapid treatment with high dose corticosteroids (eg, hydrocortisone 300 mg / day), with or without fibrinolytic agents such as heparin or tissue plasminogen activator, has been shown to be effective (see also sections Posology and method of administration and Warnings and precautions for use ).

Localized disorders at the injection site, such as venous irritations, and some of the systemic adverse reactions may be thought to result from the formation of photodegradation products. Localized pain and necrosis are to be expected in case of accidental extravasation.

Alterations in renal function with elevated blood levels of substances to be excreted in the urine are infrequent.

Central nervous system disorders such as headache, impaired vision, confusion, lethargy and seizures may occur in rare cases. Paresthesia and facial flushing may occur shortly after injection.

Allergic skin reactions such as erythema, maculopapular exanthema or urticaria are observed in rare cases. Alopecia, hyperpigmentation and skin photosensitivity may occur infrequently. Rare cases of anaphylactic reactions have been described.

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