Generic drug of the therapeutic class: Oncology and Hematology
Active ingredients: Daunorubicin
laboratory: Galen Limited
Liposomal dispersion to be diluted IV
Box of 1 bottle of 50 ml
DAUNOXOME is indicated for the treatment of extensive or visceral cutaneous and mucocutaneous Kaposi sarcoma in patients with advanced HIV infection (CD4 <200 / mm3).
Dosage DAUNOXOME 2 mg / mL Liposomal dispersion to be diluted IV injection Box of 1 bottle of 50 ml
- The dosage of DAUNOXOME must be adapted to each patient. Treatment should be initiated at 40 mg / m 2 every two weeks. Higher doses of 60 mg / m² every two weeks can be used, transiently, in severe or visceral forms of Kaposi's sarcoma.
- In patients with hepatic impairment : see section warnings and special precautions for use.
- In patients with renal impairment : no change in dosage is needed.
Administration mode :
- DAUNOXOME must be diluted in 5% glucose isotonic solution before administration. DAUNOXOME should not be mixed with saline, bacteriostatic agents such as benzyl alcohol. The recommended concentration after dilution is between 0.2 mg and 1 mg of daunorubicin per ml of solution.
- Administration is strictly intravenous in 30 to 60 minutes and within six hours of dilution.
- All handling must take place under the strictest aseptic conditions, DAUNOXOME and the products used for the dilution being free from any preservative or bacteriostatic agent.
- The use of a filter in the tubing is not recommended. However, when using a filter, the average pore diameter of the filter should not be less than 5 μm.
- Any parenteral product must be visually inspected prior to administration to detect the presence of any particles. DAUNOXOME is a sterile, pyrogen-free liposomal emulsion, red in color, clear to slightly opalescent in appearance.
- The handling techniques and disposal methods specific to anticancer drugs should be applied.
CONDUCT TO BE TAKEN IN CASE OF EXTRAVASATION :
- stop the infusion immediately,
- never administer saline solution or DMSO (risk of liposome damage). 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 .
These provisions can be envisaged within the framework of the oncology network (circular DGC / DH / 98 n ° 98/188 of March 24th, 1998) in collaboration with any adapted and satisfying structure.
CONTRAINDICATED: - Hypersensitivity to DAUNOXOME, any of the excipients or other anthracyclines / anthracenediones.
- Breast-feeding: Tolerance in lactating women has not been established. Breastfeeding should be interrupted during treatment.
- Pregnancy: Tolerance in pregnant women has not been established. However, daunorubicin, the active ingredient of DAUNOXOME, has been shown to alter reproductive function and has teratogenic effects in animals and there are also a number of arguments in favor of a fetal risk in humans. Therefore, unaware of the possible harm to the fetus during pregnancy, this drug should not be given to pregnant women. - In combination with the yellow fever vaccine (see section on interactions).
NOT RECOMMENDED :
- Associations advised against : live attenuated vaccines (except yellow fever); phenytoin (and by extrapolation fosphenytoin).
Daunoxome side effects
Adverse reactions considered at least possibly attributable to treatment with DAUNOXOME are listed below by system organ class and frequency. Frequency is defined as: very common> = 10%; Frequent> = 1% and = 0.1% and = 0.01% and <0.1%; very rare <0.01%.
- Infections and infestations:
. Very common : infection.
. Uncommon : septicemia, septic shock (see section on warnings and precautions for use).
- Hematological and lymphatic system disorders:
. Very common : myelosuppression, agranulocytosis, neutropenia, febrile neutropenia, leukopenia, pancytopenia, thrombocytopenia, and anemia (see section on warnings and precautions for use).
. As with other DNA-damaging anticancer agents, cases of myelodysplastic syndrome and acute myeloid leukemia have been observed following combination therapy including daunorubicin.
. With the topoisomerase II inhibitors, there has been reported a higher than expected incidence of secondary leukaemias presenting as de novo leukemias LAM2, LAM3, LAM4. Such forms may have a short latency period (from 1 to 3 years). These forms require early diagnosis and appropriate treatment (see section warnings and precautions for use).
- Immune system disorders:
Rare : anaphylactic reactions.
- Metabolism and nutrition disorders:
Frequent : dehydration.
- Psychiatric disorders:
Frequent : depression.
- disorders of the nervous system:
. Very common : headache.
. Frequent : vertigo.
- Cardiac disorders (see section on warnings and precautions for use):
. Frequent : decreased left ventricular ejection fraction.
. Uncommon : congestive heart failure, cardiomyopathy.
. Rare : atrial fibrillation, myocardial infarction.
- Respiratory, thoracic and mediastinal disorders:
Very common : dyspnea.
- Gastrointestinal disorders:
Very common : stomatitis, ulceration of the mucous membranes, nausea, vomiting, diarrhea, abdominal pain.
- Skin and subcutaneous tissue disorders:
. Very common : alopecia.
. Rare : palmoplantar erythrodysesthesia (see below).
. Rare cases of palmoplantar erythrodysaesthesia (hand-foot syndrome) have been reported in leukemic patients treated with high doses of DAUNOXOME and cytarabine. This disorder is characterized by swelling, pain, tingling and erythema of the palms of the hands and soles of the feet, which may lead to desquamation in some patients. Dose reduction or delayed administration may be necessary to treat this condition.
- General disorders and anomalies at the site of administration:
. Very common : asthenia, fatigue, fever, chills, reactions associated with infusion (including back pain, hot flushes, chest tightness, dyspnea, see section on warnings and precautions for use).
. Frequent : extravasation at the injection site may lead to erythema, pain and swelling (see section cautionary statements and precautions for use).