Chemodox medicine 2mg/ml Sun Pharma to treat breast cancer, ovarian, kaposi cancer and bone marrow disease (10ml)
Dosage form Box X 10ml
Specifications Doxorubicin
Ingredient Sunpharma
Ingredient
| Composition information | Content |
| Doxorubicin | 2mg/ml |
Uses
indicated
doxorubicin liposome is designated:
Pharmacokology
Code ATC: L01DB01.
Pharmacological group: anti -cancer and immunosuppressive drugs, cytotoxic.
Mechanism of impact
The active ingredient of chemodox is Doxorubicin Hydrochlorid Liposome, an antibiotic group Anthracyclin toxic cyteto obtained from Streptomyces Peucetius Var. Caesius. Currently, it is still not known for the exact mechanism of the anti -tumor activity of Doxorubicin. In general, the inhibition of DNA, RNA and the protein synthesis process is responsible for the majority of cytotoxic effects. This is probably the result of attaching anthracyclin group between adjacent base pairs of DNA twisted chains and thus, preventing the necessary torsion for copying.
Dynamic pharmacokinetics
Liposomes are pegylate containing surface segments of polymers of polymers methoxypolyethylene glycol body water (MPEG). Linear MPEG groups expanded from the liposome surface to create a protective coating that reduces the interaction between lipid double membranes and plasma components. This allows the doxorubicin liposomes to circulate during the prolonged time in the blood. Pegyl liposomes are small enough (an average diameter of approximately 100 nm) to go through intact (escape vessels) through blood vessels defects supplying blood to raise tumors. Evidence of the penetration of pegyl liposomes from blood vessels and intrusion and accumulation in tumors has been seen in mice with C-26 colon cancer tumors and in transgenic mice with kaposi Sarcoma lesions. The pegylation liposomes also have low lipid permeability and combined internal water buffer system to hold the doxorubicin hydrochlorid in the liposome during transportation.
The pharmacokinetics of doxorubicin liposome in plasma in other people with reports in literature for standard Doxorubicin hydrochlorid preparations. In low doses (10 mg/m2-20 mg/m2) doxorubicin liposome forms linear pharmacokinetic properties. Within the dose of 10 mg/m2-60 mg/m2 doxorubicin liposome forms a non-linear pharmacokinetics. Doxorubicin Hydrochlorid standard shows a wide distribution (distribution volume: 700 to 1,100 l/m2) and rapid clearance (24 to 73 l/hour/m2). In contrast, the pharmacokinetic properties of the liposome doxorubicin shows that the liposome doxorubicin is limited to the volume of fluid in the blood vessels and the release of the blood from blood depends on liposome transportation. Doxorubicin will be active after the liposomes are escaped and penetrate into the tissue compartment.At the equivalent dose, plasma concentrations and area value under the AUC curve of doxorubicin liposome representing doxorubicin hydrochlorid liposome are pegylation (containing 90-95% doxorubicin) significantly higher than Doxorubicin hydrochloride preparations.
doxorubicin liposome should not be used with other formulas of doxorubicin hydrochlorid.
Pharmacokinetic properties on the target population
The pharmacokinetic properties of the liposome doxorubicin in the dose of 10 mg/m2 to 60 mg/m2 are best described by a two-compartment non-linear model with a non-step input and except Michaelis-Menten. The average internal clearance of doxorubicin is 0.030 l/h/m2 (about 0.008 to 0.152 l/h/m2) and the average distribution of assumptions is 1.93 l/m2 (about 0.96-3.85 l/m2) approximately plasma volume. The apparent sale time ranges from 24-231 hours, with an average of 73.9 hours.
Patients with breast cancer
The pharmacokinetic properties of liposome doxorubicin in patients with breast carcinoma are similar to the pharmacokinetic properties determined in the population group greater than the cancer patients of different types. The average internal clearance is reported of 0.016 l/h/m2 (0.008 - 0.027 l/h/m2), the average distribution of assumptions is 1.46 l/m2 (about 1.10 - 1.64 l/m2). The average apparent sale time is 71.5 hours (about 45.2 - 98.5 hours).
Ovarian cancer patients
The pharmacokinetic properties of liposome doxorubicin in patients with ovarian carcinoma are similar to the pharmacokinetic properties determined in the population group larger than cancer patients of different types. The average internal clearance is 0.021 l/h/m2 (about 0.009-0.041 l/h/m2), the average distribution of the assumption distribution is 1.95 l/m2 (about 1.67- 2.40 l/m2). The average apparatus selling time is 75.0 hours (about 36.1-125 hours).
Patients with Kaposi cancer are related to AIDS
The pharmacokinetic properties of liposome doxorubicin are evaluated in patients with Kaposi cancer using a single dose of 20 mg/m2 of 30 -minute intravenous injection. The pharmacokinetics parameters of liposome doxorubicin (mainly doxorubicin hydrochloride liposome formed pegylate and low concentration doxorubicin hydrochlorid has not been captured) reported after a dose of 20 mg/m2, which is presented in Table 10 .
.
Table 10: Dynamic parameters reported in patients with Kaposi cancer related to AIDS are treated with liposome doxorubicin.
Before taking Chemodox medicine 2mg/ml Sun Pharma to treat breast cancer, ovarian, kaposi cancer and bone marrow disease (10ml)
How to use
doxorubicin liposome is used by intravenously.
Do not use liposome doxorubicin to inject bolus or not diluted. Recommendations of liposome doxorubicin intravenous lines connected through the secondary gate of 5% glucose intravenous lines (50 mg/ml) to achieve more dilution and reduce the risk of thrombosis and vascular drainage. The infusion can be done through peripheral veins. Do not use pre -installed filters. Doxorubicin liposome is not used by intramuscularly or subcutaneously.
For the dose
For dose ≥ 90 mg: dilute the liposomed doxorubicin in 500 ml of 5% glucose infusion solution (50 mg/ml).
Breast cancer / ovarian cancer / multiple myeloma
To reduce the risk of reaction due to infusion, the initial dose is used at a speed of not greater than 1 mg/min. If the reaction is not seen, the transmission can continue to do the liposome formorubicin in the 60 -minute period.
In patients with the infusion reaction, the transmission must be adjusted as follows: 5% of the total dose should be transmitted slowly in the first 15 minutes. If tolerated well and no reaction occurs, the transmission speed can double in the next 15 minutes. If well tolerated, the infusion can then be completed in the next hour with a total transmission time of 90 minutes.
Kaposi cancer is related to AIDS
Doxorubicin liposome is diluted in 250ml of 5% glucose solution (50 mg/ml) for infusion and intravenous injection for 30 minutes.
Dosage
Ovarian cancer/Ovarian cancer
liposome doxorubicin is used in intravenously at a dose of 50 mg/m2 every 4 weeks as long as the disease does not progress and the patient continues to tolerate treatment.
Multonestation
The liposome doxorubicin is used on the 4th day of a 3 -week treatment regime with Bortezomib with a dose of 30 mg/m2 transmitted within 1 hour right after Bortezomib transmission. Bortezomib treatment regime consists of 1.3 mg/m2 on 1, 4, 8 and 11 every 3 weeks. Dosage should be repeated until the patient fully responds and tolerated. Date 4 daily dosage of both drugs can be delayed up to 48 hours if necessary medical. Bortezomib dose needs at least 72 hours.Kaposi cancer is related to AIDS
Doxorubicin liposome is intravenously at 20 mg/m2 every two to three weeks. Avoid distances shorter than 10 days because of the accumulation of the drug and increasing the possibility of toxicity cannot be excluded. The treatment of patients for two to three months is recommended for treatment. Continue treatment if needed to maintain treatment.
For all patients
If the patient has early symptoms or signs of the response due to infusion, immediately stop transmission, use appropriate allergic reactions to prevent antihistamine and/or corticosteroids short) and use it at a slower speed.
Instructions for adjusting dose dose doxorubicin liposome
To control adverse events such as an abnormal erythematosa of the palms - the soles of the feet, the stomatitis or the hematology, the dose can be reduced or relaxed the dose distance. Instructions for adjusting dose dose doxorubicin liposome for these adverse events are provided in the table below. The toxic classification in this table is based on the usual toxic criteria of the National Cancer Institute.
Tables for the iridescent erythematosa of the palms - the soles of the feet (Table 1) and the stomatitis (Table 2) offer a plan to change the dose in clinical studies reported in the treatment of breast or ovaries (adjust the 4 -week treatment cycle): If these toxins occur in KAPOSI cancer patients related to AIDS, the treatment cycle from 2 weeks can be adjusted by 2 weeks.
The table applies to hematology toxicity (Table 3) providing the following dose adjustment schedule in clinical studies reported only in patients with breast or ovarian cancer.
Table 1: Perseverive Red Red Hand - Solves of Foot
(lightweight, swollen, or flaky without affecting daily activities.)
(Hong Ban, peeling or swelling, influenced but not excluded daily activities; little burns or ulcers with a diameter of less than 2cm.)
Wait another week. Back to a distance of 4 weeks.
(Burns of water, ulcers or swelling affect travel or daily activities; cannot wear regular clothes.)
Wait another week.
(local or spreading process causes infection complications, or bedridden or hospitalized.)
(painless ulcers, rash or mild pain.)
(painful, edema or ulcerative, but can still be eaten.)
(painful, edema or ulcerative, but cannot be eaten.)
Wait another week.
(need support in the intestine or outside the intestine.)
Table 4: Adjust the dose for the coordination regimen of Doxorubicin Liposome + Bortezomib in patients with multiple tumors
Platelet quantity hemoglobin ANC
Patients with impaired liver function
The pharmacokinetic properties of the liposome doxorubicin are reported in a few patients with total intake bilirubin levels are not different from patients with normal bilirubin; However, until there is additional experience of treatment, the liposome doxorubicin should be reduced in patients with liver functional impairment based on experience from clinical studies on breast and ovarian cancer, which is reported as follows: When starting treatment, if bilirubin is between 1.2-3.0 mg/dL, the first dose drops 25%. If bilirubin> 3.0 mg/dL, the first dose will decrease by 50%. If the patient tolerates the first dose without increasing the bilirubin or liver enzymes in the serum, the dose for cycle 2 may increase to the next dose level, meaning that if the first dose is reduced the first dose, increasing the dosage for cycle 2; If the first 50% decrease, up to 75% for the dose 2. The liposome doxorubicin can be used in patients with liver metastases with increased bilirubin and liver enzymes up to 4 times the upper limit of normal range. Before using liposome doxorubicin, evaluate liver function by regular subclinical tests such as ALT/AST, alkaline phosphatase and bilirubin.
Patients with impaired renal function
Because doxorubicin is metabolized by the liver and excreted in bile, no need to change the dose. The pharmacokinetic data of the target population group is reported (within the tasting of the creatinine test of 30-156 ml/minute) shows the liposome-form elimination is not affected by kidney function. There is no pharmacokinetic data on patients with creatinine clearance below 30 ml/min.
Kaposi cancer patients related to AIDS have spleen
Because there is no experience of treatment with liposome doxorubicin in patients with spleen cutting, do not recommend liposome doxorubicin treatment.
Children
Experience in children is very limited. Do not recommend treatment with liposome doxorubicin in patients under 18 years old.
Elderly
Analysis based on the target population reports that age in the test range (21-75 years old) does not significantly change the pharmacokinetic properties of doxorubicin liposome.What to do when overdose? Treatment of acute overdose in patients with severe marrow failure including hospitalization, antibiotics, platelets and granulocytes and treatment of mucositis symptoms.
What to do when forgetting a dose?
Side Effects
Safety records
The most unwanted effect in clinical studies on breast/ovarian cancer is reported (50 mg/m2 every 4 weeks) is an abnormal erythematitosa palm - soles of the feet. The ratio of the iridescent erythematosus - the soles of the feet is reported is 44.0% - 46.1%. These effects are mainly light; The severity (level 3) reports in about 17% -19.5%. The rate of life -threatening cases (degree 4) is Breast cancer program
In a reported clinical study, breast cancer patients have not been treated with chemotherapy before metastatic treatment treated with liposome doxorubicin at a dose of 50 mg/m2 every 4 weeks or doxorubicin dose of 60 mg/m2 every 3 weeks. The following common adverse events are more commonly reported in the group using doxorubicin compared to doxorubicin liposome form: nausea (53% compared to 37%; 3/4 5% compared to 3%), vomiting (31% compared to 19%; 3/4 4% compared to less than 1%), hair loss (66% compared to 20%), clear hair loss (54% compared to 7%). 4%; level 3/4 8%compared to 2%).
Mucus inflammation (23% compared to 13%; 3/4 4% compared to 2%), and stomatitis (22% compared to 15%; level 3/4 5% compared to 2%) is more commonly reported for doxorubicin liposomes compared to doxorubicin. The average time of the most serious events (level 3/4) for both groups is 30 days or less. See Table 5 to know all the unwanted effects reported in patients with liposome doxorubicin.
The ratio of life -threatening hematological effects (degree 4) is
Clinical abnormal subclinical values (level 3 and 4) reported in this group are low, including increased concentration of bilirubin, AST and ALT at a rate of 2.4%, 1.6% and
Table 5: Unwanted solutions related to treatment in breast cancer clinical studies have been reported (50 mg/m2 every 4 weeks) (on patients treated with liposome doxorubicin) according to serious levels, classified by the Meddra system and related phase:
Very popular (≥ 1/10); Popular (≥1/100,
cioms III
Not previously reported in clinical research.
Ovarian cancer program
Patients with ovarian cancer (from a small group of patients with solid tumors) have been treated with liposome doxorubicin at a dose of 50 mg/m2 in reported clinical studies. See Table 6 on unwanted effects reported in patients treated with liposome doxorubicin.
Table 6: Unwanted effects related to treatment are reported in clinical studies on ovarian cancer (50 mg/m2 every 4 weeks) (patients treated withxorubicin liposome) according to severity, the classification system according to Meddra and related stages:
Very popular (≥ 1/10); Popular (≥ 1/100,
cioms III
(≥ 5%).
Ovarian cancer
level 3/4
(≥ 5%).
Ovarian cancer
(1-5%).
common sore throat.
The marrow failure is mainly mild or medium and can be managed. Hemorrhage infections are associated with non -regular leukopenia (
In patients with ovarian cancer, unusual clinical values are reported in clinical clinical studies with liposomin -type doxorubicin, including total biirubin increased (usually in patients with liver metastases) (5%) and increased blood creatinine levels (5%). Increase AST occurs less (
On patients with hard tumors (including breast and ovarian cancer patients) are treated primarily at a dose of 50 mg/m2 every 4 weeks, safety and adverse effect rate are equivalent to patients treated with breast cancer in clinical studies on breast and ovarian cancer.
Program of multiple bone marrow
Among patients with multiple marrow tumors that have been treated at least 1 previous therapy, there are few patients treated with coordination therapy doxorubicin liposome at 30 mg/m2 in an hour of intravenous transmission on Wednesday after using Bortezomib with a dose of 1.3 mg/m2 on days 1, 4, 8, and 11 weeks, every three weeks or with Bortezomib solidarity fox. See Table 7 on adverse effects reported in ≥ 5% of patients treated with coordination therapy doxorubicin Liposome form in combination with Bortezomib.
neutropenia, thrombocytopenia and anemia are the most frequent hematological events reported with both liposome doxorubicin therapy in collaboration with bortezomib and bortezomib single therapy. Neutral leukocyte reduction rate 3 and 4 in the combined treatment group is higher than the single group (28% compared to 14%). The reduction of platelets of 3 and 4 platelets in the combined treatment group is higher than that of the single -treatment group (22% compared to 14%). The same rate of anemia in both treatment groups (7% compared to 5%).
Stomatitis is reported more often in combined treatment groups (16%) compared to single -treatment groups (3%), and most cases are at level 2 or lower. Stomatitis 3 is reported in 2% of patients in the combined treatment group. There is no stomatitis 4 reported.
Nausea and vomiting are reported more often in combined treatment groups (40% and 28%) compared to the single group (32% and 15%) and most are at levels 1 and 2.
Discontinue treatment of one or both agents due to adverse events found in 38% of patients. Common unfavorable events lead to stopping the treatment of Bortezomib and Doxorubicin Liposomes including the iridescent erythematosa of the palms - the soles of the feet, the nerve pain, the peripheral neuropathy, the peripheral sensory neuropathemia, the reduction of blood platelets, reducing blood pressure, and fatigue.
Table 7: Unwanted effects related to treatment in clinical studies on multiple marrow are reported (doxorubicin liposome 30 mg/m2 combined with Bortezomib every 3 weeks) according to the severity, the classification system according to the Meddra Agency and the related phase:
Very popular (≥ 1/10); Popular (≥ 1/100,
cioms III
(≥ 5%).
level 3/4 **
(≥ 5%).
All levels of seriousness
(1-5%).
simplex, herpes zoster.
Sodium blood, lower blood calcium.
** 3/4 adverse events are based on the adverse events of all serious levels with the entire occurrence rate of ≥ 5% (see adverse events listed in the first column).
Kaposi cancer program is related to AIDS
Clinical studies are reported on Kaposi cancer patients related to AIDS treated at the dose of 20 mg/m2 with doxorubicin liposome, showing that the most unwanted unwanted effect is related to the liposomed doxorubicin (occurring in about half of patients).
leukopenia is the most unwanted effect that is reported to doxorubicin liposome in the target population population; Neutral leukopenia, anemia and thrombocytopenia have been reported. These effects can occur early during treatment. Hematology toxicity can lead to the need for dose reduction or not indicated or delayed treatment. Temporarily stop treatment with liposome doxorubicin in patients with the number of ANCs
Unwanted respiratory effects are often reported in clinical studies on liposome -form Doxorubicin and may be related to opportunistic infections in the AIDS population group. The opportunity infection is reported in Kaposi cancer patients after liposome -formed doxorubicin, and is often reported in HIV immunodeficiency patients. The most opportunistic infections reported in clinical studies are candidiasis, cytomegalovirus, herpes simplex, pneumocystis carinii and mycobacterium avium complex.
Table 8: Unwanted effects are reported in Kaposi cancer patients related to AIDS by CIMS III frequency classification:
Very popular (≥ 1/10); Popular (≥ 1/100, common is not common . Feeling. > Respiratory, chest, interstitial disorders Variable Regularly significant clinical values are common (≥ 5%) including, increasing alkaline phosphatase; AST and Bilirubin are thought to be related to background diseases and not related to liposome doxorubicin. Reduce hemoglobin and platelets less less ( All patients 10.8% of patients with solid tumors are reported to have a reaction related to infusion during the liposome doxorubicin treatment process as determined by the following costart terms: allergic reactions, anaphylactic reactions, asthma, facial edema, blood pressure, vasodilation, urticaria, back pain, chest pain, chills, fever, puppet rhinos, dizziness, flee Ban, itching, sweating, response to the injection site and drug interaction. The permanent treatment stop is reported infrequently at a ratio of 2%. A corresponding ratio of the infusion reaction (12.4%) and discontinuation (1.5%) is reported in the anti -breast cancer program. In patients with multiple tumors using liposome doxorubicin combined with bortezomib, blood transfusion -related reactions have been reported at 3%. In Kaposi cancer patients related to AIDS, blood transfusion reactions are characterized by flushing, shortness of breath, face, headache, chills, back pain, angina and throat and/or hypotension occurs at a rate of 5% to 10%. It is rare for convulsions to be reported regarding the infusion reaction. In all patients, the reactions related to infusion are reported mainly in the first infusion. Temporarily stopping the injecting injecting often solve these symptoms without additional treatment. In most patients, doxorubicin treatment liposome may be continued after all symptoms have been resolved without recurrence. The reactions caused by infusion rarely relapse after the first treatment cycle with liposome doxorubicin. Hemostasis related to anemia, thrombocytopenia, leukopenia, and neutropenia fever but rarely, have been reported in patients treated with liposome doxorubicin. Haven't been reported in patients with continuous transmission doxorubicin hydrochlorid and are often reported in patients using liposome doxorubicin. It does not interfere with patients who are completing the treatment and does not need to adjust the dose, unless the stomatitis affects the patient's ability to eat. In this case, the dose distance may last 1-2 weeks or reduce the dose. Increased congestive heart failure rate is reported on doxorubicin therapy at cumulative dose> 450 mg/m2 or at lower doses for patients with heart risk factors. The heart muscle biopsy in Kaposi cancer patients related to AIDS receives the cumulative dose of liposomed doxorubicin liposome greater than 460 mg/m2, the report has no evidence of myocardial disease caused by anthracyclin. The recommended dose of liposome doxorubicin for Kaposi cancer patients related to AIDS is 20 mg/m2 every two to three weeks. The cumulative dose can lead to concerns about heart toxicity in Kaposi cancer patients related to AIDS (> 400 mg/m2) will need more than 20 liposome doxorubicin treatment within 40 to 60 weeks. In addition, the heart muscle biopsy is performed in patients with solid tumors with anthracyclin doses accumulated 509 mg/m2-1,680 mg/m2. Billingham heart toxicity is reported from 0 to 1.5. These points correspond to no or mild heart toxicity. In phase III study, controlled compared to doxorubicin, 11.4% of the objects are randomly divided (liposomed doxorubicin at the dose of 50 mg/m2/every 4 weeks compared to doxorubicin at the dose of 60 mg/m2/every 3 weeks) to meet the defined criteria in the outline for heart toxicity during treatment and/monitoring. The toxicity on the heart has been defined as a decrease of 20 points or more compared to the initial value if the LVEF left ventricle fraction value in a resting state is still normal or 10 points or more if the LVEF becomes abnormal (lower than the lower limit of normal). There are no objects using the liposome doxorubicin that has heart toxicity according to the LVEF criteria to report signs and symptoms of congestive heart failure. In contrast, the subjects using doxorubicin have heart toxicity according to LVEF criteria to report signs and symptoms of congestive heart failure. In patients with solid tumors, including a small group of breast and ovarian cancer patients, treated at a dose of 50 mg/m2/cycle with anthracyclin doses of accumulated up to 1,532 mg/m2, the rate of heart failure is low clinical function. Among patients treated with liposome doxorubicin at the dose of 50 mg/m2/cycle, there is a original left left ventricular fraction index and at least one monitoring measurement is evaluated by Muga Scan, 21% of patients report an accumulated anthracyclin> 400 mg/m2, which is the degree of exposure related to the increased cardiovascular risk of cardiovascular toxorubicin. Only 15% of them have at least one change with the significance of the sieve in left ventricular blood emulsion, which is defined as the value of left ventricular blood emulsion less than 45% or at least 20 points compared to the original value. As well as anti -cancer agents that damage DNA, secondary acute acute leukemia and marrow dysplasma syndrome have been reported in patients treated in combination with doxorubicin. Therefore, any patient treated with Doxorubicin should be monitored in hematology. Despite the rare local necrotic condition, the liposome doxorubicin is considered an irritant agent. Animal studies report that the use of doxorubicin hydrochlorid as a liposome formula reduces the possibility of vascular drainage damage. If there is any sign or symptom of vascular exit (such as pain, erythema), stop the infusion and start transmitting in another vein. The ice water in the circuit where the circuit is about 30 minutes may be helpful in reducing local reactions. Doxorubicin liposome is not used by intramuscular or subcutaneous injection. Radiotherapy reactions were previously reported when using liposome but rare doxorubicin. After -marketing experience, the adverse drug reactions are reported during marketing after bringing the drug to the market in the treatment regimen with the liposomed doxorubicin that has been described in Table 9 . The frequencies are provided according to the following conventions:
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Do not use liposomed doxorubicin to treat Kaposi cancer related to AIDS that can be effectively treated with local therapy or alfa-intereron.
Be cautious when using
Due to the difference in pharmacokinetics and drug use time, doxorubicin liposome is not used with other formulas of doxorubicin hydrochlorid.
heart toxicity
All patients using liposome doxorubicin are recommended regularly monitoring the electrocardiogram. The transient changes on the center of electrocardiograms such as flattening T waves, reducing S-T segment and mild arrhythmia are not considered to be a mandatory indication for the liposomicin-shaped discontinuation stopping. However, the shortening of the QRS complex is considered a sign of heart poisoning. If this change occurs, the most affirmative test for anthracyclin heart muscle lesions such as myocardial biopsy should be considered.
The more specific methods to evaluate and monitor heart functions compared to ECG is to measure left ventricular blood emulsion with an echocardiography or better than staphylococcal blood vessel (Muga). These methods must be applied regularly before starting liposome doxorubicin treatment and repeat periodically during treatment. The assessment of left ventricular function is considered to be mandatory before each additional liposomed Doxorubicin transmission exceeding the accumulated anthracyclin dose of 450 mg/m2.
The evaluation tests and methods mentioned above are related to the monitoring of the heart activity during the treatment with anthracyclin should be done in the following order: Monitoring of the electrocardiogram, measuring the rate of left ventricular blood, making myocardial biopsy. If there is a test result indicates that there may be heart damage related to liposome doxorubicin therapy, the benefits of continuing treatment must be carefully considered compared to the risk of heart damage.
In patients with heart disease that needs treatment, only liposome doxorubicin is used when the treatment benefits are greater than the risk for patients.
Be careful in patients with heart failure treatment with liposome.
Whenever there is a doubt about the condition of myocardial pain, that is, the left ventricular blood vessel is significantly reduced compared to the values before treatment and/or the left left ventricular ratio is lower than the relevant predictive value (for example: Sexy congestive heart failure can occur, no change in electrocardiogram values first and that can occur a few weeks after treatment. Be cautious in patients who have used other anthracyclin drugs. The total dose doxorubicin hydrochlorid must also take into account any previous treatment (or simultaneous) with toxic drugs on the heart such as other anthracyclin/anthraquinon or example 5- fluorouracil. Heart toxicity can also occur at an accumulated dose of anthracyclin less than 450 mg/m2 in patients with mediastinic radiation earlier or in patients being treated with cyclophosphamid.
Safety on the heart for the recommended dose for both breast and ovarian cancer (50 mg/m2) is similar to the safety of 20 mg/m2 in Kaposi cancer patients related to AIDS.
Bone marrow function decline
Many patients are treated with liposome doxorubicin with previous bone marrow failure due to factors such as their previous HIV or many drugs are using simultaneously or before, or tumors related to bone marrow. In control tests, ovarian cancer patients are treated at a dose of 50 mg/m2, bone marrow failure is usually mild to moderate, can be reversed and not related to neutrophil infection stages or blood infections. In addition, in a clinical study reported on liposome doxorubicin compared to Topotecan, the rate of blood infections due to significantly less treatment among ovarian cancer patients treated with liposome doxorubicin. The similar rate of bone marrow failure is also found in metastatic breast cancer patients with liposome doxorubicin in a reported clinical study. In contrast to the experience of treating breast or ovarian cancer patients, bone marrow failure seems to be an adverse event leading to a decrease in the dose in Kaposi cancer patients related to AIDS. Because it is likely to cause bone marrow failure, it is necessary to perform periodic blood cell counts during the liposome doxorubicin treatment, and at a minimum, before each doxorubicin liposome dose.
Serious bone marrow failure can lead to superinfection or hemorrhage.
In control clinical studies, Kaposi cancer patients are related to AIDS, compared to Bleomycin/Vincristin treatment group, chance of chance infections seems to occur more often during treatment with liposomed doxorubicin. Patients and doctors must be aware of this rate higher and have appropriate interventions.
Secondary hematology
As well as other anti -proliferation drugs that cause DNA damage, secondary acute medullary leukemia and marrow dysfunction syndrome are reported in patients treated with doxorubicin in the coordination regimen. Therefore, it is necessary to monitor hematology on any patient treatment with Doxorubicin.
Secondary oral cancer
Very rare cases of secondary oral cancer are reported in patients with long -term exposure (more than a year) with liposomed doxorubicin or people with doxorubicin doses of liposome forms higher than 720 mg/m2. Cases of secondary oral cancer are diagnosed during liposome doxorubicin treatment and up to 6 years after the last dose. Patients need to be checked periodically to see if there is an oral ulcer or any discomfort in the mouth that can show secondary oral cancer.
A reaction related to infusion
Serious reactions and sometimes threaten life, have the same characteristics as an allergic or anaphylactic reaction, with symptoms including asthma, flushing, urticaria, chest pain, fever, hypertension, fast heart rate, itching, sweating, shortness of breath, face, chip, chest pain and sore throat and/or lower blood pressure may occur within a few minutes after the beginning of the liposomicin. Convulsions associated with infusion reactions also occur but rare. Temporarily stop the infusion will solve these symptoms without additional treatment. However, drugs to treat these symptoms (for example, antihistamine, corticosteroids, adrenalin, and anti -convulsions), as well as emergency equipment, must be available for use immediately. In most patients, treatment may be continued after all symptoms have been resolved, without recurrence. The infusion reaction rarely relapses after the first treatment cycle. To minimize the risk of infusion reaction, the initial dose should be used at a speed of not greater than 1 mg/min.
Diabeten patient
Note that each liposomed doxorubicin vial contains sucrose and this dose is mixed in 5% glucose solution (50 mg/ml) for transmission.
The effect of the drug on the ability to drive and operate machinery
Do not drive or operate equipment, machines when feeling tired or drowsy due to treatment with liposome formorubicin.
Use drugs for women during pregnancy and lactation
pregnancy
Because the active component doxorubicin hydrochlorid in chemodox can cause birth defects, notify your doctor if you think you are pregnant. Another important thing is that your partner or your partner uses a reliable method of contraception to avoid pregnancy during liposome doxorubicin treatment and for 6 months after stopping treatment. This applies to both male and female patients when treated with liposome doxorubicin.
breastfeeding
Because Doxorubicin Hydrochlorid can harm children, women have to stop breastfeeding before starting liposome doxorubicin treatment. Medical experts recommend HIV -infected women who do not breastfeed in any case to avoid HIV transmission.
Drug interaction
There is no official drug interaction research with liposomed doxorubicin, although stage II trials with common chemotherapy agents have been reported in patients with gynecological malignant tumors. Be careful in using the drug products that interact with Doxorubicin Hydrochlorid. Doxorubicin liposome, like other Doxorubicin Hydrochlorid preparations, can increase the toxicity of other anti -cancer therapies. In clinical studies reported in patients with solid tumors (including breast and ovarian cancer), those who have used cyclophosphamide or taxanes, no toxicity have been recorded. In AIDS patients, cyclophosphamide hemorrhage dramatic drama and the liver toxicity of 6-Mercaptopurin have been reported to the standard Doxorubicin Hydrochlorid. Must be cautious when indicated simultaneously any other cytotoxic toxic agents, especially toxic drugs on the marrow.
The correspondence of the drug: Because there is no studies on the cavalry of the drug, does not mix this drug with other drugs.
Storage
Unright vials should be stored at temperatures from 2 ° C to 8 ° C. Avoid freezing temperatures. After dilution with 5% dextrose in intravenous water, the diluted liposome doxorubicin solution should be used immediately. The non -used diluted product is stored at a temperature from 2 ° C to 8 ° C for no more than 24 hours. The vials that have been used in part should be removed.
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