Sunpexitaz injection powder 500 Sun Pharma treat malignant pleural epithelium, non -small cell lung cancer
Dosage form Box
Specifications Pemetrexed
Ingredient
| Composition information | Content |
| Pemetrexed | 500mg |
Uses
indications
Sunpexitaz 500 drug indicated treatment in the following cases:
Malignant pleural epithelium
Sunpexitaz is combined with cisplatin in chemotherapy for patients with malignant pleural epithelium.
Small cell lung cancer
Sunpexitaz combined with cisplatin is the top chosen therapy for patients with non -small or localized cell lung cancer patients or metastatic metastases (NSCLC), not scaling cells by histological.
Sunpexitaz is indicated as a single -treatment drug in maintenance treatment for patients with non -small or localized cell lung cancer patients or has been metastatic, not scaling cells by histological but the disease does not progress after chemotherapy with platinum.
Sunpexitaz is indicated as a second row treatment for patients with non -small or localized cell lung cancer patients or has been metastatic, not scaling cells.
Pharmacokic
pemetrexed is folic acid -containing acid -containing acid -containing nucleus. ATC code: L01BA04.
Mechanism of impact
Pemetrexed is an anti -cancer anti -cancer drug with many targets, which is effective by breaking the metabolic processes mainly dependent on folats needed for cell copy.
In vitro research has shown that Pemetrexed inhibits thymidylate synthase (TS), reductase dihydrofolate (DHFR), and glycinamide ribonucleotide formyltransferase (Garft), are the main folat -dependent enzymes for the synthetic biosome of thymidine and other nucleotidide
Pemetrexed is transported into the cell by both folat reducing agents and folate -mounted protein transportation systems. Once in the cell, Pemetrexed is converted into polyglutamat form by enzyme folylpolyglutamat synthetase. Polyglutamate forms are retained in the cell and are inhibitors of TS and Garft. Polyglutamatization is the process of time and concentration that occurs in cancer cells, and to a more limited extent in normal tissues. The metabolites after the polyglutamat chemical process increases the selling time in cells, the result extends the effects of the drug in cancer cells.
Preceptic research has shown that Pemetrexed inhibits the in vitro growth of the Chinese cellular cell line (MSTO-211H, NCI-H2052). Research with MSTO-211H medium cellular cell line shows a powerful effect when Pemetrexed is combined with Cisplatin at the same time.
Dynamic pharmacokinetics
Pemetrexed pharmacokinetics properties after using the single dose were evaluated in cancer patients with solid tumors different from the dose of 0.2-838 mg/m injected in 10 minutes. Pemetrexed phase volume is 9 l/m2. In vitro studies show that Pemetrexed is connected to plasma proteins about 81%. This cohesion is not significantly affected by the level of renal failure. Pemetrexed is limited in the liver and is excreted mainly in urine with about 70% to 90% of the recovered dose with non -variable form in the urine within the first 24 hours of medication. In vitro research shows that Pemetrexed is active by OAT3 (organic anion transport).
Pemetrexed's total clearance coefficient is 91.8 ml/min and the semi -exhaust time of Pemetrexed is 3.5 hours in patients with normal kidney function (Creatinin clearance 90 mL/min). The variation of clearance among patients at an average level of 19.3%. System exposure level (AUC) of Pemetrexed and maximum concentration in plasma (CMAX) increases corresponding to the dose. Pemetrexed pharmacokinetics does not change in many treatment cycles.
Pemetrexed pharmacokinetics are not affected when used simultaneously with cisplatin. Supplementing oral folic acid or intramuscularly vitamin B2 does not affect the pharmacokinetics of Pemetrexed.
Before taking Sunpexitaz injection powder 500 Sun Pharma treat malignant pleural epithelium, non -small cell lung cancer
How to use
Sunpexitaz 500 medicine only used intravenous injection. Pemetrexed must be used under the supervision of the doctor.
Conditions to conduct cancer chemotherapy.
Dosage
Pemetrexed combined with Cisplatin: Sunpexitaz's recommended dose is 500 mg/m2 of the body surface area (BSA) using intravenously for 10 minutes on the 1st day of each 21 -day cycle. The recommended dose of cisplatin is 75mg/m2 BSA transmitted for 2 hours after the transmission of Sunpexitaz is about 30 minutes on the 1st day of each 21 -day cycle. Patients need to be fully anti -vomiting and appropriate rehydration before and/or after cisplatin transmission.
Single therapy with Pemetrexed: In patients with non -small cell lung cancer that has been chemically previously chemotherapy, the recommended dose of Sunpexitaz is 500 mg/batch of BSA using intravenously for 10 minutes on the 1st day of each 21 -day cycle.
Money treatment:
To reduce the rate and severity of severe skin reactions, a corticosteroid should be used on the previous day, the date of treatment and the day after treatment with Pemetrexed. Corticosteroid dose should be equivalent to 4 mg dexamethasone orally twice a day.
To reduce toxicity, patients should be supplemented with vitamins. Patients must take folic acid or multivitamine containing folic acid (350 to 1000 micrograms) per day. At least 5 doses of folic acid must be used during 7 days before the first pemetrexed treatment and must be maintained during the treatment and after 21 days of the last dose of Pemetrexed. Patients must be intramuscularly in the last week of the first week of the first pemetrexed dose and every 3 cycles
treated later. The next dose of vitamin B12 should be used on the same day as Pemetrexed.
Monitoring blood formulas and recommendations to reduce the dose
Patients need to be checked in the entire number of blood cells, including different types of leukocytes (WCC) and platelets before each treatment. Before each chemotherapy, it is necessary to collect blood counts to assess liver and kidney function. Before starting any chemotherapy cycle, patients must have: absolute neutrophilic amount (ANC) ≥ 1,500 cells/mm3, platelet number ≥ 100,000 cells/mm3; Creatinine clearance ≥ 45 ml/minute; The total bilirubin must be ≤ 1.5 times the above value of the normal level; Alkaline phosphate (AP), Aspartate Aminotransferase (AST or SGOT) and Alanine Aminotransferase (ALT or SGPT) must ≤ 3 times the limit value above normal level. Alkaline phosphatase, AST and ALT Recommendation of dose reduction - Adjusting the dose when catching the next cycle oil is based on the lowest number of blood cells or maximum toxicity on organs other than hematology from previous treatment cycles. The treatment may be postponed so that the patient has enough recovery time. After recovery, the patient can re -treat according to the instructions in the tables below that can be applied to Sunpexitaz for lone or in combination with cisplatin.
Sunpexitaz's dose calibration table (used or combined) and cisplatin based on hematology
If the patient appears toxicity other than hematology (except for nerve toxicity) ≥ level 3 (except for liver enzyme level 3), Sunpexitaz must be stopped until it is lower than or equal to the value before treatment of the patient. The treatment should be continued as directed by the table.
Sunpexitaz's dose calibration table (solitary or combined) and cisplatin based on toxicity other than hematology, b
| dose of Sunpexitaz (mg/m2) Dosage of cisplatin (mg/m2) That is In case of nerve toxicity, the recommended dosage for Sunpexitaz and Cisplatin is adjusted according to the table of patients to stop treatment if observed with nerve toxicity 3 or 4. Sunpexitaz's dose calibration table (solitary or combined) and cisplatin based on neurotoxicity Must stop treatment with Sunpexitaz after 2 decreased dose if the patient has any toxicity on or outside the blood system at level 3 or 4 (except for liver enzyme level 3) or stop immediately if the nerve toxicity level 3 or 4. Older patients: Do not record reports to increase the risk of unwanted effects in patients aged 65 and over. Therefore, no other dose reduction for patients over 65 years old in addition to the recommended dosage mode for all patients. Children and teenagers: There is no pemetrexed prescription for children with malignant pleural carcinoma and non -cell lung cancer. Hepatic failure: The relationship between AST (SGOT) has not been identified, ALT (SGPT) and Bilirubin with Pemetrexed pharmacokinetics. However, there are no specific reports for patients with hepatic impairment with bilirubin> 1.5 times limited to normal levels and/or aminotransferase> 3.0 times limited to normal levels (no liver metastasis) or> 5.0 times limited to normal levels (with liver metastasis). Renal failure (standard Cockroft and Gault or glomerular filtration rate measured by TC99M-DPTA serum clearance method): Pemetrexed is eliminated mainly in a constant form. Reports show that patients with creatinine clearance ≥ 45 ml/minute do not need any dose adjustments other than recommended adjustments for all patients. Not enough testing for patients with creatinine clearance below 45 ml/minute to recommend dosage for this group of patients. Therefore, Pemetrexed is not recommended for this object. Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? Complications have been known when overdose include bone marrow inhibition manifested by a decrease in neutrophils, platelets and anemia. Moreover, infections with or without fever, diarrhea, and/or mucositis have been recorded. During the overdose suspected, patients should be monitored with blood cells and should be treated when necessary. Can consider using calcium folinat/folic acid in the treatment of overdose, pemetrexed. In an emergency, call the 115 emergency center immediately or go to the nearest local health station. |
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Side Effects
Like other drugs, this drug can also cause unwanted effects, but not everyone has.
Please contact the doctor immediately if you have:
Fever or infection (common): If the body temperature increases to 38 ° C or higher, sweat or other signs of infection (because the number of white blood cells will decrease compared to normal). Infections (infections) can be severe and can lead to death.
If you feel chest pain (common) or tachycardia or abnormal heart rate (not common).
If you feel pain, redness, swelling or mouth ulcers (very common).
Allergic reaction: skin rash (very common)/feeling of burns or feeling throbbing (common), or fever (common). It is rare for severe skin reactions and can lead to death. Contact your doctor if you are severe, itchy or blistering (Stevens-Johnson syndrome or poisoned skin epidermis)
If you feel tired, faint, gasp or if your skin is pale (because the amount of haemoglobin will be lower than normal).
Bleeding gums, nose or mouth or bleeding cannot be held in any position, red or pink urine, unexpected bruises (because the number of platelets will be less than usual).
If you suddenly have trouble breathing, severe chest pain or coughing up phlegm with blood (uncommon) (which can indicate blood clots in pulmonary blood vessels).
Unwanted effects with Pemetrexed may include:
Very popular (can affect more than 1 of 10 people)
Anemal anemia is not reconstructed with a decrease in the number of white blood cells, red blood cells, platelets.
Radilic pneumonia (scars in the airbag of the lungs related to radiation) can occur when the patient is radiotherapy before or during and after treatment with Pemetrexed.
Record cases of limb pain, decreased temperature, skin discoloration, blood clot in pulmonary blood vessels (pulmonary embolism).
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Sunpexitaz 500 drug is contraindicated in the following cases:
Be cautious when using
pemetrexed can inhibit the function of the marrow, manifested by neutropenia, thrombocytopenia and anemia (or anemia). The marrow failure is usually the toxicity of dosage limits. Patients should be monitored the medullary disease during treatment and should not use Pemetrexed until the patient has absolute neutrophilic number (ANC) returning to ≥ 1500 cells/mm3, platelet number ≥ 100,000 cells/mm3. Reducing the dose for the next cycle is based on the lowest number of neutral white blood cells (ANC), the number of platelets, and the maximum toxicity on the system other than the hematology observed in previous cycles.
When treated first with folic acid and vitamin B2, less toxicity and reduce the toxicity level on hematology and outside the hematological system of 3/4. Therefore, all patients treated with Pemetrexed must be instructed to use Folic acid and vitamin B2 as preventive measures to reduce treatment toxicity.
Skin reaction has been reported in patients with no treatment for corticosteroids. Pre -treatment with dexamethasone (or equivalent) may reduce the rate and extent of skin reactions.
Not enough data for patients with creatinine clearance below 45ml/min. Therefore, it is not recommended to use Pemetrexed for patients with creatinine clearance
Patients with mild to medium to medium renal failure (Creatinine clearance from 45 to 79 ml/minute) should be avoided using nonsteroidal anti -inflammatory drugs (NSAIDs), such as ibuprofen and acetyl acetyl acetyl (> 1.3g daily) 2 days ago, on the day of use and 2 days after using Pemetrexed.
In patients with mild kidney failure, which is suitable for treatment with Pemetrexed, NSAIDs should be discontinued at least 5 days ago, dated and at least 2 days after using Pemetrexed.
Severe renal disease, including acute renal failure, has been reported when using a single pemetrexed or combined with other chemotherapy agents. In which many cases of patients who have kidney events include dehydration or a history of hypertension or diabetes.
The effect of fluid in the third cavity such as pleural spills and ascites on pemetrexed unknown. There is no difference in the dose of Pemetrexed to normalize plasma concentrations or clearance comparison in two groups of solid tumors without fluid in the third cavity and have a stable amount of fluid in the third compartment. Therefore, the drainage needed in the third cavity before treatment but this may not be necessary.
Due to the toxicity on the digestive system when using Pemetrexed with cisplatin, heavy dehydration has been reported. Therefore, patients need to be treated with appropriate anti -vomiting and rehydration before and/or after treatment.
Serious cardiovascular events, including myocardial infarction and cerebral vascular events, are not common during treatment with Pemetrexed, usually when combined with other cytotoxic agents. Most patients with these events have been reported with previous cardiovascular risk factors.
Due to immunodeficiency in cancer patients, it is not recommended to simultaneously use toxic vaccines.
Pemetrexed can damage the genetic system, male patients are advised not to have children during treatment and until 6 months after the end of treatment. Contraceptive or abstaining from sex should be recommended. Because of the influence of pemetrexed on the fertility does not recover, male patients need sperm preservation advice before starting treatment.
Women's patients of reproductive age must use effective contraception during treatment with Pemetrexed.
Cases of radiotherapy pneumonia have been reported in patients with radiation therapy earlier, during the process or after being treated with Pemetrexed. Precautions especially on this patient and careful in the process of using other radioactive agents.
Cases of reigning chemotherapy reaction after radiation have been recorded in patients with radiation therapy for weeks or many years earlier.
Warning related to excipients
The drug contains sodium hydroxid.
Each Sunpexitaz 500 vial contains about 54 mg of sodium. Caution should be used for patients with sodium diet.
Each Sunpexitaz 100 bottle contains less than 1 mmol of sodium (23 mg) is considered as no sodium.
Preparations also contain mannitol capable of causing light laxative.
Children and teenagers
There is no relevant data for the use of Pemetrexed in the young population.
Using drugs for women during pregnancy and lactation
pregnancy
If you are pregnant, you think you are pregnant or plan to have children, let your doctor.
Avoid using Pemetrexed during pregnancy. Your doctor will discuss with you the potential risk when using Pemetrexed during pregnancy. Female patients should use effective contraception during treatment with Pemetrexed.
breastfeeding
If you are breastfeeding, let your doctor know.
Should stop breastfeeding during treatment with Pemetrexed.
Reproduction
Male patients are advised not to have children during the process until 6 months after treatment with Pemetrexed and thus use effective contraceptive methods during the treatment process with Pemetrexed and until 6 months after stopping treatment. If you want to have children during treatment or for 6 months after being treated, consult your doctor or pharmacist. You may need to search for sperm preservation before starting therapy.
The effect of the drug on the ability to drive and operate machinery
Pemetrexed can make you feel tired. Be cautious when driving or operating machinery.
Drug interaction
pemetrexed is eliminated mainly in the form of unchanged by the kidneys by excretion in the renal tubules and a part of the glomerular filtration. Concomitance of the kidney toxic drugs (for example, aminoglycoside, diuretics, platinum compounds, cyclosporin) can slow down the Pemetrexed clearance.
The combination of drugs should be used carefully. If needed, closely monitor creatinine.
Simultaneous use of substances with excreted drugs in the renal tubules (for example, probenecid, penicillin) capable of slowing the Pemetrexed clearance. Be cautious when combining these drugs with Pemetrexed. If needed, closely monitor creatinine.
In patients with normal renal function (clearinine clearance ≥ 80 ml/min), high doses of non-inflammatory anti-inflammatory drugs (NSAIDs, such as ibuprofen> 1600 mg/day) and acetylsalicylic acid at high doses (> 1.3 g/day) can reduce pemetrexed elimination and increase the appearance of desirable effects of Pemetrexed. Therefore, cautious when using high doses of NSAIDs or acetylsalicylic acid simultaneously with Pemetrexed for patients with normal renal function (clearing creatinine ≥ 80ml/min).
In patients with mild to medium to medium renal failure (clearing creatinine from 45 to 79 ml/minute), it is advisable to avoid simultaneous use of pemetrexed with NSAIDs or acetylsalicylic acid high doses in the previous 2 days, during the day of use and in the next 2 days after using Pemetrexed.
Due to the lack of data related to the risk of interacting with NSAIDs with long -selling time, such as Piroxicam or Rofecoxib, it is advisable to avoid simultaneous treatment with Pemetrexed for at least 5 days ago, on use, and at least 2 days after Pemetrexed transmission. If it is necessary to simultaneously use an NSAIDs, patients need to be closely monitored, especially the inhibition of the marrow, kidney toxicity, and gastrointestinal toxicity.
Pemetrexed is less metabolized in the liver. Results from in vitro studies with liver microsome shows that pemetrexed does not cause clinical inhibition on the metabolism of the drug metabolized by CYP3A, CYP2D6, CYP2C9, and CYP1A2.
General interactions for all cellular toxins:
Due to the increased risk of thrombosis in cancer patients, anticoagulants are often used. Due to the large oscillation between individuals about coagulation in diseases and due to the ability to interact with oral anticoagulants with anti -cancer chemotherapy drugs, the Inr (International Chemical Index) needs to be monitored more frequently if deciding to use oral anticoagulants for patients.
Contraindications to simultaneously:
Concomitance Pemetrexed with a yellow fever vaccine is contraindicated due to the risk of death related to the disease ...
Concomitant use with drugs is not recommended:
Concomitance Pemetrexed with a Vaccination Vaccine reduces poison (except for yellow fever vaccine is contraindicated) is not recommended due to the risk of systemic pathology, which can be fatal and disease. The risk of increasing in the subject has been immunodefits due to pathological causes. Use inactivated vaccines if needed (polio).
Storage
Store under 30 ° C. Use the infusion within 24 hours after the beginning of the revert. Eliminate unused excess.
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