Pemetrexed is administered intravenously drip for 10 minutes.
Locally or metastatic non-small cell non-small cell lung cancer The first line of therapy.
Combined treatment with cisplatin:
The recommended dose of ALIMTA® is 500 mg / m2 on the first day of each 21-day cycle.
Cisplatin is administered at a dose of 75 mg / m against hydration (see instruction on the use of cisplatin) approximately 30 minutes after the administration of ALIMTA® on the first day of each 21-day cycle.
Supportive chemotherapy in patients with no progression after the first line of therapy based on derivatives of platinum. Monotherapy: The recommended dose of ALIMTA® is 500 mg / m2 on the first day of each 21-day cycle.
The second line of therapy. Monotherapy:
The recommended dose of ALIMTA® is 500 mg / m2 on the first day of each 21-day cycle.
Malignant pleural mesothelioma
Combined treatment with cisplatin:
The recommended dose of ALIMTA® is 500 mg / m2 on the first day of each 21-day cycle.
Cisplatin is administered at a dose of 75 mg / m against hydration (see instruction on the use of cisplatin) approximately 30 minutes after administration of ALIMTA® on the first day of each 21-day cycle.
Recommendations before starting the use of the drug ALIMTA® The administration of dexamethasone (or analogue) at a dose of 4 mg 2 times a day, 1 day before the start of treatment with pemetrexed, on the day of administration and the day after administration of pemetrexed reduces the frequency and severity of skin reactions. To reduce the toxicity of the drug to patients receiving pemetrexed, preparations of folic acid or multivitamins containing folic acid, providing its daily requirement, should be prescribed. Folic acid (from 350 μg to 1000 μg, an average of 400 μg) should be given for at least 5 days for 7 days before the first administration of pemetrexed, during the entire treatment cycle and for 21 days after the last administration of pemetrexed. Patients also need to once inject vitamin B12 at a dose of 1000 μg intramuscularly for 7 days before the first injection of pemetrexed and then every 3 cycles after the start of treatment. The subsequent administration of vitamin B12 at the same dose can be performed on the day of administration of pemetrexed. Observation |
For all patients receiving pemetrexed, it is recommended to observe before each injection of the drug for a general clinical analysis of blood, including the definition of the leukocyte formula and the number of platelets.To assess the function of the kidneys and liver, a biochemical blood test should be performed before each injection of pemetrexed. Before the beginning of each cycle of chemotherapy, the absolute number of neutrophils (ACH) should be> 1500 cells / mm3, the number of platelets -> 100000 cells / mm3, the concentration of the total bilirubin - <1.5 times the upper limit of the norm (HHV), alkaline phosphatase, aspartic and alanine aminotransferases <3 times of IGN, or <5 times of IGN in the presence of metastases in the liver. Recommendations for dose reduction. Dose adjustment before repeated cycles should be carried out, based on the lowest of the hematological parameters or at the most pronounced non-hematologic toxicity during the previous treatment cycle. Treatment can be delayed in order to recover from manifestations of toxicity. As treatment is restored, treatment should be continued in accordance with the recommendations in Tables 1-3, which relate to the use pemetrexeda in monotherapy or in combination with cisplatin.
Table 1. Dosage regimen of pemetrexed (with monotherapy or combined therapy) and cisplatin |
Hematological toxicity | Correction dose (mg / m2) |
The minimum neutrophil count <500 / μL and the minimum platelet count> 50,000 / μL | 75% from previous doses (pemetrexed and cisplatin) |
The minimum platelet count <50,000 / μl, regardless of the minimum neutrophil count | 75% from previous doses (pemetrexed and cisplatin) |
a These criteria are consistent with the definition bleeding> = 2 according with the criteria of general toxicity National Cancer Institute (NCI-CTC). With the development of non-hematological toxicity (excluding neurotoxicity) > = 3 degrees, treatment is necessary defer to restoration of indicators, corresponding to the value before the start of treatment. Further therapy should be continued in accordance with the recommendations given in Table 2.
Table 2. Dosage regimen of pemetrexed (with monotherapy or combined therapy) and cisplatin |
Non-hematologic toxicitya, b
| Dose pemetrek sediment (mg / m2) | Dose ciceres ina (mg / m2) |
Any toxicity level 3 or 4 for exclusion inflammations mucous shells | 75% of the previous dose | 75% of the previous dose |
Diarrhea requiring hospitalization and (regardless of degree) or grade 3 or 4 diarrhea | 75% of the previous dose | 75% of the previous dose |
Inflammation | 50% of | 100% from |
mucous | previous | previous |
shell 3 | dose | dose |
or 4 degrees |
|
|
a According to the criteria NCI CTC; b Excluding neurotoxicity. |
AT the case neurotoxicity, the recommended dose adjustment for pemetrexed and cisplatin is shown in Table 3. For neurotoxicity of grade 3 or 4, treatment should be discontinued.
Table 3. The dosage regimen of pemetrexed (with monotherapy or combined therapy) and cisplatin |
Power neurotok blue | Dose pemetrek sediment (mg / m2) | Dose cisplatin on (mg / m2) |
0-1 | 100% of the previous dose | 100% of the previous dosage |
2 | 100% of the previous dose | 50% of the previous dose |
Treatment pemetrexed should be discontinued if the patient has hematologic and non-hematologic toxicity grade 3 or 4 after two decreases in doses or immediately reversed if neurotoxicity is 3 or 4 degrees.
Special patient groups
Elderly Patients: Data on The risk of side effects in patients 65 years of age or older is absent. Reduction mode doses meet the general recommendations.
Patients with impaired renal function: At QC values of at least 45 ml / min, dose adjustment and administration of the drug is not required.Patients with SC less than 45 ml / min pemetrexed is not recommended (due to insufficiency of data on the use of the drug in this category of patients).
Patients with impaired hepatic function: Insufficient data on the use of the drug in patients with impaired liver function with an excess of bilirubin concentration is more than 1.5 times the upper limit of the norm (UGN), or the excess of aminotransferase activity is more than 3 times that of UGH (in the absence of metastases in the liver), or more than 5 times from VGN (in the presence of metastases in the liver).
Recommendations for the preparation of a solution for infusions
1. Only 0.9 is used as a solvent % solution of sodium chloride.
2. For the preparation with a dosage of 100 mg: to obtain a solution for infusions, the contents of the vial (100 mg) are dissolved in 4.2 ml of 0.9% sodium chloride solution (without preservatives) 25 mg / ml (approximately). Each vial is gently shaken until completely dissolved lyophilisate.
The resulting solution should be clear; it is permissible to change the color of the solution from colorless to yellowish or greenish-yellow in color.
3. The corresponding volume of the obtained pemetrexed solution must be further diluted to 100 ml 0.9 % solution of sodium chloride.
4. Before administration, the drug solution should be inspected for particles and discoloration.
The solution for administration should be used immediately or within 24 hours if stored at 2-8 ° C, since pemetrexed and the recommended solvent not contain antibacterial preservatives. Unused solution must be disposed of.