Pemetrexed Disodium for Injection
Manufacturer
Jiangsu Hansoh Pharmaceutical Group Co., Ltd. – China
Applicant company
TV Pharmaceutical Trade Promotion and Investment Co., Ltd.
Active ingredient
Pemetrexed (as pemetrexed disodium hemipentahydrate 120.8 mg)
Content
100 mg
Shelf life
36 months
Dosage Form
Powder for concentrate for solution for infusion (Lyophilized powder for injection)
Package
Box of 1 vial
Visa Number
690114133726
Issuing Date
July 10, 2026
Expiration Date
July 10, 2031
Therapeutic area
Antimetabolite
Indication
Malignant Pleural Mesothelioma:
Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma.
Non-Small Cell Lung Cancer:
Pemetrexed in combination with cisplatin is indicated as first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section Pharmacodynamic Properties).
Pemetrexed is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section Pharmacodynamic Properties).
Pemetrexed is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section Pharmacodynamic Properties).
Dosage
Pemetrexed must only be administered under the supervision of a physician qualified in the use of antineoplastic chemotherapy.
Pemetrexed in Combination with Cisplatin:
The recommended dose of pemetrexed is 500 mg/m² of body surface area (BSA) administered as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle. The recommended dose of cisplatin is 75 mg/m² BSA infused over 2 hours, approximately 30 minutes after completing the pemetrexed infusion on Day 1 of each 21-day cycle. Patients must receive adequate antiemetic premedication and appropriate hydration prior to and/or after receiving cisplatin (refer to the Summary of Product Characteristics for cisplatin for specific dosing guidelines).
Pemetrexed as Monotherapy:
In patients treated for non-small cell lung cancer who have received prior chemotherapy, the recommended dose of pemetrexed is 500 mg/m² BSA administered as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle.
Premedication Regimen:
To reduce the incidence and severity of skin reactions, a corticosteroid should be given the day prior to, on the day of, and the day after pemetrexed administration. The corticosteroid should be equivalent to oral dexamethasone 4 mg twice daily (see Special Warnings and Precautions for Use).
To reduce toxicity, patients treated with pemetrexed must receive vitamin supplementation (see Special Warnings and Precautions for Use). Patients must take oral folic acid or a multivitamin product containing folic acid (350 to 1,000 mcg) daily. At least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and dosing must continue throughout the entire course of therapy and for 21 days following the last dose of pemetrexed. Patients must also receive an intramuscular injection of vitamin B12 (1,000 mcg) in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be administered on the same day as pemetrexed.
Monitoring:
Prior to each dose of pemetrexed, patients must be monitored with a complete blood count (CBC), including differential white cell count and platelet count. Periodic blood chemistry tests must be performed to evaluate renal and hepatic function prior to each cycle of chemotherapy. Prior to initiating each cycle of chemotherapy, patients must meet the following requirements:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³.
- Platelet count ≥ 100,000 cells/mm³.
- Creatinine clearance (CrCl) ≥ 45 mL/min.
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN).
- Alkaline phosphatase (AP), aspartate aminotransferase (AST/SGOT), and alanine aminotransferase (ALT/SGPT) ≤ 3 times the ULN (≤ 5 times the ULN is acceptable if the liver has metastases).
Dose Adjustments:
Dose adjustments at the start of a subsequent cycle should be based on nadir hematologic counts or maximum non-hematologic toxicity from the preceding cycle of therapy. Treatment may be delayed to allow sufficient time for recovery. Upon recovery, patients should be retreated using the guidelines in Tables 1, 2, and 3, which apply to pemetrexed used as a single agent or in combination with cisplatin.
| Table 1 – Dose adjustment table for pemetrexed (as single-agent or in combination) and cisplatin – Hematologic toxicities | |
|---|---|
| Nadir ANC < 500/mm³ and nadir platelets ≥ 50,000/mm³ | 75% of previous dose (both pemetrexed and cisplatin) |
| Nadir platelets < 50,000/mm³ regardless of nadir ANC | 75% of previous dose (both pemetrexed and cisplatin) |
| Nadir platelets < 50,000/mm³ with bleedingᵃ, regardless of nadir ANC | 50% of previous dose (both pemetrexed and cisplatin) |
If patients develop non-hematologic toxicities ≥ Grade 3 (excluding neurotoxicity), pemetrexed should be withheld until resolution to less than or equal to the patient's pre-treatment value. Treatment should be resumed according to guidelines in Table 2.
| Table 2 – Dose adjustment table for pemetrexed (as single-agent or in combination) and cisplatin – Non-hematologic toxicities ᵃ,ᵇ | ||
|---|---|---|
| Dose of Pemetrexed (mg/m²) | Dose of Cisplatin (mg/m²) | |
| Any Grade 3 or 4 toxicity except mucositis | 75% of previous dose | 75% of previous dose |
| Diarrhea requiring hospitalization (irrespective of grade) or Grade 3 or 4 diarrhea | 75% of previous dose | 75% of previous dose |
| Grade 3 or 4 mucositis | 50% of previous dose | 100% of previous dose |
ᵇ Excluding neurotoxicity.
In the event of neurotoxicity, the recommended dose adjustments for pemetrexed and cisplatin are described in Table 3. Patients must discontinue therapy if Grade 3 or 4 neurotoxicity is observed.
| Table 3. Dose adjustment table for pemetrexed (as single-agent or in combination) and cisplatin – Neurotoxicity | ||
|---|---|---|
| CTC Grade ᵃ | Dose of Pemetrexed (mg/m²) | Dose of Cisplatin (mg/m²) |
| 0-1 | 100% of previous dose | 100% of previous dose |
| 2 | 100% of previous dose | 50% of previous dose |
Pemetrexed therapy must be discontinued if a patient experiences any Grade 3 or 4 hematologic or non-hematologic toxicity after 2 dose reductions, or immediately if Grade 3 or 4 neurotoxicity is observed.
Elderly:
In clinical trials, there was no evidence that patients ≥ 65 years of age are at increased risk of adverse reactions compared to patients < 65 years of age. No dose reductions other than those recommended for all patients are necessary.
Pediatric population:
Pemetrexed is not recommended for use in patients under 18 years of age, as the safety and efficacy have not been established in this population. There is no relevant use of pemetrexed in the pediatric population for the indications of malignant pleural mesothelioma and non-small cell lung cancer.
Renal impairment (Standard Cockcroft and Gault formula or Glomerular Filtration Rate measured by Tc99m-DTPA serum clearance method):
Pemetrexed is primarily eliminated unchanged by renal excretion. In clinical trials, patients with a creatinine clearance ≥ 45 mL/min required no dose adjustments other than those recommended for all patients. There are insufficient data on the use of pemetrexed in patients with a creatinine clearance < 45 mL/min; therefore, the use of pemetrexed is not recommended in these patients (see section Special Warnings and Precautions for Use).
Hepatic impairment:
No relationship between AST (SGOT), ALT (SGPT), or total bilirubin and the pharmacokinetics of pemetrexed was observed. However, patients with hepatic impairment such as bilirubin > 1.5 times the upper limit of normal (ULN) and/or aminotransferase > 3.0 times the ULN (in the absence of liver metastases) or > 5.0 times the ULN (with liver metastases) have not been specifically studied.
Contact
