Pemetrexed

Visa No.: 400114330525

Product: Pemetrexed Stada 100 mg

API: Pemetrexed

Product Category: Oncology

Version approved leaflet: 359/QĐ-QLD_17/07/2025_125.2

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Visa No.: 400114348700

Product: Pemetrexed Stada 500 mg

API: Pemetrexed

Product Category: Oncology

Version approved leaflet: 33235e/QLD-ĐK_17/09/2025

INDICATIONS

Malignant Pleural Mesothelioma

Pemetrexed STADA in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma who are not eligible for curative surgical resection.

Non-Small Cell Lung Cancer (NSCLC)
Pemetrexed STADA in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer, excluding predominantly squamous cell carcinoma histology.

Pemetrexed STADA is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer, excluding predominantly squamous cell carcinoma, in patients whose disease has not progressed immediately following platinum-based chemotherapy.

Pemetrexed STADA is indicated as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer, excluding predominantly squamous cell carcinoma, after prior chemotherapy.
 

DOSAGE AND ADMINISTRATION

Method of Administration 
For intravenous use only. Pemetrexed STADA must be administered as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle.

Pemetrexed in Combination with Cisplatin
The recommended dose of pemetrexed is 500 mg/m² 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, administered approximately 30 minutes after completion of the pemetrexed infusion on Day 1 of each 21-day cycle. Patients must receive adequate anti-emetic treatment and appropriate hydration prior to and/or following cisplatin administration (see also the Summary of Product Characteristics of cisplatin for specific dosing information).

Pemetrexed Monotherapy
In patients with non-small cell lung cancer who have received prior chemotherapy, the recommended dose of pemetrexed is 500 mg/m² body surface area (BSA), administered as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle.

Premedication
To reduce the incidence and severity of cutaneous reactions, corticosteroids should be administered prior to, on the day of, and after pemetrexed administration. The corticosteroid regimen should be equivalent to dexamethasone 4 mg administered orally twice daily (see section Warnings and Precautions).
To reduce toxicity, patients treated with pemetrexed must also receive vitamin supplementation (see section Warnings and Precautions). Patients should take oral folic acid or a multivitamin preparation containing folic acid (350–1,000 micrograms) once daily. At least five doses of folic acid must be taken during the seven days preceding the first dose of pemetrexed. Folic acid supplementation must be continued throughout treatment and for 21 days after the last dose of pemetrexed. Patients must also receive vitamin B12 (1,000 micrograms) by intramuscular injection during the week preceding the first dose of pemetrexed and once every three cycles thereafter. Subsequent vitamin B12 injections may be administered on the same day as pemetrexed. 

Monitoring During Treatment
Prior to each dose of pemetrexed, patients should undergo a complete blood count (CBC), including white blood cell count (WCC) and platelet count. Before each chemotherapy cycle, blood chemistry tests must be performed to assess hepatic and renal function.
Before initiating any cycle of chemotherapy, patients must meet the following criteria:

• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³
• Platelet count ≥ 100,000 cells/mm³
• Creatinine clearance ≥ 45 mL/min
• Total bilirubin must be ≤ 1.5 times the upper limit of normal (ULN).

Alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT), and alanine aminotransferase (ALT or SGPT) must be ≤ 3 times ULN. AP, AST, and ALT values of ≤ 5 times ULN are acceptable in patients with hepatic metastases.

Dose Adjustments
Dose adjustments at the start of subsequent cycles must be based on the lowest hematologic values (nadir) or the maximum non-hematologic toxicity observed during the preceding treatment cycle. Treatment may be delayed to allow sufficient recovery.
Following recovery, patients should be re-treated according to the recommendations outlined in Tables 1, 2, and 3, applicable to pemetrexed monotherapy or pemetrexed in combination with cisplatin.

Table 1 – Dose Adjustment Based on Hematologic Toxicity (Pemetrexed ± Cisplatin)

^a These criteria follow the National Cancer Institute Common Toxicity Criteria, version 2.0 (1998) for  bleeding events of Grade 2 or higher.

If a patient experiences severe non-hematologic side effects (Grade 3 or higher), excluding effects on the nervous system, treatment with pemetrexed should be temporarily stopped until the side effects improve to the patient’s condition before treatment. Treatment may then be restarted according to the dose adjustment recommendations in Table 2.

Table 2 - Dose Adjustment for Pemetrexed (Monotherapy or in Combination with Cisplatin) – Non-Hematologic Toxicities ^{a, b}

^a Toxicity grading is based on the National Cancer Institute Common Toxicity Criteria, version 2.0 (1998).
^b Excluding neurotoxicity.
In cases of neurotoxicity, dose adjustment recommendations for pemetrexed and cisplatin are provided in Table 3. Treatment should be discontinued if Grade 3 or Grade 4 neurotoxicity is observed.

Table 3 – Dose Adjustment for Pemetrexed (Monotherapy or in Combination with Cisplatin) – Neurotoxicity

^a Toxicity grading is based on the National Cancer Institute Common Toxicity Criteria, version 2.0 (1998).
Treatment with pemetrexed should be discontinued if a patient experiences any Grade 3 or Grade 4 hematologic toxicity after two dose reductions, or immediately if Grade 3 or Grade 4 neurotoxicity is observed.

Elderly Patients
In clinical studies, there was no evidence of an increased risk of adverse reactions in patients aged 65 years and older compared with patients younger than 65 years. No additional dose reduction is required, other than the dose adjustments recommended for all patients.

Pediatric Population
There is no relevant indication for the use of pemetrexed in children for the treatment of malignant pleural mesothelioma or non-small cell lung cancer.

Renal Impairment
Renal function should be assessed using the standard Cockcroft–Gault formula or glomerular filtration rate measured by technetium-99m diethylenetriamine pentaacetic acid clearance.
Pemetrexed is primarily eliminated unchanged via the kidneys. In clinical studies, patients with creatinine clearance of 45 milliliters per minute or greater did not require dose adjustment beyond the recommendations applicable to all patients
There are insufficient data on the use of pemetrexed in patients with creatinine clearance below 45 milliliters per minute. Therefore, use of pemetrexed is not recommended in this population (see section Warnings and Precautions).

Hepatic Impairment
No relationship between aspartate aminotransferase (serum glutamic oxaloacetic transaminase), alanine aminotransferase (serum glutamic pyruvic transaminase), or total bilirubin and the pharmacokinetics of pemetrexed has been identified.
However, patients with hepatic impairment characterized by total bilirubin greater than 1.5 times the upper limit of normal and/or aminotransferase levels greater than 3.0 times the upper limit of normal in the absence of hepatic metastases, or greater than 5.0 times the upper limit of normal in the presence of hepatic metastases, have not been specifically studied.

Method of administration
Pemetrexed should be administered as an intravenous infusion over more than 10 minutes on Day 1 of each 21-day cycle.

Special precautions for disposal and other handling

1. Aseptic technique should be used throughout the dilution and preparation of pemetrexed for intravenous infusion.
2. Calculate the required dose and the number of vials of Pemetrexed STADA needed. Each vial contains an overfill of pemetrexed to facilitate delivery of the labeled dose.
3. The appropriate volume of pemetrexed solution should be further diluted to a total volume of 100 milliliters with 9 milligrams per milliliter (0.9%) sodium chloride solution for injection, without preservatives, and administered as an intravenous infusion over more than 10 minutes.
4. Pemetrexed infusion solutions prepared as described above are compatible with polyvinyl chloride and polyolefin infusion sets and bags.
5. Parenteral medicinal products should be visually inspected for particulate matter and discoloration prior to administration. Do not use the product if particulate matter is observed.
6. Pemetrexed solution is intended for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Precautions for preparation and administration
As with other potentially toxic anticancer medicinal products, caution should be exercised when handling and preparing pemetrexed infusion solutions. The use of protective gloves is recommended.
If pemetrexed solution comes into contact with the skin, the affected area should be washed immediately and thoroughly with soap and water. If pemetrexed solution comes into contact with mucous membranes, they should be rinsed thoroughly with water.
Pemetrexed is not a vesicant. There is no specific antidote for pemetrexed extravasation. A limited number of cases of pemetrexed extravasation have been reported; however, these were not considered serious by investigators. Extravasation should be managed according to standard operating procedures applicable to non-vesicant medicinal products.
 

CONTRAINDICATIONS

• Hypersensitivity to pemetrexed or to any of the excipients of the medicinal product.
• Breast-feeding (see section Pregnancy and Lactation).
• Concomitant use with yellow fever vaccine (see section Interactions).
   

WARNINGS AND PRECAUTIONS

This medicinal product should be used under medical supervision only.
Read the instructions for use carefully before administration.
If additional information is required, consult a physician or pharmacist. 
Keep out of the reach of children.