ALIMTA(注射用培美曲塞)

ALIMTA (pemetrexed for injection) Function and indications] FDA-approved indications: 2004, malignant pleural mesothelioma; 2008, non-small cell lung cancer; 2009, long-term treatment of non-small cell lung cancer

[Model and specification] 50ml

[Usage and dosage] This product should be used under the guidance of qualified physicians with experience in the application of anti-tumor chemotherapy. This product can only be used for intravenous infusion.

Malignant pleural mesothelioma:
The recommended dose of this product combined with cisplatin for the treatment of malignant pleural mesothelioma is 500mg/m2 infusion of this product for more than 10 minutes every 21 days, and the recommended dose of cisplatin is 75mg/m2 infusion for more than 2 hours. Cisplatin infusion should be given 30 minutes after the end of this product administration. A hydration plan is required for cisplatin treatment.

[Precautions] ALIMTA should be used under the guidance of qualified physicians with experience in the application of anti-tumor drugs. This product should be treated in medical institutions with sufficient diagnostic and treatment technology, which can also ensure the timely treatment of complications. All treatment-related adverse reactions seen in clinical studies are reversible. Patients who were not given corticosteroids pretreatment before administration are prone to rash. Pretreatment with dexamethasone (or similar drugs) can reduce the incidence and severity of skin reactions.
It is unclear whether Alimta causes fluid retention such as pleural effusion or ascites. For patients with fluid retention with obvious clinical symptoms, drainage of body cavity effusions can be considered before using this product.

[Contraindications]
It is contraindicated in patients with a history of severe allergies to pemetrexed or other ingredients of the drug.

[Use in pregnant women]
Pregnancy: Treatment with this product may be harmful to the fetus in pregnant women. Intravenous administration of 0.2 mg/kg (0.6 mg/m 2) or 5 mg/kg (15 mg/m 2) pemetrexed in mice from 6 to 15 days of pregnancy was fetotoxic and teratogenic. Giving mice a dose of 0.2 mg/kg (approximately 1/833 of the recommended human dose) of pemetrexed can cause fetal malformations (incomplete ossification of the talus and skull), and 5 mg/kg can cause cleft palate (equivalent to 1/33 of the recommended human dose). Embryotoxicity is mainly manifested in increased embryonic mortality and delayed embryonic development. There are no studies on pregnant women treated with this product, because patients are advised to use contraception. If this product is used during pregnancy or the patient becomes pregnant while using this product, the potential risk to the fetus should be informed.
Breastfeeding: It has not been determined whether this product or its metabolites can be secreted from breast milk. However, this product may have potential serious harm to breastfeeding infants, and mothers treated with this product should stop breastfeeding.

[Pediatric Use] The safety and effectiveness of the drug for children have not been determined.

[Drug Interactions]
Chemotherapy drugs-cisplatin does not change the pharmacokinetics of pemetrexed, and pemetrexed has no effect on the pharmacokinetics of all platinum drugs.
Vitamins – Concomitant administration of oral folic acid and intramuscular vitamin B12 did not alter the pharmacokinetics of pemetrexed.

Drug metabolism by cytochrome P450 enzymes – Results of an in vitro liver microglobulin prediction study showed that pemetrexed did not result in a decrease in the clearance of drugs metabolized by CYP3A, CYP2D6, CYP2C9, and CYP1A2. No studies have been conducted to observe the effects of pemetrexed on cytochrome P450 isoenzymes. Because, if the recommended dosing schedule (once every 21 days) is followed, this product has no significant induction effect on any enzyme.

Aspirin – Administration of low to moderate doses of aspirin (325 mg every 6 hours) did not affect the pharmacokinetics of pemetrexed. The effect of high doses of aspirin on the pharmacokinetics of pemetrexed is currently unknown.
Ibuprofen – In patients with normal renal function, ibuprofen at a daily dose of 400 mg, 4 times / day, can reduce the clearance of pemetrexed by 20% (increase AUC by 20%). The effect of higher doses of ibuprofen on the pharmacokinetics of pemetrexed is currently unknown.
Alimta is mainly excreted from the body in the urinary tract in the form of the original drug through glomerular filtration and tubular excretion. Concomitant administration of drugs that are harmful to the kidneys will delay the elimination of this product, and concomitant administration of other drugs that increase the burden on the renal tubules (such as probenecid) may also delay the elimination of this product.
For patients with normal renal function (creatinine clearance of 3 80 ml/min), this product can be used simultaneously with ibuprofen (400 mg, 4 times / day), but for patients with mild to moderate renal insufficiency (creatinine clearance between 45 and 79 ml/min), this product should be used with caution with ibuprofen. Patients with mild to moderate renal insufficiency should not use short half-life NSAIDs 2 days before, on, and 2 days after treatment with this product.
The potential interaction between long half-life NSAIDs and this product is still uncertain. However, NSAID treatment should also be interrupted 5 days before, on, and 2 days after treatment with this product. If NSAIDs must be used, toxic reactions must be closely monitored, especially bone marrow suppression, renal and gastrointestinal toxicity.

[Storage] This product should be stored at room temperature (15-30 ° C).