Package(a):
VIAL: 1 x 100 mg. Dosage(a):
500 mg/m2 body surface area. See prescribing information for full details. Prescribing Restrictions: None
Package(b):
VIAL: 1 x 500 mg. Dosage(b):
500 mg/m2 body surface area. See prescribing information for full details. Prescribing Restrictions:
Indications: In combination with cisplatin: Treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curatible surgery. For first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. As monotherapy:Treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy. For second line treatment of patients with locally advanced or metastatic non-small cell lung cancer, other than predominantly squamous cell histology.
Contra-Indications:
Severe hypersensitivity to pemetrexed or other ingredients of the preparation.
Special Precautions:
Should not be administered to patients whose creatinine clearance is <45ml/minute. Patients must be instructed to take folic acid and vitamin B12 as a prophylactic measure to reduce treatment-related hematologic and GI toxicity. Should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Complete blood cell counts, including platelet counts and periodic chemistry tests, should be performed on all patients. Patients should be monitored for nadir and recovery, which were tested in the clinical study before each dose and on days 8 and 15 of each cycle. Patients should not begin a new cycle of treatment unless the ANC is higher than or equal to 1,500 cells/mm3, the platelet count is higher than or equal to 100,000 cells/mm3, and creatinine clearance is higher than or equal to 45ml/minute. Pregnancy and lactation: May cause fetal harm. Patients should be advised to avoid becoming pregnant. If used during pregnancy, or if the patient becomes pregnant during therapy, the patient should be apprised of the potential hazard to the fetus. It is recommended that nursing be discontinued if the mother is treated with Alimta.
Safety and effectiveness in pediatric patients have not been established.
See prescribing information for full details.
Side Effects:
Neutropenia, leukopenia, anemia, thrombocytopenia, creatinine elevation, renal failure. Thrombosis/embolism. Fatigue, fever, nausea, vomiting, constipation, anorexia, stomatitis/pharyngitis, diarrhea without colostomy, dehydration, dysphagia/esophagitis/odynophagia. Dyspnea, chest pain, neuropathy/sensory, mood alteration/depression. Infection without neutropenia, infection with Grade 3 or Grade 4 neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, rash/desquamation. See prescribing information for full details.
Drug Interactions:
Concomitant administration of nephrotoxic drugs and substances that are also tubularly secreted (e.g. probenecid), could result in delayed clearance of Alimta. Caution should be used when administering ibuprofen concurrently with Alimta to patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/minute). Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of Alimta.
