Home FDA labels bf1de3fa-e7f8-4beb-beeb-6272709d13f2 pemetrexed openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name pemetrexed
Generic name PEMETREXED DISODIUM
Manufacturer Zydus Pharmaceuticals USA Inc.
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 363665ca-db15-4123-84ac-0ae66b5f1363
SPL ID bf1de3fa-e7f8-4beb-beeb-6272709d13f2
Version 1
Effective date 2022-05-26
Source export date 2026-10-12
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warnings and cautions 5 WARNINGS AND PRECAUTIONS Myelosuppression: Can cause severe bone marrow suppression resulting in cytopenia and an increased risk of infection. Do not administer pemetrexed when the absolute neutrophil count is less than 1500 cells/mm 3 and platelets are less than 100,000 cells/mm 3 . Initiate supplementation with oral folic acid and intramuscular vitamin B 12 to reduce the severity of hematologic and gastrointestinal toxicity of pemetrexed. ( 2.4 , 5.1 ) Renal Failure: Can cause severe, and sometimes fatal, renal failure. Do not administer when creatinine clearance is less than 45 mL/min. ( 2.3 , 5.2 ) Bullous and Exfoliative Skin Toxicity: Permanently discontinue for severe and life-threatening bullous, blistering or exfoliating skin toxicity. ( 5.3 ) Interstitial Pneumonitis: Withhold for acute onset of new or progressive unexplained pulmonary symptoms. Permanently discontinue if pneumonitis is confirmed. ( 5.4 ) Radiation Recall: Can occur in patients who received radiation weeks to years previously; permanently discontinue for signs of radiation recall. ( 5.5 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.7 , 8.1 , 8.3 ) 5.1 Myelosuppression and Increased Risk of Myelosuppression without Vitamin Supplementation Pemetrexed can cause severe myelosuppression resulting in a requirement for transfusions and which may lead to neutropenic infection. The risk of myelosuppression is increased in patients who do not receive vitamin supplementation. In Study JMCH, incidences of Grade 3-4 neutropenia (38% versus 23%), thrombocytopenia (9% versus 5%), febrile neutropenia (9% versus 0.6%), and neutropenic infection (6% versus 0) were higher in patients who received pemetrexed plus cisplatin without vitamin supplementation as compared to patients who were fully supplemented with folic acid and vitamin B 12 prior to and throughout pemetrexed plus cisplatin treatment. Initiate supplementation with oral folic acid and intramuscular vitamin B 12 prior to the first dose of pemetrexed; continue vitamin supplementation during treatment and for 21 days after the last dose of pemetrexed to reduce the severity of hematologic and gastrointestinal toxicity of pemetrexed [see Dosage and Administration ( 2.4 )] . Obtain a complete blood count at the beginning of each cycle. Do not administer pemetrexed until the ANC is at least 1500 cells/mm 3 and platelet count is at least 100,000 cells/mm 3 . Permanently reduce pemetrexed in patients with an ANC of less than 500 cells/mm 3 or platelet count of less than 50,000 cells/mm 3 in previous cycles [see Dosage and Administration ( 2.6 )] . In Studies JMDB and JMCH, among patients who received vitamin supplementation, incidence of Grade 3-4 neutropenia was 15% and 23%, the incidence of Grade 3-4 anemia was 6% and 4%, and incidence of Grade 3-4 thrombocytopenia was 4% and 5%, respectively. In Study JMCH, 18% of patients in the pemetrexed arm required red blood cell transfusions compared to 7% of patients in the cisplatin arm [see Adverse Reactions ( 6.1 )]. In Studies JMEN, PARAMOUNT, and JMEI, where all patients received vitamin supplementation, incidence of Grade 3-4 neutropenia ranged from 3% to 5%, and incidence of Grade 3-4 anemia ranged from 3% to 5%. 5.2 Renal Failure Pemetrexed can cause severe, and sometimes fatal, renal toxicity. The incidences of renal failure in clinical studies in which patients received pemetrexed with cisplatin were: 2.1% in Study JMDB and 2.2% in Study JMCH. The incidence of renal failure in clinical studies in which patients received pemetrexed as a single agent ranged from 0.4% to 0.6% (Studies JMEN, PARAMOUNT, and JMEI [see Adverse Reactions ( 6.1 )] . Determine creatinine clearance before each dose and periodically monitor renal function during treatment with pemetrexed. Withhold pemetrexed in patients with a creatinine clearance of less than 45 mL/minute [see Dosage and Administration ( 2.3 )] . 5.3 Bullous and Exfoliative Skin Toxicity Serious and sometimes fatal, bullous, blistering and exfoliative skin toxicity, including cases suggestive of Stevens-Johnson Syndrome/Toxic epidermal necrolysis can occur with pemetrexed. Permanently discontinue pemetrexed for severe and life-threatening bullous, blistering or exfoliating skin toxicity. 5.4 Interstitial Pneumonitis Serious interstitial pneumonitis, including fatal cases, can occur with pemetrexed treatment. Withhold pemetrexed for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, or fever pending diagnostic evaluation. If pneumonitis is confirmed, permanently discontinue pemetrexed. 5.5 Radiation Recall Radiation recall can occur with pemetrexed in patients who have received radiation weeks to years previously. Monitor patients for inflammation or blistering in areas of previous radiation treatment. Permanently discontinue pemetrexed for signs of radiation recall. 5.6 Increased Risk of Toxicity with Ibuprofen in Patients with Renal Impairment Exposure to pemetrexed is increased in patients with mild to moderate renal impairment who take concomitant ibuprofen, increasing the risks of adverse reactions of pemetrexed. In patients with creatinine clearances between 45 mL/min and 79 mL/min, avoid administration of ibuprofen for 2 days before, the day of, and 2 days following administration of pemetrexed. If concomitant ibuprofen use cannot be avoided, monitor patients more frequently for pemetrexed adverse reactions, including myelosuppression, renal, and gastrointestinal toxicity [see Dosage and Administration ( 2.5 ), Drug Interactions ( 7 ), and Clinical Pharmacology ( 12.3 )] . 5.7 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, pemetrexed can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, intravenous administration of pemetrexed to pregnant mice during the period of organogenesis was teratogenic, resulting in developmental delays and increased malformations at doses lower than the recommended human dose of 500 mg/m 2 . Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with pemetrexed and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with pemetrexed and for 3 months after the final dose [see Use in Specific Populations ( 8.1 , 8.3 ) and Clinical Pharmacology ( 12.1 )] .
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adverse reactions table <table ID="ID76" width="100%" styleCode="Noautorules"><tfoot><tr><td align="left" colspan="5"><paragraph styleCode="Footnote"><sup>a </sup>NCI CTCAE version 3.0.</paragraph></td></tr></tfoot><tbody><tr><td rowspan="2" styleCode="Lrule Toprule Botrule Rrule" align="left"><content styleCode="bold"> Adverse Reaction<sup>a</sup></content> </td><td colspan="2" styleCode=" Toprule Botrule Rrule" align="center"><content styleCode="bold"> Pemetrexed</content><content styleCode="bold"> (N=438)</content> </td><td colspan="2" styleCode=" Toprule Botrule Rrule" align="center"><content styleCode="bold"> Placebo</content><content styleCode="bold"> (N=218)</content> </td></tr><tr><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> All Grades</content><content styleCode="bold"> (%)</content> </td><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> Grade 3-4</content><content styleCode="bold"> (%)</content> </td><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> All Grades</content><content styleCode="bold"> (%)</content> </td><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> Grade 3-4</content><content styleCode="bold"> (%)</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> All adverse reactions</content> </td><td styleCode=" Botrule Rrule" align="center"> 66 </td><td styleCode=" Botrule Rrule" align="center"> 16 </td><td styleCode=" Botrule Rrule" align="center"> 37 </td><td styleCode=" Botrule Rrule" align="center"> 4 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Laboratory</content> </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Hematologic</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Anemia </td><td styleCode=" Botrule Rrule" align="center"> 15 </td><td styleCode=" Botrule Rrule" align="center"> 3 </td><td styleCode=" Botrule Rrule" align="center"> 6 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Neutropenia </td><td styleCode=" Botrule Rrule" align="center"> 6 </td><td styleCode=" Botrule Rrule" align="center"> 3 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Hepatic</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Increased ALT </td><td styleCode=" Botrule Rrule" align="center"> 10 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 4 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Increased AST </td><td styleCode=" Botrule Rrule" align="center"> 8 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 4 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Clinical</content> </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Constitutional symptoms</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Fatigue </td><td styleCode=" Botrule Rrule" align="center"> 25 </td><td styleCode=" Botrule Rrule" align="center"> 5 </td><td styleCode=" Botrule Rrule" align="center"> 11 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Gastrointestinal</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Nausea </td><td styleCode=" Botrule Rrule" align="center"> 19 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 6 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Anorexia </td><td styleCode=" Botrule Rrule" align="center"> 19 </td><td styleCode=" Botrule Rrule" align="center"> 2 </td><td styleCode=" Botrule Rrule" align="center"> 5 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Vomiting </td><td styleCode=" Botrule Rrule" align="center"> 9 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Mucositis/stomatitis </td><td styleCode=" Botrule Rrule" align="center"> 7 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 2 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Diarrhea </td><td styleCode=" Botrule Rrule" align="center"> 5 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 3 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Infection</content> </td><td styleCode=" Botrule Rrule" align="center"> 5 </td><td styleCode=" Botrule Rrule" align="center"> 2 </td><td styleCode=" Botrule Rrule" align="center"> 2 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Neurology</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Sensory neuropathy </td><td styleCode=" Botrule Rrule" align="center"> 9 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 4 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Dermatology/Skin</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Rash/desquamation </td><td styleCode=" Botrule Rrule" align="center"> 10 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 3 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr></tbody></table>
adverse reactions table <table ID="ID78" width="100%" styleCode="Noautorules"><tfoot><tr><td align="left" colspan="5"><paragraph styleCode="Footnote"><sup>a </sup>NCI CTCAE version 3.0.</paragraph></td></tr></tfoot><tbody><tr><td rowspan="2" styleCode="Lrule Toprule Botrule Rrule" align="left"><content styleCode="bold"> Adverse Reaction<sup>a</sup></content> </td><td colspan="2" styleCode=" Toprule Botrule Rrule" align="center"><content styleCode="bold"> Pemetrexed</content> <content styleCode="bold"> (N=333)</content> </td><td colspan="2" styleCode=" Toprule Botrule Rrule" align="center"><content styleCode="bold"> Placebo</content> <content styleCode="bold"> (N=167)</content> </td></tr><tr><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> All Grades</content> <content styleCode="bold"> (%)</content> </td><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> Grade 3-4</content> <content styleCode="bold"> (%)</content> </td><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> All Grades</content> <content styleCode="bold"> (%)</content> </td><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> Grades 3-4</content> <content styleCode="bold"> (%)</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> All adverse reactions</content> </td><td styleCode=" Botrule Rrule" align="center"> 53 </td><td styleCode=" Botrule Rrule" align="center"> 17 </td><td styleCode=" Botrule Rrule" align="center"> 34 </td><td styleCode=" Botrule Rrule" align="center"> 4.8 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Laboratory</content> </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Hematologic</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Anemia </td><td styleCode=" Botrule Rrule" align="center"> 15 </td><td styleCode=" Botrule Rrule" align="center"> 4.8 </td><td styleCode=" Botrule Rrule" align="center"> 4.8 </td><td styleCode=" Botrule Rrule" align="center"> 0.6 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Neutropenia </td><td styleCode=" Botrule Rrule" align="center"> 9 </td><td styleCode=" Botrule Rrule" align="center"> 3.9 </td><td styleCode=" Botrule Rrule" align="center"> 0.6 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Clinical</content> </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Constitutional symptoms</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Fatigue </td><td styleCode=" Botrule Rrule" align="center"> 18 </td><td styleCode=" Botrule Rrule" align="center"> 4.5 </td><td styleCode=" Botrule Rrule" align="center"> 11 </td><td styleCode=" Botrule Rrule" align="center"> 0.6 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Gastrointestinal</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Nausea </td><td styleCode=" Botrule Rrule" align="center"> 12 </td><td styleCode=" Botrule Rrule" align="center"> 0.3 </td><td styleCode=" Botrule Rrule" align="center"> 2.4 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Vomiting </td><td styleCode=" Botrule Rrule" align="center"> 6 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 1.8 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Mucositis/stomatitis </td><td styleCode=" Botrule Rrule" align="center"> 5 </td><td styleCode=" Botrule Rrule" align="center"> 0.3 </td><td styleCode=" Botrule Rrule" align="center"> 2.4 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> General disorders</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Edema </td><td styleCode=" Botrule Rrule" align="center"> 5 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 3.6 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr></tbody></table>
adverse reactions table <table ID="ID80" width="100%" styleCode="Noautorules"><tfoot><tr><td align="left" colspan="5"><paragraph styleCode="Footnote"><sup>a </sup>NCI CTCAE version 2.0.</paragraph></td></tr></tfoot><tbody><tr><td rowspan="2" styleCode="Lrule Toprule Botrule Rrule" align="left"><content styleCode="bold"> Adverse Reaction<sup>a</sup></content> </td><td colspan="2" styleCode=" Toprule Botrule Rrule" align="center"><content styleCode="bold"> Pemetrexed</content> <content styleCode="bold"> (N=265)</content> </td><td colspan="2" styleCode=" Toprule Botrule Rrule" align="center"><content styleCode="bold"> Docetaxel</content> <content styleCode="bold"> (N=276)</content> </td></tr><tr><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> All Grades</content> <content styleCode="bold"> (%)</content> </td><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> Grades 3-4</content> <content styleCode="bold"> (%)</content> </td><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> All Grade</content> <content styleCode="bold"> (%)</content> </td><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> Grades 3-4</content> <content styleCode="bold"> (%)</content> </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Laboratory</content> </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Hematologic</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Anemia </td><td styleCode=" Botrule Rrule" align="center"> 19 </td><td styleCode=" Botrule Rrule" align="center"> 4 </td><td styleCode=" Botrule Rrule" align="center"> 22 </td><td styleCode=" Botrule Rrule" align="center"> 4 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Neutropenia </td><td styleCode=" Botrule Rrule" align="center"> 11 </td><td styleCode=" Botrule Rrule" align="center"> 5 </td><td styleCode=" Botrule Rrule" align="center"> 45 </td><td styleCode=" Botrule Rrule" align="center"> 40 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Thrombocytopenia </td><td styleCode=" Botrule Rrule" align="center"> 8 </td><td styleCode=" Botrule Rrule" align="center"> 2 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Hepatic</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Increased ALT </td><td styleCode=" Botrule Rrule" align="center"> 8 </td><td styleCode=" Botrule Rrule" align="center"> 2 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Increased AST </td><td styleCode=" Botrule Rrule" align="center"> 7 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Clinical</content> </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Gastrointestinal</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Nausea </td><td styleCode=" Botrule Rrule" align="center"> 31 </td><td styleCode=" Botrule Rrule" align="center"> 3 </td><td styleCode=" Botrule Rrule" align="center"> 17 </td><td styleCode=" Botrule Rrule" align="center"> 2 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Anorexia </td><td styleCode=" Botrule Rrule" align="center"> 22 </td><td styleCode=" Botrule Rrule" align="center"> 2 </td><td styleCode=" Botrule Rrule" align="center"> 24 </td><td styleCode=" Botrule Rrule" align="center"> 3 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Vomiting </td><td styleCode=" Botrule Rrule" align="center"> 16 </td><td styleCode=" Botrule Rrule" align="center"> 2 </td><td styleCode=" Botrule Rrule" align="center"> 12 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Stomatitis/pharyngitis </td><td styleCode=" Botrule Rrule" align="center"> 15 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 17 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Diarrhea </td><td styleCode=" Botrule Rrule" align="center"> 13 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 24 </td><td styleCode=" Botrule Rrule" align="center"> 3 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Constipation </td><td styleCode=" Botrule Rrule" align="center"> 6 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 4 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Constitutional symptoms</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Fatigue </td><td styleCode=" Botrule Rrule" align="center"> 34 </td><td styleCode=" Botrule Rrule" align="center"> 5 </td><td styleCode=" Botrule Rrule" align="center"> 36 </td><td styleCode=" Botrule Rrule" align="center"> 5 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Fever </td><td styleCode=" Botrule Rrule" align="center"> 8 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 8 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Dermatology/Skin</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Rash/desquamation </td><td styleCode=" Botrule Rrule" align="center"> 14 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 6 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Pruritus </td><td styleCode=" Botrule Rrule" align="center"> 7 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 2 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Alopecia </td><td styleCode=" Botrule Rrule" align="center"> 6 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 38 </td><td styleCode=" Botrule Rrule" align="center"> 2 </td></tr></tbody></table>
adverse reactions table <table ID="ID82" width="100%" styleCode="Noautorules"><tfoot><tr><td align="left" colspan="5"><paragraph styleCode="Footnote"><sup>a</sup> In Study JMCH, 226 patients received at least one dose of pemetrexed in combination with cisplatin and 222 patients received at least one dose of cisplatin. Table 8 provides the ADRs for subgroup of patients treated with pemetrexed in combination with cisplatin (168 patients) or cisplatin alone (163 patients) who received full supplementation with folic acid and vitamin B<sub>12</sub> during study therapy.</paragraph></td></tr><tr><td align="left" colspan="5"><paragraph styleCode="Footnote"><sup>b</sup> NCI CTCAE version 2.0.</paragraph></td></tr></tfoot><tbody><tr><td rowspan="2" styleCode="Lrule Toprule Botrule Rrule" align="left"><content styleCode="bold"> Adverse Reaction<sup>b</sup></content> </td><td colspan="2" styleCode=" Toprule Botrule Rrule" align="center"><content styleCode="bold"> Pemetrexed/cisplatin</content> <content styleCode="bold"> (N=168)</content> </td><td colspan="2" styleCode=" Toprule Botrule Rrule" align="center"><content styleCode="bold"> Cisplatin</content> <content styleCode="bold"> (N=163)</content> </td></tr><tr><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> All Grades</content> <content styleCode="bold"> (%)</content> </td><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> Grade 3-4</content> <content styleCode="bold"> (%)</content> </td><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> All Grades</content> <content styleCode="bold"> (%)</content> </td><td styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> Grade 3-4</content> <content styleCode="bold"> (%)</content> </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Laboratory</content> </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Hematologic</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Neutropenia </td><td styleCode=" Botrule Rrule" align="center"> 56 </td><td styleCode=" Botrule Rrule" align="center"> 23 </td><td styleCode=" Botrule Rrule" align="center"> 13 </td><td styleCode=" Botrule Rrule" align="center"> 3 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Anemia </td><td styleCode=" Botrule Rrule" align="center"> 26 </td><td styleCode=" Botrule Rrule" align="center"> 4 </td><td styleCode=" Botrule Rrule" align="center"> 10 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Thrombocytopenia </td><td styleCode=" Botrule Rrule" align="center"> 23 </td><td styleCode=" Botrule Rrule" align="center"> 5 </td><td styleCode=" Botrule Rrule" align="center"> 9 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Renal</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Elevated creatinine </td><td styleCode=" Botrule Rrule" align="center"> 11 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 10 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Decreased creatinine clearance </td><td styleCode=" Botrule Rrule" align="center"> 16 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 18 </td><td styleCode=" Botrule Rrule" align="center"> 2 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Clinical</content> </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Eye Disorder</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Conjunctivitis </td><td styleCode=" Botrule Rrule" align="center"> 5 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Gastrointestinal</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Nausea </td><td styleCode=" Botrule Rrule" align="center"> 82 </td><td styleCode=" Botrule Rrule" align="center"> 12 </td><td styleCode=" Botrule Rrule" align="center"> 77 </td><td styleCode=" Botrule Rrule" align="center"> 6 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Vomiting </td><td styleCode=" Botrule Rrule" align="center"> 57 </td><td styleCode=" Botrule Rrule" align="center"> 11 </td><td styleCode=" Botrule Rrule" align="center"> 50 </td><td styleCode=" Botrule Rrule" align="center"> 4 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Stomatitis/pharyngitis </td><td styleCode=" Botrule Rrule" align="center"> 23 </td><td styleCode=" Botrule Rrule" align="center"> 3 </td><td styleCode=" Botrule Rrule" align="center"> 6 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Anorexia </td><td styleCode=" Botrule Rrule" align="center"> 20 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 14 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Diarrhea </td><td styleCode=" Botrule Rrule" align="center"> 17 </td><td styleCode=" Botrule Rrule" align="center"> 4 </td><td styleCode=" Botrule Rrule" align="center"> 8 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Constipation </td><td styleCode=" Botrule Rrule" align="center"> 12 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 7 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Dyspepsia </td><td styleCode=" Botrule Rrule" align="center"> 5 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Constitutional Symptoms</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Fatigue </td><td styleCode=" Botrule Rrule" align="center"> 48 </td><td styleCode=" Botrule Rrule" align="center"> 10 </td><td styleCode=" Botrule Rrule" align="center"> 42 </td><td styleCode=" Botrule Rrule" align="center"> 9 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Metabolism and Nutrition</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Dehydration </td><td styleCode=" Botrule Rrule" align="center"> 7 </td><td styleCode=" Botrule Rrule" align="center"> 4 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Neurology</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Sensory neuropathy </td><td styleCode=" Botrule Rrule" align="center"> 10 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 10 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Taste disturbance </td><td styleCode=" Botrule Rrule" align="center"> 8 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 6 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="5" styleCode="Lrule Botrule Rrule" align="left"> <content styleCode="bold"> Dermatology/Skin</content> </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Rash </td><td styleCode=" Botrule Rrule" align="center"> 16 </td><td styleCode=" Botrule Rrule" align="center"> 1 </td><td styleCode=" Botrule Rrule" align="center"> 5 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td styleCode="Lrule Botrule Rrule" align="left"> Alopecia </td><td styleCode=" Botrule Rrule" align="center"> 11 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td><td styleCode=" Botrule Rrule" align="center"> 6 </td><td styleCode=" Botrule Rrule" align="center"> 0 </td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.