A COURSE YOU CAN RELY ON

ALIMTA has been used by doctors for more than 10 years and is supported by clinical trial data showing potential benefit in patients with advanced nonsquamous* non-small cell lung cancer (NSCLC).1,2

ALIMTA/CISPLATIN IN 1ST-LINE See efficacy data, safety information and dosing instructions.

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1st-LINE DATA

CONTINUATION TREATMENT WITH ALIMTA AS A SINGLE AGENT Learn how maintenance therapy may play a role in your treatment plan.

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MAINTENANCE DATA

SUPPORT YOUR PATIENTS AT EVERY STEP Download therapy guides to reinforce your conversations about what to expect.

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Limitation of Use: ALIMTA is not indicated for the treatment of patients with squamous cell non-small cell lung cancer.

Myelosuppression is usually the dose-limiting toxicity with ALIMTA therapy.

* Includes adenocarcinoma, large cell carcinoma, and other histologies except those with squamous cell type.

† Only patients with stable disease or better are eligible for continuation maintenance with ALIMTA single agent.

Video series

Thoracic Treatment Talks: Illuminating a Complex Topic

There are more options than ever for treating lung cancer. Lilly has created a video series featuring leading experts to help you sort through clinical data and evaluate appropriate regimens for your patients. Like you, Lilly is committed to supporting people living with cancer.

Video: Jack West, MD, discusses the role of continuation maintenance therapy in the evolving treatment paradigm for advanced NSCLC.

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NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC3

Category 1: NCCN Guidelines® recommend pemetrexed for injection (ALIMTA)/cisplatin as a treatment option for first-line advanced nonsquamous NSCLC. Pemetrexed is not recommended for squamous histology.

Category 1: NCCN Guidelines recommend continuation of pemetrexed for injection (ALIMTA) as a treatment option after four to six cycles of cisplatin and pemetrexed chemotherapy in the absence of disease progression for patients with advanced or metastatic nonsquamous NSCLC.

‡ Based on high-level evidence (eg, randomized controlled trials) and there is uniform NCCN consensus that the intervention is appropriate.

Data by indication

1st-line trial results

1st-line advanced nonsquamous NSCLC

ALIMTA/cisplatin vs gemcitabine/cisplatin: See results from the largest trial in first-line advanced NSCLC (n=1725).1,4

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Continuation maintenance trial results

Continuation maintenance

ALIMTA single agent was studied in patients with stable disease or better after induction therapy with ALIMTA/cisplatin (PARAMOUNT trial).1

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2nd-line trial results

2nd-line advanced nonsquamous NSCLC

ALIMTA was studied in a multicenter, randomized, phase III, open-label trial vs docetaxel in patients with advanced NSCLC previously treated with chemotherapy.1,5

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MPM trial results

Malignant pleural mesothelioma

ALIMTA/cisplatin was studied in one of the largest multicenter, randomized phase III trials to be conducted in malignant pleural mesothelioma (MPM).1,6

Go to MPM data
References
  1. ALIMTA (pemetrexed for injection) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2013.
  2. Eli Lilly and Company. Lilly Receives Fourth FDA Approval for ALIMTA® (pemetrexed for injection) [press release]. https://investor.lilly.com/releasedetail.cfm?releaseid=393967. Accessed January 3, 2017.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.8.2017. © National Comprehensive Cancer Network, Inc 2017. All rights reserved. Accessed July 31, 2017. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
  4. Scagliotti GV, et al. J Clin Oncol. 2008;26(21):3543-3551.
  5. Hanna N, et al. J Clin Oncol. 2004;22(9):1589-1597.
  6. Vogelzang NJ, et al. J Clin Oncol. 2003;21(14):2636-2644.

Indications for ALIMTA® (pemetrexed for injection)

ALIMTA® (pemetrexed for injection) is indicated in combination with cisplatin therapy for the initial treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer.

ALIMTA is indicated for the maintenance treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

ALIMTA is indicated as a single agent for the treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy.

Limitation of Use: ALIMTA is not indicated for the treatment of patients with squamous cell non-small cell lung cancer.

ALIMTA in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.

Important Safety Information for ALIMTA

Myelosuppression is usually the dose-limiting toxicity with ALIMTA therapy.

Contraindication

ALIMTA is contraindicated in patients who have a history of severe hypersensitivity reaction to pemetrexed.

Warnings and Precautions

Prior to treatment with ALIMTA, patients must be instructed to initiate supplementation with oral folic acid. Additionally, intramuscular injections of vitamin B12 are also required prior to ALIMTA treatment. Folic acid and vitamin B12 supplementation should be continued throughout treatment as they may reduce the severity of treatment-related hematologic and GI toxicities.

Dexamethasone or its equivalent should be administered the day before, the day of, and the day after ALIMTA treatment.

ALIMTA can suppress bone marrow function, as manifested by neutropenia, thrombocytopenia, and anemia (or pancytopenia). Reduce doses for subsequent cycles based on hematologic and nonhematologic toxicities.

ALIMTA should not be administered to patients with a creatinine clearance <45 mL/min. One patient with severe renal impairment (creatinine clearance 19 mL/min) who did not receive folic acid and vitamin B12 died of drug-related toxicity following administration of ALIMTA alone.

Caution should be used when administering NSAIDs concurrently with ALIMTA to patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 mL/min). 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. In the absence of data regarding potential interaction between ALIMTA and NSAIDs with longer half-lives, all patients taking these NSAIDs should interrupt dosing for at least 5 days before, the day of, and 2 days following ALIMTA administration. If concomitant administration of NSAIDs is necessary, patients should be monitored closely for toxicity, especially myelosuppression, renal, and gastrointestinal toxicity. No dose adjustment of ALIMTA is needed with concomitant NSAIDs in patients with normal renal function.

Do not initiate a cycle of treatment in patients unless the ANC is ≥1500 cells/mm3, the platelet count is ≥100,000 cells/mm3, and creatinine clearance is ≥45 mL/min.

Pregnancy Category D—ALIMTA may cause fetal harm when administered to a pregnant woman. Women should be apprised of the potential hazard to the fetus and should be advised to use effective contraceptive measures to prevent pregnancy during treatment with ALIMTA.

Drug Interactions

See Warnings and Precautions for specific information regarding NSAID administration in patients with renal insufficiency.

Concomitant administration of nephrotoxic drugs or substances that are tubularly secreted could result in delayed clearance of ALIMTA.

Use in Specific Patient Populations

It is recommended that nursing be discontinued if the mother is being treated with ALIMTA or discontinue the drug, taking into account the importance of the drug for the mother.

Efficacy of ALIMTA in pediatric patients has not been demonstrated. The most common toxicities reported in the studied pediatric patients were hematological (leukopenia, neutropenia/granulocytopenia, anemia, thrombocytopenia, and lymphopenia), liver function abnormalities (increased ALT/AST), fatigue, and nausea.

Dosage and Administration Guidelines

Complete blood cell counts, including platelet counts and periodic chemistry tests, which include renal and hepatic function tests, should be performed on all patients receiving ALIMTA.

Dose adjustments at the start of a subsequent cycle should be based on nadir hematologic counts or maximum nonhematologic toxicity from the preceding cycle of therapy. Modify or suspend therapy according to the Dosage Reduction Guidelines in the full Prescribing Information.

Abbreviated Adverse Reactions (% incidence) – 1st-line advanced nonsquamous non-small cell lung cancer (NS NSCLC)

The most severe adverse reactions (grades 3-4) with ALIMTA in combination with cisplatin versus gemcitabine in combination with cisplatin, respectively, for the 1st-line treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC) were neutropenia (15% vs 27%); leukopenia (5% vs 8%); thrombocytopenia (4% vs 13%); anemia (6% vs 10%); fatigue (7% vs 5%); nausea (7% vs 4%); vomiting (6% vs 6%); anorexia (2% vs 1%); creatinine elevation (1% vs 1%); and diarrhea (1% vs 2%).

Common adverse reactions (all grades) with ALIMTA in combination with cisplatin versus gemcitabine in combination with cisplatin, respectively, were nausea (56% vs 53%); fatigue (43% vs 45%); vomiting (40% vs 36%); anemia (33% vs 46%); neutropenia (29% vs 38%); anorexia (27% vs 24%); constipation (21% vs 20%); leukopenia (18% vs 21%); stomatitis/pharyngitis (14% vs 12%); alopecia (12% vs 21%); diarrhea (12% vs 13%); thrombocytopenia (10% vs 27%); neuropathy/sensory (9% vs 12%); taste disturbance (8% vs 9%); rash/desquamation (7% vs 8%); dyspepsia/heartburn (5% vs 6%); and creatinine elevation (10% vs 7%).

Abbreviated Adverse Reactions (% incidence) – Maintenance in advanced NS NSCLC following non-ALIMTA containing, platinum-based induction therapy

The most severe adverse reactions (grades 3-4) with ALIMTA as a single agent versus placebo, respectively, for the maintenance treatment of patients with locally advanced nonsquamous non-small cell lung cancer (NS NSCLC) following non-ALIMTA containing platinum-based induction therapy were anemia (3% vs 1%); neutropenia (3% vs 0%); leukopenia (2% vs 1%); fatigue (5% vs 1%); nausea (1% vs 1%); anorexia (2% vs 0%); mucositis/stomatitis (1% vs 0%); diarrhea (1% vs 0%); infection (2% vs 0%); and neuropathy-sensory (1% vs 0%).

Common adverse reactions (all grades) with ALIMTA as a single agent versus placebo, respectively, after non-ALIMTA containing platinum-based induction therapy were anemia (15% vs 6%); neutropenia (6% vs 0%); leukopenia (6% vs 1%); increased ALT (10% vs 4%); increased AST (8% vs 4%); fatigue (25% vs 11%); nausea (19% vs 6%); anorexia (19% vs 5%); vomiting (9% vs 1%); mucositis/stomatitis (7% vs 2%); diarrhea (5% vs 3%); infection (5% vs 2%); neuropathy-sensory (9% vs 4%); and rash/desquamation (10% vs 3%).

Abbreviated Adverse Reactions (% incidence) – Maintenance in advanced NS NSCLC following ALIMTA plus cisplatin induction therapy

The most severe adverse reactions (grades 3-4) with ALIMTA as a single agent versus placebo, respectively, for the maintenance treatment of patients with locally advanced nonsquamous non-small cell lung cancer (NS NSCLC) following ALIMTA plus cisplatin induction therapy were anemia (4.8% vs 0.6%); neutropenia (3.9% vs 0%); and fatigue (4.5% vs 0.6%).

Common adverse reactions (all grades) with ALIMTA as a single agent versus placebo, respectively, following ALIMTA plus cisplatin induction therapy were anemia (15% vs 4.8%); neutropenia (9% vs 0.6%); fatigue (18% vs 11%); nausea (12% vs 2.4%); vomiting (6% vs 1.8%); mucositis/stomatitis (5% vs 2.4%); and edema (5% vs 3.6%).

Abbreviated Adverse Reactions (% incidence) – 2nd-line advanced NS NSCLC

The most severe adverse reactions (grades 3-4) with ALIMTA as a single agent versus docetaxel, respectively, for the 2nd-line treatment of patients with advanced non-small cell lung cancer (NSCLC) were neutropenia (5% vs 40%); leukopenia (4% vs 27%); thrombocytopenia (2% vs 0%); anemia (4% vs 4%); fatigue (5% vs 5%); nausea (3% vs 2%); anorexia (2% vs 3%); vomiting (2% vs 1%); increased ALT (2% vs 0%); increased AST (1% vs 0%); and stomatitis/pharyngitis (1% vs 1%).

Common adverse reactions (all grades) with ALIMTA as a single agent versus docetaxel, respectively, were fatigue (34% vs 36%); nausea (31% vs 17%); anorexia (22% vs 24%); anemia (19% vs 22%); vomiting (16% vs 12%); stomatitis/pharyngitis (15% vs 17%); rash (14% vs 6%); diarrhea (13% vs 24%); leukopenia (12% vs 34%); thrombocytopenia (8% vs 1%); increased ALT (8% vs 1%); increased AST (7% vs 1%); constipation (6% vs 4%); fever (8% vs 8%); pruritus (7% vs 2%); alopecia (6% vs 38%); and neutropenia (11% vs 45%).

Abbreviated Adverse Reactions (% incidence) – MPM

The most severe adverse reactions (grades 3-4) with ALIMTA in combination with cisplatin versus cisplatin alone, respectively, for the treatment of patients with malignant pleural mesothelioma (MPM) were neutropenia (23% vs 3%); leukopenia (15% vs 1%); thrombocytopenia (5% vs 0%); anemia (4% vs 0%); nausea (12% vs 6%); vomiting (11% vs 4%); fatigue (10% vs 9%); creatinine elevation (1% vs 1%); stomatitis/pharyngitis (3% vs 0%); anorexia (1% vs 1%); diarrhea (4% vs 0%); constipation (1% vs 1%); dyspepsia (1% vs 0%); dehydration (4% vs 1%); neuropathy-sensory (0% vs 1%); rash (1% vs 0%); and creatinine clearance decrease (1% vs 2%).

Common adverse reactions (all grades) with ALIMTA in combination with cisplatin versus cisplatin alone, respectively, were neutropenia (56% vs 13%); leukopenia (53% vs 17%); anemia (26% vs 10%); thrombocytopenia (23% vs 9%); nausea (82% vs 77%); vomiting (57% vs 50%); fatigue (48% vs 42%); creatinine elevation (11% vs 10%); creatinine clearance decreased (16% vs 18%); conjunctivitis (5% vs 1%); anorexia (20% vs 14%); diarrhea (17% vs 8%); constipation (12% vs 7%); dyspepsia (5% vs 1%); dehydration (7% vs 1%); neuropathy-sensory (10% vs 10%); taste disturbance (8% vs 6%); rash (16% vs 5%); alopecia (11% vs 6%); and stomatitis/pharyngitis (23% vs 6%).

For safety and dosing guidelines, see complete Warnings and Precautions, Adverse Reactions, and Dosage and Administration sections in the Prescribing Information and Patient Prescribing Information.

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