Alimta

Last updated on RxList: 12/15/2020
Alimta Side Effects Center

What Is Alimta?

Alimta (pemetrexed) for Injection is a chemotherapy drug indicated for treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer.

What Are Side Effects of Alimta?

Side effects of Alimta include:

Tell your doctor if you have serious side effects of Alimta including:

  • fast or pounding heartbeat,
  • changes in the amount of urine,
  • dark urine,
  • yellowing eyes or skin,
  • severe stomach or abdominal pain,
  • pain/redness/swelling of arms or legs,
  • sore throat,
  • painful or difficult swallowing,
  • mental/mood changes,
  • depression,
  • numbness or tingling of the hands or feet, or
  • easy bruising or bleeding.

Dosage for Alimta

Alimta is available in strengths of 100 and 500mg in vials.

What Drugs, Substances, or Supplements Interact with Alimta?

Caution should be used when administering NSAIDs concurrently with Almita to patients with mild to moderate renal insufficiency. Patients treated with Almita must be instructed to take folic acid and vitamin B12 as a prophylactic measure to reduce treatment-related hematologic and GI toxicity. Alimta may interact with lithium, methotrexate, probenecid, NSAIDs (nonsteroidal anti-inflammatory drugs), medicines used to treat ulcerative colitis, medicines used to prevent organ transplant rejection, IV antibiotics, antiviral medicines, or other cancer medicines. Tell your doctor all medications and supplements you use.

Alimta During Pregnancy and Breastfeeding

Women of childbearing potential using Alimta should be advised to avoid becoming pregnant. It is unknown if Alimta passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Alimta (pemetrexed) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Lung Cancer: Early Signs, Symptoms, Stages See Slideshow
Alimta Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

  • little or no urination;
  • new or worsening cough, fever, trouble breathing;
  • swelling, redness, or blistering of skin that was treated with radiation in the past; or
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

  • feeling tired or short of breath;
  • loss of appetite, weight loss; or
  • nausea, vomiting, diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Alimta (Pemetrexed)

QUESTION

Lung cancer is a disease in which lung cells grow abnormally in an uncontrolled way. See Answer
Alimta Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.

In clinical trials, the most common adverse reactions (incidence ≥20%) of ALIMTA, when administered as a single agent, are fatigue, nausea, and anorexia. The most common adverse reactions (incidence ≥20%) of ALIMTA, when administered in combination with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation. The most common adverse reactions (incidence ≥20%) of ALIMTA, when administered in combination with pembrolizumab and platinum chemotherapy, are fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, and pyrexia.

Non-Squamous NSCLC

First-line Treatment Of Metastatic Non-Squamous NSCLC With Pembrolizumab And Platinum Chemotherapy

The safety of ALIMTA, in combination with pembrolizumab and investigator's choice of platinum (either carboplatin or cisplatin), was investigated in Study KEYNOTE-189, a multicenter, double-blind, randomized (2:1), active-controlled trial in patients with previously untreated, metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. A total of 607 patients received ALIMTA, pembrolizumab, and platinum every 3 weeks for 4 cycles followed by ALIMTA and pembrolizumab (n=405), or placebo, ALIMTA, and platinum every 3 weeks for 4 cycles followed by placebo and ALIMTA (n=202). Patients with autoimmune disease that required systemic therapy within 2 years of treatment; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within the prior 26 weeks were ineligible [see Clinical Studies].

The median duration of exposure to ALIMTA was 7.2 months (range: 1 day to 1.7 years). Seventy-two percent of patients received carboplatin. The study population characteristics were: median age of 64 years (range: 34 to 84), 49% age 65 years or older, 59% male, 94% White and 3% Asian, and 18% with history of brain metastases at baseline.

ALIMTA was discontinued for adverse reactions in 23% of patients in the ALIMTA, pembrolizumab, and platinum arm. The most common adverse reactions resulting in discontinuation of ALIMTA in this arm were acute kidney injury (3%) and pneumonitis (2%). Adverse reactions leading to interruption of ALIMTA occurred in 49% of patients in the ALIMTA, pembrolizumab, and platinum arm. The most common adverse reactions or laboratory abnormalities leading to interruption of ALIMTA in this arm (≥2%) were neutropenia (12%), anemia (7%), asthenia (4%), pneumonia (4%), thrombocytopenia (4%), increased blood creatinine (3%), diarrhea (3%), and fatigue (3%).

Table 2 summarizes the adverse reactions that occurred in ≥20% of patients treated with ALIMTA, pembrolizumab, and platinum.

Table 2: Adverse Reactions Occurring in ≥20% of Patients in KEYNOTE-189

Adverse Reaction ALIMTA Pembrolizumab Platinum Chemotherapy
n=405
Placebo ALIMTA Platinum Chemotherapy
n=202
All Gradesa (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%)
Gastrointestinal Disorders
Nausea 56 3.5 52 3.5
Constipation 35 1.0 32 0.5
Diarrhea 31 5 21 3.0
Vomiting 24 3.7 23 3.0
General Disorders and Administration Site Conditions
Fatigueb 56 12 58 6
Pyrexia 20 0.2 15 0
Metabolism and Nutrition Disorders
Decreased appetite 28 1.5 30 0.5
Skin and Subcutaneous Tissue Disorders
Rashc 25 2.0 17 2.5
Respiratory, Thoracic and Mediastinal Disorders
Cough 21 0 28 0
Dyspnea 21 3.7 26 5
a Graded per NCI CTCAE version 4.03.
b Includes asthenia and fatigue.
c Includes genital rash, rash, rash generalized, rash macular, rash maculo-papular, rash papular, rash pruritic, and rash pustular.

Table 3 summarizes the laboratory abnormalities that worsened from baseline in at least 20% of patients treated with ALIMTA, pembrolizumab, and platinum.

Table 3: Laboratory Abnormalities Worsened from Baseline in ≥20% of Patients in KEYNOTE-189

Laboratory Testa ALIMTA Pembrolizumab Platinum Chemotherapy Placebo ALIMTA Platinum Chemotherapy
All Gradesb % Grades 3-4 % All Grades % Grades 3-4 %
Chemistry
Hyperglycemia 63 9 60 7
Increased ALT 47 3.8 42 2.6
Increased AST 47 2.8 40 1.0
Hypoalbuminemia 39 2.8 39 1.1
Increased creatinine 37 4.2 25 1.0
Hyponatremia 32 7 23 6
Hypophosphatemia 30 10 28 14
Increased alkaline phosphatase 26 1.8 29 2.1
Hypocalcemia 24 2.8 17 0.5
Hyperkalemia 24 2.8 19 3.1
Hypokalemia 21 5 20 5
Hematology
Anemia 85 17 81 18
Lymphopenia 64 22 64 25
Neutropenia 48 20 41 19
Thrombocytopenia 30 12 29 8
a Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: ALIMTA/pembrolizumab/platinum chemotherapy (range: 381 to 401 patients) and placebo/ALIMTA/platinum chemotherapy (range: 184 to 197 patients).
b Graded per NCI CTCAE version 4.03.

Initial Treatment In Combination With Cisplatin

The safety of ALIMTA was evaluated in Study JMDB, a randomized (1:1), open-label, multicenter trial conducted in chemotherapy-naive patients with locally advanced or metastatic NSCLC. Patients received either ALIMTA 500 mg/m² intravenously and cisplatin 75 mg/m² intravenously on Day 1 of each 21-day cycle (n=839) or gemcitabine 1250 mg/m² intravenously on Days 1 and 8 and cisplatin 75 mg/m² intravenously on Day 1 of each 21-day cycle (n=830). All patients were fully supplemented with folic acid and vitamin B12.

Study JMDB excluded patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS of 2 or greater), uncontrolled third-space fluid retention, inadequate bone marrow reserve and organ function, or a calculated creatinine clearance less than 45 mL/min. Patients unable to stop using aspirin or other non-steroidal anti-inflammatory drugs or unable to take folic acid, vitamin B12 or corticosteroids were also excluded from the study.

The data described below reflect exposure to ALIMTA plus cisplatin in 839 patients in Study JMDB. Median age was 61 years (range 26-83 years); 70% of patients were men; 78% were White, 16% were Asian, 2.9% were Hispanic or Latino, 2.1% were Black or African American, and <1% were other ethnicities; 36% had an ECOG PS 0. Patients received a median of 5 cycles of ALIMTA.

Table 4 provides the frequency and severity of adverse reactions that occurred in ≥5% of 839 patients receiving ALIMTA in combination with cisplatin in Study JMDB. Study JMDB was not designed to demonstrate a statistically significant reduction in adverse reaction rates for ALIMTA, as compared to the control arm, for any specified adverse reaction listed in Table 4.

Table 4: Adverse Reactions Occurring in ≥5% of Fully Vitamin-Supplemented Patients Receiving ALIMTA in Combination with Cisplatin Chemotherapy in Study JMDB

Adverse Reactiona ALIMTA/ Cisplatin
(N=839)
Gemcitabine/ Cisplatin
(N=830)
All Grades (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%)
All adverse reactions 90 37 91 53
Laboratory
Hematologic
Anemia 33 6 46 10
Neutropenia 29 15 38 27
Thrombocytopenia 10 4 27 13
Renal
Elevated creatinine 10 1 7 1
Clinical
Constitutional symptoms
Fatigue 43 7 45 5
Gastrointestinal
Nausea 56 7 53 4
Vomiting 40 6 36 6
Anorexia 27 2 24 1
Constipation 21 1 20 0
Stomatitis/pharyngitis 14 1 12 0
Diarrhea 12 1 13 2
Dyspepsia/heartburn 5 0 6 0
Neurology
Sensory neuropathy 9 0 12 1
Taste disturbance 8 0 9 0
Dermatology/Skin
Alopecia 12 0 21 1
Rash/Desquamation 7 0 8 1
a NCI CTCAE version 2.0.

The following additional adverse reactions of ALIMTA were observed.

Incidence 1% To <5%

Body as a Whole - febrile neutropenia, infection, pyrexia

General Disorders - dehydration

Metabolism and Nutrition - increased AST, increased ALT

Renal -renal failure

Eye Disorder - conjunctivitis

Incidence <1%

Cardiovascular - arrhythmia

General Disorders - chest pain

Metabolism and Nutrition - increased GGT

Neurology - motor neuropathy

Maintenance Treatment Following First-line Non-ALIMTA Containing Platinum-Based Chemotherapy

In Study JMEN, the safety of ALIMTA was evaluated in a randomized (2:1), placebo-controlled, multicenter trial conducted in patients with non-progressive locally advanced or metastatic NSCLC following four cycles of a first-line, platinum-based chemotherapy regimen. Patients received either ALIMTA 500 mg/m² or matching placebo intravenously every 21 days until disease progression or unacceptable toxicity. Patients in both study arms were fully supplemented with folic acid and vitamin B12.

Study JMEN excluded patients with an ECOG PS of 2 or greater, uncontrolled third-space fluid retention, inadequate bone marrow reserve and organ function, or a calculated creatinine clearance less than 45 mL/min. Patients unable to stop using aspirin or other non-steroidal anti-inflammatory drugs or unable to take folic acid, vitamin B12 or corticosteroids were also excluded from the study.

The data described below reflect exposure to ALIMTA in 438 patients in Study JMEN. Median age was 61 years (range 26-83 years), 73% of patients were men; 65% were White, 31% were Asian, 2.9% were Hispanic or Latino, and <2% were other ethnicities; 39% had an ECOG PS 0. Patients received a median of 5 cycles of ALIMTA and a relative dose intensity of ALIMTA of 96%. Approximately half the patients (48%) completed at least six, 21-day cycles and 23% completed ten or more 21-day cycles of ALIMTA.

Table 5 provides the frequency and severity of adverse reactions reported in ≥5% of the 438 ALIMTA-treated patients in Study JMEN.

Table 5: Adverse Reactions Occurring in ≥5% of Patients Receiving ALIMTA in Study JMEN

Adverse Reactiona ALIMTA
(N=438)
Placebo
(N=218)
All Grades (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%)
All adverse reactions 66 16 37 4
Laboratory
Hematologic
Anemia 15 3 6 1
Neutropenia 6 3 0 0
Hepatic
Increased ALT 10 0 4 0
Increased AST 8 0 4 0
Clinical
Constitutional symptoms
Fatigue 25 5 11 1
Gastrointestinal
Nausea 19 1 6 1
Anorexia 19 2 5 0
Vomiting 9 0 1 0
Mucositis/stomatitis 7 1 2 0
Diarrhea 5 1 3 0
Infection 5 2 2 0
Neurology
Sensory neuropathy 9 1 4 0
Dermatology/Skin
Rash/desquamation 10 0 3 0
a NCI CTCAE version 3.0.

The requirement for transfusions (9.5% versus 3.2%), primarily red blood cell transfusions, and for erythropoiesis stimulating agents (5.9% versus 1.8%) were higher in the ALIMTA arm compared to the placebo arm.

The following additional adverse reactions were observed in patients who received ALIMTA.

Incidence 1% to<5%

Dermatology/Skin - alopecia, pruritus/itching

Gastrointestinal - constipation

General Disorders - edema, fever

Hematologic - thrombocytopenia

Eye Disorder - ocular surface disease (including conjunctivitis), increased lacrimation

Incidence <1%

Cardiovascular - supraventricular arrhythmia

Dermatology/Skin - erythema multiforme

General Disorders - febrile neutropenia, allergic reaction/hypersensitivity

Neurology - motor neuropathy

Renal - renal failure

Maintenance Treatment Following First-line ALIMTA Plus Platinum Chemotherapy

The safety of ALIMTA was evaluated in PARAMOUNT, a randomized (2:1), placebo-controlled study conducted in patients with non-squamous NSCLC with non-progressive (stable or responding disease) locally advanced or metastatic NSCLC following four cycles of ALIMTA in combination with cisplatin as first-line therapy for NSCLC. Patients were randomized to receive ALIMTA 500 mg/m² or matching placebo intravenously on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. Patients in both study arms received folic acid and vitamin B12 supplementation.

PARAMOUNT excluded patients with an ECOG PS of 2 or greater, uncontrolled third-space fluid retention, inadequate bone marrow reserve and organ function, or a calculated creatinine clearance less than 45 mL/min. Patients unable to stop using aspirin or other non-steroidal anti-inflammatory drugs or unable to take folic acid, vitamin B12 or corticosteroids were also excluded from the study.

The data described below reflect exposure to ALIMTA in 333 patients in PARAMOUNT. Median age was 61 years (range 32 to 83 years); 58% of patients were men; 94% were White, 4.8% were Asian, and <1% were Black or African American; 36% had an ECOG PS 0. The median number of maintenance cycles was 4 for ALIMTA and placebo arms. Dose reductions for adverse reactions occurred in 3.3% of patients in the ALIMTA arm and 0.6% in the placebo arm. Dose delays for adverse reactions occurred in 22% of patients in the ALIMTA arm and 16% in the placebo arm.

Table 6 provides the frequency and severity of adverse reactions reported in ≥5% of the 333 ALIMTA-treated patients in PARAMOUNT.

Table 6: Adverse Reactions Occurring in ≥5% of Patients Receiving ALIMTA in PARAMOUNT

Adverse Reactiona ALIMTA
(N=333)
Placebo
(N=167)
All Grades (%) Grade 3-4 (%) All Grades (%) Grades 3-4 (%)
All adverse reactions 53 17 34 4.8
Laboratory
Hematologic
Anemia 15 4.8 4.8 0.6
Neutropenia 9 3.9 0.6 0
Clinical
Constitutional symptoms
Fatigue 18 4.5 11 0.6
Gastrointestinal
Nausea 12 0.3 2.4 0
Vomiting 6 0 1.8 0
Mucositis/stomatitis 5 0.3 2.4 0
General disorders
Edema 5 0 3.6 0
a NCI CTCAE version 3.0.

The requirement for red blood cell (13% versus 4.8%) and platelet (1.5% versus 0.6%) transfusions, erythropoiesis stimulating agents (12% versus 7%), and granulocyte colony stimulating factors (6% versus 0%) were higher in the ALIMTA arm compared to the placebo arm.

The following additional Grade 3 or 4 adverse reactions were observed more frequently in the ALIMTA arm.

Incidence 1% To <5%

Blood/Bone Marrow - thrombocytopenia

General Disorders - febrile neutropenia

Incidence <1%

Cardiovascular - ventricular tachycardia, syncope

General Disorders - pain

Gastrointestinal - gastrointestinal obstruction

Neurologic - depression

Renal - renal failure

Vascular - pulmonary embolism

Treatment Of Recurrent Disease After Prior Chemotherapy

The safety of ALIMTA was evaluated in Study JMEI, a randomized (1:1), open-label, active-controlled trial conducted in patients who had progressed following platinum-based chemotherapy. Patients received ALIMTA 500 mg/m² intravenously or docetaxel 75 mg/m² intravenously on Day 1 of each 21-day cycle. All patients on the ALIMTA arm received folic acid and vitamin B12 supplementation.

Study JMEI excluded patients with an ECOG PS of 3 or greater, uncontrolled third-space fluid retention, inadequate bone marrow reserve and organ function, or a calculated creatinine clearance less than 45 mL/min. Patients unable to discontinue aspirin or other non-steroidal anti-inflammatory drugs or unable to take folic acid, vitamin B12 or corticosteroids were also excluded from the study.

The data described below reflect exposure to ALIMTA in 265 patients in Study JMEI. Median age was 58 years (range 22 to 87 years); 73% of patients were men; 70% were White, 24% were Asian, 2.6% were Black or African American, 1.8% were Hispanic or Latino, and <2% were other ethnicities; 19% had an ECOG PS 0.

Table 7 provides the frequency and severity of adverse reactions reported in ≥5% of the 265 ALIMTA-treated patients in Study JMEI. Study JMEI is not designed to demonstrate a statistically significant reduction in adverse reaction rates for ALIMTA, as compared to the control arm, for any specified adverse reaction listed in the Table 7 below.

Table 7: Adverse Reactions Occurring in ≥5% of Fully Supplemented Patients Receiving ALIMTA in Study JMEI

Adverse Reactiona ALIMTA
(N=265)
Docetaxel
(N=276)
All Grades (%) Grades 3-4 (%) All Grade (%) Grades 3-4 (%)
Laboratory
Hematologic
Anemia 19 4 22 4
Neutropenia 11 5 45 40
Thrombocytopenia 8 2 1 0
Hepatic
Increased ALT 8 2 1 0
Increased AST 7 1 1 0
Clinical
Gastrointestinal
Nausea 31 3 17 2
Anorexia 22 2 24 3
Vomiting 16 2 12 1
Stomatitis/pharyngitis 15 1 17 1
Diarrhea 13 0 24 3
Constipation 6 0 4 0
Constitutional symptoms
Fatigue 34 5 36 5
Fever 8 0 8 0
Dermatology/Skin
Rash/desquamation 14 0 6 0
Pruritus 7 0 2 0
Alopecia 6 1 38 2
a NCI CTCAE version 2.0.

The following additional adverse reactions were observed in patients assigned to receive ALIMTA.

Incidence 1% To <5%

Body as a Whole - abdominal pain, allergic reaction/hypersensitivity, febrile neutropenia, infection

Dermatology/Skin - erythema multiforme

Neurology - motor neuropathy, sensory neuropathy

Incidence <1%

Cardiovascular - supraventricular arrhythmias

Renal - renal failure

Mesothelioma

The safety of ALIMTA was evaluated in Study JMCH, a randomized (1:1), single-blind study conducted in patients with MPM who had received no prior chemotherapy for MPM. Patients received ALIMTA 500 mg/m² intravenously in combination with cisplatin 75 mg/m² intravenously on Day 1 of each 21-day cycle or cisplatin 75 mg/m² intravenously on Day 1 of each 21-day cycle administered until disease progression or unacceptable toxicity. Safety was assessed in 226 patients who received at least one dose of ALIMTA in combination with cisplatin and 222 patients who received at least one dose of cisplatin alone. Among 226 patients who received ALIMTA in combination with cisplatin, 74% (n=168) received full supplementation with folic acid and vitamin B12 during study therapy, 14% (n=32) were never supplemented, and 12% (n=26) were partially supplemented.

Study JMCH excluded patients with Karnofsky Performance Scale (KPS) of less than 70, inadequate bone marrow reserve and organ function, or a calculated creatinine clearance less than 45 mL/min. Patients unable to stop using aspirin or other non-steroidal anti-inflammatory drugs were also excluded from the study.

The data described below reflect exposure to ALIMTA in 168 patients that were fully supplemented with folic acid and vitamin B12. Median age was 60 years (range 19 to 85 years); 82% were men; 92% were White, 5% were Hispanic or Latino, 3.0% were Asian, and <1% were other ethnicities; 54% had KPS of 90-100. The median number of treatment cycles administered was 6 in the ALIMTA/cisplatin fully supplemented group and 2 in the ALIMTA/cisplatin never supplemented group. Patients receiving ALIMTA in the fully supplemented group had a relative dose intensity of 93% of the protocol-specified ALIMTA dose intensity. The most common adverse reaction resulting in dose delay was neutropenia.

Table 8 provides the frequency and severity of adverse reactions ≥5% in the subgroup of ALIMTA-treated patients who were fully vitamin supplemented in Study JMCH. Study JMCH was not designed to demonstrate a statistically significant reduction in adverse reaction rates for ALIMTA, as compared to the control arm, for any specified adverse reaction listed in the table below.

Table 8: Adverse Reactions Occurring in ≥5% of Fully Supplemented Subgroup of Patients Receiving ALIMTA/Cisplatin in Study JMCHa

Adverse Reactionb ALIMTA/cisplatin
(N=168)
Cisplatin
(N=163)
All Grades (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%)
Laboratory
Hematologic
Neutropenia 56 23 13 3
Anemia 26 4 10 0
Thrombocytopenia 23 5 9 0
Renal
Elevated creatinine 11 1 10 1
Decreased creatinine clearance 16 1 18 2
Clinical
Eye Disorder
Conjunctivitis 5 0 1 0
Gastrointestinal
Nausea 82 12 77 6
Vomiting 57 11 50 4
Stomatitis/pharyngitis 23 3 6 0
Anorexia 20 1 14 1
Diarrhea 17 4 8 0
Constipation 12 1 7 1
Dyspepsia 5 1 1 0
Constitutional Symptoms
Fatigue 48 10 42 9
Metabolism and Nutrition
Dehydration 7 4 1 1
Neurology
Sensory neuropathy 10 0 10 1
Taste disturbance 8 0 6 0
Dermatology/Skin
Rash 16 1 5 0
Alopecia 11 0 6 0
a In Study JMCH, 226 patients received at least one dose of ALIMTA 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 ALIMTA in combination with cisplatin (168 patients) or cisplatin alone (163 patients) who received full supplementation with folic acid and vitamin B12 during study therapy.
b NCI CTCAE version 2.0.
The following additional adverse reactions were observed in patients receiving ALIMTA plus cisplatin:

Incidence 1% To <5%

Body as a Whole - febrile neutropenia, infection, pyrexia

Dermatology/Skin - urticaria

General Disorders - chest pain

Metabolism and Nutrition - increased AST, increased ALT, increased GGT

Renal - renal failure

Incidence <1%

Cardiovascular - arrhythmia

Neurology - motor neuropathy

Exploratory Subgroup Analyses based On Vitamin Supplementation

Table 9 provides the results of exploratory analyses of the frequency and severity of NCI CTCAE Grade 3 or 4 adverse reactions reported in more ALIMTA-treated patients who did not receive vitamin supplementation (never supplemented) as compared with those who received vitamin supplementation with daily folic acid and vitamin B12 from the time of enrollment in Study JMCH (fully-supplemented).

Table 9: Exploratory Subgroup Analysis of Selected Grade 3/4 Adverse Reactions Occurring in Patients Receiving ALIMTA in Combination with Cisplatin with or without Full Vitamin Supplementation in Study JMCHa

Grade 3-4 Adverse Reactions Fully Supplemented Patients
N=168 (%)
Never Supplemented Patients
N=32 (%)
Neutropenia 23 38
Thrombocytopenia 5 9
Vomiting 11 31
Febrile neutropenia 1 9
Infection with Grade 3/4 neutropenia 0 6
Diarrhea 4 9
a NCI CTCAE version 2.0.

The following adverse reactions occurred more frequently in patients who were fully vitamin supplemented than in patients who were never supplemented:

  • hypertension (11% versus 3%),
  • chest pain (8% versus 6%),
  • thrombosis/embolism (6% versus 3%).

Additional Experience Across Clinical Trials

Sepsis, with or without neutropenia, including fatal cases: 1%

Severe esophagitis, resulting in hospitalization: <1%

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ALIMTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System - immune-mediated hemolytic anemia

Gastrointestinal - colitis, pancreatitis

General Disorders and Administration Site Conditions - edema

Injury, poisoning, and procedural complications - radiation recall

Respiratory - interstitial pneumonitis

Skin - Serious and fatal bullous skin conditions, Stevens-Johnson syndrome, and toxic epidermal necrolysis

Read the entire FDA prescribing information for Alimta (Pemetrexed)

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