Alimta Side Effects
Generic Name: pemetrexed
Please note - some side effects for Alimta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Alimta - for the Consumer
Alimta
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Alimta:
Seek medical attention right away if any of these SEVERE side effects occur when using Alimta:Constipation; diarrhea; hair loss; indigestion; loss of appetite; mild sore throat; nausea; pain, swelling, or redness at the injection site; taste changes; tiredness or weakness; vomiting; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; chest pain; chills; decreased amount of urine; fever; irregular heartbeat; mood or mental changes; mouth, throat, or lip sores; persistent cough; persistent sore throat; red, swollen, blistered, or peeling skin; severe or persistent diarrhea, nausea, vomiting, or stomach pain; severe or persistent tiredness or weakness; shortness of breath; swelling of the hands, ankles, or feet; symptoms of dehydration (eg, sluggishness, very dry mouth or eyes); trouble swallowing; unusual bruising or bleeding; unusually pale skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopAlimta Side Effects - for the Professional
Alimta
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%) during therapy with Alimta as a single-agent were fatigue, nausea, and anorexia. Additional common adverse reactions (incidence ≥20%) during therapy with Alimta when used in combination with cisplatin included vomiting, neutropenia, leukopenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation.
Non-Small Cell Lung Cancer (NSCLC) — Combination with Cisplatin
Table 4 provides the frequency and severity of adverse reactions that have been reported in >5% of 839 patients with NSCLC who were randomized to study and received Alimta plus cisplatin and 830 patients with NSCLC who were randomized to study and received gemcitabine plus cisplatin. All patients received study therapy as initial treatment for locally advanced or metastatic NSCLC and patients in both treatment groups were fully supplemented with folic acid and vitamin B12.
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a For the purpose of this table a cut off of 5% was used for inclusion of all events where the reporter considered a possible relationship to Alimta. |
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b Refer to NCI CTC Criteria version 2.0 for each Grade of toxicity. |
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c According to NCI CTC Criteria version 2.0, this adverse event term should only be reported as Grade 1 or 2. |
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| Reactionb | Alimta/cisplatin (N=839) |
Gemcitabine/cisplatin (N=830) |
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| All Grades Toxicity (%) | Grade 3-4 Toxicity (%) | All Grades Toxicity (%) | Grade 3-4 Toxicity (%) | |
| All Adverse Reactions | 90 | 37 | 91 | 53 |
| Laboratory | ||||
| Hematologic | ||||
| Anemia | 33 | 6 | 46 | 10 |
| Neutropenia | 29 | 15 | 38 | 27 |
| Leukopenia | 18 | 5 | 21 | 8 |
| Thrombocytopenia | 10 | 4 | 27 | 13 |
| Renal | ||||
| Creatinine elevation | 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 | ||||
| Neuropathy-sensory | 9 | 0 | 12 | 1 |
| Taste disturbance | 8 | 0c | 9 | 0c |
| Dermatology/Skin | ||||
| Alopecia | 12 | 0c | 21 | 1c |
| Rash/Desquamation | 7 | 0 | 8 | 1 |
No clinically relevant differences in adverse reactions were seen in patients based on histology.
In addition to the lower incidence of hematologic toxicity on the Alimta and cisplatin arm, use of transfusions (RBC and platelet) and hematopoietic growth factors was lower in the Alimta and cisplatin arm compared to the gemcitabine and cisplatin arm.
The following additional adverse reactions were observed in patients with non-small cell lung cancer randomly assigned to receive Alimta plus cisplatin.
Incidence 1% to 5%
- Body as a Whole — febrile neutropenia, infection, pyrexia
- General Disorders — dehydration
- Metabolism and Nutrition — increased AST, increased ALT
- Renal — creatinine clearance decrease, renal failure
- Special Senses — conjunctivitis
Incidence Less than 1%
- Cardiovascular — arrhythmia
- General Disorders — chest pain
- Metabolism and Nutrition — increased GGT
- Neurology — motor neuropathy
Non-Small Cell Lung Cancer (NSCLC) — Maintenance
Table 5 provides the frequency and severity of adverse reactions that have been reported in >5% of 438 patients with NSCLC who received Alimta and 218 patients with NSCLC who received placebo. All patients received study therapy immediately following 4 cycles of platinum-based treatment for locally advanced or metastatic NSCLC. Patients in both study arms were fully supplemented with folic acid and vitamin B12.
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a For the purpose of this table a cut off of 5% was used for inclusion of all events where the reporter considered a possible relationship to Alimta. |
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b Refer to NCI CTCAE Criteria version 3.0 for each Grade of toxicity. |
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| Alimta (N=438) |
Placebo (N=218) |
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| Reactionb | All Grades Toxicity (%) | Grade 3-4 Toxicity (%) | All Grades Toxicity (%) | Grade 3-4 Toxicity (%) |
| All Adverse Reactions | 66 | 16 | 37 | 4 |
| Laboratory | ||||
| Hematologic | ||||
| Anemia | 15 | 3 | 6 | 1 |
| Neutropenia | 6 | 3 | 0 | 0 |
| Leukopenia | 6 | 2 | 1 | 1 |
| 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 | ||||
| Neuropathy-sensory | 9 | 1 | 4 | 0 |
| Dermatology/Skin | ||||
| Rash/Desquamation | 10 | 0 | 3 | 0 |
No clinically relevant differences in Grade 3/4 adverse reactions were seen in patients based on age, gender, ethnic origin, or histology except a higher incidence of Grade 3/4 fatigue for Caucasian patients compared to non-Caucasian patients (6.5% versus 0.6%).
Safety was assessed by exposure for patients who received at least one dose of Alimta (N=438). The incidence of adverse reactions was evaluated for patients who received ≤6 cycles of Alimta, and compared to patients who received >6 cycles of Alimta. Increases in adverse reactions (all grades) were observed with longer exposure; however no clinically relevant differences in Grade 3/4 adverse reactions were seen.
Consistent with the higher incidence of anemia (all grades) on the Alimta arm, use of transfusions (mainly RBC) and erythropoiesis stimulating agents (ESAs; erythropoietin and darbepoetin) were higher in the Alimta arm compared to the placebo arm (transfusions 9.5% versus 3.2%, ESAs 5.9% versus 1.8%).
The following additional adverse reactions were observed in patients with non-small cell lung cancer who received Alimta.
Incidence 1% to 5%
- Dermatology/Skin — alopecia, pruritis/itching
- Gastrointestinal — constipation
- General Disorders — edema, fever (in the absence of neutropenia)
- Hematologic — thrombocytopenia
- Renal — decreased creatinine clearance, increased creatinine, decreased glomerular filtration rate
- Special Senses — ocular surface disease (including conjunctivitis), increased lacrimation
Incidence Less than 1%
- Cardiovascular — supraventricular arrhythmia
- Dermatology/Skin — erythema multiforme
- General Disorders — febrile neutropenia, allergic reaction/hypersensitivity
- Neurology — motor neuropathy
- Renal — renal failure
Non-Small Cell Lung Cancer (NSCLC) – After Prior Chemotherapy
Table 6 provides the frequency and severity of adverse reactions that have been reported in >5% of 265 patients randomly assigned to receive single-agent Alimta with folic acid and vitamin B12 supplementation and 276 patients randomly assigned to receive single-agent docetaxel. All patients were diagnosed with locally advanced or metastatic NSCLC and received prior chemotherapy.
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a For the purpose of this table a cut off of 5% was used for inclusion of all events where the reporter considered a possible relationship to Alimta. |
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b Refer to NCI CTC Criteria for lab values for each Grade of toxicity (version 2.0). |
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c According to NCI CTC Criteria version 2.0, this adverse event term should only be reported as Grade 1 or 2. |
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| Alimta (N=265) |
Docetaxel (N=276) |
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| Reactionb | All Grades Toxicity (%) | Grades 3-4 Toxicity (%) | All Grades Toxicity (%) | Grades 3-4 Toxicity (%) |
| Laboratory | ||||
| Hematologic | ||||
| Anemia | 19 | 4 | 22 | 4 |
| Leukopenia | 12 | 4 | 34 | 27 |
| 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 |
| Pruritis | 7 | 0 | 2 | 0 |
| Alopecia | 6 | 1c | 38 | 2c |
No clinically relevant differences in adverse reactions were seen in patients based on histology.
Clinically relevant adverse reactions occurring in <5% of patients that received Alimta treatment but >5% of patients that received docetaxel include CTC Grade 3/4 febrile neutropenia (1.9% Alimta, 12.7% docetaxel).
The following additional adverse reactions were observed in patients with non-small cell lung cancer randomly 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
- Renal — increased creatinine
Incidence Less than 1%
- Cardiovascular — supraventricular arrhythmias
Malignant Pleural Mesothelioma (MPM)
Table 7 provides the frequency and severity of adverse reactions that have been reported in >5% of 168 patients with mesothelioma who were randomly assigned to receive cisplatin and Alimta and 163 patients with mesothelioma randomly assigned to receive single-agent cisplatin. In both treatment arms, these chemonaive patients were fully supplemented with folic acid and vitamin B12.
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a For the purpose of this table a cut off of 5% was used for inclusion of all events where the reporter considered a possible relationship to Alimta. |
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b Refer to NCI CTC Criteria version 2.0 for each Grade of toxicity except the term “creatinine clearance decreased” which is derived from the CTC term “renal/genitourinary-other”. |
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c According to NCI CTC Criteria version 2.0, this adverse event term should only be reported as Grade 1 or 2. |
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| Alimta/cisplatin (N=168) |
Cisplatin (N=163) |
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| Reactionb | All Grades Toxicity (%) | Grade 3-4 Toxicity (%) | All Grades Toxicity (%) | Grade 3-4 Toxicity (%) |
| Laboratory | ||||
| Hematologic | ||||
| Neutropenia | 56 | 23 | 13 | 3 |
| Leukopenia | 53 | 15 | 17 | 1 |
| Anemia | 26 | 4 | 10 | 0 |
| Thrombocytopenia | 23 | 5 | 9 | 0 |
| Renal | ||||
| Creatinine elevation | 11 | 1 | 10 | 1 |
| Creatinine clearance decreased | 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 | ||||
| Neuropathy-sensory | 10 | 0 | 10 | 1 |
| Taste Disturbance | 8 | 0c | 6 | 0c |
| Dermatology/Skin | ||||
| Rash | 16 | 1 | 5 | 0 |
| Alopecia | 11 | 0c | 6 | 0c |
The following additional adverse reactions were observed in patients with malignant pleural mesothelioma randomly assigned to receive 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 Less than 1%
- Cardiovascular — arrhythmia
- Neurology — motor neuropathy
Effects of Vitamin Supplementations
Table 8 compares the incidence (percentage of patients) of CTC Grade 3/4 toxicities in patients who received vitamin supplementation with daily folic acid and vitamin B12 from the time of enrollment in the study (fully supplemented) with the incidence in patients who never received vitamin supplementation (never supplemented) during the study in the Alimta plus cisplatin arm.
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a Refer to NCI CTC criteria for lab and non-laboratory values for each grade of toxicity (Version 2.0). |
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| Adverse Eventa (%) | Fully Supplemented Patients (N=168) |
Never Supplemented Patients (N=32) |
| Neutropenia/granulocytopenia | 23 | 38 |
| Thrombocytopenia | 5 | 9 |
| Vomiting | 11 | 31 |
| Febrile neutropenia | 1 | 9 |
| Infection with Grade 3/4 neutropenia | 0 | 6 |
| Diarrhea | 4 | 9 |
The following adverse events were greater in the fully supplemented group compared to the never supplemented group: hypertension (11%, 3%), chest pain (8%, 6%), and thrombosis/embolism (6%, 3%).
Subpopulations
No relevant effect for Alimta safety due to gender or race was identified, except an increased incidence of rash in men (24%) compared to women (16%).
Additional Clinical Trials Experience
Across clinical trials, sepsis, which in some cases was fatal, occurred in approximately 1% of patients.
Post-Marketing 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.
These reactions have occurred with Alimta when used as a single-agent and in combination therapies.
Gastrointestinal — colitis
General Disorders and Administration Site Conditions — edema
Injury, poisoning, and procedural complications — Radiation recall has been reported in patients who have previously received radiotherapy.
Respiratory — interstitial pneumonitis
Skin — Bullous conditions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Some cases were fatal.
TopSide Effects by Body System - for Healthcare Professionals
Other
Side effects below show the incidence of CTC grade 3/4 toxicities in patients who received both pemetrexed and cisplatin along with vitamin supplementation including daily folic acid and vitamin B12.
Gastrointestinal
Gastrointestinal side effects including nausea (84%), vomiting (58%), constipation (44%), anorexia (35%), stomatitis/pharyngitis (28%), diarrhea without colostomy (26%), dehydration (7%), and dysphagia/esophagitis/odynophagia (6%) have been reported. Colitis has been reported rarely.
General
General side effects including fatigue (80%), chest pain (40%), fever (17%), other constitutional symptoms (11%), and edema have been reported.
Respiratory
Respiratory side effects including dyspnea (66%) and interstitial pneumonitis have been reported.
Hematologic
Hematologic side effects including neutropenia (58%), leukopenia (55%), anemia (33%), and thrombocytopenia (27%) have been reported.
Dermatologic
Dermatologic side effects including rash/desquamation (22%) have been reported.
Nervous system
Nervous system side effects including neuropathy/sensory effects (17%) have been reported.
Renal
Renal side effects including creatinine elevation (16%), and renal failure (2%) have been reported.
Psychiatric
Psychiatric side effects including mood alterations/depression (14%) have been reported.
Cardiovascular
Cardiovascular side effects including thrombosis/embolism (7%) have been reported.
Immunologic
Immunologic side effects including infection without neutropenia (1%), infection with grade 3 or grade 4 neutropenia (6%), infection/febrile neutropenia-other (3%), and febrile neutropenia (1%) have been reported.
Hypersensitivity
Hypersensitivity side effects including allergic reactions (2%) have been reported.
Other
Other side effects including radiation recall have been reported in patients who have previously received radiotherapy.
TopMore Alimta resources
- Alimta Prescribing Information (FDA)
- Alimta Monograph (AHFS DI)
- Alimta Advanced Consumer (Micromedex) - Includes Dosage Information
- Alimta Consumer Overview
- Alimta MedFacts Consumer Leaflet (Wolters Kluwer)
- Pemetrexed Professional Patient Advice (Wolters Kluwer)
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