Alimta
Alimta Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Alimta (pemetrexed) for Injection is currently not available in generic form. Alimta is indicated for treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer. Possible side effects include but are not limited to: stomach upset, including nausea, and vomiting.
Alimta is available in strengths of 100 and 500mg in vials. 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. Women of childbearing potential using Alimta should be advised to avoid becoming pregnant. It is not known whether Alimta or its metabolites are excreted in human milk so risk versus benefits should be considered.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Alimta in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- pale skin, easy bruising or bleeding, unusual weakness;
- fever, chills, body aches, flu symptoms;
- white patches or sores inside your mouth or on your lips;
- urinating less than usual, or not at all;
- chest pain, trouble breathing;
- swelling, rapid weight gain.
Less serious side effects may include:
- skin rash;
- numbness or tingling;
- depressed mood;
- sore throat;
- tired feeling;
- nausea, vomiting, diarrhea, constipation, indigestion, loss of appetite; or
- muscle pain.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Alimta (Pemetrexed) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Alimta Overview - Patient Information: Side Effects
Temporary hair loss may occur. Normal hair growth should return after treatment has ended.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: fast/pounding heartbeat, change in the amount of urine, dark urine, yellowing eyes/skin, severe stomach/abdominal pain, pain/redness/swelling of arms or legs, sore throat, painful/difficult swallowing, mental/mood changes, depression, numbness or tingling of the hands/feet, easy bruising/bleeding.
Get medical help right away if any of these rare but very serious side effects occur: chest pain, new or worsening shortness of breath.
This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills or persistent sore throat.
A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
Pemetrexed can commonly cause a rash that is usually not serious and that can be prevented by taking corticosteroid medication (see How to Use section). However, if you do develop a rash, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, get medical help right away if you develop a rash.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Alimta (Pemetrexed)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Alimta FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
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)
ALIMTA in 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.
Table 4: Adverse Reactions in Fully Supplemented Patients
Receiving ALIMTA plus Cisplatin in NSCLCa
| Reactionb | ALIMTA/cisplatin (N=839) |
Gemcitabine/cisplatin (N=830) |
||
| 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 |
| aFor 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. bRefer to NCI CTC Criteria version 2.0 for each Grade of toxicity. cAccording to NCI CTC Criteria version 2.0, this adverse event term should only be reported as Grade 1 or 2. |
||||
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
ALIMTA Maintenance Following Non-ALIMTA Containing, Platinum-Based Induction Therapy
Table 5 provides the frequency and severity of adverse reactions reported in > 5% of the 438 patients with NSCLC who received ALIMTA maintenance and the 218 patients with NSCLC who received placebo following a platinum-based induction therapy.
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.
Table 5: Adverse Reactions in Patients Receiving ALIMTA
versus Placebo in NSCLCa Following Platinum-Based Induction Therapy
| Reactionb | ALIMTA (N=438) |
Placebo (N=218) |
||
| 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 |
| aFor 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. bRefer to NCI CTCAE Criteria version 3.0 for each Grade of toxicity. |
||||
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
Continuation of ALIMTA as Maintenance Following ALIMTA Plus Platinum Induction Therapy
Table 6 provides the frequency and severity of adverse reactions reported in > 5% of the 500 patients with non-squamous NSCLC who received at least one cycle of ALIMTA maintenance (n=333) or placebo (n=167) on the continuation maintenance trial.
The median of maintenance cycles administered to patients receiving one or more doses of maintenance therapy was 4 on both the pemetrexed and placebo arms. Dose reductions for adverse events occurred in 3.3% of patients in the ALIMTA arm and 0.6% in the placebo arm. Dose delays for adverse events occurred in 22% of patients in the ALIMTA arm and 16% in the placebo arm. Patients in both study arms were supplemented with folic acid and vitamin B12.
Table 6: Selecteda Adverse Reactionsb
Occurring in ≥ 5% of Patients Receiving ALIMTA in Nonsquamous NSCLC
Following ALIMTA Plus Cisplatin Induction Therapy
| Adverse Reaction Organ System and Term | ALIMTA (N=333) |
Placebo (N=167) |
||
| All Gradesa Toxicity (%) | Grade 3-4a Toxicity (%) | All Gradesa Toxicity (%) | Grades 3-4a Toxicity (%) | |
| 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 |
| aAdverse reactions of any severity (all grades) occurring
more frequently ( ≥ 5%) or Grade 3-4 adverse reactions occurring more
frequently ( ≥ 2%) in ALIMTA-treated patients compared to those receiving
placebo. bNCI CTCAE Criteria version 3.0 |
||||
Administration of RBC (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 Less than 1%
Cardiovascular - ventricular tachycardia, syncope
General Disorders - pain
Gastrointestinal - gastrointestinal obstruction
Neurologic - depression
Renal - renal failure
Vascular - pulmonary embolism
Non-Small Cell Lung Cancer (NSCLC) - After Prior Chemotherapy
Table 7 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.
Table 7: Adverse Reactions in Fully Supplemented Patients
Receiving ALIMTA versus Docetaxel in NSCLCa
| Reactionb | ALIMTA (N=265) |
Docetaxel (N=276) |
||
| 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 |
| aFor 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. bRefer to NCI CTC Criteria for lab values for each Grade of toxicity (version 2.0). cAccording to NCI CTC Criteria version 2.0, this adverse event term should only be reported as Grade 1 or 2. |
||||
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 8 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.
Table 8: Adverse Reactions in
Fully Supplemented Patients Receiving ALIMTA plus Cisplatin in MPMa
| Reactionb | ALIMTA/cisplatin (N=168) |
Cisplatin (N=163) |
||
| 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 |
| aFor 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. bRefer 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”. cAccording to NCI CTC Criteria version 2.0, this adverse event term should only be reported as Grade 1 or 2. |
||||
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 on Toxicity
Table 9 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.
Table 9: Selected Grade 3/4
Adverse Events Comparing Fully Supplemented versus Never Supplemented Patients
in the ALIMTA plus Cisplatin arm (% incidence)
| 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 |
| aRefer to NCI CTC criteria for lab and non-laboratory values for each grade of toxicity (Version 2.0). | ||
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%).
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 Experience Across Clinical Trials
Sepsis, which in some cases was fatal, occurred in approximately 1% of patients.
Esophagitis occurred in less than 1% of patients.
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.
These reactions occurred with ALIMTA when used as a single-agent and in combination therapies.
Gastrointestinal - colitis, pancreatitis
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.
Read the entire FDA prescribing information for Alimta (Pemetrexed) »
Additional Alimta Information
Alimta - User Reviews
Alimta User Reviews
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