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:

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Alimta:

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.

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Alimta 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.

Table 4: Adverse Reactions in Fully Supplemented Patients Receiving Alimta plus Cisplatin in NSCLCa

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.
b Refer to NCI CTC Criteria version 2.0 for each Grade of toxicity.
c According to NCI CTC Criteria version 2.0, this adverse event term should only be reported as Grade 1 or 2.
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

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.

Table 5: Adverse Reactions in Patients Receiving Alimta versus Placebo in NSCLCa

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.
b Refer to NCI CTCAE Criteria version 3.0 for each Grade of toxicity.
	Alimta (N=438)		Placebo (N=218)
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.

Table 6: Adverse Reactions in Fully Supplemented Patients Receiving Alimta versus Docetaxel in NSCLCa

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.
b Refer to NCI CTC Criteria for lab values for each Grade of toxicity (version 2.0).
c According to NCI CTC Criteria version 2.0, this adverse event term should only be reported as Grade 1 or 2.
	Alimta (N=265)		Docetaxel (N=276)
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.

Table 7: Adverse Reactions in Fully Supplemented Patients Receiving Alimta plus Cisplatin in MPMa

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.
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”.
c According to NCI CTC Criteria version 2.0, this adverse event term should only be reported as Grade 1 or 2.
	Alimta/cisplatin (N=168)		Cisplatin (N=163)
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.

Table 8: Selected Grade 3/4 Adverse Events Comparing Fully Supplemented versus Never Supplemented Patients in the Alimta plus Cisplatin arm (% incidence)

a Refer to NCI CTC criteria for lab and non-laboratory values for each grade of toxicity (Version 2.0).
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.

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Side 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.

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