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Alimta (Pemetrexed Disodium) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Malignant Pleural Mesothelioma --In Table 5 adverse events occurring in at least 5% of patients are shown along with important effects (renal failure, infection) occurring at lower rates. Adverse events equally or more common in the cisplatin group are not included. The adverse effects more common in the ALIMTA group were primarily hematologic effects, fever and infection, stomatitis/pharyngitis, and rash/desquamation.

Table 5: Adverse Events * in Fully Supplemented Patients Receiving ALIMTA plus Cisplatin in MPM
CTC Grades (% incidence)
All Reported Adverse Events Regardless of Causality
ALIMTA/cis
(N=168)
Cisplatin
(N=163)
All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4
Laboratory
Hematologic
Neutropenia 58 19 5 16 3 1
Leukopenia 55 14 2 20 1 0
Anemia 33 5 1 14 0 0
Thrombocytopenia 27 4 1 10 0 0
Renal
Creatinine elevation 16 1 0 12 1 0
Renal failure 2 0 1 1 0 0
Clinical
Constitutional Symptoms
Fatigue 80 17 0 74 12 1
Fever 17 0 0 9 0 0
Other constitutional symptoms 11 2 1 8 1 1
Cardiovascular General
Thrombosis/embolism 7 4 2 4 3 1
Gastrointestinal
Nausea 84 11 1 79 6 0
Vomiting 58 10 1 52 4 1
Constipation 44 2 1 39 1 0
Anorexia 35 2 0 25 1 0
Stomatitis/pharyngitis 28 2 1 9 0 0
Diarrhea without colostomy 26 4 0 16 1 0
Dehydration 7 3 1 1 1 0
Dysphagia/esophagitis/odynophagia 6 1 0 6 0 0
Pulmonary
Dyspnea 66 10 1 62 5 2
Pain
Chest pain 40 8 1 30 5 1
Neurology
Neuropathy/sensory 17 0 0 15 1 0
Mood alteration/depression 14 1 0 9 1 0
Infection/Febrile Neutropenia
Infection without neutropenia 11 1 1 4 0 0
Infection with Grade 3 or Grade 4
neutropenia
6 1 0 4 0 0
Infection/febrile neutropenia-other 3 1 0 2 0 0
Febrile neutropenia 1 1 0 1 0 0
Immune
Allergic reaction/hypersensitivity 2 0 0 1 0 0
Dermatology/Skin
Rash/desquamation 22 1 0 9 0 0
* Refer to NCI CTC Version 2.0.

Table 6 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 6: Selected Grade 3/4 Adverse Events Comparing
Fully Supplemented versus Never Supplemented Patients
in the ALIMTA plus Cisplatin arm in MPM (% incidence)
Adverse Event Regardless of Causality a (%) Fully Supplemented Patients
(N=168)
Never Supplemented Patients
(N=32)
Neutropenia 24 38
Thrombocytopenia 5 9
Nausea 12 31
Vomiting 11 34
Anorexia 2 9
Diarrhea without
colostomy
4 9
Dehydration 4 9
Fever 0 6
Febrile neutropenia 1 9
Infection with Grade 3/4
neutropenia
1 6
Fatigue 17 25
a Refer 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%).

For fully supplemented patients treated with ALIMTA plus cisplatin, the incidence of CTC Grade 3/4 fatigue, leukopenia, neutropenia, and thrombocytopenia were greater in patients 65 years or older as compared to patients younger than 65. 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%).

Non-Small Cell Lung Cancer (NSCLC) --Table 7 provides the clinically relevant undesirable effects that have been reported in 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 had received prior chemotherapy.

Table 7: Adverse Events * in Patients Receiving ALIMTA vs. Docetaxel in NSCLC
CTC Grades (% incidence)
All Reported Adverse Events Regardless of Causality
ALIMTA
(N=265)
Docetaxel
(N=276)
All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4
Laboratory
Hematologic
Anemia 33 6 2 33 6 <1
Leukopenia 13 4 <1 34 17 11
Neutropenia 11 3 2 45 8 32
Thrombocytopenia 9 2 0 1 1 0
Hepatic/Renal
ALT elevation 10 2 1 2 <1 0
AST elevation 8 <1 1 1 <1 0
Decreased creatinine clearance 5 1 0 1 0 0
Creatinine elevation 3 0 0 1 0 0
Renal failure <1 0 0 <1 0 0
Clinical
Constitutional Symptoms
Fatigue 87 14 2 81 16 1
Fever 26 1 <1 19 <1 0
Edema 19 <1 0 24 <1 0
Myalgia 13 2 0 20 3 0
Alopecia 11 NA NA 42 NA NA
Arthralgia 8 <1 0 13 3 0
Other constitutional symptoms 8 1 1 6 1 <1
Cardiovascular General
Thrombosis/embolism 4 2 1 3 2 1
Cardiac ischemia 3 2 1 2 <1 0
Gastrointestinal
Anorexia 62 4 1 58 7 <1
Nausea 39 4 0 25 3 0
Constipation 30 0 0 23 1 0
Vomiting 25 2 0 19 1 0
Diarrhea without colostomy 21 <1 0 34 4 0
Stomatitis/pharyngitis 20 1 0 23 1 0
Dysphagia/esophagitis/odynophagia 5 1 <1 7 1 0
Dehydration 3 1 0 4 1 0
Pulmonary
Dyspnea 72 14 4 74 17 9
Pain
Chest pain 38 6 <1 32 7 <1
Neurology
Neuropathy/sensory 29 2 0 32 1 0
Mood alteration/depression 11 0 <1 10 1 0
Infection/Febrile Neutropenia
Infection without neutropenia 23 5 <1 17 3 1
Infection/febrile neutropenia-other 6 2 0 2 <1 0
Febrile neutropenia 2 1 1 14 10 3
Infection with Grade 3 or Grade 4
neutropenia
<1 0 0 6 4 1
Immune
Allergic reaction/hypersensitivity 8 0 0 8 1 <1
Dermatology/Skin
Rash/desquamation 17 0 0 9 0 0
*Refer to NCI CTC Criteria for lab values for each Grade of toxicity (version 2.0).

Clinically relevant Grade 3 and Grade 4 laboratory toxicities were similar between integrated Phase 2 results from three single-agent ALIMTA studies (N=164) and the Phase 3 single-agent ALIMTA study described above, with the exception of neutropenia (12.8% versus 5.3%, respectively) and alanine transaminase elevation (15.2% versus 1.9%, respectively). These differences were likely due to differences in the patient population, since the Phase 2 studies included chemonaive and heavily pretreated breast cancer patients with pre-existing liver metastases and/or abnormal baseline liver function tests.

The incidence of CTC Grade 3/4 hypertension was the only finding demonstrating an age difference in patients treated with ALIMTA and was greater in patients 65 years or older as compared to younger patients. There are insufficient numbers of non-white patients to assess ethnic differences. The incidence of CTC Grade 3/4 dyspnea was higher in males for both treatment arms.



REPORTS OF SUSPECTED ALIMTA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Alimta. The information is not vetted and should not be considered as verified clinical evidence.

Possible Alimta side effects / adverse reactions in 70 year old male

Reported by a physician from China on 2011-10-05

Patient: 70 year old male

Reactions: White Blood Cell Count Decreased, Escherichia Test Positive, Counterfeit Drug Administered

Suspect drug(s):
Alimta

Other drugs received by patient: Dexamethasone; Folic Acid; Cisplatin; Vitamin B-12



Possible Alimta side effects / adverse reactions in 65 year old female

Reported by a consumer/non-health professional from Japan on 2011-10-07

Patient: 65 year old female

Reactions: Tympanic Membrane Perforation

Suspect drug(s):
Alimta

Other drugs received by patient: Cisplatin; Vitamin B-12; Folic Acid



Possible Alimta side effects / adverse reactions in 56 year old male

Reported by a physician from Japan on 2011-10-11

Patient: 56 year old male

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Alimta
    Dosage: dosage is uncertain.
    Indication: non-Small Cell Lung Cancer

Avastin
    Indication: non-Small Cell Lung Cancer
    Start date: 2011-02-01
    End date: 2011-04-01

Cisplatin
    Dosage: dosage is uncertain.
    Indication: non-Small Cell Lung Cancer



See index of all Alimta side effect reports >>

Drug label data at the top of this Page last updated: 2006-11-15

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