Pexate 100/Pexate 500

Pexate 100/Pexate 500 Adverse Reactions

pemetrexed

Manufacturer:

Naprod

Distributor:

Multicare

Marketer:

Multicare
Full Prescribing Info
Adverse Reactions
The most commonly reported undesirable effects related to pemetrexed, whether used as monotherapy or in combination, are bone marrow suppression manifested as anaemia, neutropenia, leukopenia, thrombocytopenia; and gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhea, constipation, pharyngitis, mucositis, and stomatitis. Other undesirable effects include renal toxicities, increased aminotransferases, alopecia, fatigue, dehydration, rash, infection/sepsis and neuropathy. Rarely seen events include Stevens-Johnson syndrome and Toxic epidermal necrolysis.
Table 4 provides the frequency and severity of undesirable effects that have been reported in >5% of 168 patients with mesothelioma who were randomised to receive cisplatin and Pemetrexed and 163 patients with mesothelioma randomised to receive single agent cisplatin. In both treatment arms, these chemonaive patients were fully supplemented with folic acid and vitamin B12 (see Table 4).
Very common ≥10%; common is normally defined as >1% and <10%. For the purpose of Table 4, cut off of 5% was used for inclusion of all events where the reporter considered a possible relationship to Pemetrexed ad cisplatin. Clinically relevant CTC toxicities that were reported in ≥1% and ≤5% (common) of the patients that were randomly assigned to receive cisplatin and Pemetrexed include: Increased AST, ALT, and GGT, infection, pyrexia, febrile neutropenia, renal failure, chest pain, and urticaria. Clinically relevant CTC toxicities that were reported in 1% (uncommon) of the patients that were randomly assigned to receive cisplatin and Pemetrexed include arrhythmia and motor neuropathy. See Table 4.

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Table 5 provides the frequency and severity of undesirable effects that have been reported in >5% of 265 patients randomly assigned to receive single agent Pemetrexed 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 non-small cell lung cancer and received prior chemotherapy. See Table 5.
Very common ≥10%; common is normally defined as >1% and <10. For the purpose of Table 5, a cut off 5% was used for the inclusion of all events where the reporter considered a possible relationship to Pemetrexed.
Clinically relevant CTC toxicities that were reported in >1% and <5% (common) of the patients that were randomly assigned to Pemetrexed include: Sensory neuropathy, abdominal pain, increased creatinine febrile neutropenia, infection without neutropenia, allergic reaction/hypersensitivity and erythema multiforme.
Clinically relevant CTC toxicities that were reported in <1% (uncommon) of the patients that were randomly assigned to Pemetrexed include supraventricular arrhythmias.
Clinically relevant Grade 3 and Grade 4 laboratory toxicities were similar between integrated Phase 2 results from three single agent Pemetrexed studies (n=164) and the Phase 3 single agent Pemetrexed study previously described, 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 both chemonaive and heavily pre-treated breast patients with pre-existing liver metastases and/or abnormal liver function tests.

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Table 6 provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in >5% of 839 patients with NSCLC who were randomized to study and received cisplatin and Pemetrexed and 830 patients with NSCLC who were randomized to study and received cisplatin and gemcitabine. 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 (see Table 6).
Very common ≥10%, common is normally defined as >1% and <10%. For the purpose Table 6, a cut off of 5% was used for inclusion of all events where the reporter considered a possible relationship to Pemetrexed. Clinically relevant toxicity that was reported in ≥1% and ≤5% (common) of the patients that were randomly assigned to receive cisplatin and Pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis and creatinine clearance decreases.
Clinically relevant toxicity that was reported in <1% (uncommon) of the patients that were randomly assigned to receive cisplatin and Pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.

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Table 7 provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in >5% of 800 patients randomly assigned to receive single agent Pemetrexed ad 402 patients randomly assigned to receive placebo in the single agent Pemetrexed maintenance (JMEN:N=663) and continuation Pemetrexed maintenance (PARAMOUNT:N=663) and continuation Pemetrexed maintenance (PARAMOUNT:N=539) studies. All patients were diagnosed with stage IIIB of IV NSCLC and had received prior platinum-based chemotherapy.
Patients in both study arms were fully supplemented with folic acid and vitamin B12 (see Table 7).

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Clinically relevant CTC toxicity of any grade that was reported in ≥1% and ≤5% of the patients that were randomly assigned to Pemetrexed include: Febrile neutropenia, infection, decreased platelets, decreased creatinine clearance, diarrhoea, constipation, edema, alopecia, increased creatinine, pruritus/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, decreased glomerular filtration rate, dizziness and motor neuropathy.
Clinically relevant CTC toxicity that was reported in <1% (uncommon) of the patients that were randomly assigned to Pemetrexed include: Allergic reaction/hypersensitivity, erythema multiforme, renal failure, supraventricular arrhythmia and pulmonary embolism.
Safety was assessed for patients who were randomised to receive Pemetrexed (N=800). The incidence of adverse reactions was evaluated for patients who received ≤6 cycles of Pemetrexed maintenance (N=568), and compared to patients who received >6 cycles of Pemetrexed (N=232). Increases in adverse reactions (all grades) were observed with longer exposure; however, no statistically significant differences in any individual Grade 3/4/5 adverse reactions were seen.
Serious cardiovascular and cerebrovascular events, including myocardial infarction, angina pectoris, cerebrovascular accident and transient ischaemic attack have been uncommonly reported during clinical studies with Pemetrexed, usually when given in combination with another cytotoxic agent.
Most of the patients in whom these events have been observed had pre-existing cardiovascular risk factors.
Rare cases of hepatitis, potentially serious, have been reported during clinical studies with Pemetrexed. Pancytopenia has been uncommonly reported during clinical trials with Pemetrexed.
Additional Clinical Trial Data: In clinical trials, sepsis which in some cases was fatal occurred in approximately 1% of patients.
Cases of esophagitis have been reported uncommonly in clinical trials with Pemetrexed.
During post-marketing surveillance, the following adverse reactions have been reported in patients treated with Pemetrexed.
Gastrointestinal: Rare cases of colitis have been reported in patients treated with Pemetrexed.
General Disorders and Administration Site Conditions: Uncommon cases of edema have been reported in patients treated with Pemetrexed.
Injury, Poisoning and Procedural Complications: Rare cases of radiation recall have been reported in patients who have previously received radiotherapy.
Respiratory: Rare cases of interstitial pneumonitis have been reported in patients treated with Pemetrexed.
Skin: Rare cases of bullous conditions have been reported including Stevens-Johnson syndrome and Toxic epidermal necrolysis which in some cases were fatal.
Cases of peripheral ischemia leading sometimes to extremity necrosis have been reported.
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