Neutrexin
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Neutrexin
Please Note: This Brand Name drug is no longer available in the US.(Generic versions may still be available.)
Neutrexin Side Effects Center
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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Neutrexin FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Because many patients who participated in clinical trials of Neutrexin (trimetrexate glucuronate for injection) had complications of advanced HIV disease, it is difficult to distinguish adverse events caused by Neutrexin (trimetrexate glucuronate inj) from those resulting from underlying medical conditions.
Table 3 lists the adverse events that occurred in ≥ 1% of the patients who participated in the Comparative Study of Neutrexin (trimetrexate glucuronate inj) plus leucovorin versus TMP/SMX.
TABLE 3: NEUTREXIN (trimetrexate glucuronate inj) COMPARATIVE TRIAL Comparison of Adverse
Events Reported for ≥ 1% of Patients
| Adverse Events | Number and Percent (%) of Patients with Adverse Events | |
| TMTX/LV (n = 109) |
TMP/SMX (n = 111) |
|
| Non-Laboratory Adverse Events: | ||
| Fever | 9 (8.3) | 14 (12.6) |
| Rash/Pruritus | 6 (5.5) | 14 (12.6) |
| Nausea/Vomiting | 5 (4.6)a | 15 (13.5)a |
| Confusion | 3 (2.8) | 3 (2.7) |
| Fatigue | 2 (1.8) | 0 (0.0) |
| Hematologic Toxicity: | ||
| Neutropenia ( ≤ 1000/mm3) | 33 (30.3) | 37 (33.3) |
| Thrombocytopenia ( ≤ 75,000/mm3) | 11 (10.1) | 17 (15.3) |
| Anemia (Hgb < 8 g/dL) | 8 (7.3) | 10 (9.0) |
| Hepatotoxicity: | ||
| Increased AST ( > 5 x ULNb) | 15 (13.8) | 10 (9.0) |
| Increased ALT ( > 5 x ULN) | 12 (11.0) | 13 (11.7) |
| Increased Alkaline Phosphatase ( > 5 x ULN) | 5 (4.6) | 3 (2.7) |
| Increased Bilirubin (2.5 x ULN) | 2 (1.8) | 1 (0.9) |
| Renal: | ||
| Increased Serum Creatinine ( > 3 x ULN) | 1 (0.9) | 2 (1.8) |
| Electrolyte Imbalance: | ||
| Hyponatremia | 5 (4.6) | 10 (9.0) |
| Hypocalcemia | 2 (1.8) | 0 (0.0) |
| No. of Patients With at Least one Adverse Eventc | 58 (53.2) | 60 (54.1) |
| a Statistically significant difference between
treatment groups (Chi-square: p=0.022) b ULN = Upper limit of normal range c Patients could have reported more than one adverse event; therefore, the sum of adverse events exceeds the number of patients |
||
Laboratory toxicities were generally manageable with dose modification of trimetrexate/leucovorin (see DOSAGE AND ADMINISTRATION).
Table 4 lists the adverse events resulting in discontinuation of study therapy in the Neutrexin (trimetrexate glucuronate inj) Comparative Study with TMP/SMX. Twenty-nine percent of the patients on the TMP/SMX arm discontinued therapy due to adverse events compared to 10% of the patients treated with TMTX/LV (p < 0.001).
TABLE 4: NEUTREXIN (trimetrexate glucuronate inj) COMPARATIVE TRIAL Adverse Events Resulting
in Discontinuation of Therapy
| Adverse Events | Number and Percent (%) of Patients Discontinued for Adverse Eventsb | |||
| TMTX/LV (n = 109) |
TMP/SMX (n = 111) |
|||
| Non-Laboratory Adverse Events: | ||||
| Rash/Pruritus | 3 | (2.8) | 5 | (4.5) |
| Fever | 2 | (1.8) | 4 | (3.6) |
| Nausea/Vomiting | 1 | (0.9) | 8 | (7.2) |
| Neurologic Toxicity | 1 | (0.9)c | 2 | (1.8) |
| Hematologic Toxicity: | ||||
| Neutropenia ( ≤ 1000/mm3) | 4 | (3.7) | 6 | (5.4) |
| Thrombocytopenia ( ≤ 75,000/mm3) | 0 | (0.0) | 4 | (3.6) |
| Anemia (Hgb < 8 g/dL) | 0 | (0.0) | 4 | (3.6) |
| Hepatotoxicity: | ||||
| Increased AST ( > 5 x ULNa) | 3 | (2.8) | 9 | (8.1) |
| Increased ALT ( > 5 x ULN) | 1 | (0.9) | 4 | (3.6) |
| Increased Alkaline Phosphatase ( > 5 x ULN) | 0 | (0.0) | 1 | (0.9) |
| Electrolyte Imbalance: | ||||
| Hyponatremia | 0 | (0.0) | 3 | (2.7) |
| No. of Patients Discontinuing Therapy Due to an Adverse Eventb | 11 | (10.1)d | 32 | (28.8)d |
| a ULN = Upper limit of normal range b Patients could discontinue therapy due to more than one toxicity; therefore the sum exceeds number of patients who discontinued due to toxicity c Patient discontinued TMTX/LV due to seizure, though causal relationship could not be established. d Statistically significant difference between treatment groups (Chi-square: p < 0.001) |
||||
Hematologic toxicity was the principal dose-limiting side effect.
Read the entire FDA prescribing information for Neutrexin (Trimetrexate Glucuronate Inj) »
Additional Neutrexin Information
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