Vinorelbine - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Vinorelbine. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: MYELOSUPPRESSION Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death can occur [see Warnings and Precautions ]. Decrease the dose or withhold vinorelbine in accord with recommended dose modifications [see Dosage and Administration ]. WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. Severe myelosuppression resulting in serious infection, septic shock, and death can occur . Decrease the dose or withhold vinorelbine in accord with recommended dose modifications .
5 WARNINGS AND PRECAUTIONS Hepatic Toxicity: Monitor hepatic function prior to initiation and during treatment Severe constipation and bowel obstruction, including necrosis and perforation, occur.
Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction and/or paralytic ileus Extravasation can result in severe tissue injury, local tissue necrosis and/or thrombophlebitis.
Immediately stop vinorelbine and institute recommended management procedures Neurologic Toxicity: Severe sensory and motor neuropathies occur.
Monitor patients for new or worsening signs and symptoms of neuropathy.
Discontinue for Grade 2 or greater neuropathy Pulmonary toxicity and respiratory failure occur.
Interrupt vinorelbine in patients who develop unexplained dyspnea or have any evidence of pulmonary toxicity.
Permanently discontinue for confirmed interstitial pneumonitis or ARDS Embryo-Fetal Toxicity: Can cause fetal harm.
Advise females of reproductive potential of potential risk to the fetus and to use effective contraception ( 5.7 , 8.1 , 8.3 ) 5.1 Myelosuppression Myelosuppression, manifested by neutropenia, anemia and thrombocytopenia, occur in patients receiving vinorelbine as a single agent and in combination with cisplatin [see Adverse Reactions ( 6.1 , 6.2 )] .
Neutropenia is the major dose-limiting toxicity with vinorelbine.
Grade 3-4 neutropenia occurred in 53% of patients treated with vinorelbine at 30 mg/m 2 per week.
Dose adjustment due to myelosuppression occurred in 51% of patients (Study 2).
In clinical trials with vinorelbine administered at 30 mg/m 2 per week, neutropenia resulted in hospitalizations for pyrexia and/or sepsis in 8% of patients.
Death due to sepsis occurred in 1% of patients.
Neutropenia nadirs occur between 7 and 10 days after dosing with neutropenia count recovery usually occurring within the following 7 to 14 days.
Monitor complete blood counts prior to each dose of vinorelbine.
Do not administer vinorelbine to patients with neutrophil counts <1,000 cells/mm 3 .
Adjustments in the dosage of vinorelbine should be based on neutrophil counts obtained on the day of treatment [see Dosage and Administration ].
5.2 Hepatic Toxicity Drug-induced liver injury manifest by elevated aspartate aminotransferase (AST) and bilirubin occur in patients receiving vinorelbine as a single agent and in combination with cytotoxic agents.
Assess hepatic function prior to initiation of vinorelbine and periodically during treatment.
Reduce the dose of vinorelbine for patients who develop elevations in total bilirubin ≥ 2 times upper limit of normal [see Dosage and Administration and Use in Specific Populations ].
5.3 Severe Constipation and Bowel Obstruction Severe and fatal paralytic ileus, constipation, intestinal obstruction, necrosis, and perforation occur in patients receiving vinorelbine.
Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction and/or paralytic ileus, considering adequate dietary fiber intake, hydration and routine use of stool softeners.
5.4 Extravasation and Tissue Injury Extravasation of vinorelbine can result in severe irritation, local tissue necrosis and/or thrombophlebitis.
If signs or symptoms of extravasation occur, immediately stop administration of vinorelbine and institute recommended management procedures [see Dosage and Administration and Adverse Reactions ].
5.5 Neurologic Toxicity Sensory and motor neuropathies, including severe neuropathies, occur in patients receiving vinorelbine.
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