Navelbine Injection Adverse Reactions

Infections and infestations: Mild to moderate bacterial, viral or fungal infection at different localization (respiratory, urinary, gastrointestinal tract…) are common and usually reversible with an appropriate treatment.
Severe sepsis with other visceral failure and septicaemia occured in less than 1% of patients.
Complicated septicaemia and sometimes fatal are very rare. Neutropenic sepsis have been reported in post-marketing experience.
Haematological tolerance: The limiting toxicity is bone marrow depression resulting mainly neutropenia (G3: 24.3%; G4: 27.8%) which is reversible within 5 to 7 days and noncumulative overtime; neutrophil nadir occurs usually between 7 and 14 days after administration.
Anaemia (G3-4: 7.4%) and thrombocytopenia (G3-4: 2.5%) may occur, but are seldom severe,
Febrile neutropenia have been identified in post-marketing experience.
Immune system disorders: System allergic reactions as anaphylaxis, anaphylactic shock or anaphylactoïd type reaction have been reported in post-marketing experience.
Endocrine disorders: Patients treated by Navelbine have reported an inappropriate antidiuretic hormone secretion (SIADH).
Metabolism and nutrition disorders: Rare cases of severe hyponatraemia have been reported.
Anorexia has been identified as a post-marketing adverse effect.
Neurological tolerance: Neurologic disorders including loss of deep tendon reflexes are very common (in Iess than 5% of patients).
Weakness of the lower extremities has been reported after a prolonged treatment. Severe paresthesias with sensory and motor symptoms are uncommon and generally reversible.
Gastrointestinal tolerance: Constipation is the main symptom (G3-4: 2.7%) which rarely progress to paralytic ileus. Treatment may be resumed after recovery of normal bowel mobility. Stomatitis and diarrhoea usually mild to moderate may occur.
Nausea and vomiting may occur. The incidence of severe effects is low (G3-4: 2.2%). Anti-emetic therapy may reduce their occurence.
Rare cases of pancreatitis have been reported.
Liver: Transient elevations of liver function tests without clinical symptoms were reported.
Skin: Alopecia usually mild in nature may occur.
Rarely Navelbine may produce generalized cutaneous reaction,
Erythema on hands and feet has been reported as a post-marketing adverse effect.
Musculoskeletal and connective tissue disorders: Arthralgia including jaw pain and myalgia have been commonly experienced by patients receiving Navelbine therapy.
Respiratory system: As with other vinca alkaloids, Navelbine may occasionally produce acute shortness of breath, dyspnoea and severe bronchospasm. These adverse events may require treatment with supplemental oxygen, bronchodilators, and/or corticosteroids, particularly when there is pre-existing pulmonary dysfunction.
Rare cases of interstitial pneumopathy have been reported in patients treated with Navelbine in combination with mitomycin.
Cardiovascular system: There have been rare reports of ischemic cardiac disease (angina pectoris, myocardial infarction),
Tachycardia, palpitations and heart rhythm disorders are very rare adverse effects,
Chest pain was reported in 5% of patients. Most reports of chest pain were in patients who had either a history of cardiovascular disease or tumor within the chest.
Vascular disorders: Hypotension, hypertension, flushing and peripheral coldness are uncommon adverse effects. Severe hypotension and collapse are rare.
Local reaction: Like with other vinca alkaloids, Navelbine is a moderate vesicant.
Injection site reactions including erythema, vein discoloration, burning pain and local phlebitis may be observed in approximately one third of patients; 5% were severe.
Chemical phlebitis along the vein proximal to the site of injection was reported in 10% of patients. Bolus injection followed by abundant flushing of the vein can limit this effect. Insertion of a central venous line may be necessary.
Other undesirable effects: Fever, asthenia, fatigue, chest pain and pain at the tumor site have been experienced by patients receiving Navelbine therapy.
Any extravasations may induce local reactions which rarely progress to necrosis (see Precautions).