Navelbine Capsule Adverse Reactions

Adverse reactions reported are listed as follow, by system organ and by frequency.
The reactions were described using the NCI common toxicity criteria. (See Table 3.)


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Undesirable effects reported with Navelbine soft capsule: Pre-marketing experience: The most commonly reported adverse drug reactions are bone marrow depression with neutropenia, anaemia and thrombocytopenia, gastrointestinal toxicity with nausea, vomiting, diarrhoea, stomatitis and constipation. Fatigue and fever were also reported very commonly.
Post-marketing experience: The most commonly system organ classes involved during post-marketing experience are: 'Blood and lymphatic system disorders', 'Gastrointestinal disorders’ and 'General disorders and administration site conditions. This information is consistent with the pre-marketing experience.
Infections and Infestations: Very common: Bacterial, viral or fungal infections without neutropenia at different sites G1-4: 12.7%; G3-4: 4.4%. Common: Bacterial, viral or fungal infections resulting from bone marrow depression and/or immune system compromise (neutropenic infections) are usually reversible with an appropriate treatment. Neutropenic infection G3-4: 3.5%. Not known: Neutropenic sepsis. Complicated septicaemia and sometimes fatal.
Blood and lymphatic system disorders: Very common: Bone marrow depression resulting mainly in neutropenia (G1-4: 71.5%; G3: 21.8%; G4: 25.9%) is reversible and is the dose limiting toxicity. Leucopenia G1-4: 70.6%; G3: 24.7%; G4: 6%.
Anemia G1-4: 67.4%; G3-4: 3.8%. Thrombocytopenia G1-2: 10.8%. Common: G4 Neutropenia associated with fever over 38°C including febrile neutropenia: 2.8%.
Metabolism and nutrition disorders: Not Known: Severe hyponatraemia.
Psychiatric disorders: Common: Insomnia G1-2: 2.8%.
Nervous system disorders: Very common: Neurosensory disorders G1-2: 11.1% were generally limited to loss of tendon reflexes and infrequently severe. Common: Neuromotor disorders G1-4: 9.2%; G3-4: 1.3%. Headache: G1-4: 4.1%, G3-4: 0.6%. Dizziness: G1-4: 6%; G3-4: 0.6%. Taste disorders: G1-2: 3.8%. Uncommon: Ataxia grade 3: 0.3%.
Eye disorders: Common: Visual disorders G1-2: 1.3%.
Cardiac disorders: Uncommon: Heart failure and cardiac dysrhythmia. Not Known: Myocardial infarction in patients with cardiac medical history or cardiac risk factors.
Vascular disorders: Common: Hypertension G1-4: 2.5%; G3-4: 0.3%. Hypotension G1-4: 2.2%; G3-4: 0.6%.
Respiratory, thoracic and mediastinal disorders: Common: Dyspnoea G1-4: 2.8%; G3-4: 0.3%. Cough: G1-2: 2.8%.
Gastrointestinal disorders: Very Common: Nausea G1-4: 74.7%; G3-4: 7.3%. Vomiting G1-4: 54.7%; G3-4: 6.3%; supportive treatment (such as 5HT₃ antagonists (ondansetron)) may reduce the occurrence of Nausea and vomiting. Diarhoea G1-4: 49.7%; G3-4: 5.7%. Anorexia G 1-4: 38.6%; G 3-4: 4.1%. Stomatitis G1-4:10.4 %; G3-4: 0.9%. Abdominal pain: G1-4: 14.2%. Constipation G1-4: 19%; G3-4: 0.9%. Prescription of laxatives may be appropriate in patients with prior history of constipation and/or who received concomitant treatment with morphine or morphinemimetics. Gastric disorders: G1-4: 11.7%. Common: Oesophagitis: G1-3: 3.8%; G3: 0.3%. Dysphagia: G1-2: 2.3%. Uncommon: Paralytic ileus G3-4: 0.9% [exceptionally fatal] treatment may be resumed after recovery of normal bowel mobility. Not Known: Gastrointestinal bleeding.
Hepatobiliary disorders: Common: Hepatic disorders: G1-2: 1.3%.
Skin and subcutaneous tissue disorders: Very common: Alopecia usually mild in nature G1-2: 29.4% may occur. Common: Skin reactions G1-2: 5.7%.
Musculoskeletal and connective tissue disorders: Common: Arthralgia including jaw pain. Myalgia G1-4: 7%, G3-4: 0.3%.
Renal and urinary disorders: Common: Dysuria G1-2: 1.6%. Other genitourinary disorders G1-2: 1.9%.
General disorders and administration site conditions: Very common: Fatigue/malaise G1-4: 36.7%; G3-4: 8.5%. Fever G 1-4: 13.0%, G3-4: 12.1%. Common: Pain including pain at the tumour site G1-4: 3.8%, G3-4: 0.6%. Chills: G1-2: 3.8%.
Investigations: Very common: Weight loss G1-4: 25%, G3-4: 0.3%. Common: Weight gain G1-2: 1.3%.