Relubin

Relubin Adverse Reactions

vinorelbine

Manufacturer:

Sanbe

Marketer:

Sanbe
Full Prescribing Info
Adverse Reactions
Haematological tolerance: The limiting toxicity is bone marrow depression resulting mainly neutropenia which is reversible within 5 to 7 days and non cumulative over time; neutrophil nadir occurs usually between 7 to 14 days after administration.
Anaemia and thrombocytopenia may occur, but are seldom severe.
Neurological tolerance: Mild to moderate peripheral neuropathy manifested by paresthesia and hyperesthesia were the most frequently reported neurologic toxicities. The development of severe peripheral neuropathy was infrequent and generally reversible.
Gastrointestinal tolerance: Constipation is the main symptom which rarely progresses to paralytic ileus. Treatment may be resumed after recovery of normal bowel mobility. Stomatitis and diarrhea usually mild to moderate may occur.
Nausea and vomiting may occur. The incidence of severe effects is low. Antiemetic therapy may reduce their occurrence.
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 Vinorelbine Tartrate may produce generalized cutaneous reactions.
Respiratory system: As with other Vinca Alkoloid, Vinorelbine Tartrate may occasionally produce acute shortness of breath, dyspnea 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 Vinorelbine Tartrate in combination with mitomycin.
Cardiovascular system: There have been rare reports of ischemic cardiac disease (angina pectoris, myocardial infarction).
Most reports of chest pain were in patients who had either a history of cardiovascular disease or tumor within the chest.
Local reaction: Like with other Vinca Alkaloid, Vinorelbine Tartrate is a moderate vesicant. lnjection site reactions including erythema, vein discoloration, burning pain and local phlebitis.
Chemical phlebitis along the vein proximal to the site of injection. 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, fatigue, arthralgia including jaw pain, myalgia, chest pain and pain at the tumor site have been experienced by patients receiving Vinorelbine Tartrate therapy.
Any extravasations may induce local reactions which rarely progress to necrosis (see Warnings and Precautions).
Rare cases of severe hyponatraemia have been reported.
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