Vexdo 20/Vexdo 80

Vexdo 20/Vexdo 80 Adverse Reactions

docetaxel

Manufacturer:

Vexxa Lifesciences

Distributor:

VE Pharma
Full Prescribing Info
Adverse Reactions
The most common adverse reactions across all Vexdo (Docetaxel Injection) indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia.
Neutropenia, anaemia and skin reactions are common with docetaxel and may be severe. Fluid retention, resulting in oedema, ascites, pleural and pericardial effusion, and weight gain, is also common, and may be cumulative; premedication with a corticosteroid can reduce fluid retention as well as the severity of hypersensitivity reactions. Asthenia and fatigue have also been reported. Rare cases of ototoxicity, hearing impairment or loss have occurred.
Very rare cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported with combination chemotherapy regimens containing docetaxel; haematological follow-up may be required.
Effects on the eyes: Excessive tear formation (epiphora) severe enough to interfere with reading and driving has been reported in patients given docetaxel. Canalicular stenosis has been described as the mechanism for this effect, and docetaxel has been measured in tear fluid suggesting that irritation of the ocular surface and fibrosis of the tear drainage ducts may be caused by direct contact with docetaxel. Epiphora and canalicular stenosis are more severe and occur more frequently in patients who receive weekly docetaxel than in those who receive the drug every 3 weeks. The mean cumulative dose of docetaxel was found to be higher in those patients who developed stenosis. Management of this adverse effect includes probing and irrigation of the lachrymal ducts and canalicular silicone tubing placement, or surgery followed by tube placement. The condition is generally reversible and tubing can be removed 4 to 6 weeks after stopping docetaxel therapy. The use of topical tobramycin and dexamethasone on a tapering regimen can eliminate the need for silicone intubation or surgery in some patients.
Very rare cases of transient visual disturbances such as flashing lights and scotomata have occurred during docetaxel infusion, and in association with hypersensitivity reactions. These were reversible upon stopping the infusion. For reference to a report of glaucoma possibly related to docetaxel.
Effects on the gastrointestinal tract: Ischaemic colitis has occurred in patients treated with docetaxel. Some patients also received vinorelbine, which may have exacerbated this complication.
Effects on the heart: For comment on the increased risk of heart failure when docetaxel is given with trastuzumab and after anthracyclines, see under Interactions.
Effects on the musculoskeletal system: For reference to cases of taxane-induced arthralgia and myalgia successfully treated with gabapentin.
Effects on the skin and nails: Palmar-plantar erythrodysesthesia syndrome has been reported with the use of docetaxel. For reference to the use of vitamin E to alleviate palmar-plantar erythrodysesthesia syndrome caused by docetaxel and capecitabine. Cases of radiation recall dermatitis associated with docetaxel have also been reported. There is a further report of recall dermatitis at sites previously treated with a laser. A hyperpigmented eruption developed in a patient at the site of docetaxel injection after insufficient venous flushing; no eruption occurred after a second infusion with abundant venous flushing. Licensed drug information states that very rare cases of bullous eruption such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported with docetaxel, but that other factors may have contributed to the development of these reactions. For further reference to reports of scleroderma and adverse effects on the nails after the use of docetaxel.
In a multicentre study, patients given docetaxel wore a frozen glove on the right hand, leaving the left hand unprotected to serve as a control. The use of the glove significantly reduced skin and nail toxicity.
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