New alerts for Velcade (Bortezomib)
Velcade (Bortezomib) is FDA approved for the treatment of multiple myeloma. Previously this drug was approved for patients who have received at least two prior therapies, but now this drug is approved for use in patients with multiple myeloma, who have received at least one prior therapy. Several thousand patients have been treated with velcade up to this date for multiple myeloma. The manufacturers are now issuing some new alerts for the use of velcade while treating patients with multiple myeloma.
Newly issued alerts:
Cardiac disorders:
Acute development or exacerbation of CHF and or new onset of decreased left ventricular ejection fraction has been reported. Patients with risk factors for or existing heart disease should be closely monitored.
Hepatic events:
Rare cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic events include increase in liver enzymes, hyperbilirubinemia, and hepatitis. Such changes may be reversible upon discontinuation of Velcade.
Other side effects from the use of velcade include:
Peripheral neuropathy:
Velcade (Bortezomib) causes neuropathy, which is predominantly sensory however some cases of motor neuropathy have also been reported. Patients should be monitored for symptoms of neuropathy such as numbness, burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort or neuropathic pain.
Thrombocytopenia:
Velcade (Bortezomib) treatment is usually associated with a drop in the platelet count. The platelet counts are lowest around day 11 of each cycle. Platelet counts usually recover before the next treatment due date. Velcade (Bortezomib) therapy should be halted if the platelet count drops below 25,000.
Hypotension:
Treatment with Velcade may lead to hypotension. The incidence of hypotension (postural, orthostatic, and hypotesion NOS combined) was 11 to 12% in the clinical studies. When patients have pre-existing condition like syncopy, or when patients are taking medications that can cause hypotension or dehydration, they should be closely monitored.
Gastrointestinal side effects:
Apart from the side effects related to liver, velcade also can cause nausea, vomiting, diarrhea, constipation. These symptoms may be managed with the used of anti-nausea medications, anti-diarrheals or laxatives.
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