Cath Lab Digest

New Drug for Gaucher Disease
The FDA has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease. VPRIV is manufactured by Shire Human Genetic Therapies Inc.

Gaucher disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. VPRIV provides long-term enzyme replacement therapy for Type 1 Gaucher disease, the most common form of the genetic disorder. It is an alternative to imiglucerase (Cerezyme), another enzyme replacement therapy. According to the FDA, imiglucerase is currently in short supply, and patients receiving the drug can be safely switched to VPRIV.
 
The safety and effectiveness of VPRIV was assessed in 3 clinical studies involving 82 patients ages 4 years and older with Type 1 Gaucher disease. The studies included patients who switched to VPRIV after being treated with imiglucerase.

Name Change for Heartburn Drug
As part of the agency’s efforts to prevent medication errors, the FDA has approved a name change for the heartburn drug dexlansoprazole (Kapidex) to avoid confusion with two other medications—bicalutamide (Casodex) and a brand of morphine sulfate extended-release (Kadian). Effective in late April 2010, Takeda Pharmaceuticals North America Inc will market dexlansoprazole under the new name Dexilant.

Since dexlansoprazole was approved in January 2009, there have been reports of dispensing errors because of confusion with the drugs, which have very different uses from dexlansoprasole and from each other.

Kapidex is a proton pump inhibitor used to treat heartburn and other conditions by reducing the amount of acid produced in the stomach. Casodex, marketed by AstraZeneca, is used to treat men with advanced prostate cancer. Kadian, distributed by Actavis Kadian LLC, is an opioid analgesic used to treat pain.

Generic Option for BPH
The FDA has approved the first generic version of tamsulosin hydrochloride (Flomax Capsules 0.4 mg) to treat benign prostatic hyperplasia (BPH), a condition in which an enlarged prostate gland causes problems with urination. An FDA official said the approval of generic tamsulosin offers greater access to a widely used treatment for BPH.

The prescribing information and safety warnings for the generic version of tamsulosin are the same as those for Flomax Capsules. Impax Laboratories Inc manufactures generic tamsulosin capsules. Information about the marketing and availability of this generic drug can be obtained from the manufacturer.

Treatment for Chronic Lymphocytic Leukemia
The FDA has announced approval of rituximab (Rituxan) to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer. The anti-cancer drug, is intended for patients with CLL who are beginning chemotherapy for the first time and for those who have not responded to other cancer drugs for CLL.

Rituximab, manufactured by Genentech, is a monoclonal antibody that binds to the surface of cancer cells, making it easier for the patient’s immune system to attack the cancer cell as if it were a foreign pathogen. Rituximab is administered with two other chemotherapy drugs—fludarabine and cyclophosphamide.

The safety and effectiveness of rituximab was evaluated in 2 studies that measured progression-free survival, defined as the time a patient in the study lived without the cancer progressing.