Medication Monitor

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  • November 8, 2011

    Cetuximab is now approved for the treatment of metastatic head and neck cancer in combination with other chemotherapy, according to an FDA news release. The decision was based on data from a multicenter study conducted in 442 patients with inoperable or widespread disease in which patients were randomized to cetuximab plus chemotherapy (cisplatin or carboplatin and 5-fluorouracil) or chemotherapy only.

    The addition of cetuximab to chemotherapy was associated with significantly longer median overall survival times, 10.1 months in the group that received chemotherapy plus cetuximab versus 7.4 months in the chemotherapy-only group. In addition, use of cetuximab prolonged the median progression-free survival time from 3.3 to 5.6 months and increased the response rate from 20% to 36%.

    The most common grade 3 or 4 adverse events in both groups were anemia, neutropenia, and thrombocytopenia. Sepsis occurred in 9 patients in the cetuximab group and 1 patient in the chemotherapy-only group.

    Cetuximab was previously approved by FDA for certain types of colon cancer and for nonmetastatic head and neck cancer in combination with radiation therapy or as a single agent following standard treatment.

  • November 4, 2011


    Reduce risk of stroke and systemic embolism in patients with nonvalvular AF

    Rivaroxaban is now approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF), according to a FDA news release. In September, the Cardiovascular and Renal Drugs Advisory Committee voted 9 to 2 in favor of recommending the drug for approval.

    Approval was based on results of the pivotal, double-blind Phase III ROCKET-AF (Rivaroxaban Once-daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for the prevention of stroke and Embolism Trial in Atrial Fibrillation) trial, in which once-daily rivaroxaban was found to be noninferior to warfarin in terms of reducing the risk of stroke and systemic embolism in patients with nonvalvular AF. A major criticism of this trial was that warfarin-treated patients spent only 57.8 percent of the time in therapeutic range, which led some experts to question the wisdom of using rivaroxaban in patients who are well-controlled on warfarin therapy.

    ROCKET-AF showed that major bleeding rates for rivaroxaban were comparable with those of warfarin. FDA has required a Risk Evaluation and Mitigation Strategy (REMS) for rivaroxaban to communicate the risks of increased risk of thrombotic events, including stroke, if the drug is discontinued without introducing an adequate alternative anticoagulant. The REMS consists of a Medication Guide and a communication plan.

    The recommended dose for patients with nonvalvular AF is 20 mg once daily or 15 mg once daily for those with moderate to severe renal impairment. The dose should be taken with the evening meal. This dosing differs from the previous approved indication of venous thromboembolism prophylaxis in patients undergoing hip or knee surgery (10 mg once daily).

  • November 4, 2011

    FDA has authorized the market return of Octagam 5 percent after the product was voluntarily withdrawn from the market by the manufacturer in August 2010 because of an observed increase in thromboembolic events (TEEs), according to a news release from Octapharma. For those TEE cases involving Octagam, the root cause was determined to be associated with activated Factor XI, one of the many coagulation factors involved in the complex clotting cascade.

    Over the past year, the manufacturer has collaborated with FDA to develop and validate a scientific method to measure the amount of activated Factor XI in its product and made changes to its manufacturing process to utilize a commercial absorbent early in the manufacturing process that minimizes the presence of Factor XI. A quality control test will now occur on every batch of the product and the manufacturer will implement postmarketing studies to ensure product safety.

    The product is expected to be available in the coming weeks.

  • October 31, 2011

    A novel, extended-release 1.3% bupivacaine liposome injectable suspension has been approved by FDA for administration into the surgical site to produce postsurgical analgesia, according to a news release by Pacira Pharmaceuticals. This new product consists of bupivacaine encapsulated in the multivesicular liposome DepoFoam that is designed to extend the duration of analgesia provided by bupivacaine for up to 72 hours. The recommended dose is based on the surgical site and volume required to cover the area.

    Approval was based on data from 10 randomized, double-blind clinical trials evaluating the product in 823 patients. In a pivotal hemorrhoidectomy trial, use of bupivacaine liposome injectable suspension demonstrated significant reductions in cumulative pain scores with an attendant decrease in opioid consumption for up to 72 hours compared with placebo. The most common adverse events, occurring in 10% or more of patients, following administration were nausea, constipation, and vomiting.

  • October 25, 2011

    The first generic versions of olanzapine tablets and orally disintegrating tablets have been approved, according to a FDA news release. The oral tablets will be manufactured by Dr. Reddy’s Laboratories and Teva Pharmaceuticals, and the orally disintegrating tablets will be manufactured by Apotex, Dr. Reddy’s Laboratories, and Par Pharmaceuticals.