Medication Monitor

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  • April 19, 2018

    FDA has expanded the approval of idarucizumab as an antidote to the anticoagulant dabigatran in patients requiring emergency surgery or urgent procedures or who face life-threatening or uncontrolled bleeding.

    It is the first of its kind for a reversal agent of a novel oral anticoagulant.

    Approval of  idarucizumab as a reversal agent was based on data from the RE-VERSE Ad Phase III trial of dabigatran, which was conducted in October 2015. In the trial, 503 patients worldwide at 173 sites were split into two groups: group A (n = 301), in which 60% presented with uncontrolled or life-threatening bleeding, and group B (n = 202), in which 40% required an invasive procedure or an emergency surgery or intervention.

    The final results of the trial, published in July 2017, revealed that in 90 patients who received idarucizumab (group A, 51 patients; group B, 39 patients), the median maximum percentage reversal was 100% (95% CI 100-100). According to the researchers, test results were normalized within minutes in 88% to 98% of patients, as measured by ecarin clotting time (82%) or diluted thrombin time (99%).

    After 24 hours, concentrations of unbound dabigatran were below 20 mg/mL in 79% of patients. In group A, 35 patients could be assessed for hemostasis, which was restored at a mean of 11.4 hours. In group B, of the 36 patients who underwent a procedure, 33 reported intraoperative hemostasis, and 3 patients reported mildly or moderately abnormal hemostasis.

    Only one thrombotic event occurred within 72 hours after idarucizumab was administered to a patient who was not reinitiated to anticoagulants. No adverse safety signals were observed in the study.

  • April 16, 2018

    FDA granted approvals to nivolumab and ipilimumab in combination to treat intermediate or poor risk, previously untreated advanced renal cell carcinoma.

    Approvals were based on CheckMate 214 (NCT02231749), a randomized open-label trial. Patients with previously untreated advanced RCC received nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks for four doses, followed by nivolumab monotherapy (3 mg/kg) every 2 weeks, or sunitinib 50 mg daily for 4 weeks followed by 2 weeks off every cycle.

    Efficacy was evaluated in intermediate or poor-risk patients (n = 847). The trial demonstrated statistically significant improvements in overall survival (OS) and objective response rate (ORR) for patients receiving the combination (n = 425) compared with those receiving sunitinib (n = 422). Estimated median OS was not estimable in the combination arm compared with 25.9 months in the sunitinib arm (hazard ratio 0.63 [95% CI 0.44–0.89]; P < 0.0001). The ORR was 41.6% (95% CI 36.9–46.5) for the combination versus 26.5% (95% CI 22.4–31) in the sunitinib arm (P < 0.0001). The efficacy of the combination in patients with previously untreated renal cell carcinoma with favorable-risk disease was not established.

    The most common adverse reactions (reported in at least 20% of patients treated with the combination) were fatigue, rash, diarrhea, musculoskeletal pain, pruritus, nausea, cough, pyrexia, arthralgia, and decreased appetite.

    The recommended schedule and dose for this combination is nivolumab 3 mg/kg, followed by ipilimumab 1 mg/kg on the same day every 3 weeks for four doses, then nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks.

    Prescribing information for both nivolumab and ipilimumab have been updated with these results. Full prescribing information is available at:

    nivolumab PI:
    ipilimumab PI:

  • April 13, 2018

    FDA approved everolimus tablets for oral suspension for adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)–associated partial-onset seizures.

    Everolimus is also approved for TSC-associated subependymal giant cell astrocytoma (SEGA) and TSC-associated renal angiomyolipoma.

    Approval was based on EXIST-3, a randomized, double-blind, multicenter trial in 366 patients with TSC-associated partial-onset seizures, inadequate seizure control with 2 or more sequential antiepileptic drug (AED) regimens, and a TSC diagnosis (modified Gomez criteria). In addition, eligible patients were required to have had 16 or more partial-onset seizures during the 8-week baseline phase on a stable AED regimen.

    Patients were randomized (1:1.09:1) to everolimus targeting a low trough (LT, n = 117) or high trough (HT, n = 130) concentration of everolimus or placebo (n = 119). Patients initiated treatment with everolimus/matching placebo at 3–6 mg/m2 (depending on age or further adjusted for concomitant CYP3A4/P-glycoprotein inducer use) orally once daily.

    Subsequent doses were titrated to achieve the targeted trough concentrations as directed by an automated system to maintain the study blind. The major efficacy measure was the percentage reduction in average weekly seizures during a 12-week treatment period compared with the average weekly seizures during the 8-week baseline period.

    The trial demonstrated statistically significant reductions in seizures for each of the everolimus arms (LT arm, 29.3%; HT arm, 39.6%), compared with the placebo arm (14.9%). The proportion of patients with 50% reduction in seizure frequency during the 12-week treatment period compared with baseline also was higher in the LT and HT everolimus arms (28.2% and 40%, respectively) compared with the placebo arm (15.1%). 

    The most common adverse reactions, occurring in at least 10% of patients, were stomatitis, diarrhea, vomiting, nasopharyngitis, upper respiratory tract infection, pyrexia, cough, and rash.

    The recommended starting dose of everolimus arms for this indication is 5 mg/m2 orally once daily with dose adjustments (in increments up to 5 mg) to achieve trough concentrations of 5–15 ng/mL.

    The dose should be reduced in patients with severe hepatic impairment or in patients taking concurrent P-glycoprotein and moderate CYP3A4 inhibitors. The dose should be increased in patients taking concurrent P-glycoprotein and strong CYP3A4 inducers.

  • April 12, 2018

    FDA approved a new indication for bupivacaine liposome injectable suspension for use as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia following shoulder surgery in adults for 48 to 72 hours following administration. Interscalene brachial plexus nerve block works by anesthetizing the body’s nerves nearest the shoulder to help curb pain.

    The new indication's approval was based on the results of one multicenter clinical study, which demonstrated that the product is safe and effective for use as an interscalene brachial plexus nerve block to provide postsurgical regional analgesia for shoulder surgeries, such as total shoulder arthroplasty and rotator cuff repair.

    In accordance with recommendations made by an FDA advisory committee in February, the agency has determined that clinical trial data are not sufficient to support the general use of the agent for regional nerve blocks for postsurgical analgesia other than shoulder surgery. As such, the product’s updated labeling clearly articulates both the agent's limitations of use as well as the most up-to-date safety and efficacy data associated with this new indication.

    In 2011, the agent was approved for local administration to provide postsurgical analgesia.

  • April 12, 2018

    FDA approved rucaparib, a poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who achieved complete or partial response to platinum-based chemotherapy.

    Approval was based on ARIEL3 (NCT01968213), a randomized, double-blind, placebo-controlled trial in 561 patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had been treated with at least two prior treatments of platinum-based chemotherapy and were in complete or partial response to the most recent platinum-based chemotherapy. Patients were randomized (2:1) to rucaparib 600 mg orally twice daily (n = 372) or placebo (n = 189) and were treated until disease progression or unacceptable toxicity.

    Tumor tissue samples were examined with a next-generation sequencing assay to determine whether DNA contained a deleterious somatic or germline BRCA mutation (tBRCA). This test was also used to determine the percentage of genomic loss of heterozygosity (LOH). Positive homologous recombination deficiency (HRD) status was defined as tBRCA-positive and/or LOH high. Three patient outcomes analyses were performed on the following groups: all patients, HRD subgroup, and tBRCA subgroup.

    ARIEL3 demonstrated a statistically significant improvement in estimated median progression-free survival (PFS) assessed by investigator for patients randomized to rucaparib compared with placebo in all patients, in the HRD subgroup, and in the tBRCA subgroup.

    In ARIEL3, the most common adverse reactions in at least 20% of patients treated with rucaparib included nausea, fatigue (including asthenia), abdominal pain/distension, rash, dysgeusia, anemia, ALT/AST elevation, constipation, vomiting, diarrhea, thrombocytopenia, nasopharyngitis/URI, stomatitis, decreased appetite, and neutropenia. Myelodysplastic syndrome and/or acute myeloid leukemia occurred in 7 of 372 (1.9%) patients treated with rucaparib and in 1 of 189 (0.5%) patients assigned to placebo.

    Discontinuation due to adverse reactions occurred in 15% of patients receiving rucaparib and 2% of those assigned to placebo.

    The recommended rucaparib dose is 600 mg (two 300-mg tablets) taken orally twice daily with or without food.