Medication Monitor



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  • September 12, 2018

    FDA has approved riluzole oral suspension for the treatment of amyotrophic lateral sclerosis (ALS). It is the first and only easy-to-swallow thickened riluzole liquid for ALS and is administered twice daily via an oral syringe.

    Approval was based on bioavailability studies comparing oral riluzole tablets to riluzole oral suspension. While riluzole's mechanism of action is not fully understood, in clinical studies it has been shown repeatedly to modulate glutamate neurotransmission by inhibiting both glutamate release and postsynaptic glutamate receptor signaling.

    The most common adverse effects of the oral suspension are consistent with the established clinical profile of riluzole and include oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain.

    Riluzole oral suspensionhas has received orphan drug designation from FDA. The product will be available in mid-October.

  • September 12, 2018

    FDA has approved buprenorphine and naloxone sublingual film under the trade name Cassipa for maintenance treatment of opioid dependence. This action provides a new dosage strength (16 mg/4 mg) of the sublingual film, which is also approved in both brand name and generic versions and in various strengths.

    Cassipa should be used as part of a complete treatment plan that includes counseling and psychosocial support and should be used only after patient induction and stabilization up to a dose of 16 mg of buprenorphine using another marketed product.

    Common adverse events are oral numbness, burning mouth, inflammation of oral mucous membrane, headache, nausea, vomiting, excessive sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

    These products may only be prescribed by Drug Addiction Treatment Act–certified prescribers.

  • August 31, 2018

    FDA has approved lenvatinib capsules for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

    Approval was based on an international, multicenter, randomized, open-label, noninferiority trial conducted in 954 patients with previously untreated, metastatic or unresectable HCC.

    Patients were randomized (1:1) to receive lenvatinib (12 mg orally once daily for patients with a baseline body weight of ≥60 kg and 8 mg orally once daily for patients with a baseline body weight of <60 kg) or sorafenib (400 mg orally twice daily). Treatment continued until radiological disease progression or unacceptable toxicity.

    The trial demonstrated that lenvatinib was noninferior but not statistically superior to sorafenib for overall survival and a statistically significant improvement in progression-free survival compared with sorafenib. The overall response rate was higher for the lenvatinib arm compared with sorafenib (41% vs. 12% per mRECIST and 19% vs. 7% per RECIST 1.1).

    The most common adverse reactions observed in the lenvatinib-treated patients with HCC (≥20%) in order of decreasing frequency were hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea.

    The recommended lenvatinib dosages for patients with HCC are the following: 12 mg orally once daily in patients 60 kg or greater actual body weight or 8 mg orally once daily in patients less than 60 kg actual body weight.

  • August 29, 2018

    AbbVie announced FDA approval of ibrutinib plus rituximab to treat adult patients with Waldenström's macroglobulinemia (WM), a rare and incurable type of non–Hodgkin lymphoma. WM typically affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen also may be affected.

    With this approval, ibrutinib plus rituximab is the first and only chemotherapy-free combination treatment indicated specifically for the disease.

    The first-in-class Bruton's tyrosine kinase inhibitor was first approved as a single-agent therapy for WM in January 2015

    FDA approval of the combination for treatment of WM was supported by data from the Phase III iNNOVATE trial evaluating ibrutinib in combination with rituximab, versus rituximab alone, in 150 patients with previously untreated and relapsed/refractory WM.

    The most common adverse reactions (occurring in 20% or more of patients) in the iNNOVATE study were bruising, musculoskeletal pain, hemorrhage, diarrhea, rash, arthralgia, nausea, and hypertension.

    In combination with rituximab or as a single agent, the recommended dose for adults with WM is 420 mg taken orally once daily until disease progression or unacceptable toxicity.

  • August 29, 2018

    Ortho Dermatologics announced FDA approval of tretinoin 0.05% lotion as a topical treatment of acne vulgaris in patients aged 9 years and older.

    The product, the first formulation of a tretinoin in a lotion, has been shown to be effective and generally well tolerated. It spreads easily and is quickly absorbed into the skin, allowing patients with acne to easily incorporate the once-daily treatment into their skin care regimen, stated the news release. 

    Extensive clinical data have shown that retinoids are highly effective in treating acne and are considered a cornerstone of topical therapy. However, a common perceived barrier to their use is that treatment with retinoids is associated with skin irritation, such as dryness, peeling, and sensitivity.

    Tretinoin lotion was evaluated in two identical multicenter, randomized, double-blind, vehicle-controlled Phase III studies totaling 1,640 patients to determine its safety and efficacy. The data demonstrated that use of the product resulted in statistically significant reductions in both inflammatory and noninflammatory lesions compared with placebo.

    The most common adverse reactions, occurring in greater than 1% of participants and greater than placebo, were dryness, pain erythema, irritation, and exfoliation. Sunscreen and protective clothing should be worn when sun exposure cannot be avoided.

    The product is expected to become available during the fourth quarter of 2018. 

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