Medication Monitor



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  • October 9, 2018

    FDA approved a supplemental application for human papillomavirus (HPV) 9-valent vaccine, recombinant (Gardasil 9), expanding the approved use to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.

    Gardasil, a vaccine approved by FDA in 2006 to prevent certain cancers and diseases caused by four HPV types, is no longer distributed in the United States. In 2014, FDA approved Gardasil 9, which covers the same four HPV types as Gardasil, as well as an additional five HPV types. Gardasil 9 was approved for use in males and females aged 9 through 26 years.

    Effectiveness of Gardasil is relevant to Gardasil 9 since the vaccines are manufactured similarly and cover four of the same HPV types. In a study in approximately 3,200 women aged 27 through 45 who were followed for an average of 3.5 years, Gardasil was 88% effective in preventing a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.

    FDA’s approval of Gardasil 9 in women aged 27 through 45 is based on these results and new data on long-term follow-up from this study.

    Effectiveness of Gardasil 9 in men aged 27 through 45 is inferred from the data described above in women aged 27 through 45, as well as efficacy data from Gardasil in younger men (aged 16–26 y) and immunogenicity data from a clinical trial in which 150 men, aged 27 through 45, received a three-dose regimen of Gardasil over 6 months.

    Safety of Gardasil 9 was evaluated in approximately 13,000 males and females. The most commonly reported adverse reactions were injection-site pain, swelling, redness, and headaches.

    FDA granted the Gardasil 9 application priority review status. This program facilitates and expedites the review of medical products that address a serious or life-threatening condition. 
     

  • September 27, 2018

    Sun Pharma announced FDA approval of latanoprost ophthalmic emulsion 0.005% for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

    It is the first and only form of latanoprost that is not formulated with benzalkonium chloride, a preservative commonly used in topical ocular preparations.

    Recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. Reduction of IOP starts approximately 3 to 4 hours after administration, and the maximum effect is reached after 8 to 12 hours. 

    In clinical trials, the most frequently reported adverse reactions were eye pain/stinging upon instillation and ocular hyperemia (redness).  

  • 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.

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