June 10, 2018

Drug Approvals Impacting Workers’ Comp

LucemyraTM – Opioid Dependence

The FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of opioid withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days.

The following language is extracted from the Lucemyra product label:

Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine, which is believed to play a role in many of the symptoms of opioid withdrawal, such as anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea and drug craving.

Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD. Common side effects include hypotension (low blood pressure), bradycardia (slow heart rate), somnolence (sleepiness), sedation and dizziness. Lucemyra was also associated with a few cases of syncope (fainting). Lucemyra effects the heart’s electrical activity, which can increase the risk of abnormal heart rhythms. When Lucemyra use is stopped, patients can experience a marked increase in blood pressure.

AimovigTM – Migraine

The FDA approved Aimovig (erenumab-aooe), a once-monthly, self-administered injection for the preventive treatment of migraine in adults.

The following language is extracted from the Aimovig product label:

Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.

Clinical trials for Aimovig resulted in a range of one to two-and-a-half fewer migraine days per month when compared to patients receiving placebos. The most common side effects of Aimovig reported in the clinical trials were injection site reactions and constipation.

Olumiant® – Rheumatoid Arthritis

The FDA approved Olumiant (baricitinib), a once-daily oral medication for the treatment of moderate-to-severe active rheumatoid arthritis in patients who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies.

The following language is extracted from the Olumiant product label:

Use of Olumiant in combination with other Janus kinase (JAK) inhibitors or biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. Olumiant may be used as monotherapy or in combination with methotrexate (MTX) or other non-biologic DMARDs.

Olumiant includes a Boxed Warning for the risk of serious infections, malignancies and thrombosis. Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving Olumiant. Lymphoma and other malignancies have been observed in patients treated with Olumiant as well.

Other warnings and precautions include gastrointestinal perforations, laboratory abnormalities (including neutropenia, lymphopenia, anemia, liver enzyme elevations, and lipid elevations) and a warning against the use of live vaccines with Olumiant. The most common adverse events included upper respiratory tract infections, nausea, herpes simplex and herpes zoster.

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