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CLINICAL CONTENT UPDATES

Selected New Drug Approvals - New Monographs and Patient Medication Instructions

U.S. Food and Drug Administration (FDA)

Abacavir/dolutegravir/lamivudine (Triumeq®): Approved to treat HIV-1 infection. Triumeq® is a once daily, single-pill regimen that includes the integrase strand transfer inhibitor dolutegravir, as well as the nucleoside reverse transcriptase inhibitors abacavir and lamivudine.

Canagliflozin/metformin (Invokamet™): Approved as the first oral fixed-dose type 2 diabetes combination therapy available in the US.

Cobicistat (Tybost®):Approved to treat HIV-1 infection. Cobicistat is administered once daily in combination with either atazanavir or darunavir.

Dulaglutide (Trulicity®):Approved as a once-weekly subQ injection to treat adults with type 2 diabetes. It can be administered alone or with other therapies and carries a boxed warning for causing C-cell tumors in rats.

Eliglustat (Cerdelga™): Approved for the long-term treatment of type 1 Gaucher disease in adult patients. Eliglustat is taken orally and works by inhibiting the metabolic process that forms fatty materials, thereby slowing fatty material production.

Elvitegravir (Vitekta®):Approved for use in treatment-experienced patients with HIV-1. Elvitegravir has been approved in Europe since 2013. Elvitegravir should be used concomitantly with background therapy that consists of an HIV protease inhibitor coadministered with ritonavir and another antiretroviral drug.

Empagliflozin (Jardiance®):Approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The once-daily tablet can be taken alone or in combination with other type 2 diabetes therapies. 

Ferric citrate:Approved to treat hyperphosphatemia in patients with chronic kidney disease on dialysis. Ferric citrate is contraindicated in patients with iron overload.

Immune globulin/recombinant human hyaluronidase (Hyqvia): Approved to treat primary immunodeficiency in adults. Hyqvia offers a simpilified dosing regimen compared to existing therapies; however, it carries a black box warning for an increased risk for thrombosis.

Naloxegol (Movantik™):Approved to treat opioid-induced constipation in adults with chronic, non-cancer-based pain. Naloxegol is effective in patients with at least 4 weeks of opioid exposure.

Naltrexone hcl/bupropion hcl (Contrave®):Approved for chronic weight management in obese adults or overweight adults with an additional weight-related condition. Contrave® carries a black box warning for suicidal thoughts and neuropsychiatric symptoms.

Olodaterol (Striverdi® Respimat®):Approved to treat airflow obstruction in patients with COPD. Olodaterol, a long-acting beta agonist (LABA) once-daily inhalation spray, is not indicated to treat acutely deteriorating COPD or asthma and carries a boxed warning for an increased risk of asthma-related death with LABA use.

Oritavancin (Orbactiv™):Approved to treat adults with acute bacterial skin and skin structure infections (ABSSSI) caused by MRSA and other susceptible bacteria. The 3-hour IV infusion is given as a single dose.

Peginterferon beta-1a (Plegridy™):Approved to treat relapsing multiple sclerosis. Peginterferon beta-1a is dosed every two weeks and can be administered subcutaneously with the ready-to-use auto-injecting Plegridy™ Pen or a prefilled syringe.

Pembrolizumab (Keytruda®):Approved to treat patients with advanced or unresectable melanoma. Administered as an IV infusion every 3 weeks.

Suvorexant (Belsomra®):The first orexin receptor antagonist approved for insomnia. Suvorexant, a schedule IV controlled substance, was found to impair driving performance at higher doses, so all patients should be warned about activities that require mental alertness the following day.

European Medicines Agency Approvals (not already approved by the FDA) - New Monographs

Ataluren (Translarna): Indicated to treat Duchenne muscular dystrophy in ambulatory patients 5 years of age or older.  Ataluren is designated by the EMA as an orphan drug and is the first in its class to be approved for Duchenne muscular dystrophy.

Daclatasvir (Daklinza): Indicated to treat chronic hepatitis C virus (HCV) infection in adults.  Daclatasvir is considered breakthrough therapy for HCV and is to be used in combination with other drugs, including sofosbuvir or peginterferon alfa-2b with or without ribavirin.

New FDA-Approved Indications - Revised Monographs and Patient Medication Instructions

Adalimumab (Humira®): Expanded approval for treatment of moderate to severe Crohn disease to include use in patients 6 years of age or older who have not responded to other treatments. Approval for reducing signs and symptoms of moderately to severely active polyarticular JIA was also expanded to include patients 2 years of age or older; previously approved in pediatric patients 4 years or older.

Alglucosidase alfa (Lumizyme®): Now approved to treat infantile-onset Pompe disease in patients younger than 8 years of age. The FDA also eliminated the REMS after determining that alglucosidase alfa is comparable with Myozyme®, an FDA-approved alglucosidase alfa product for use in patients of all ages. 

Bevacizumab (Avastin®): Now approved in combination with paclitaxel and cisplatin or paclitaxel and topotecan, to treat patients with persistent, recurrent, or metastatic cervical cancer.

Coagulation factor XI recombinant (Rixubis): Expanded approval to include use in patients younger than 12 years of age. The drug is indicated for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis in patients with hemophilia B. 

Eltrombopag (Promacta®): Now approved for use in patients with severe aplastic anemia in which immunosuppressive therapy has been ineffective.

Fluocinolone acetonide (Iluvien®): Now approved as the first long-term treatment for diabetic macular edema in patients who did not have a significant rise in intraocular pressure with corticosteroid treatment. 

Lacosamide (Vimpat®): Expanded approval to include monotherapy and single loading-dose administration for adults with partial-onset seizures. Loading doses should be given under medical supervision because of potential CNS effects. 

Methylnaltrexone bromide (Relistor®): Now approved for treatment of opioid-induced constipation in adults with chronic non-cancer-based pain.

New Off-Label Indications 

Apixaban for the treatment of venous thromboembolism (Class IIa, Recommended in most)

Rosuvastatin for the prophylaxis of radiographic contrast agent nephropathy (Class IIb, Recommended in some)

Other Significant Updates - Drug Content

START/STOPP Criteria -  Appropriate Use of Medications in Elderly Patients Drug Consult

A new drug consult was created to address START (Screening Tool to Alert doctors to Right Treatment) and STOPP (Screening Tool of Older Persons’ potentially inappropriate Prescriptions) criteria, which are published screening tools to assist in the appropriate use of medications in elderly patients.

Atorvastatin vs rosuvastatin: In the prophylaxis of postcardiac surgery atrial fibrillation, rosuvastatin and atorvastatin were similarly effective in patients undergoing isolated coronary artery bypass graft surgery (n=168). In Micromedex: see the Comparative Efficacy section of the Drugdex Evaluation monographs for each drug for additional details.

Enoxaparin dosage adjustment in burn patients: Added a new formula to calculate the enoxaparin dose for patients with moderate burn injuries. In Micromedex: see Dosage Adjustment section and summary and detailed enoxaparin monographs for additional details.

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