|
Eliglustat – Cerdelga (Genzyme)
|
| Comparative agents: |
Imiglucerase, Velaglucerase, Taliglucerase |
| Indication: |
Long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test |
| Mechanism of action: |
Specific inhibitor of glucosylceramide synthase |
| Common adverse effects: |
Fatigue, headache, nausea, diarrhea, back pain, pain in extremities, upper abdominal pain |
| Dosage form & strength: |
Capsules; 84 mg |
| Product labeling: |
http://www.cerdelga.com/pdf/cerdelga_prescribing_information.pdf |
|
| Ferric citrate – (Keryx Biopharmaceuticals) |
| Comparative agents: |
Calcium acetate, calcium carbonate, lanthanum carbonate, sevelamer hydrochloride, sevelamer carbonate, sucroferric oxyhydroxide |
| Indication: |
Control of serum phosphorus levels in patients with chronic kidney disease on dialysis |
| Mechanism of action: |
Iron-based phosphate binder complex |
| Common adverse effects: |
Diarrhea, discolored feces, constipation, nausea, and vomiting |
| Dosage form & strength: |
Oral; 210 mg ferric iron (equivalent to 1 g ferric citrate) |
| Product labeling: |
http://keryx.com/wp-content/uploads/Keryx_FerricCitrate_PI.pdf |
|
|
Fluticasone furoate –
Arnuity Ellipta (GlaxoSmithKline)
|
| Comparative agents: |
Fluticasone propionate |
| Indication: |
Maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older |
| Mechanism of action: |
Corticosteroid; anti-inflammatory activity |
| Common adverse effects: |
Upper respiratory tract infection, nasopharyngitis, headache, and bronchitis |
| Dosage form & strength: |
Inhalation powder; 100 mcg, 200 mcg |
| Product labeling: |
https://www.gsksource.com/gskprm/htdocs/documents/ARNUITY-ELLIPTA-PI-PIL.PDF |
|
|
Naltrexone HCl & Bupropion HCl –
Contrave (Orexigen Therapeutics)
|
| Comparative agents: |
Individual ingredients |
| Indication: |
Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia) |
| Mechanism of action: |
Opioid antagonist; aminoketone antidepressant; mechanism for weight control unknown, but may be related to activity in the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system) |
| Common adverse effects: |
Nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea |
| Dosage form & strength: |
Extended-release tablet; naltrexone 8 mg/bupropion HCl 90 mg |
| Product labeling: |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200063s000lbl.pdf |
|
|
Peginterferon beta-1A –
Plegridy (Biogen IDEC)
|
| Comparative agents: |
Interferon beta 1-A |
| Indication: |
Treatment of patients with relapsing forms of multiple sclerosis |
| Mechanism of action: |
Unknown |
| Common adverse effects: |
Injection site erythremia, influenza-like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia |
| Dosage form & strength: |
Injection – single-dose prefilled syringe; 63 mcg/0.5 mL, 94 mcg/0.5 mL, 125 mcg/0.5 mL |
| Product labeling: |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125499s000lbl.pdf |