Epocrates Drug Updates - Editor's Pick
March 2, 2015
Ibrance Approved for Metastatic Breast Cancer
Ibrance (palbociclib) is the first FDA-approved cyclin-dependent kinase inhibitor, and it represents a new option for the initial endocrine-based treatment for metastatic, hormone receptor-positive, HER2-negative breast cancer. It is given as 125 mg orally once daily on days 1-21 of a 28-day cycle in combination with letrozole 2.5 mg daily, which is administered on a continuous basis. Notable adverse reactions associated with Ibrance include neutropenia, infections, and pulmonary embolism.
Flonase Now Available Over-the-Counter
Flonase (fluticasone propionate nasal) is the latest drug to undergo an Rx-to-OTC switch. Like its prescription-status predecessor, the new OTC product, Flonase Allergy Relief, is available in a 50-mcg/spray strength. The corticosteroid nasal spray is used to treat allergy symptoms in patients ≥4 years old.
Flonase Allergy Relief
Noteworthy Recent Updates
February 23, 2015
Vyvanse – first drug approved for binge eating disorder
The FDA recently approved Vyvanse (lisdexamfetamine) as the first medication to treat binge eating disorder. Use of Vyvanse, a Schedule II drug and CNS stimulant, was expanded to include treatment of moderate to severe binge eating disorder in adults. Vyvanse is also indicated for ADHD in patients ≥6 years old. It is not approved for weight loss.
February 11, 2015
Viekira Pak Approved for Hepatitis C
The FDA recently approved Viekira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir) for the treatment of chronic hepatitis C infection (genotype 1). Given as a 12-week or 24-week course, Viekira Pak is supplied as daily dose packs containing 2 ombitasvir/paritaprevir/ritonavir tablets and 2 dasabuvir tablets. Of note, ritonavir is used to boost the levels of paritaprevir, and does not have activity against hepatitis C virus. Viekira Pak is combined with ribavirin, except for in patients with genotype 1b virus and no cirrhosis, where it is given alone. Viekira Pak is contraindicated in the setting of severe hepatic impairment (Child-Pugh Class C).
February 2, 2015
Savaysa Approved for Stroke Prevention and VTE Treatment
The FDA recently approved Savaysa (edoxaban), a factor Xa inhibitor indicated for stroke prevention and DVT/PE treatment. Savaysa is administered once daily and should be avoided in patients with significant renal and/or hepatic impairment. As compared to the other oral anticoagulant agents in this class, Savaysa is initiated 5-10 days after parenteral anticoagulant therapy when used for DVT/PE treatment.
January 28, 2015
Generic Colchicine Available Again
Generic colchicine is now available again, following the launch of the authorized generic for Colcrys. In 2010, FDA action resulted in the removal of unapproved versions of colchicine from the market. Colchicine is indicated for treatment of gout flares in adults, gout prophylaxis in patients >16 years old, and familial Mediterranean fever in patients >4 years old.
January 21, 2015
Belsomra, First Orexin Receptor Antagonist Approved for Insomnia
The FDA recently approved Belsomra (suvorexant), a first-in-class orexin receptor antagonist, for the treatment of insomnia in adults. Orexins are neurotransmitters involved in regulating the sleep-wake cycle and maintaining wakefulness. Belsomra is a Schedule IV drug and should be given at least 7 hours before the planned time of awakening.
New Drug Monographs
- Afrezza (insulin inhaled)
- Belsomra (suvorexant)
- Blincyto (blinatumomab)
- dihydroergotamine (generic for D.H.E. 45)
- Duopa (carbidopa/levodopa)
- Flonase Allergy Relief (fluticasone propionate nasal)
- Gardasil 9 (human papillomavirus 9-valent vaccine (recombinant))
- Glyxambi (empagliflozin/linagliptin)
- Hysingla ER (hydrocodone)
- Ibrance (palbociclib)
- Iluvien (fluocinolone intravitreal)
- linezolid (generic for Zyvox)
- Lynparza (olaparib)
- Mitigare (colchicine)
- Opdivo (nivolumab)
- Prezcobix (darunavir/cobicistat)
- Rapivab (peramivir)
- Rytary (carbidopa/ levodopa)
- Savaysa (edoxaban)
- Soolantra (ivermectin topical)
- Sotylize (sotalol)
- Spiriva Respimat (tiotropium inhaled)
- Viekira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir)
- Vitekta (elvitegravir)
- Zerbaxa (ceftolozane/tazobactam)
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