Epocrates Drug Updates - Editor's Pick
June 29, 2015
Promacta Now Approved for Chronic ITP in Pediatric Patients
The FDA recently approved the use of Promacta (eltrombopag) in patients 6 years and older for the treatment of relapsed or refractory chronic ITP. Promacta is administered orally once daily at a starting dose of 50 mg, unless the patient is of East Asian descent, in which the starting dose is reduced to 25 mg. This is identical to the adult dosing regimen for the same indication. The dose of Promacta must be titrated according to the platelet count. Promacta should be taken on an empty stomach, and also needs to be separated from medications or supplements that contain polyvalent cations, such as calcium, magnesium, or aluminum.
June 29, 2015
MedWatch Safety Alert for Daytrana (methylphenidate transdermal)
A permanent loss of skin color has been reported with an onset ranging from 2 months to 4 years after starting treatment. These areas of depigmentation occurred primarily at the patch application sites, though in a few patients, a loss of skin color was also reported at body sites where the patch was not applied. Prescribers should consider alternative therapy for patients who experience any skin color changes.
Noteworthy Recent Updates
May 22, 2015
FDA MedWatch Safety Alert: Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors
The FDA recently warned that the type 2 diabetes medications canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis and result in hospitalization. In postmarketing reports, there was a temporal association between initiation of an SGLT2 inhibitor and diabetic ketoacidosis, ketoacidosis, or ketosis. The median time between starting an SGLT2 inhibitor and onset of ketoacidosis was 2 weeks. The FDA is investigating this safety issue and advises providers to evaluate for the presence of ketoacidosis in patients experiencing any signs or symptoms. If ketoacidosis is confirmed, discontinue the SGLT2 inhibitor, correct the acidosis, and monitor glucose levels.
May 15, 2015
First-Time Generic for Abilify Tablets
The FDA recently approved aripiprazole, the first-time generic for Abilify. Generic aripiprazole—an atypical antipsychotic used for conditions including, but not limited to, schizophrenia and bipolar I disorder—is now available as an oral tablet in strengths of 2, 5, 10, 15, 20, and 30 mg. The exact mechanism of action is unknown, but involves being a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, and an antagonist at serotonin 5-HT2A receptors.
May 15, 2015
Corlanor Approved for Stable, Symptomatic Chronic Heart Failure
The FDA recently approved Corlanor (ivabradine), a novel drug therapy for treating chronic heart failure patients. It is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that decreases HR by selectively inhibiting cardiac pacemaker current in the SA node. Corlanor is indicated for stable, symptomatic chronic heart failure patients with an LVEF less than or equal to 35% and a resting HR of at least 70 bpm. Dosing is adjusted to maintain a resting HR of 50-60 bpm.
May 8, 2015
Cyramza Now Approved for Metastatic Colon Cancer
The FDA recently approved Cyramza (ramucirumab) in combination with chemotherapy (FOLFIRI regimen) for the treatment of metastatic colorectal cancer that has progressed following a regimen of bevacizumab, oxaliplatin, and a fluoropyrimidine. Cyramza is given as an IV infusion every 2 weeks on the same day as FOLFIRI. Cyramza should be held before and around the time of surgery due to impaired wound healing risk, which is now included in the black box warning along with GI perforation and hemorrhage. Also of note, thyroid function should be monitored during treatment.
May 8, 2015
Avycaz Approved for Complicated Bacterial Infections
The FDA has given Avycaz (ceftazidime/avibactam) its seal of approval for the treatment of complicated intra-abdominal infections in combination with metronidazole, as well as for complicated UTIs including pyelonephritis. Ceftazidime is a 3rd-generation anti-pseudomonal cephalosporin, and avibactam is a novel beta-lactamase inhibitor that prevents microbial resistance. Avycaz is available only as an IV infusion, and the dose must be adjusted according to renal function. Unfortunately, it is not active against MRSA.
New Drug Monographs
- alosetron (generic for Lotronex)
- Aptensio XR (methylphenidate)
- aripiprazole (generic for Abilify)
- bimatoprost ophthalmic (generic for Lumigan)
- Corlanor (ivabradine)
- Ixinity (coagulation factor IX (recombinant))
- Junel Fe 24 (norethindrone/ethinyl estradiol)
- levoleucovorin (generic for Fusilev)
- Lomedia 24 Fe (norethindrone/ethinyl estradiol)
- naftifine topical (generic for Naftin)
- Namzaric (memantine/donepezil)
- norethindrone acetate/ethinyl estradiol (generic for Femhrt)
- Prestalia (perindopril arginine/amlodipine)
- ProAir RespiClick (albuterol inhaled)
- tolcapone (generic for Tasmar)
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