What are the latest drugs available in primary care and what role do they play in pharmacy practice?
Despite a downturn in FDA approvals in 2016, many pharmaceutical companies continue to develop novel treatments, and the number of medications that have received breakthrough therapy, orphan drug, and priority review designations, is evidence of that.
Tom Frank, PharmD, BCPS, Director of Research and Education at UAMS Northwest, led a session at the ASHP 2017 Summer Meeting in Minneapolis, Minn. to discuss some recent approvals, noting that some new therapeutic options are helping to drastically reduce the incidence of illnesses like diabetes, Clostridium difficile, and hepatitis C. These are just some recently-approved medications that Dr. Frank highlighted in the presentation:
Soliqua is a combination of long-acting insulin with a glucagon-like peptide-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on basal insulin or lixisenatide, Frank said.
Frank noted that patients should be counseled about the usual insulin precautions with lixisenatide, particularly regarding delayed gastric emptying. Patients should take oral contraceptives, acetaminophen, and antibioics 1 hour prior to administration.
iGlarLixi dose of 15 units if on less than 30 units of basal insulin per day, given within 1 hour before first meal. If the patient has been on 30-60 units of glargine, start with 30 units of iGlarLixi per day.
Hypoglycemia, nasopharyngitis, diarrhea, upper respiratory infection, headache, have been reported, so patients should be aware of these, as well as GLP1 receptor agonist precautions about pancreatitis.
For more on this medication, view the video:
2. Crisaborole (Eucrisa, Anacor)
Crisaborole is a phosphodiesterase 4 inhibitor indicated for the topical treatment of mild-to-moderate atopic dermatitis in patients 2 years of age and older. It increases cyclic AMP levels that suppress the release of cytokines, and changes downstream regulation of the nuclear factor kappa b and the nuclear factor of activated T-cell signaling pathways.
Crisaborole and its metabolites are not inhibitors or inducers of the CYP system.
Apply a thin layer twice a day to affected areas.
Application site pain has been reported.
3. Bezlotoxumab (Zinplava, Merck)
Bezlotoxumab is indicated to reduce the recurrence of C difficile in patients 18 years of age or older who are receiving antibacterial drug treatment and are at high risk of infection recurrence. It is a humanized monoclonal IgG1/kappa antibody that binds to C difficle toxin B and prevents binding of toxin B to colonic cells with the intent of avoiding colonic cell inflammation. It binds to the B2 region of the combined repetitive oligopeptide.
10 mg/kg, infused over 60 minutes.
Nausea, pyrexia, headache, and infusion-related reactions have been reported.
4. Pimavanserin (Nuplazid, Acadia)
Pimavanserin is an atypical antipsychotic indicated to treat hallucination and delusions associated with Parkinson’s disease psychosis. It is an inverse agonist and antagonist with a high affinity for 5HT2a receptors, a low affinity for 5HT2c receptors, and no affinity at dopaminergic, histaminergic, cholinergic, or adrenergic receptors
Strong CYP 3A4 inhibiton (reduce pimavanserin dose by half), strong CYP 3A4 inducers (increased dose may be needed). Pimavanserin should be used with caution when taken with drugs known to cause prolongation of QT interval.
Take 2, 17-mg tablets with or without food.
Peripheral edema, nausea, confusional state. Nuplazid also has a black box warning regarding risk of death in dementia-related psychosis.
5. Sofosbuvir/velpatasvir (Epclusa, Gilead)
Sofosbuvir/velpatasvir is a fixed-dose combination of 2 direct acting antivirals indicated for the treatment of adult patients with chronic hepatitis C genotype 1,2,3,4,5 or 6. The combination of these 2 prevents all genotypes of hepatitis C from replicating.
There is an important interaction with amiodarone, which can result in serious symptomatic bradycardia, particularly in patients taking beta-blockers.
One tablet taken once daily with or without food for a 12-week period. Patients with decompensated cirrhosis should take 1 tablet daily plus ribavirin for 12 weeks.
Headache, fatigue, nausea, asthenia, insomnia habe been reported. Patients should be aware of ribavirin adverse effects and precautions if added.