10 New Drug Approvals Pharmacy Techs Should Know

Learn about the new drugs and expanded indications approved by the FDA in May 2016.

1. Akovaz

The FDA approved Flamel Technologies’ ephedrine sulfate (Akovaz) injection on May 2, 2016.

Akovaz is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent indicated for the treatment of clinically important hypotension (low blood pressure) in surgical settings.

Although Akovaz is the first ephedrine sulfate product to receive FDA approval, an “unapproved marketed” formulation of the drug is currently available, with more than 5 million vials sold each year. Flamel plans to launch a 50 mg/mL strength of Akovaz during the third quarter of 2016.

2. Ameluz

The FDA approved Biofrontera’s 5-aminolevulinic acid hydrochloride (Ameluz) gel, along with the manufacturer’s BF-RhodoLED photodynamic therapy lamp, on May 11, 2016. Both products must be used together for the treatment of mild to moderate actinic keratosis on the face and scalp.

The most common adverse effects associated with use of Ameluz include headache, skin tension, increased sensitivity to pain, and warmth. Biofrontera plans to launch both products by September 2016.

3. Axumin

The FDA approved Blue Earth Diagnostics’ fluciclovine F 18 (Axumin) injection on May 27, 2016. This radioactive diagnostic agent is used with positron emission tomography imaging to detect suspected prostate cancer recurrence based on elevated prostate specific antigen levels.

Because of the drug’s radioactivity, health care providers should ensure to minimize radiation exposure in patients prescribed Axumin. The most common adverse events reported by trial participants treated with Axumin include pain at the injection site, a metallic taste in the mouth, and redness.

4. Jentadueto XR

The FDA approved Lilly and Boehringer Ingelheim’s extended-release linagliptin and metformin hydrochloride (Jentadueto XR) tablets on May 31, 2016. This drug combines either 2.5 mg or 5 mg of linagliptin with 1000 mg of metformin and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Jentadueto XR was approved with a boxed warning alerting patients and providers to an associated risk of lactic acidosis, which could lead to complications and potentially death. The FDA also noted that the drug should not be prescribed to patients with type 1 diabetes or diabetic ketoacidosis.

Patients treated with Jentadueto XR should seek immediate medical attention if they experience cold hands or feet, dizziness, an irregular or slow heartbeat, fatigue, muscle pain, weakness, stomach pains, or nausea and vomiting.

5. Lenvima

The FDA expanded the indication of Eisai’s lenvatinib (Lenvima) on May 13, 2016, approving the drug for the treatment of advanced renal cell carcinoma in combination with everolimus after prior antiangiogenic therapy.

Lenvima is a kinase inhibitor initially approved in February 2015 for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

Adverse events commonly reported by trial patients treated with Lenvima included hypertension, fatigue, diarrhea, arthralgia, myalgia, decreased appetite, decreased weight, nausea, stomatitis, headache, vomiting, proteinuria, abdominal pain, dysphonia, and palmar-plantar erythrodysesthesia syndrome. The drug’s use is also associated with less common but more serious serious side effects, such as hypertension, cardiac dysfunction, and arterial thromboembolic events.

6. Ocaliva

The FDA granted accelerated approval to Intercept Pharmaceutical’s obeticholic acid (Ocaliva) on May 27, 2016.

Ocaliva is indicated for the treatment of primary biliary cholangitis, previously known as primary biliary cirrhosis. The drug should be used either in combination with ursodeoxycholic acid (UDCA) or as a monotherapy in adults who can’t tolerate UDCA.

The most common adverse events associated with the use of Ocaliva include itching, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema.

Intercept plans to make Ocaliva available through specialty pharmacy networks in early June 2016.

7. Opdivo

The FDA expanded the indication of Bristol-Myers Squibb’s nivolumab (Opdivo) on May 17, 2016.

Opdivo can now be used for the treatment of patients with classical Hodgkin lymphoma who have relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin (Adcetris) therapy.

The drug was initially approved in December 2014 for the treatment patients with unresectable or metastatic melanoma who no longer respond to other drugs. Since then, it has also received FDA approval for the treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.

Adverse events associated with the use of Opdivo include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, and encephalitis.

8. Probuphine

The FDA approved Titan Pharmaceuticals’ subcutaneous buprenorphine implant (Probuphine) on May 26, 2016.

The first product of its kind to receive FDA approval, Probuphine is indicated for the maintenance treatment of opioid dependence in patients who are already stable on low-to-moderate doses of other forms of buprenorphine. Probuphine consists of 4 rods, each an inch long, that are surgically implanted under the skin on the inside of the upper arm; previously, buprenorphine was only available as a pill or a film.

The most common adverse events associated with the use of Probuphine include headache, depression, constipation, nausea, vomiting, back pain, toothache, oropharyngeal pain, and implant-site pain, itching, and redness. Additionally, the drug carries a boxed warning alerting patients and prescribers about the risk of implant migration, protrusion, expulsion, and nerve damage linked to the insertion and removal of Probuphine.

9. Tecentriq

The FDA approved Genentech’s atezolizumab (Tecentriq) for the treatment of urothelial carcinoma, the most common type of bladder cancer, on May 18, 2016.

Specifically, Tecentriq is indicated for patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 1 year of receiving platinum-containing chemotherapy, either before or after surgical treatment.

The PD-1/PD-L1 inhibitor is the first drug of its class to receive FDA approval for this purpose. It was approved alongside the Ventana PD-L1 (SP142) assay, a complimentary diagnostic to help providers determine their patients’ PD-L1 protein expression.

Adverse events observed in patients treated with Tecentriq include fatigue, decreased appetite, nausea, urinary tract infection, fever, and constipation.

10. Teflaro

The FDA updated the label of Allergan’s intravenous ceftaroline fosamil (Teflaro) on May 31, 2016, allowing the drug to be used for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia in patients aged 2 months to 18 years. Teflaro was initially approved for this purpose in adults in October 2010.

With this label update, Teflaro is the first branded intravenous antibiotic to be approved for pediatric patients in more than a decade, according to Allergan.

Adverse events associated with the use of Teflaro in both adult and pediatric patients include diarrhea, nausea, and rash; pediatric patients treated with Teflaro have also experienced vomiting and pyrexia.