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7 New Drug Approvals Pharmacy Techs Should Know
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Pharmacy technicians should know the following new drugs and expanded indications approved by the FDA in August 2015.
Pharmacy technicians should know the following new drugs and expanded indications approved by the FDA in August 2015.
The FDA approved Sprout Pharmaceuticals’ flibanserin (Addyi) on August 18, 2015.
This serotonin 1A receptor agonist and serotonin 2A receptor antagonist is often described as a female equivalent to erectile dysfunction drugs such as sildenafil (Viagra) and indicated for the treatment of generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
The use of Addyi carries an elevated risk of severe hypotension and loss of consciousness, prompting the FDA to approve the drug with a risk evaluation and mitigation strategy (REMS).
Potential Addyi prescribers will have to become certified with the REMS program, while patients will be required to complete a Patient-Provider Agreement form to acknowledge the risks of drinking while taking the drug.
Additionally, pharmacists can only despense Addyi if the patient has a prescription from a certified prescriber, and they are require to counsel patients on the important of alcohol abstinence.
Other adverse events associated with the use of Addyi include dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth.
The drug will be available as a 100 mg tablet on October 17, 2015.
The FDA expanded the use of Purdue Pharma’s extended-release oxycodone (OxyContin) on August 13, 2015, for the treatment of chronic pain in patients ages 11 to 16.
The agency has placed strict limitations on the opioid’s pediatric use. Prior to receiving OxyContin, children must have already been treated with an opioid and must also tolerate at least 20 mg of oxycodone.
This Schedule 2 controlled substance is currently available as 10, 15, 20, 30, 40, 60, and 80 mg tablets.
The FDA expanded the use of Raptor Pharmaceutical’s delayed-release cysteamine bitartrate (Procysbi) in nephropathic cystinosis on August 14, 2015.
Previously approved to treat this rare kidney condition in patients ages 6 and older, the drug can now be prescribed to those ages 2 to 6.
The most common adverse events associated with the use of Procysbi are vomiting, nausea, abdominal pain, breath odor, diarrhea, skin odor, fatigue, rash, and headache. The drug is also contraindicated in patients with hypersensitivity to cysteamine or penicillamine.
Procysbi is currently available as 25 and 75 mg capsules.
The FDA approved Amgen’s injectable evolocumab (Repatha) on August 27, 2015.
This drug is indicated as an adjunct to diet and statin therapy for treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein (LDL) cholesterol.
Repatha is the second proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to receive FDA approval. Unlike oral statins, PCSK9 inhibitors are self-injected monoclonal antibodies that block the PCSK9 protein from inhibiting removal of LDL from the liver.
The most common adverse events associated with the use of Repatha include nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.
The drug will be available as a 140 mg/ml injection in both a single-use prefilled syringe and autoinjector.
The FDA approved Aprecia Pharmaceuticals’ anticonvulsant levetiracetam (Spritam) on August 3, 2015.
This drug is indicated for the treatment of partial-onset, myoclonic, and primary generalized tonic-clonic seizures in adults and children with epilepsy.
Spiritam is the first FDA-approved drug to be manufactured with 3-dimensional (3D) printing, a process that gives the pill a unique porous structure. This allows Spritam to be quickly dissolved with a sip of liquid, making it easier for epileptic patients who often have difficulty swallowing to take the drug.
The most common adverse events associated with the use of Spritam include sleepiness, weakness, dizziness, and infection. Additional side effects observed in children treated with the drug include tiredness, aggressive behavior, nasal congestion, decreased appetite, and irritability.
The drug will be available as 250, 500, 750, and 1000 mg tablets in the first quarter of 2016.
The FDA approved Boehringer Ingelheim and Eli Lilly’s empagliflozin/metformin (Synjardy) on August 27, 2015.
This drug is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The 2 active ingredients in Synjardy work together to control blood glucose. Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, removes excess glucose through urine by blocking glucose reabsorption in the kidney, while metformin, a commonly-used biguanide, lowers glucose production by the liver and absorption in the intestine.
The most common adverse events associated with the use of empagliflozin include urinary tract infection and female genital mycotic infections, while the most frequent side effect reported by patients treated with metformin include diarrhea, nausea, vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache.
Synjardy carries a boxed warning for risk of lactic acidosis due to metformin accumulation.
The drug will be available as 5/500, 5/1000, 12.5/500, and 12.5/1000 mg tablets.
The FDA expanded the indication of Orexo’s sublingual buprenorphine/naloxone (Zubsolv) on August 11, 2015.
This partial opioid agonist was previously approved for the maintenance treatment of opioid dependence, but it is now also indicated for the induction of buprenorphine maintenance therapy in opioid-dependent patients, allowing them to be transitioned to Zubsolv directly from the opioid on which they are dependent.
The most commonly observed adverse events associated with the use of sublingual buprenorphine/naloxone tablets during clinical trials include headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.
The drug is currently available as 1.4/0.36, 2.9/0.71, 5.7/1.4, 8.6/2.1, and 11.4/2.9 mg tablets.
