Updates from FDA
New drugs
INMAZEB
(Atoltivimab, maftivimab, and odesivimab-ebgn—Regeneron)
Drug class: Glycoprotein-directed monoclonal antibodies.
Indication: First FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Ebola virus infection.
Recommended dosage and administration: Atoltivimab 50 mg, maftivimab 50 mg, and odesivimab 50 mg per kg, diluted and administered as a single I.V. infusion.
Common adverse effects: Fever, chills, tachycardia, tachypnea, vomiting (these are also common symptoms of Ebola virus infection).
Warnings and precautions: Hypersensitivity reactions, including acute, life-threatening reactions during and after the infusion.
Drug interactions: Avoid concurrent administration of a live vaccine because Inmazeb may reduce the vaccine’s efficacy.
TIGILANOL TIGLATE INJECTION
(Stelfonta—QBiotics Group)
Drug class: Antineoplastic.
Indication: First intratumoral injection to treat nonmetastatic, cutaneous mast cell tumors in dogs.
Recommended dosage and administration: See prescribing information.
Common adverse effects: Wound formation at tumor site, injection site reactions, lameness in treated leg, vomiting, diarrhea, hypoproteinemia, hypoalbuminemia.
Boxed warning: In humans, risk of severe wound formation from accidental self-injection or needle-stick injuries. Always administer drug with a corticosteroid and H1 and H2 receptor blocking agents to decrease risk of severe systemic adverse reactions, including death, from mast cell degranulation.
IVERMECTIN LOTION, 0.5%
(Sklice—Arbor Pharmaceuticals)
Drug class: Pediculicide.
Indication: Nonprescription version of ivermectin to treat head lice infestation in patients ages 6 months and older. Originally approved as a prescription drug in February 2012, ivermectin was approved for OTC use through a process called a prescription (Rx)-to-OTC switch. It will no longer be available as a prescription drug. Patients who currently use prescription versions of this product should consult their health professional.
Recommended dosage and administration: Apply lotion to dry hair in an amount sufficient (up to one tube) to thoroughly coat the hair and scalp. After 10 minutes, rinse off with water. Discard any unused portion.
Common adverse effects: Conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, skin burning sensation.
Warnings and precautions: Because accidental ingestion in pediatric patients may occur, administer only under direct adult supervision.
New indications
CEFIDEROCOL
(Fetroja—Shionogi)
Drug class: Cephalosporin antibacterial.
Indication: Treatment of patients ages 18 years or older with hospital-acquired and ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii complex, Escherichia coli,
Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens.
Recommended dosage and administration: 2 g for injection every 8 hours by I.V. infusion over 3 hours in patients with creatinine clearance (CrCL) 60–119 mL/min. Adjust dose for patients with CrCL < 60 mL/min, including patients receiving intermittent hemodialysis or continuous renal replacement therapy and those with CrCL ≥ 120 mL/min.
Common adverse effects: Elevations in liver tests, hypokalemia, diarrhea, hypomagnesemia, atrial fibrillation.
Warnings and precautions: Warnings and precautions: Increase in all-cause mortality in patients with carbapenem-resistant Gram-negative bacterial infections; serious and occasionally fatal anaphylactic reactions, including cross-hypersensitivity in patients with a history of penicillin allergy; Clostridioides difficile–associated diarrhea; seizures and other CNS adverse reactions.
FDA approves remdesivir as first COVID-19 treatment, issues EUA for bamlanivimab for mild to moderate disease
On October 22, FDA approved REMDESIVIR (Veklury—Gilead Sciences), for hospitalized patients with COVID-19 ages 12 years and older who weigh at least 40 kg (about 88 lb).
This approval does not include the entire population that had been authorized to use remdesivir under the emergency use authorization (EUA) originally issued on May 1, 2020. To ensure continued access to the pediatric population previously covered under the EUA, FDA revised the EUA to authorize the drug’s use for treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients younger than 12 years who weigh at least 3.5 kg. Clinical trials assessing remdesivir’s safety and efficacy in this pediatric patient population are ongoing.
Possible adverse effects associated with the drug include increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating, or shivering.
On November 10, FDA also issued an EUA to Eli Lilly for the use of BAMLANIVIMAB, an investigational monoclonal antibody, to treat mild to moderate COVID-19 in adult and pediatric patients.
Bamlanivimab is authorized for patients ages 12 years and older who test positive for SARS-CoV-2 virus, weigh at least 40 kg (about 88 lb), and are at high risk for progressing to severe COVID-19 and/or hospitalization. It is also authorized for adults ages 65 years or older or those with certain chronic medical conditions.
The EUA allows for bamlanivimab to be distributed and administered as a single dose intravenously by health care providers. The EUA requires that fact sheets with dosing instructions, potential adverse effects, and drug interactions be made available to health care providers, patients, and caregivers.
Possible adverse effects of bamlanivimab include anaphylaxis and infusion-related reactions, nausea, diarrhea, dizziness, headache, itching, and vomiting.
Bamlanivimab is not authorized for patients who are hospitalized or require oxygen therapy due to COVID-19, as a benefit of bamlanivimab treatment has not been shown in these patients. Monoclonal antibodies such as bamlanivimab may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 who require high-flow oxygen or mechanical ventilation.
FDA authorizes first test that detects neutralizing antibodies from recent or prior COVID-19 infection
On November 6, FDA issued an emergency use authorization (EUA) for the first—GenScript USA) that detects neutralizing antibodies from recent or prior SARS-CoV-2 (COVID-19) infection. These antibodies bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells.
“There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus,” stated Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health, in an FDA news release. “Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”
Although FDA has previously issued EUAs to more than 50 antibody (serology) tests, those tests only detect the presence of binding antibodies, the agency noted. Binding antibodies bind to a pathogen, such as a virus, but do not necessarily decrease the infection and destruction of cells. FDA stressed that the effect of neutralizing antibodies for SARS-CoV-2 in humans is still being researched.
The agency cautions patients against using the results from this test, or any serology test, as an indication that they can stop taking steps to protect themselves and others, such as stopping social distancing, discontinuing wearing masks, or returning to work. FDA also reminded patients that serology tests should not be used to diagnose an active infection, as they only detect antibodies that the immune system develops in response to the virus, not the virus itself.
New device designed to reduce nightmare-related sleep disturbance
On November 6, 2020, FDA permitted marketing of NightWare (manufactured by a health care startup of the same name), a new device for temporary reduction of sleep disturbance related to nightmares in adults ages 22 years or older who have nightmare disorder or nightmares from PTSD.
The digital therapeutic uses an Apple Watch and iPhone that are configured and logged into a software application and the NightWare server. Throughout the night, Apple Watch sensors monitor body movement and heart rate during sleep. When NightWare detects that a patient is experiencing a nightmare based on its analysis of heart rate and body movement, the device provides vibrations through the Apple Watch.
NightWare is available by prescription only and is intended for home use under the supervision of a health care provider. Patients should contact their health care provider if daytime sleepiness occurs, if the watch vibration causes awakenings not associated with nightmares, or if nightmares persist, worsen, or recur. The watch included in the NightWare kit should be used every night when the user is planning to go to sleep. It should not be worn while reading or watching television in bed, as this may trigger false alerts.
Users should not wear the watch too tightly. If skin irritation occurs, users should discontinue use and contact their health care provider. The watch may disturb the sleep of the user’s bed partner if the bed partner is in contact with the watch when it vibrates. Patients who have been known to “act out” during their nightmares (sleepwalking, violence) should not use NightWare.