Approval for Zevtera
Zevtera® (ceftobiprole – Basilea) for injection, was approved by the U.S. Food and Drug Administration (FDA) on April 3, 2024. It is a next-generation cephalosporin antibiotic that is given as intravenous (IV) infusions. It is indicated to treat adults who have bacteremia (blood infections) caused by Staphylococcus aureus (SAB) or acute bacterial skin and skin structure infections (ABSSSI). Its third indication is for the treatment of community-acquired bacterial pneumonia (CABP) for patients as young as three months old. Zevtera should not be used for patients who have bacterial pneumonia associated with the use of a ventilator. For adults, the recommended dose is 667mg given once every six hours or once every eight hours depending on the condition being treated. For SAB, treatment can last for as long as six weeks; for ABSSSI and CABP in adults, treatment continues between five days and 10 days. Doses for children and teens who have CABP depend on the child’s age and weight. Recommended treatment duration for pediatric patients is from one week to two weeks. Most antibiotics, including Zevtera, cause diarrhea, which may become severe. Other side effects may include fever, headaches, nausea, vomiting, and elevated liver enzymes. As a Qualified Infectious Disease Product, Zevtera will have 10 years of exclusivity. The launch will be delayed until Basilea identifies a marketing partner in the U.S., and pricing will not be announced until closer to launch. Here is its full prescribing information.

First Prescription App for Depression Approved
Rejoyn^™, a digital therapeutic developed by Otsuka Pharmaceuticals and Click Therapeutics, was approved by the FDA on March 30, 2024. It will be used only in combination with an antidepressant medication and professional counseling to treat major depressive disorder (MDD) for patients who are at least 22 years old. Available only through a prescription, it is a six-week-long course of three-times-a-week brain exercises and therapy sessions aimed at retraining cognitive processing to enhance emotional control. Parts of the complete program may be repeated for four more weeks. The app includes some individualized messaging, but it does not share any information with healthcare providers. Compared to patients using a sham app, patients using Rejoyn in a clinical trial showed improvement in three measures of depression severity for at least one month after the therapy was completed. None of the patients had side effects that were attributed to using the app. Individuals who have a Rejoyn prescription, which will be filled at specified pharmacies, should be able to download it from an iOS^® or Android^™ app store in the second half of 2024. Health providers can find more information here and patients’ directions are here.

Risvan Obtains FDA Approval
A new dosage form of the atypical antipsychotic, risperidone, was FDA-approved on March 29, 2024. Risvan^® (risperidone ISM^® – Laboratorios Framacéuticos ROVI) is a long-acting intramuscular (IM) injection for treating adults who have schizophrenia. Risvan uses a unique patented technology to allow rapid achievement of effective blood levels, so it does not need a loading dose. However, patients should be tested for tolerance to the drug with an oral risperidone product before treatment with Risvan starts. The recommended dose is either 75mg or 100mg once a month given by a healthcare provider. It may not be appropriate for individuals who need less than 3mg/day or more than 4mg/day of oral risperidone to maintain relief of schizophrenia. Four other extended-release risperidone injections — Perseris^® (given subcutaneously [SC] once a month), Risperdal Consta^® (given IM once every two weeks), Rykindo^® (given IM once every two weeks) and Uzedy^™ (given IM either once a month or once every two months) — already are marketed in the U.S. Also available are extended-release injectable forms of the other branded atypical antipsychotics, paliperidone (Invega^® products) and aripiprazole (Abilify^® and Aristada^® lines). No true generics presently are approved by the FDA for any of the extended-release injections. All drugs in the class have a boxed warning about an increased chance of death for senior patients who have psychoses associated with dementia. No launch or pricing plans currently are available for Risvan. For Risvan’s full prescribing information, look here.

Bipolar I Indication for Fanapt
The FDA approved Vanda Pharmaceuticals’ Fanapt^® (iloperidone) tablets on April 2, 2024, for a new indication to treat bipolar I disorder. The atypical antipsychotic has been FDA-approved since 2009 to treat schizophrenia in adults. It now also is indicated as an acute treatment for adults to manage manic and mixed incidents of bipolar I disorder. The maintenance dose of 24mg per day for patients who have bipolar I disorder must be attained gradually to limit the chance that blood pressure will drop too low. Patients begin with 1mg twice daily on the first day of treatment, increasing to 3mg twice daily on the second day, 6mg twice daily on the third, 9mg twice daily on the fourth, and then 12mg twice daily on the fifth. Smaller doses are used to treat schizophrenia. Although several other brand and generic antipsychotic drugs also are FDA approved to treat manic and mixed episodes of bipolar I disorder, patients may need to try different ones to find the most effective medication. Like all of the other antipsychotics, Fanapt has a boxed warning that it should not be used to treat senior patients who have psychoses related to dementia, because it may raise their chances of death. Here is the revised prescribing information.

Pediatric Indication Expanded for Vemlidy
On March 27, 2024, the FDA extended the pediatric indication for Gilead Sciences’ Vemlidy^® (tenofovir alafenamide) tablets. The nucleoside analog reverse transcriptase inhibitor (NRTI) treats hepatitis B virus (HBV) infection.  It now is indicated to treat patients who are as young as six years old, who weigh 25kg (55 pounds) or more, and who have compensated (not yet progressed to cirrhosis) liver disease. It has been approved for adults since 2016 and for patients aged 12 years old and older since 2022. For patients of any age, the recommended dose is 25mg once every day along with a meal or snack. Labeling for Vemlidy includes a boxed warning that hepatitis B may reactivate after treatment with it ends. It should not be used for patients who also have HIV or kidney conditions. For updated prescribing information, go here.

Relyvrio Withdrawn
After a required post-marketing clinical study failed to support the effectiveness of Relyvrio^™ (sodium phenylbutyrate/taurursodiol) for oral suspension, Amylyx Pharmaceuticals has removed it from the market. FDA approved in September 2022, it was indicated to treat amyotrophic lateral sclerosis (ALS), a disease that gradually destroys the nerves involved in voluntary movement. In the study, taking Relyvrio did not produce results that were better than taking a placebo. No safety issues were seen. Amylyx is collaborating with the FDA, ALS advocacy groups, and healthcare professionals to ensure that patients currently taking Relyvrio can continue therapy with it if they and their providers agree it is their best choice. They will be served through a free distribution program administered through the company. Other patients will be transitioned to alternative treatments. No new patients will be started on Relyvrio and no refills for it will be processed through the usual pharmacies after April 4, 2024.

Recalls

Vancomycin
Four lots of three bottle sizes (80mL, 150mL, and 300mL) of vancomycin oral solution (Amneal) were recalled on March 27, 2024. Because the bottles were overfilled, doses may be too large – posing a hazard for patients who have kidney disorders or intestinal inflammation. Vancomycin is an antibiotic that treats enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by Clostridioides difficile. Read the FDA’s notice for more information about the recall.

Methocarbamol
Eugia US recalled one lot of methocarbamol injection, 100mg/mL in single-dose, 10mL vials on March 28, 2024, after unidentified particles were found in some vials from the lot. It is used to treat musculoskeletal conditions such as carpal tunnel syndrome, muscle strains, and tendinitis.  If injected, particulates may cause irritation and inflammation at the injection site, as well as blood clots or blood vessel blockages that could result in life-threatening conditions. For additional information, see the FDA’s notice.

Atovaquone
On April 1, 2024, AvKARE recalled one lot of atovaquone oral suspension, an antiprotozoal agent used to prevent and treat Pneumocystis jiroveci pneumonia (PCP) for patients who are 13 years of age and older and who are unable to use other medicines. Possible microbial contamination in the recalled product could cause severe, potentially fatal, infections for patients exposed to it. The FDA notice has more information.