May 2024

PDR Drug Update 

Oral Antihypertensive Approved for Resistant High Blood Pressure

Uncontrolled high blood pressure is a risk factor for serious cardiovascular complications, including end-organ damage. When high blood pressure persists above a target level even after a patient has been treated with multiple antihypertensive medications concurrently with varying mechanisms of action, the condition is classified as resistant. Prescribers now have a novel agent that works on a new therapeutic pathway, broadening the array of therapies available to help combat difficult-to-control hypertension.

The new approval is for Tryvio (aprocitentan), which is a dual endothelin-1 (ET-1) antagonist. The endothelin pathway is an underlying mechanism of hypertension, so a therapy that can take advantage of this route can be an effective tool to help control blood pressure. ET-1 is a highly active vasoconstrictor. By inhibiting ET-1 from binding to endothelin A and endothelin B receptors, the activation that would constrict smooth muscles of blood vessel walls to raise blood pressure can be interrupted.

Taken as a single oral dose once a day, aprocitentan is intended to be used in combination with the existing hypertensive pharmacotherapy that is part of a patient’s treatment plan to lower blood pressure in adults. Clinical trials showed that aprocitentan was capable of reducing both standardized, automated office and 24-hour ambulatory blood pressure compared to placebo after four weeks. Maintenance of the blood pressure-lowering effect was sustained past the 48-week mark. The most common adverse event associated with the administration of aprocitentan was edema/fluid retention, noted within the first four weeks of treatment time. These effects were successfully managed through the addition or adjustment of the use of diuretics in impacted patients.

Aprocitentan prescribing information does come with a black box warning due to the risk of embryo-fetal toxicity. There is a potential for the drug to cause major congenital disabilities if it is used by patients who are pregnant. The warning advises that a negative pregnancy test should be obtained before beginning the drug in patients who can become pregnant. Those patients should also be informed to conduct monthly pregnancy tests while using aprocitentan and for one month after stopping the medication. Use of contraception before, throughout, and one month after stopping treatment is also necessary for patients who can become pregnant. Due to the risk, aprocitentan can only be obtained through its REMS at www.TRYVIOREMS.com. Prescribers of the drug and pharmacies that dispense it must be certified with the restricted program under the REMS.

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FDA New Approvals

Anktiva

The FDA has approved Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. Learn more about Anktiva

Lumisight

The FDA has approved Lumisight (pegulicianine) for injection, an optical imaging agent. Lumisight is for use with the Lumicell Direct Visualization System, together referred to as LumiSystem. LumiSystem enables surgeons to scan the breast cavity post-lumpectomy to detect and resect residual cancer. Learn more about Lumisight

Lutathera

The FDA has approved Lutathera (lutetium Lu 177 dotatate) for the treatment of pediatric patients aged 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs. This approval makes Lutathera the first therapy specifically reviewed and approved for use in pediatric patients with GEP-NETs. Learn more about Lutathera

Opsynvi

The FDA has approved Opsynvi (macitentan/tadalafil), a single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a phosphodiesterase 5 inhibitor, for the chronic treatment of adults with pulmonary arterial hypertension WHO Group I and WHO functional class II-III. Learn more about Opsynvi

Risvan

The FDA has approved Risvan (risperidone) for the treatment of schizophrenia in adults. Risvan is a prolonged-release injectable antipsychotic that, as of the first injection, provides immediate and sustained plasmatic drug levels and does not require loading doses or supplementation with oral risperidone. Learn more about Risvan

Selarsdi

The FDA has approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use as a biosimilar to Stelara for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients aged 6 years and older. Learn more about Selarsdi

Vafseo

The FDA has approved Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months. Learn more about Vafseo

Voydeya

The FDA has approved Voydeya (danicopan) as an add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria. Learn more about Voydeya

Winrevair

The FDA has approved Winrevair (sotatercept-csrk) for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group I) to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events. Learn more about Winrevair

Zevtera

The FDA has approved Zevtera (ceftobiprole medocaril sodium) for injection for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections and for adult and pediatric patients (aged 3 months to less than 18 years) with community-acquired bacterial pneumonia. Learn more about Zevtera

FDA New Indications

Abecma

The FDA has approved Abecma (idecabtagene vicleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Learn more about Abecma

Alecensa

The FDA has approved Alecensa (alectinib) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase-positive non-small cell lung cancer (tumors ≥4cm or node-positive), as detected by an FDA-approved test. Learn more about Alecensa

Carvykti

The FDA has approved Carvykti (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. Learn more about Carvykti

Dovato

The FDA has approved Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adolescents aged 12 years and older and weighing at least 25kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato. Learn more about Dovato

Elahere

The FDA has approved Elahere (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal adult cancer patients treated with up to three prior therapies. Learn more about Elahere

Enhertu

The FDA has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. Learn more about Enhertu

Entyvio

The FDA has approved Entyvio (vedolizumab) for subcutaneous administration for maintenance therapy in adults with moderately to severely active Crohn's disease after intravenous induction therapy with Entyvio. Learn more about Entyvio

Fanapt

The FDA has approved Fanapt (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Learn more about Fanapt

Fasenra

The FDA has approved Fasenra (benralizumab) as an add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an eosinophilic phenotype. Learn more about Fasenra

Nexletol and Nexlizet

The FDA has approved label expansions for Nexletol (bempedoic acid) tablets and Nexlizet (bempedoic acid/ezetimibe) tablets that include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients. In addition, the enhanced labels support the use of Nexletol and Nexlizet either alone or in combination with statins. They also include new indications for primary hyperlipidemia, alone or in combination with statins. Learn more about Nexletol and Nexlizet

Spevigo

The FDA has approved Spevigo (spesolimab-sbzo) injection for the treatment of generalized pustular psoriasis in adults and pediatric patients aged 12 and above weighing ≥40kg. Learn more about Spevigo

Ultomiris

The FDA has approved Ultomiris (ravulizumab-cwvz) as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder. Learn more about Ultomiris

Vemlidy

The FDA has approved the supplemental new drug application for Vemlidy (tenofovir alafenamide) 25mg tablets as a once-daily treatment for chronic hepatitis B virus infection in pediatric patients aged 6 years and older and weighing at least 25kg with compensated liver disease. Learn more about Vemlidy

FDA Recalls

Amneal Pharmaceuticals Vancomycin HCl

Amneal Pharmaceuticals is voluntarily recalling four lots of vancomycin HCl for oral solution, 250mg/5mL packaged in 80mL, 150mL, or 300mL pack sizes, to the consumer level. Some bottles may have been overfilled, which can result in an over-potent dosing regimen. Learn more about the vancomycin HCl recall

Aruba Aloe Balm N.V. Aruba Aloe Hand Sanitizer and Alcoholada Gels

Aruba Aloe Balm N.V. is voluntarily recalling 40 lots of Aruba Aloe hand sanitizer gel alcohol 80% and Aruba Aloe Alcoholada gel, to the consumer level. The products have been found to contain alcohol denatured with methanol. Learn more about the Aruba Aloe hand sanitizer and Alcoholada gels recall

Avkare Atovaquone

Avkare is voluntarily recalling lot # AW0221A of atovaquone oral suspension 750mg/5mL to the consumer/user level, due to the potential Bacillus cereus contamination in the product found during stability testing at a third-party lab. Learn more about the atovaquone recall

Dr. Reddy's Sapropterin Dihydrochloride

Dr. Reddy's announced that it is voluntarily recalling six lots of sapropterin dihydrochloride powder for oral solution, 100mg, to the consumer level, due to powder discoloration in some packets leading to decreased potency. Learn more about the sapropterin dihydrochloride recall

Eugia Methocarbamol

Eugia has initiated a voluntary recall of lot number 3MC23011 of methocarbamol injection, 1000mg/10mL (100mg/mL) (single-dose vial), 10mL vial, to the consumer level, due to a customer product complaint for the presence of white particles floating inside of the vial. Learn more about the methocarbamol recall

FAonline ForeverMen

FAonline is voluntarily recalling all lots within expiry of ForeverMen capsules, to the consumer level. FDA analysis found these products to be tainted with sildenafil and tadalafil. Learn more about the ForeverMen recall

Global Mix Tejocote

Global Mix is recalling tejocote products to include the following brands: Eva Nutrition, Science of Alpha, Niwali, and NWL Nutra. The recalled products are labeled as tejocote root but are toxic yellow oleander. Learn more about the tejocote products recall

Honeywell Non-Sterile Eyewash Cartridgee

Honeywell is voluntarily recalling the Fendall 2000 non-sterile eyewash cartridge for the Fendall 2000 eyewash station. This recall is being conducted at the industrial consumer level. Honeywell's cartridge supplier has been found to be non-compliant with current good manufacturing practice requirements. Learn more about the non-sterile eyewash cartridge recall

Stop Clopez Schwinnng

Stop Clopez is voluntarily recalling one lot of Schwinnng capsules to the consumer level. FDA analysis has found the Schwinnng products to contain nortadalafil. Learn more about the Schwinnng recall

FDA Alerts

Counterfeit Botox

The FDA is alerting healthcare professionals and consumers that unsafe counterfeit versions of Botox (botulinum toxin) have been found in multiple states and administered to consumers for cosmetic purposes. Learn more about counterfeit Botox

Topical Analgesics

The FDA is warning consumers not to use certain over-the-counter analgesic products marketed for topical use to relieve pain before, during, or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing, and piercing. The agency issued warning letters to six companies for marketing these products that are higher than permitted for over-the-counter, topical pain relief products. Learn more about topical analgesics

Labeling Updates - No updates this month