--- title: PDR Drug Update - December 2023 description: The PDR Labeling Updates provide physicians with the latest FDA recalls, warnings and approval information - available in PDR's monthly eDrug Update --- # December 2023 PDR Drug Update  Type Drug Name Here Search - Lead Story - Latest FDA News - FDA Recalls & Alerts - Labeling Updates Lead Story ##### **Long-Awaited, First-in-Class Option for Hyperphosphatemia in CKD ** Individuals with chronic kidney disease (CKD) are at risk for severe complications. One of the potential issues is hyperphosphatemia. This serious condition affects a great many of the 550,000 CKD patients in the US who are on maintenance dialysis. Approaches such as careful nutrition management and treatment with phosphate binders are standards of care, but they are not absolute solutions for some individuals. For those who do not respond well to phosphate binders, a new option to aid in managing hyperphosphatemia has been greatly desired, and a recent FDA approval of a first-in-class add-on therapy is helping fill this previously unmet need. CKD is a leading cause of death globally and is expected to become the fifth-highest cause of life-years lost as soon as the year 2040. As the statistics increase across the population, expanding ways to control comorbidity-related complications becomes even more critical. The challenges related to disease management for hyperphosphatemia have been persistent. It is difficult to achieve the targeted serum phosphate concentrations for patients, which should be less than 5mg/dL. Above that level, a patient would be classified as having hyperphosphatemia, which brings with it the risk of related life-threatening issues such as mineral and bone disorders stemming from hypocalcemia. An entirely new approach for hyperphosphatemia treatment has now been FDA-approved. The approval was granted to [Xphozah (tenapanor)](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213931s000lbl.pdf) as an add-on therapy for reducing serum phosphorus in adults with CKD who are on dialysis but have an inadequate response to phosphate binders or intolerance of any dose of phosphate binder therapy. Xphozah has a unique targeted mechanism of action that blocks the intestinal absorption of dietary phosphate through the paracellular pathway. According to the manufacturer, the drug inhibits the sodium/hydrogen exchanger 3 (NHE3) in the gut, resulting in a conformational change of the epithelial cell junctions, reducing permeability specific to phosphate. The result is decreased phosphate absorption, helping patients achieve target serum phosphate concentrations. Another differentiator of Xphozah is its simplified dosing as compared to phosphate binders. It is administered as one tablet twice daily, whereas other therapies have more frequent dosing in a larger pill size. The only adverse reaction reported in at least 5% of patients in the clinical trials for Xphozah was diarrhea, which occurred in 43-53% of patients. The active ingredient in Xphozah, tenapanor, was previously approved for irritable bowel syndrome and is marketed under the name Ibsrela. Research and development are ongoing for this unique agent, and soon after its initial approval, the FDA granted Orphan Drug Designation to Xphozah for treating pediatric hyperphosphatemia. Stay informed about critical drug information, including targeted therapies for CKD, by exploring [PDR by ConnectiveRx](https://www.pdr.net/?hsLang=en). You can also stay current by using the official PDR app, [*mobile*PDR](https://www.pdr.net/mobilepdr/?hsLang=en), which is available for free from your preferred app store. Latest FDA News ### FDA New Approvals ##### Augtyro The FDA has approved Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic *ROS1*-positive non-small cell lung cancer. [Learn more about Augtyro](https://news.bms.com/news/corporate-financial/2023/U.S.-Food-and-Drug-Administration-Approves-Augtyro-repotrectinib-a-Next-Generation-Tyrosine-Kinase-Inhibitor-TKI-for-the-Treatment-of-Locally-Advanced-or-Metastatic-ROS1-Positive-Non-Small-Cell-Lung-Cancer-NSCLC/default.aspx) ##### Jaypirca The FDA has approved Jaypirca (pirtobrutinib), 100mg and 50mg tablets, for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a Bruton's tyrosine kinase inhibitor and a BCL-2 inhibitor. [Learn more about Jaypirca](https://investor.lilly.com/news-releases/news-release-details/jaypircar-pirtobrutinib-now-approved-us-fda-treatment-adult) ##### Ogsiveo The FDA has approved Ogsiveo (nirogacestat), an oral gamma secretase inhibitor, for the treatment of adult patients with progressing desmoid tumors who require systemic treatment. The FDA previously granted breakthrough therapy, fast track, and orphan drug designations to nirogacestat for the treatment of desmoid tumors. [Learn more about Ogsiveo](https://ir.springworkstx.com/news-releases/news-release-details/springworks-therapeutics-announces-fda-approval-ogsiveotm) ##### Ryzneuta The FDA has approved Ryzneuta (efbemalenograstim alfa-vuxw) indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. [Learn more about Ryzneuta](https://www.evivebiotech.com/en/newsd/index?id=56) ##### Truqap The FDA has approved Truqap (capivasertib) in combination with Faslodex (fulvestrant) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1, or PTEN). [Learn more about Truqap](https://www.astrazeneca.com/media-centre/press-releases/2023/truqap-approved-in-us-for-hr-plus-breast-cancer.html) ### FDA First-Time Generic Approvals ##### Forteo The FDA has a generic version of Forteo (teriparatide) injection. Teriparatide injection is indicated to treat osteoporosis among certain women and men. [Learn more about the generic equivalent of Forteo](https://www.tevapharm.com/news-and-media/latest-news/teva-announces-approval-of-a-generic-version-of-forteo-teriparatide-injection-in-the-u.s/) ### FDA New Indications ##### Keytruda The FDA has approved Keytruda (pembrolizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma. [Learn more about Keytruda](https://www.merck.com/news/fda-approves-mercks-keytruda-pembrolizumab-plus-chemotherapy-as-first-line-treatment-for-locally-advanced-unresectable-or-metastatic-her2-negative-gastric-or-gastroesophageal-junction/) ##### Xtandi The FDA has approved Xtandi (enzalutamide) for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). Patients with nmCSPC with high-risk BCR may be treated with Xtandi with or without a gonadotropin-releasing hormone analog therapy. [Learn more about Xtandi](https://www.astellas.com/en/news/28626) FDA Recalls & Alerts ### FDA Recalls ##### Bayer Vitrakvi Bayer is voluntarily recalling one lot of Vitrakvi (larotrectinib) oral solution 20mg/mL in 100mL glass bottles, to the consumer/user level. The product is being recalled due to microbial contamination identified as *Penicillium brevicompactum* observed during routine ongoing stability testing. [Learn more about the Bayer Vitrakvi recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-issues-voluntary-recall-nationwide-vitrakvir-larotrectinib-oral-solution-20-mgml-due-presence) ##### Insight Pharmaceuticals Ting Insight Pharmaceuticals is voluntarily recalling two lots of Ting 2% miconazole nitrate athlete's foot spray antifungal spray powder, to the consumer level. A recent review by the manufacturer and their third-party lab found that samples from two lots of the product contained elevated levels of benzene. [Learn more about the Insight Pharmaceuticals Ting recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insight-pharmaceuticals-issues-voluntary-nationwide-recall-tingr-2-miconazole-nitrate-athletes-foot) ##### KinderFarms KinderMed KinderFarms is voluntarily recalling all lots of KinderMed Infants' Pain & Fever (oral suspension) and KinderMed Kids' Pain & Fever (oral suspension), to the retail and consumer level. These products are being voluntarily recalled due to acetaminophen instability. [Learn more about the KinderFarms KinderMed recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kinderfarms-llc-voluntarily-recalling-all-kindermed-pain-fever-products-due-acetaminophen) ##### Meta Herbal Magnum Meta Herbal is voluntarily recalling 500 blister packs of Magnum XXL 9800, 2000mg per capsule, to the consumer level. The products have been found to be tainted with sildenafil. [Learn more about the Meta Herbal Magnum recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/meta-herbal-issues-voluntary-nationwide-recall-magnum-xxl-9800-capsules-due-presence-undeclared) ##### Noah's Wholesale Original The Rock Noah's Wholesale is voluntarily recalling one lot of Original The Rock, Lot#: 03032021, exp: 12/2027, 1200mg/capsule, to the consumer level. FDA analysis has found the product to be tainted with sildenafil. [Learn more about the Noah's Wholesale Original The Rock recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/noahs-wholesale-llc-issues-voluntary-nationwide-recall-rock-due-presence-undeclared-sildenafil) ##### Novartis Sandimmune Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune (cyclosporine) oral solution, 100mg/mL, due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. [Learn more about the Novartis Sandimmune recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-us-nationwide-recall-two-lots-sandimmuner-oral-solution-cyclosporine-oral) ### FDA Alerts ##### Neptune's Fix and Other Tianeptine Products The FDA is warning consumers not to purchase or use any Neptune's Fix products or any other product with tianeptine. This potentially dangerous substance is not FDA-approved for any medical use but is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder, and other conditions. The FDA has received severe adverse event reports after the use of Neptune's Fix products, including seizures and loss of consciousness leading to hospitalization. Consumers who experience a bad reaction to any tianeptine product should seek immediate medical help. [Learn more about the Neptune's Fix and other tianeptine products alert](https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-neptunes-fix-or-any-tianeptine-product-due-serious-risks) ##### Serious Drug Reaction to Levetiracetam and Clobazam The FDA is warning that the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan) can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). It may start as a rash but can quickly progress, resulting in injury to internal organs, the need for hospitalization, and even death. As a result, the FDA is requiring warnings about this risk to be added to the prescribing information and patient Medication Guides for these medicines. [Learn more about the serious drug reaction to levetiracetam and clobazam alert](https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-rare-serious-drug-reaction-antiseizure-medicines-levetiracetam-keppra-keppra-xr-elepsia-xr) ##### Tainted Arthritis/Pain Products The FDA is notifying consumers of certain products promoted for arthritis and pain management that have been found to contain hidden ingredients and may pose a significant health risk. The 25 public notifications include those products FDA testing found to contain active drug ingredients not listed on the product labels, including some with ingredients found in prescription drugs. The products may cause potentially serious side effects and may interact with a consumer's medications or dietary supplements. Consumers should use caution when considering purchasing these types of products. [Learn more about the tainted arthritis/pain products alert](https://www.fda.gov/drugs/medication-health-fraud/tainted-arthritis-pain-products) Labeling Updates **Labeling Updates - No Updates this Month.** ```json { "@context" : "https://schema.org", "@id" : "https://www.pdr.net#website", "@type" : "Website", "name" : "", "potentialAction" : { "@type" : "SearchAction", "query-input" : "required name=search_term_string", "target" : { "@type" : "EntryPoint", "urlTemplate" : "https://www.pdr.net/?site-search={search_term_string}" } }, "publisher" : { "@id" : "https://www.pdr.net#organization" }, "url" : "https://www.pdr.net" } ``` ```json { "@context" : "https://schema.org", "@id" : "https://www.pdr.net/edrug-updates/dec2023#webpage", "@type" : "WebPage", "about" : { "@id" : "https://www.pdr.net#organization" }, "dateModified" : "2024-10-01T12:0000+0000", "datePublished" : "2023-12-12T14:3436+0000", "description" : "The PDR Labeling Updates provide physicians with the latest FDA recalls, warnings and approval information - available in PDR's monthly eDrug Update\t", "inLanguage" : null, "isPartOf" : { "@id" : "https://www.pdr.net#website" }, "name" : "PDR Drug Update - December 2023", "url" : "https://www.pdr.net/edrug-updates/dec2023" } ```