July 2024

PDR Drug Update 

First Approval in Decades for Female Adults with UTI

More than half of the women in the US acquire a urinary tract infection (UTI) at some point during their lives. It is a common condition that often necessitates prescribing antibiotics such as ceftriaxone or nitrofurantoin. Unfortunately, pathogens continue to mutate over time, sometimes resulting in loss of effectiveness of existing medications. Therefore, a recent FDA approval for a new oral antibacterial drug is a welcome addition to the current options for combating uncomplicated UTIs.

Pivya (pivmecillinam) has been used to treat women with UTIs for over four decades overseas. As a synthetic version of penicillin, it is a narrow-spectrum antibiotic. The new FDA approval specifies using Pivya to treat uncomplicated UTIs caused only by susceptible Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus isolates. These bacteria are part of normal human intestinal flora colonizing the skin and rectum. Infection from the organisms can occur when they enter the urethra and travel up into the bladder, resulting in cystitis. Pivya has not received approval for treatment of complicated UTI, which would include UTI in patients who are immunocompromised, male, or pregnant or whose infection involves the kidneys (pyelonephritis).

Side effects associated with the use of Pivya were reported, including nausea and diarrhea. Pivya includes several contraindications. It is not recommended to use Pivya if patients have experienced severe hypersensitivity reactions to any beta-lactam antibacterial drugs. Additionally, Pivya should not be used by patients with primary or secondary carnitine deficiency resulting from inherited disorders of mitochondrial fatty acid oxidation and carnitine metabolism or by those suffering from porphyria.

The prescribing information for Pivya details specific warnings and precautions for providers to consider before prescribing and to counsel patients regarding, such as hypersensitivity reactions, severe cutaneous adverse reactions, drug interactions that cause risk for carnitine depletion, Clostridioides difficile–associated diarrhea, and the potential for interference in a certain newborn screening test if the pregnant mother was treated with Pivya prior to delivery.

Availability of alternative antibiotics such as Pivya is a significant development. According to the CDC’s report, Antibiotic Resistance Threats in the United States, 2019, improved antibiotic use is imperative, as the annual number of US individuals with antibiotic resistance reaches approximately 3 million. Accordingly, the label for Pivya notes in its usage and patient counseling sections that to reduce the development of drug-resistant bacteria and maintain effectiveness, Pivya should be used only to treat or prevent infections that are proven, or strongly suspected, to be caused by susceptible bacteria. Stay informed about additional medication advances for infections by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Approvals

Austedo XR

The FDA has approved Austedo XR (deutetrabenazine) extended-release tablets as a one-pill, once-daily treatment option, now with four new tablet strengths (30, 36, 42, 48mg) indicated in adults for tardive dyskinesia and Huntington's disease chorea. Learn more about Austedo XR

Bkemv

The FDA has approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment indications, which are also currently approved for Soliris: the treatment of patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis and the treatment of patients with atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy. Learn more about Bkemv

Capvaxive

The FDA has approved Capvaxive (pneumococcal 21-valent conjugate vaccine) for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. Learn more about Capvaxive

Iqirvo

The FDA has approved Iqirvo (elafibranor) 80mg tablets as a first-in-class treatment for primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Learn more about Iqirvo

Mresvia

The FDA has approved Mresvia (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. Learn more about Mresvia

Onyda XR

The FDA has approved Onyda XR (clonidine HCl), a once-a-day extended-release oral suspension with nighttime dosing, for the treatment of ADHD as a monotherapy or as an adjunctive therapy to approved central nervous system stimulant medications in pediatric patients aged 6 years and older. Learn more about Onyda XR

Piasky

The FDA has approved Piasky (crovalimab-akkz) for the treatment of adult and pediatric patients aged 13 years and older with paroxysmal nocturnal hemoglobinuria and a body weight of at least 40kg. Learn more about Piasky

Rytelo

The FDA has approved Rytelo (imetelstat) for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to, have lost response to, or are ineligible for erythropoiesis-stimulating agents. Learn more about Rytelo

Sofdra

The FDA has approved Sofdra (sofpironium) topical gel 12.45% for the treatment of primary axillary hyperhidrosis in patients aged 9 and older. Learn more about Sofdra

Yimmugo

The FDA has approved Yimmugo (immune globulin intravenous, human - dira), 10% liquid, for the treatment of primary humoral immunodeficiency in patients aged 2 years or older. Learn more about Yimmugo

FDA New Indications

Arexvy

The FDA has approved an expanded age indication for Arexvy (respiratory syncytial virus (RSV) vaccine, adjuvanted) for the prevention of RSV lower respiratory tract disease in adults aged 50 through 59 years who are at increased risk. In the US, the vaccine is currently approved for use in adults aged 60 and older and recommended by CDC/ACIP using shared clinical decision-making. Learn more about Arexvy

Augtyro

The FDA has approved Augtyro (repotrectinib) for the treatment of adult and pediatric patients aged 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. Learn more about Augtyro

Blincyto

The FDA has approved Blincyto (blinatumomab) for the treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia in the consolidation phase, regardless of measurable residual disease status. Learn more about Blincyto

Breyanzi

The FDA has approved Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor. Learn more about Breyanzi

Elevidys

The FDA has approved expansion to the labeled indication for Elevidys (delandistrogene moxeparvovec-rokl) to include individuals with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who are at least aged 4 years. Learn more about Elevidys

Farxiga

The FDA has approved Farxiga (dapagliflozin) to improve glycemic control in pediatric patients with type-2 diabetes who are aged 10 years and older. Learn more about Farxiga

Iqirvo

The FDA has granted accelerated approval for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Learn more about Iqirvo

Kevzara

The FDA has approved Kevzara (sarilumab) for the treatment of patients weighing 63kg or greater with active polyarticular juvenile idiopathic arthritis. Learn more about Kevzara

Retevmo

The FDA has approved Retevmo (selpercatinib) in patients aged 2 and older with either advanced or metastatic medullary thyroid cancer with a RET mutation; advanced or metastatic thyroid cancer with a RET gene fusion; or locally advanced or metastatic solid tumors with a RET gene fusion. Learn more about Retevmo

Skyrizi

The FDA has approved Skyrizi (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn's disease. Learn more about Skyrizi

Vyvgart Hytrulo

The FDA has approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). It is the first and only neonatal Fc receptor blocker approved for the treatment of CIDP. Learn more about Vyvgart Hytrulo

FDA New Combinations

Imfinzi + Carboplatin and Paclitaxel

The FDA has approved Imfinzi (durvalumab) in combination with carboplatin and paclitaxel followed by Imfinzi monotherapy as treatment for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient. Learn more about Imfinzi plus carboplatin and paclitaxel

Keytruda + Carboplatin and Paclitaxel

The FDA has approved Keytruda in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. Learn more about plus carboplatin and paclitaxel

Krazati + Cetuximab

The FDA has granted accelerated approval for Krazati (adagrasib) in combination with cetuximab as a targeted treatment option for adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Learn more about Krazati plus cetuximab

FDA Recalls

Glenmark Potassium Chloride

Glenmark Pharmaceuticals Inc. is voluntarily recalling 114 batches of potassium chloride extended-release capsules, USP (750mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution. Learn more about the Glenmark potassium chloride recall

HomeoCare Homeopathic Stella Life Oral Care

HomeoCare Laboratories is voluntarily recalling two batches of Homeopathic StellaLife Oral Care Products manufactured in 2024 due to FDA findings of microbial contamination. This recall is to be performed at the consumer level. Learn more about the HomeoCare Homeopathic Stella Life Oral Care recall

Integrity Products Male Enhancement Supplements

Integrity Products is voluntarily recalling a tainted lot (HGW221116) within expiry of the Ram It & To The Moon capsules to the consumer level. FDA analysis found these products to be tainted with sildenafil and tadalafil. Learn more about the Integrity Products male enhancement supplements recall

Penn Herb Nature's Wonderland

Penn Herb Company is recalling 51 bottles (60 capsules per bottle) of Nature's Wonderland Thyroid Formula (Item #: Sm32x, Lot #: 23289A) because it has the potential to be contaminated with Salmonella. Learn more about the Penn Herb Nature's Wonderland recall

Sagent Pharmaceuticals Docetaxel

Sagent Pharmaceuticals announced the voluntary nationwide recall of two lots of docetaxel injection, USP (80mg per 8mL multi-dose vials and 160mg per 16mL multi-dose vials) to the user level as the result of a customer complaint due to potential presence of particulate matter from the stopper in the drug product. Learn more about the Sagent Pharmaceuticals docetaxel recall

Suntegrity Skincare Sunscreen

Suntegrity Skincare initiated a voluntary recall of nine lots of Suntegrity Impeccable Skin Sunscreen Foundation (multiple shades) based on its discovery of a higher-than-acceptable microbiological mold count (species: Aspergillus Sydowii) in some tubes of Lot 115BU that developed post-release and over time in a recent test. Out of an abundance of caution while investigating the situation, the company has decided to voluntarily recall these additional lots: 107IV, 107NU, 109NU, 117BU, 113SA, 114SA, 106BR, and 101MO even though all original and recent test results received have come back clear. Learn more about the Suntegrity Skincare Sunscreen recall

Labeling Updates - No updates this month