Azstarys (Serdexmethylphenidate/Dexmethylphenidate) for ADHD
Date: October 4, 2021
Issue #:
1634Summary:
The FDA has approved a long-acting fixed-dose
combination of the stimulant dexmethylphenidate
and the prodrug serdexmethylphenidate (Azstarys–
Corium) for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years
old.Azstarys is the first product containing serdexmethylphenidate
to become available in the US. (Source: The Medical Letter)
Source: The Medical Letter - September 7, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Influenza Vaccine for 2021-2022
Date: October 4, 2021
Issue #:
1634Summary:
Annual vaccination against influenza A and B viruses
is recommended for everyone ≥6 months old without a
contraindication.1 Available influenza vaccines for the
2021-2022 season are listed in Table 2. (Source: The Medical Letter)
Source: The Medical Letter - August 24, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
In Brief: Third Dose of mRNA-based COVID-19 Vaccines for Immunocompromised Persons
Date: September 20, 2021
Issue #:
1633Summary:
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA-based COVID-19 vaccines
manufactured by Pfizer/BioNTech(Comirnaty) and
Moderna(Spikevax) to include administration of a third
dose in persons ≥12 years old (Pfizer/BioNTech) or ≥18
years old (Moderna) who have undergone solid organ
transplantation or have a condition that compromises
the immune system to a similar extent (see Table 1). (Source: The Medical Letter)
Source: The Medical Letter - August 18, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Anifrolumab (Saphnelo) for Systemic Lupus Erythematosus
Date: September 20, 2021
Issue #:
1633Summary:
The FDA has approved anifrolumab-fnia (Saphnelo– AstraZeneca), a type I interferon receptor antagonist, for IV treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard treatment. Anifrolumab has not been studied in patients with severe active lupus nephritis or severe active CNS lupus. It is the first type I interferon receptor antagonist to become available
in the US. (Source: The Medical Letter)
Source: The Medical Letter - August 10, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Ibrexafungerp (Brexafemme) for Vulvovaginal Candidiasis
Date: September 6, 2021
Issue #:
1632Summary:
The FDA has approved ibrexafungerp (Brexafemme–
Scynexis), a first-in-class triterpenoid antifungal
( " fungerp " ), for oral treatment of vulvovaginal candidiasis
in postmenarchal females. (Source: The Medical Letter)
Source: The Medical Letter - August 10, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Brexafemme Butoconazole Canesten Clotrimazole Diflucan Fluconazole Gynazole Gyne-Lotrimin ibrexafungerp Monistat terconazole Tioconazole Vagistat Vulvovaginal candidiasis Source Type: research
In Brief: Oritavancin (Kimyrsa) for Skin and Skin Structure Infections (online only)
Date: August 23, 2021
Issue #:
1631Summary:
The FDA has approvedKimyrsa (Melinta), a new
IV formulation of the long-acting lipoglycopeptide
antibiotic oritavancin, for treatment of adults with acute
bacterial skin and skin structure infections caused by
susceptible gram-positive bacteria.Orbactiv (Melinta),
another IV formulation of oritavancin, was approved in
2014 for the same indication.Kimyrsa has a smaller
infusion volume (250 mL vs 1 L) and a shorter infusion
time (1 hour vs 3 hours) compared toOrbactiv (see
Table 1). (Source: The Medical Letter)
Source: The Medical Letter - August 9, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Antibacterials dalbavancin Kimyrsa methicillin-resistant staphylococcus aureus Orbactiv oritavancin skin and skin structure infections televancin Vancomycin Source Type: research
Finerenone (Kerendia) for Chronic Kidney Disease
Date: August 23, 2021
Issue #:
1631Summary:
Finerenone (Kerendia– Bayer), an oral nonsteroidal
mineralocorticoid receptor antagonist (MRA), has
been approved by the FDA to reduce the risk of
sustained eGFR decline, end-stage renal disease,
nonfatal MI, hospitalization for heart failure (HF), and
cardiovascular death in adults with chronic kidney
disease (CKD) associated with type 2 diabetes. It is the
first nonsteroidal MRA to be approved in the US. (Source: The Medical Letter)
Source: The Medical Letter - August 6, 2021 Category: Drugs & Pharmacology Authors: admin Tags: ACE inhibitors ARBs chronic kidney disease finerenone Hypertension Kerendia type 2 diabetes Source Type: research
Casirivimab and Imdevimab (REGEN-COV) for Post-Exposure Prophylaxis of COVID-19
Date: August 23, 2021
Issue #:
1631Summary:
The investigational monoclonal antibodies casirivimab
and imdevimab (REGEN-COV– Regeneron) have
been available in the US under an Emergency Use
Authorization (EUA) since late 2020 for use together
to treat mild to moderate COVID-19 in persons ≥12
years old who weigh ≥40 kg and are at high risk of
progression to severe disease or hospitalization. The
FDA has now expanded this EUA to allow use of the
antibodies together for post-exposure prophylaxis
of COVID-19 in such persons, if they are not fully
vaccinated against COVID-19 or ar...
Source: The Medical Letter - August 6, 2021 Category: Drugs & Pharmacology Authors: admin Tags: casirivimab COVID-19 imdevimab REGEN-COV vaccines Source Type: research
In Brief: Shingrix for Immunocompromised Adults
Date: August 23, 2021
Issue #:
1631Summary:
The FDA has licensed the adjuvanted, recombinant
varicella zoster virus (VZV) vaccineShingrix (GSK) for
prevention of herpes zoster (shingles) in adults of any
age who are or will be at elevated risk because of disease-
or therapy-induced immunodeficiency or immunosuppression.Shingrix has been licensed for herpes
zoster prevention in adults ≥50 years old since 2017.1
It is the only VZV vaccine currently available in the US;Zostavax, a live-attenuated VZV vaccine, was withdrawn
from the market in 2020. (Source: The Medical Letter)
Source: The Medical Letter - August 3, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Shingles Shingrix vaccines varicella zoster virus Source Type: research
Rilonacept (Arcalyst) for Recurrent Pericarditis
Date: September 6, 2021
Issue #:
1632Summary:
Rilonacept (Arcalyst– Kiniksa), an interleukin-1 (IL-1)
antagonist that has been available for years for
treatment of cryopyrin-associated periodic syndromes,
has now been approved by the FDA for treatment
of recurrent pericarditis and prevention of further
recurrences in patients ≥12 years old. It is the first dru g
to be approved in the US for this indication. Anakinra(Kineret), an IL-1 receptor antagonist FDA-approved for
treatment of rheumatoid arthritis, has been used off-label
for years for treatment of recurrent pericarditi...
Source: The Medical Letter - July 28, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Anakinra Arcalyst Colchicine Kineret NSAIDs pericarditis Prednisone rilonacept Source Type: research
Ozanimod (Zeposia) for Ulcerative Colitis
Date: September 20, 2021
Issue #:
1633Summary:
The oral sphingosine 1-phosphate (S1P) receptor
modulator ozanimod (Zeposia– Bristol Myers Squibb)
has been approved by the FDA for treatment of adults
with moderately to severely active ulcerative colitis. It
is the first S1P receptor modulator to be approved for
treatment of ulcerative colitis. Ozanimod was approved
in March 2020 for use in adults with relapsing forms of
multiple sclerosis. (Source: The Medical Letter)
Source: The Medical Letter - July 27, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Treatment of Clostridioides difficile Infection
Date: September 6, 2021
Issue #:
1632Summary: Clostridioides (formerlyClostridium)difficile infection
(CDI) is the most common infectious cause of
healthcare-associated diarrhea in adults. Guidelines
on management of CDI have recently been updated. (Source: The Medical Letter)
Source: The Medical Letter - July 27, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Antibacterials bezlotoxumab Clindamycin Clostridiodes difficile Clostridium difficile Dificid fidaxomicin Firvanq Flagyl Fluoroquinolones Metro IV metronidazole Rifaximin Vancocin Vancomycin Xifaxan Zaxine Zinplava Source Type: research
Voclosporin (Lupkynis) for Lupus Nephritis
Date: August 23, 2021
Issue #:
1631Summary:
Voclosporin (Lupkynis– Aurinia), an oral calcineurin
inhibitor, has been approved by the FDA for use
in combination with the antimetabolite immunosuppressant
mycophenolate mofetil (Cellcept, and
generics) and a corticosteroid for treatment of adults
with active lupus nephritis. It is the first calcineurin
inhibitor to be approved in the US for this indication.
Tacrolimus (Prograf, and others) and cyclosporine
(Neoral, and others), the other available systemic
calcineurin inhibitors, are approved for prophylaxis of
organ rejection in t...
Source: The Medical Letter - July 19, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Abatacept Azathioprine belimumab Benlysta Cellcept corticosteroids Cyclophosphamide Cyclosporine Cytoxan Imuran Lupkynis Lupus Mycophenolate mofetil Neoral Orencia Procytox Prograf Rituxan Rituximab Tacrolimus voclo Source Type: research
In Brief: A Shorter Treatment Regimen for Tuberculosis (online only)
Date: August 23, 2021
Issue #:
1631Summary:
In a clinical trial conducted by the CDC ' s Tuberculosis
Trials Consortium in collaboration with the NIH-funded
AIDS Clinical Trials Group, a new 4-month regimen
for treatment of drug-susceptible pulmonary tuberculosis
was found to be noninferior to 6 months of
standard treatment. (Source: The Medical Letter)
Source: The Medical Letter - July 19, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Ethambutol Isoniazid Moxifloxacin Pyrazinamide Rifampin Rifapentine Tuberculosis Source Type: research
In Brief: Guillain-Barr é Syndrome with the Johnson & Johnson COVID-19 Vaccine
Date: August 9, 2021
Issue #:
1630Summary:
On July 12, 2021, the FDA added a warning to the
Fact Sheet for the Johnson& Johnson (Janssen)
adenovirus-based COVID-19 vaccine about an
increased risk of Guillain-Barr é syndrome (GBS)
following administration of the product. (Source: The Medical Letter)
Source: The Medical Letter - July 15, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
