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In Brief: New Warnings for Janus Kinase Inhibitors

   
The Medical Letter on Drugs and Therapeutics • Oct 04, 2021  (Issue 1634)
events, malignancy, thrombosis, and death with their use.1 The new warnings were prompted ...
The FDA has required updates to the boxed warnings in the labeling of the Janus kinase (JAK) inhibitors tofacitinib (Xeljanz, Xeljanz XR), baricitinib (Olumiant), and upadacitinib (Rinvoq) describing increased risks of major adverse cardiovascular events, malignancy, thrombosis, and death with their use. The new warnings were prompted by the results of a postmarketing safety trial with tofacitinib and were added to the labels of baricitinib and upadacitinib based on the presumption of a class effect. The tofacitinib package insert had contained a boxed warning about an increased risk of...
Med Lett Drugs Ther. 2021 Oct 4;63(1634):160 | Show Introduction Hide Introduction

Clascoterone Cream (Winlevi) for Acne

   
The Medical Letter on Drugs and Therapeutics • Dec 27, 2021  (Issue 1640)
not respond to topical combination therapy, addition of an oral tetracycline is recommended.1,2 The most ...
The FDA has approved Winlevi (Sun), a 1% cream formulation of the androgen receptor inhibitor clascoterone, for treatment of acne vulgaris in patients ≥12 years old. It is the first topical androgen receptor inhibitor to be approved by the FDA.
Med Lett Drugs Ther. 2021 Dec 27;63(1640):202-4 | Show Introduction Hide Introduction

Insulin Degludec/Liraglutide (Xultophy 100/3.6) for Type 2 Diabetes

   
The Medical Letter on Drugs and Therapeutics • Sep 11, 2017  (Issue 1529)
/3.6 (Novo Nordisk), a fixed-ratio combination of insulin degludec and the GLP-1 (glucagon-like peptide-1 ...
The FDA has approved Xultophy 100/3.6 (Novo Nordisk), a fixed-ratio combination of insulin degludec and the GLP-1 (glucagon-like peptide-1) receptor agonist liraglutide, for once-daily treatment of adults with type 2 diabetes inadequately controlled on basal insulin (<50 units daily) or liraglutide (≤1.8 mg daily).
Med Lett Drugs Ther. 2017 Sep 11;59(1529):147-9 | Show Introduction Hide Introduction

Lixisenatide for Type 2 Diabetes

   
The Medical Letter on Drugs and Therapeutics • Jan 30, 2017  (Issue 1513)
The FDA has approved lixisenatide (Sanofi), a short-acting injectable GLP-1 (glucagon-like peptide ...
The FDA has approved lixisenatide (Sanofi), a short-acting injectable GLP-1 (glucagon-like peptide-1) receptor agonist, for once-daily treatment of adults with type 2 diabetes, both alone (Adlyxin) and in a fixed-ratio combination with insulin glargine (Soliqua 100/33). Lixisenatide has been available since 2013 in many other countries as Lyxumia. It is the fifth GLP-1 receptor agonist to be approved in the US.
Med Lett Drugs Ther. 2017 Jan 30;59(1513):19-21 | Show Introduction Hide Introduction

Oral Semaglutide (Rybelsus) for Type 2 Diabetes

   
The Medical Letter on Drugs and Therapeutics • Oct 21, 2019  (Issue 1583)
-1 (GLP-1) receptor agonist semaglutide (Rybelsus – Novo Nordisk) has been approved by the FDA ...
An oral formulation of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Rybelsus – Novo Nordisk) has been approved by the FDA for once-daily treatment of type 2 diabetes in adults. Semaglutide, which has been available in a subcutaneously-injected formulation (Ozempic) since 2017, is the first GLP-1 receptor agonist to become available for oral administration; the 4 other GLP-1 receptor agonists currently available in the US are administered by subcutaneous (SC) injection.
Med Lett Drugs Ther. 2019 Oct 21;61(1583):166-8 | Show Introduction Hide Introduction

In Brief: Semglee - A New Insulin Glargine for Diabetes

   
The Medical Letter on Drugs and Therapeutics • Jan 25, 2021  (Issue 1616)
), an insulin glargine product similar to Lantus, for treatment of type 1 diabetes in children and adults ...
The FDA has approved Semglee (Mylan), an insulin glargine product similar to Lantus, for treatment of type 1 diabetes in children and adults and type 2 diabetes in adults. Semglee is the second "follow-on" insulin glargine product to become available in the US; Basaglar, which is also similar to Lantus, was the first. Lantus is a recombinant analog of human insulin that forms microprecipitates in subcutaneous tissue, prolonging its duration of action to a mean of about 24 hours with no pronounced peak effect.
Med Lett Drugs Ther. 2021 Jan 25;63(1616):14-5 | Show Introduction Hide Introduction

In Brief: Shingrix for Immunocompromised Adults

   
The Medical Letter on Drugs and Therapeutics • Aug 23, 2021  (Issue 1631)
IN BRIEF Shingrix for Immunocompromised Adults Table 1. Some Shingrix Clinical Trial Results ...
The FDA has licensed the adjuvanted, recombinant varicella zoster virus (VZV) vaccine Shingrix (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.
Med Lett Drugs Ther. 2021 Aug 23;63(1631):129 | Show Introduction Hide Introduction

Semaglutide (Wegovy) for Weight Loss

   
The Medical Letter on Drugs and Therapeutics • Jul 12, 2021  (Issue 1628)
of obesityrelated comorbidities.4 MECHANISM OF ACTION — Activation of brain GLP-1 receptors potentiates glucose ...
The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide, previously approved by the FDA as Ozempic to treat type 2 diabetes and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, has now been approved in a higher dose as Wegovy (Novo Nordisk) for chronic weight management in adults with or without type 2 diabetes who have a body mass index (BMI) ≥30 kg/m2 or a BMI ≥27 kg/m2 and ≥1 weight-related comorbidity (e.g., hypertension, dyslipidemia). An oral formulation of semaglutide (Rybelsus)...
Med Lett Drugs Ther. 2021 Jul 12;63(1628):106-8 | Show Introduction Hide Introduction

Glucagon Nasal Powder (Baqsimi) for Severe Hypoglycemia

   
The Medical Letter on Drugs and Therapeutics • Sep 23, 2019  (Issue 1581)
see' mee SEVERE HYPOGLYCEMIA – Hypoglycemia is classified as level 1 (blood glucose ≥54 and ...
The FDA has approved glucagon nasal powder (Baqsimi – Lilly) for treatment of severe hypoglycemia in patients ≥4 years old with diabetes. Baqsimi is the first noninjectable glucagon formulation to become available in the US. Injectable glucagon emergency kits (GlucaGen Hypokit, and generic) have been available for years, but they require reconstitution of the lyophilized powder by the caregiver immediately before injection. An injectable glucagon formulation that does not require reconstitution was recently approved by the FDA (Gvoke) and is expected to become available later in 2019; it...
Med Lett Drugs Ther. 2019 Sep 23;61(1581):148-9 | Show Introduction Hide Introduction

An EUA for Sotrovimab for Treatment of COVID-19

   
The Medical Letter on Drugs and Therapeutics • Jun 28, 2021  (Issue 1627)
of progressing to severe disease, including hospitalization and death.1 Two other monoclonal antibody ...
The investigational monoclonal antibody sotrovimab (VIR-7831; GSK/Vir Biotechnology) has been granted an FDA Emergency Use Authorization (EUA) for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease, including hospitalization and death.1 Two other monoclonal antibody regimens are authorized for the same indication: casirivimab (REGN10933) and imdevimab (REGN10987) administered together, and bamlanivimab (LY-CoV555) and etesevimab (LYCoV016) administered together. The FDA revoked its EUA for...
Med Lett Drugs Ther. 2021 Jun 28;63(1627):97-8 | Show Introduction Hide Introduction