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Peanut Allergen Powder (Palforzia)

   
The Medical Letter on Drugs and Therapeutics • Mar 09, 2020  (Issue 1593)
in the Palforzia group than in the placebo group (see Table 1).4 ADVERSE EFFECTS — The most common adverse ...
The FDA has approved peanut allergen powder-dnfp (Palforzia – Aimmune) for use as oral immunotherapy to mitigate allergic reactions, including anaphylaxis, caused by accidental peanut exposure in patients with a confirmed peanut allergy. It is the first drug to be approved in the US for this indication; Viaskin Peanut, an immunotherapy patch, is under FDA review for the same indication.
Med Lett Drugs Ther. 2020 Mar 9;62(1593):33-4 | Show Introduction Hide Introduction

Addendum: Drug Interaction between Opioids and Oral P2Y12 Platelet Inhibitors

   
The Medical Letter on Drugs and Therapeutics • Mar 09, 2020  (Issue 1593)
of oral P2Y12 inhibitors and increased platelet reactivity.1 Recently published clinical outcomes data ...
Opioids delay gastric emptying and the absorption of many oral drugs, including the P2Y12 inhibitors clopidogrel (Plavix, and generics), prasugrel (Effient, and generics), and ticagrelor (Brilinta), which are commonly used for initial treatment of acute coronary syndrome (ACS). An article in our February 25, 2019 issue reviewed studies showing that coadministration of opioids delayed and decreased absorption of oral P2Y12 inhibitors and increased platelet reactivity. Recently published clinical outcomes data may add to these concerns.
Med Lett Drugs Ther. 2020 Mar 9;62(1593):40 | Show Introduction Hide Introduction

Vibegron (Gemtesa) for Overactive Bladder

   
The Medical Letter on Drugs and Therapeutics • May 03, 2021  (Issue 1623)
to be approved in the US; mirabegron (Myrbetriq) was the first.1 STANDARD TREATMENT — Overactive bladder (OAB ...
The FDA has approved the selective beta-3 adrenergic agonist vibegron (Gemtesa – Urovant Sciences) for treatment of overactive bladder in adults with symptoms of urge urinary incontinence, urgency, and urinary frequency. It is the second beta-3 agonist to be approved in the US; mirabegron (Myrbetriq) was the first.
Med Lett Drugs Ther. 2021 May 3;63(1623):67-9 | Show Introduction Hide Introduction

An EUA for Baricitinib (Olumiant) for COVID-19

   
The Medical Letter on Drugs and Therapeutics • Dec 28, 2020  (Issue 1614)
in combination with the IV antiviral drug remdesivir (Veklury).1 Baricitinib has been available for treatment ...
The oral Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of confirmed or suspected COVID-19 in hospitalized patients ≥2 years old who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO); the EUA requires that baricitinib be used in combination with the IV antiviral drug remdesivir (Veklury). Baricitinib has been available for treatment of rheumatoid arthritis since 2018. Remdesivir was recently approved by the FDA for treatment of COVID-19 in hospitalized...
Med Lett Drugs Ther. 2020 Dec 28;62(1614):202-3 | Show Introduction Hide Introduction

FDA Authorizes Moderna COVID-19 Vaccine

   
The Medical Letter on Drugs and Therapeutics • Jan 25, 2021  (Issue 1616)
on December 11, 2020.1 CLINICAL STUDY — Issuance of the EUA was based primarily on the results ...
On December 18, 2020, the FDA issued an Emergency Use Authorization (EUA) for the Moderna mRNA-based vaccine for prevention of COVID-19 in persons ≥18 years old. The Pfizer-BioNTech mRNA-based vaccine received an FDA EUA for the same indication in persons ≥16 years old on December 11, 2020.
Med Lett Drugs Ther. 2021 Jan 25;63(1616):9-10 | Show Introduction Hide Introduction

Rilonacept (Arcalyst) for Recurrent Pericarditis

   
The Medical Letter on Drugs and Therapeutics • Sep 06, 2021  (Issue 1632)
Rilonacept (Arcalyst) for Recurrent Pericarditis Rilonacept (Arcalyst – Kiniksa), an interleukin-1 ...
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 drug 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 pericarditis.
Med Lett Drugs Ther. 2021 Sep 6;63(1632):143-4 | Show Introduction Hide Introduction

Plenvu - A Low-Volume PEG-Based Colonoscopy Preparation

   
The Medical Letter on Drugs and Therapeutics • Jan 28, 2019  (Issue 1564)
in adults. Plenvu is the first PEG-containing colonoscopy preparation that requires only 1 L of water ...
The FDA has approved Plenvu (Salix), a polyethylene glycol (PEG)-containing oral powder for reconstitution, for colon cleansing prior to colonoscopy in adults. Plenvu is the first PEG-containing colonoscopy preparation that requires only 1 L of water for dissolution and ingestion of 1 L of clear fluid in addition.
Med Lett Drugs Ther. 2019 Jan 28;61(1564):11-4 | Show Introduction Hide Introduction

A Two-Dose Hepatitis B Vaccine for Adults (Heplisav-B)

   
The Medical Letter on Drugs and Therapeutics • Jan 29, 2018  (Issue 1539)
hepatitis B component as Engerix-B and is licensed for use only in adults. 1 Table 1. Hepatitis B Vaccines ...
The FDA has approved a two-dose hepatitis B virus (HBV) vaccine (Heplisav-B – Dynavax) for use in adults ≥18 years old. The three other HBV vaccines marketed in the US are usually administered in 3 doses. Engerix-B and Recombivax HB are licensed for use in persons of all ages. A combination hepatitis A/B vaccine (Twinrix) contains the same hepatitis B component as Engerix-B and is licensed for use only in adults.
Med Lett Drugs Ther. 2018 Jan 29;60(1539):17-8 | Show Introduction Hide Introduction

Ozanimod (Zeposia) for Multiple Sclerosis

   
The Medical Letter on Drugs and Therapeutics • Aug 24, 2020  (Issue 1605)
), a sphingosine 1-phosphate (S1P) receptor modulator, for treatment of adults with relapsing forms of multiple ...
The FDA has approved ozanimod (Zeposia – Celgene), a sphingosine 1-phosphate (S1P) receptor modulator, for treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). It is the third oral S1P receptor modulator to be approved in the US for treatment of relapsing forms of MS; siponimod (Mayzent) is also indicated for use in adults, and fingolimod (Gilenya) is approved for use in patients ≥10 years old.
Med Lett Drugs Ther. 2020 Aug 24;62(1605):132-4 | Show Introduction Hide Introduction

Brodalumab (Siliq) - Another IL-17A Antagonist for Psoriasis

   
The Medical Letter on Drugs and Therapeutics • Jul 17, 2017  (Issue 1525)
earlier.1,2 STANDARD TREATMENT — Plaque psoriasis is a chronic, inflammatory, immune-mediated skin ...
The FDA has approved brodalumab (Siliq – Valeant), an injectable human interleukin (IL)-17A receptor antagonist, for treatment of adults with moderate to severe plaque psoriasis who have failed to respond to other systemic therapies. Brodalumab is the third IL-17A antagonist to be approved in the US for this indication; secukinumab (Cosentyx) and ixekizumab (Taltz) were approved earlier.
Med Lett Drugs Ther. 2017 Jul 17;59(1525):118-9 | Show Introduction Hide Introduction