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Inotuzumab Ozogamicin (Besponsa) - An Antibody-Drug Conjugate for ALL (online only)

   
The Medical Letter on Drugs and Therapeutics • May 21, 2018  (Issue 1547)
on day 1 (0.8 mg/m2), day 8 (0.5 mg/m2), and day 15 (0.5 mg/m2), followed by 7 days off. For subsequent ...
The FDA has approved inotuzumab ozogamicin (Besponsa – Pfizer), a humanized anti-CD22 monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin, for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. It is the first CD22-directed antibody-drug conjugate to be approved in the US.
Med Lett Drugs Ther. 2018 May 21;60(1547):e90-1 |  Show IntroductionHide Introduction

Brexpiprazole (Rexulti) for Agitation in Alzheimer's Dementia

   
The Medical Letter on Drugs and Therapeutics • Jun 26, 2023  (Issue 1679)
treatment of choice has been off-label use of an antipsychotic drug such as aripiprazole (Abilify ...
The FDA has approved the oral second-generation antipsychotic drug brexpiprazole (Rexulti – Otsuka/Lundbeck) for once-daily treatment of agitation associated with dementia due to Alzheimer's disease (AD). Brexpiprazole is the first drug to be approved in the US for this indication. It is also approved for treatment of schizophrenia and as an adjunct to antidepressants for treatment of major depressive disorder.
Med Lett Drugs Ther. 2023 Jun 26;65(1679):99-101   doi:10.58347/tml.2023.1679b |  Show IntroductionHide Introduction

In Brief: New Warning for Extended-Release Stimulants for ADHD

   
The Medical Letter on Drugs and Therapeutics • Jul 08, 2025  (Issue 5115)
used off label in these patients. The new warnings were based on an analysis that found that patients ...
The FDA now requires that the labels of all extendedelease stimulants used for treatment of attention-deficit/hyperactivity disorder (ADHD) include a warning about the risks of weight loss and other adverse effects associated with their use in children <6 years old. The labels of all stimulants used for treatment of ADHD already contain a boxed warning about the high risk of abuse and dependence associated with their use.
Med Lett Drugs Ther. 2025 Jul 8;67(5115):1   doi:10.58347/tml.2025.5115a |  Show IntroductionHide Introduction

Omalizumab (Xolair) for Chronic Urticaria

   
The Medical Letter on Drugs and Therapeutics • May 27, 2013  (Issue 1417)
allergic asthma.1 It has been used off-label for treatment of allergic rhinitis and food allergies ...
Omalizumab (Xolair) is a recombinant humanized monoclonal anti-IgE antibody currently approved by the FDA for treatment of moderate to severe persistent allergic asthma. It has been used off-label for treatment of allergic rhinitis and food allergies. Recently the results of a phase III clinical trial indicated that omalizumab may be effective in treating chronic urticaria as well.
Med Lett Drugs Ther. 2013 May 27;55(1417):43-4 |  Show IntroductionHide Introduction

Teprotumumab (Tepezza) for Thyroid Eye Disease

   
The Medical Letter on Drugs and Therapeutics • May 31, 2021  (Issue 1625)
) have been used off-label to reduce inflammation, but they are not effective long-term and adverse effects limit ...
Teprotumumab-trbw (Tepezza - Horizon), an insulin-like growth factor-1 receptor (IGF-1R) inhibitor, has been approved by the FDA for IV treatment of thyroid eye disease. It is the first drug to be approved in the US for this indication.
Med Lett Drugs Ther. 2021 May 31;63(1625):87-8 |  Show IntroductionHide Introduction

In Brief: Hyperthermia with Scopolamine Patches

   
The Medical Letter on Drugs and Therapeutics • Jun 30, 2025  (Issue 5114)
or recovery after surgery in adults; it is often used off-label to reduce drooling in children ...
The FDA has required a new warning in the label for the scopolamine transdermal patch (Transderm-Scōp, and generics) about a risk of serious or fatal hyperthermia. Scopolamine, an anticholinergic drug, is FDA-approved for prevention of nausea and vomiting associated with motion sickness or recovery after surgery in adults; it is often used off-label to reduce drooling in children and adolescents with neurologic disorders.
Med Lett Drugs Ther. 2025 Jun 30;67(5114):1   doi:10.58347/tml.2025.5114a |  Show IntroductionHide Introduction

Drugs for Sexually Transmitted Infections

   
The Medical Letter on Drugs and Therapeutics • Jun 27, 2022  (Issue 1653)
3 days, then 4 days off, repeat up to 4x2 Sinecatechins 15% tid up to 16 weeks2,38 MU = million ...
This article includes recommendations for management of most sexually transmitted infections (STIs) other than HIV and viral hepatitis. Some of the indications and dosages recommended here have not been approved by the FDA (see Table 1).
Med Lett Drugs Ther. 2022 Jun 27;64(1653):97-104 |  Show IntroductionHide Introduction

In Brief: Glycopyrrolate Oral Solution for Sialorrhea

   
The Medical Letter on Drugs and Therapeutics • Jan 10, 2011  (Issue 1355)
), a synthetic muscarinic receptor antagonist, has been used off-label for many years for treatment ...
Glycopyrrolate (Robinul, and others), a synthetic muscarinic receptor antagonist, has been used off-label for many years for treatment of excessive drooling in patients with Parkinson’s disease, in patients taking clozapine for schizophrenia, and in developmentally disabled children.1-3 It has now been approved by the FDA as Cuvposa (Shionogi) for use specifically in children 3-16 years old with severe chronic drooling due to a neurologic condition, such as cerebral palsy. It is being marketed as an oral solution, which will permit more precise weight-based dosing than was possible with the...
Med Lett Drugs Ther. 2011 Jan 10;53(1355):4 |  Show IntroductionHide Introduction

Edaravone (Radicava) for ALS

   
The Medical Letter on Drugs and Therapeutics • Nov 06, 2017  (Issue 1533)
-week cycles. Edaravone should be administered once daily for 14 days, followed by 14 days off ...
The FDA has approved edaravone (Radicava – Mitsubishi Tanabe Pharma) for treatment of amyotrophic lateral sclerosis (ALS). It is the second drug to be approved in the US for this indication; riluzole (Rilutek, and generics) was approved in 1995. Edaravone was approved for treatment of ALS as Radicut in Japan and South Korea in 2015. It has been used in Japan and other Asian countries since 2001 for treatment of acute ischemic stroke.
Med Lett Drugs Ther. 2017 Nov 6;59(1533):180-2 |  Show IntroductionHide Introduction

Oxybutynin for Hot Flashes in Women with Breast Cancer

   
The Medical Letter on Drugs and Therapeutics • Feb 25, 2019  (Issue 1566)
-controlled trial suggest that off-label use of the anticholinergic drug oxybutynin may reduce the frequency ...
Interim results of a double-blind, placebo-controlled trial suggest that off-label use of the anticholinergic drug oxybutynin may reduce the frequency and severity of hot flashes in women with breast cancer. Extended-release oral oxybutynin (Ditropan XL, and generics) has been shown to reduce the frequency and severity of hot flashes in healthy menopausal women.
Med Lett Drugs Ther. 2019 Feb 25;61(1566):30-1 |  Show IntroductionHide Introduction