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In Brief: Risk of Pulmonary Thromboembolism and Death with Tofacitinib (Xeljanz)

   
The Medical Letter on Drugs and Therapeutics • Aug 26, 2019  (Issue 1579)
thromboembolism and death with a dosage of 10 mg twice daily.1 Tofacitinib is approved for treatment ...
The FDA has required updates to the labeling of the Janus kinase (JAK) inhibitor tofacitinib (Xeljanz, Xeljanz XR) based on interim results of a postmarketing safety trial that showed an increased risk of pulmonary thromboembolism and death with a dosage of 10 mg twice daily.1 Tofacitinib is approved for treatment of rheumatoid arthritis (RA),2 psoriatic arthritis, and ulcerative colitis.In the postmarketing trial, RA patients ≥50 years old taking methotrexate who had at least one cardiovascular risk factor were randomized to receive add-on treatment with tofacitinib 5 mg twice daily (the...
Med Lett Drugs Ther. 2019 Aug 26;61(1579):136 |  Show IntroductionHide Introduction

Jornay PM - Evening-Dosed Methylphenidate for ADHD

   
The Medical Letter on Drugs and Therapeutics • Aug 12, 2019  (Issue 1578)
in the evening; other long-acting methylphenidate formulations are taken in the morning.1,2 It is being ...
The FDA has approved Jornay PM (Ironshore), a capsule formulation of methylphenidate with a delayed-release outer layer and an extended-release inner layer, for once-nightly treatment of attention-deficit hyperactivity disorder (ADHD) in patients >6 years old. Jornay PM is the first methylphenidate product to become available in the US that is taken in the evening; other long-acting methylphenidate formulations are taken in the morning. It is being marketed specifically for patients who have disruptive ADHD symptoms in the morning.
Med Lett Drugs Ther. 2019 Aug 12;61(1578):126-8 |  Show IntroductionHide Introduction

Cyclosporine 0.09% Solution (Cequa) for Dry Eye Disease

   
The Medical Letter on Drugs and Therapeutics • Jul 29, 2019  (Issue 1577)
adults.1 STANDARD TREATMENT — Treatments for dry eye disease include artificial tears (ophthalmic drops ...
The FDA has approved cyclosporine 0.09% ophthalmic solution (Cequa – Sun) to increase tear production in patients with keratoconjunctivitis sicca (dry eye disease). Restasis, a 0.05% cyclosporine emulsion, was approved in the US in 2003 for the same indication.
Med Lett Drugs Ther. 2019 Jul 29;61(1577):116-8 |  Show IntroductionHide Introduction

Bremelanotide (Vyleesi) for Hypoactive Sexual Desire Disorder

   
The Medical Letter on Drugs and Therapeutics • Jul 29, 2019  (Issue 1577)
; flibanserin (Addyi), which was approved in 2015, was the first.1 Pronunciation Key Bremelanotide: bre” me ...
The FDA has approved bremelanotide (Vyleesi – Amag), a melanocortin receptor agonist, for subcutaneous treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). Bremelanotide is not approved for use in men or postmenopausal women. It is the second drug to be approved in the US for this indication; flibanserin (Addyi), which was approved in 2015, was the first.
Med Lett Drugs Ther. 2019 Jul 29;61(1577):114-6 |  Show IntroductionHide Introduction

Zolgensma - One-Time Gene Therapy for Spinal Muscular Atrophy

   
The Medical Letter on Drugs and Therapeutics • Jul 29, 2019  (Issue 1577)
muscular atrophy (SMA) and bi-allelic mutations in the survival motor neuron 1 (SMN1) gene ...
The FDA has approved onasemnogene abeparvovec-xioi (Zolgensma – Avexis), an adeno-associated virus vector-based gene therapy, for one-time IV treatment of children <2 years old who have spinal muscular atrophy (SMA) and bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. It is the first gene therapy and the second drug to be approved in the US for SMA; nusinersen (Spinraza) was approved in 2016.
Med Lett Drugs Ther. 2019 Jul 29;61(1577):113-4 |  Show IntroductionHide Introduction

Cladribine (Mavenclad) for Multiple Sclerosis

   
The Medical Letter on Drugs and Therapeutics • Jul 29, 2019  (Issue 1577)
(PML) compared to other MS treatments.1-3 Oral fingolimod (Gilenya), teriflunomide (Aubagio ...
The FDA has approved cladribine (Mavenclad – EMD Serono), a purine antimetabolite, for oral treatment of adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting disease and active secondary progressive MS (SPMS), who cannot tolerate or have had an inadequate response to other drugs indicated for treatment of MS. It is not recommended for use in patients with clinically isolated syndrome (CIS). IV cladribine, which is FDA-approved for treatment of hairy cell leukemia, has been used off-label for treatment of MS.
Med Lett Drugs Ther. 2019 Jul 29;61(1577):118-20 |  Show IntroductionHide Introduction

Addendum: Estradiol/Progesterone (Bijuva) for Menopausal Vasomotor Symptoms

   
The Medical Letter on Drugs and Therapeutics • Jul 29, 2019  (Issue 1577)
Lett Drugs Ther 2019; 61:99), Table 1 should have included single-ingredient oral formulations ...
In our article on Bijuva, the oral fixed-dose combination of estradiol and progesterone (Med Lett Drugs Ther 2019; 61:99), Table 1 should have included single-ingredient oral formulations of estradiol and progesterone (see below). They will be added to the table as it appears online, along with medroxyprogesterone (Provera, and generics), another single-ingredient progestin available for use in women with an intact uterus who take systemic estrogen for menopausal symptoms. Taking generic estradiol and progesterone separately may be less convenient than taking Bijuva, but they cost less and...
Med Lett Drugs Ther. 2019 Jul 29;61(1577):120 |  Show IntroductionHide Introduction

Drugs for Smoking Cessation

   
The Medical Letter on Drugs and Therapeutics • Jul 15, 2019  (Issue 1576)
in the US. Smoking cessation often requires both pharmacotherapy and behavioral support.1,2 NICOTINE REPLACEMENT ...
Smoking tobacco remains the primary preventable cause of death in the US. Smoking cessation often requires both pharmacotherapy and behavioral support.
Med Lett Drugs Ther. 2019 Jul 15;61(1576):105-10 |  Show IntroductionHide Introduction

Benzhydrocodone/Acetaminophen (Apadaz) for Pain

   
The Medical Letter on Drugs and Therapeutics • Jul 15, 2019  (Issue 1576)
and acetaminophen or ibuprofen have been available for years and are the most abused opioid products in the US.1 ...
The FDA has approved Apadaz (KemPharm), a short-acting, fixed-dose combination of benzhydrocodone and acetaminophen, for short-term management (≤14 days) of acute pain severe enough to require an opioid and for which alternative treatment options are inadequate. Benzhydrocodone is a prodrug of hydrocodone. Fixed-dose combinations of short-acting hydrocodone and acetaminophen or ibuprofen have been available for years and are the most abused opioid products in the US. Apadaz was developed under the presumption that inclusion of the inactive prodrug would reduce the potential for...
Med Lett Drugs Ther. 2019 Jul 15;61(1576):110-2 |  Show IntroductionHide Introduction

Expanded Table: Some Drugs for Smoking Cessation (online only)

   
The Medical Letter on Drugs and Therapeutics • Jul 15, 2019  (Issue 1576)
) Nicotine transdermal patch – generic NicoDerm CQ (GSK) 7, 14, 21 mg/24 hr patches 1 patch/day ...
View the Expanded Table: Some Drugs for Smoking Cessation
Med Lett Drugs Ther. 2019 Jul 15;61(1576):e112-4 |  Show IntroductionHide Introduction