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Guselkumab (Tremfya) for Psoriasis
The Medical Letter on Drugs and Therapeutics • Nov 06, 2017 (Issue 1533)
release of pro-inflammatory
cytokines (such as IL-17A) and chemokines.
Table 1. Pharmacology
Class IL ...
The FDA has approved the interleukin (IL)-23 blocker
guselkumab (Tremfya – Janssen) for treatment of
moderate to severe plaque psoriasis in adults who
are candidates for systemic therapy or phototherapy.
Guselkumab is the first selective IL-23 blocker to
become available in the US.
Montelukast for Persistent Asthma
The Medical Letter on Drugs and Therapeutics • Jul 17, 1998 (Issue 1031)
with inhaled corticosteroids, found that 10
mg of montelukast nightly increased the morning FEV
1
(forced ...
Montelukast sodium (Singulair - Merck), a leukotriene receptor antagonist, has been approved by the US Food and Drug Administration (FDA) for oral prophylaxis and chronic treatment of asthma in adults and children at least 6 years old. It is the third 'leukotriene modifier' to become available in the USA; zafirlukast (Accolate - Medical Letter, 38:111, 1996) and zileuton (Zyflo - Medical Letter, 39:18, 1997) were marketed previously. Neither zafirlukast nor zileuton has been approved by the FDA for use in children less than 12 years old. Leukotriene modifiers are not recommended for...
Liraglutide (Saxenda) for Weight Loss
The Medical Letter on Drugs and Therapeutics • Jun 22, 2015 (Issue 1471)
Liraglutide (Saxenda) for
Weight Loss The injectable glucagon-like peptide-1 (GLP-1)
receptor agonist ...
The injectable glucagon-like peptide-1 (GLP-1)
receptor agonist liraglutide, previously approved by the
FDA for treatment of type 2 diabetes as Victoza, has
now also been approved at a higher dose as Saxenda
(Novo Nordisk) for chronic weight management
in adults with a BMI ≥30, or a BMI ≥27 with a
weight-related comorbidity such as hypertension,
dyslipidemia, or diabetes.
Dupilumab (Dupixent) for Asthma
The Medical Letter on Drugs and Therapeutics • Jan 14, 2019 (Issue 1563)
inadequately controlled with
topical therapies.1
Pronunciation Key
Dupilumab: doo pil’ ue mab Dupixent: du ...
The FDA has approved the subcutaneously injected
monoclonal antibody dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of
patients ≥12 years old with moderate to severe
asthma with an eosinophilic phenotype or with oral
corticosteroid-dependent asthma. Dupilumab was
approved earlier to treat adults with moderate to
severe atopic dermatitis inadequately controlled with
topical therapies.
Ponesimod (Ponvory) for Multiple Sclerosis
The Medical Letter on Drugs and Therapeutics • Aug 09, 2021 (Issue 1630)
), a sphingosine 1-phosphate (S1P) receptor
modulator, for treatment of adults with relapsing
forms of multiple ...
The FDA has approved ponesimod (Ponvory –
Janssen), 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). Ponesimod is the fourth oral S1P receptor
modulator to be approved in the US for once-daily
treatment of relapsing forms of MS; ozanimod
(Zeposia) and siponimod (Mayzent) are also approved
for use in adults, and fingolimod (Gilenya) is indicated
for use in patients...
A Combination of Ledipasvir and Sofosbuvir (Harvoni) for Hepatitis C
The Medical Letter on Drugs and Therapeutics • Nov 10, 2014 (Issue 1455)
virus (HCV) genotype 1 infection. Genotype 1 is
responsible for 70-80% of HCV infections ...
The FDA has approved a fixed-dose combination (Harvoni [har voe' nee] – Gilead) of sofosbuvir and ledipasvir (led' i pas' vir), two oral direct-acting antiviral agents, for treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Genotype 1 is responsible for 70-80% of HCV infections in the US. Sofosbuvir (Sovaldi) was approved earlier for use in combination with other antiviral drugs for treatment of HCV infection. Ledipasvir is a new drug.
Three More Immune Checkpoint Inhibitors for Advanced Bladder Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Dec 04, 2017 (Issue 1535)
(Opdivo) and
atezolizumab (Tecentriq) were approved earlier for
this indication.1
Table 1. Clinical ...
The FDA has approved avelumab (Bavencio – EMD
Serono) and durvalumab (Imfinzi – AstraZeneca),
two new immune check point inhibitors, and
pembrolizumab (Keytruda – Merck), a checkpoint
inhibitor that has been available in the US since
2014, for treatment of locally advanced or
metastatic bladder cancer. Nivolumab (Opdivo) and
atezolizumab (Tecentriq) were approved earlier for
this indication.
In Brief: Hepatitis B Reactivation with Direct-Acting Antiviral Drugs for Hepatitis C
The Medical Letter on Drugs and Therapeutics • Oct 24, 2016 (Issue 1506)
warning about a risk of hepatitis B virus (HBV)
reactivation associated with their use.1
Table 1. Direct ...
The FDA recently announced that it will require the labeling of all direct-acting antiviral drugs used for treatment of hepatitis C virus (HCV) infection to include a boxed warning about a risk of hepatitis B virus (HBV) reactivation associated with their use.1Twenty-four cases of HBV reactivation occurring during treatment with direct-acting antiviral drugs for HCV were identified from the FDA Adverse Event Reporting System and the medical literature.2-5 Before starting direct-acting antiviral treatment for HCV, some of these patients were hepatitis B surface antigen (HbsAG) positive and...
Microx
The Medical Letter on Drugs and Therapeutics • Jun 17, 1988 (Issue 768)
(0.5, 1 or 2 mg per day)
with placebo in 105 patients with mild to moderate hypertension. A decrease ...
Microx (Pennwalt), a new low-dosage formulation of the thiazide-type diuretic metolazone (Zaroxolyn; Diulo), was recently marketed in the USA. The manufacturer claims that the low dose of controls hypertension with less potassium loss, making it safer than other diuretics and as effective as combination drugs, such as Dyazide, that include both a thiazide and a potassium-sparing diuretic. Medical Letter consultants generally do not recommend Dyazide or other fixed-dose combinations for treatment of hypertension.
Testosterone Nasal Gel (Natesto) for Hypogonadism
The Medical Letter on Drugs and Therapeutics • May 11, 2015 (Issue 1468)
infarction (MI)
and stroke.1
Pronunciation Key
Testosterone: tes tos' ter one Natesto: na tes' toe ...
The FDA has approved an intranasal gel formulation of
testosterone (Natesto – Trimel/Endo) for replacement
therapy in men with hypogonadism. Packaged in a
metered-dose pump, Natesto is the first intranasal
testosterone to become available in the US. Like other
testosterone products, it is classified as a schedule
III controlled substance. The FDA recently cautioned
against using testosterone to treat low testosterone
levels solely due to aging because the benefits and
safety of such use have not been established, and there
is a possible increased risk of myocardial infarction...