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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...
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.
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.
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.
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.
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.
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...
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.
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...
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