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In Brief: Acalabrutinib (Calquence) for Mantle Cell Lymphoma (online only)
The Medical Letter on Drugs and Therapeutics • Nov 05, 2018 (Issue 1559)
, that may
be related to inhibition of kinases other than BTK.1
Acalabrutinib is a more selective BTK inhibitor than ...
The FDA has approved the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence – AstraZeneca) for oral treatment of relapsed or refractory mantle cell lymphoma. Acalabrutinib is the second BTK inhibitor to be approved for this indication; ibrutinib (Imbruvica) was approved in 2013.Ibrutinib inhibits other kinases in addition to BTK and has been associated with severe adverse effects, particularly atrial fibrillation, infection, rash, and bleeding, that may be related to inhibition of kinases other than BTK.1 Acalabrutinib is a more selective BTK inhibitor than ibrutinib; whether...
In Brief: Brentuximab Vedotin (Adcetris) for Classical Hodgkin's Lymphoma (online only)
The Medical Letter on Drugs and Therapeutics • Nov 05, 2018 (Issue 1559)
fungoides.
FDA approval for the new indication was based on the
results of an open-label trial (ECHELON-1 ...
The FDA has approved the anti-CD30 antibody-drug conjugate brentuximab vedotin (Adcetris – Seattle Genetics) for use in combination with chemotherapy for IV treatment of adults with previously untreated stage 3 or 4 classical Hodgkin's lymphoma (cHL). Adcetris was approved earlier for consolidation treatment of cHL and for treatment of relapsed or refractory cHL, anaplastic large cell lymphoma, and CD30-expressing mycosis fungoides.FDA approval for the new indication was based on the results of an open-label trial (ECHELON-1) in 1334 patients with previously untreated stage 3 or 4 cHL.1...
Tezacaftor/Ivacaftor (Symdeko) for Cystic Fibrosis
The Medical Letter on Drugs and Therapeutics • Oct 22, 2018 (Issue 1558)
on the results of two doubleblind
trials in CF patients ≥12 years old. In Trial 1,
504 patients who were ...
The FDA has approved the fixed-dose combination
of tezacaftor and ivacaftor (Symdeko – Vertex) for
oral treatment of cystic fibrosis (CF) in patients ≥12
years old who are homozygous for the F508del (also
called Phe508del or ΔF508) mutation or have at least
one mutation in the cystic fibrosis transmembrane
conductance regulator (CFTR) gene that is responsive
to the combination. About 50% of CF patients in the
US are homozygous for the F508del mutation. This is
the first approved indication for tezacaftor. Ivacaftor
is also available in combination with lumacaftor...
OTC Brimonidine (Lumify) for Ocular Redness
The Medical Letter on Drugs and Therapeutics • Oct 22, 2018 (Issue 1558)
brimonidine product to be approved for OTC use.
1. Brinzolamide/brimonidine (Simbrinza) for glaucoma. Med ...
The FDA has approved an over-the-counter (OTC)
0.025% ophthalmic formulation of the selective
alpha2-adrenergic agonist brimonidine tartrate (Lumify
– Bausch & Lomb) for treatment of ocular redness in
adults and children ≥5 years old. Lumify is the first
brimonidine product to be approved for OTC use.
Antiviral Drugs for Varicella-Zoster Virus and Herpes Simplex Virus Infections
The Medical Letter on Drugs and Therapeutics • Sep 24, 2018 (Issue 1556)
are listed in tables 1 and 2. Vaccination
against VZV was reviewed in a previous issue.1
VZV Infection ...
The recommendations for treatment of varicella-zoster
virus (VZV) and herpes simplex virus (HSV)
infections are listed in tables 1 and 2. Vaccination
against VZV was reviewed in a previous issue.
Elagolix (Orilissa) - An Oral GnRH Antagonist for Endometriosis Pain
The Medical Letter on Drugs and Therapeutics • Sep 24, 2018 (Issue 1556)
) and luteinizing hormone
(LH), and decreasing ovarian production of estradiol
and progesterone.
Table 1 ...
The FDA has approved elagolix (Orilissa – AbbVie),
an oral gonadotropin-releasing hormone (GnRH)
antagonist, for management of moderate to severe
pain associated with endometriosis.
Hydrogen Peroxide 40% (Eskata) for Seborrheic Keratoses
The Medical Letter on Drugs and Therapeutics • Sep 24, 2018 (Issue 1556)
that occur in about 83 million people in the US,
primarily middle-aged and older adults.1 They
generally do ...
The FDA has approved hydrogen peroxide 40% topical
solution (Eskata – Aclaris Therapeutics) for treatment
of raised seborrheic keratoses (SKs) in adults. It is the
first drug to be approved for this indication. (Hydrogen
peroxide is available over the counter for topical use
as a 3% solution.)
Table: Mechanisms of Drug Interactions (online only)
The Medical Letter on Drugs and Therapeutics • Sep 24, 2018 (Issue 1556)
methotrexate
concentrations
CYP = cytochrome P450; P-gp = P-glycoprotein
1. Drug interactions ...
View Table: Mechanisms of Drug Interactions
Imvexxy - Another Estradiol Vaginal Insert for Dyspareunia
The Medical Letter on Drugs and Therapeutics • Sep 10, 2018 (Issue 1555)
formulation, was the first.1 Vagifem and Imvexxy are
both available in inserts containing 10 mcg of estradiol ...
The FDA has approved an estradiol softgel vaginal
insert (Imvexxy – TherapeuticsMD) for treatment of
postmenopausal women with moderate to severe
dyspareunia due to vulvovaginal atrophy (VVA).
Imvexxy is the second estradiol vaginal insert to be
approved in the US; Vagifem, an intravaginal tablet
formulation, was the first. Vagifem and Imvexxy are
both available in inserts containing 10 mcg of estradiol;
Imvexxy is also available in a 4-mcg strength.
Roxybond - An Abuse-Deterrent Formulation of Short-Acting Oxycodone
The Medical Letter on Drugs and Therapeutics • Sep 10, 2018 (Issue 1555)
for treatment of pain was reviewed in a
recent issue.1
THE NEW FORMULATION — Roxybond tablets
contain ...
The FDA has approved Roxybond (Daiichi Sankyo), an
short-acting (SA) oxycodone formulation with
abuse-deterrent properties, for treatment of pain
requiring management with an opioid. Roxybond
is the first SA opioid to be approved as an abuse-deterrent
product. Oxaydo, another IR oxycodone
formulation, has properties that discourage its
intranasal and intravenous use, but is not considered
an abuse-deterrent product by the FDA. Use of
opioids for treatment of pain was reviewed in a
recent issue.