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Venetoclax (Venclexta) for Chronic Lymphocytic Leukemia
The Medical Letter on Drugs and Therapeutics • Aug 01, 2016 (Issue 1500)
The Medical Letter®
on Drugs and Therapeutics
Volume 58 (Issue 1500) August 1, 2016
Published ...
The FDA has approved venetoclax (Venclexta –
Abbvie/Genentech), an oral selective BCL-2 inhibitor,
for treatment of chronic lymphocytic leukemia (CLL) in
patients with a 17p deletion who have received at least
one prior therapy. The 17p deletion is associated with a
poor prognosis in patients with CLL; it is prevalent in
about 20% of patients with relapsed CLL. Venetoclax is
the fi rst BCL-2 inhibitor to become available in the US.
Addendum: Depression and Suicidality with Isotretinoin
The Medical Letter on Drugs and Therapeutics • Aug 01, 2016 (Issue 1500)
The Medical Letter®
on Drugs and Therapeutics
Volume 58 (Issue 1500) August 1, 2016
Published ...
Our article earlier this year on Drugs for Acne1 stated that the oral retinoid isotretinoin (Accutane, and others) is the most effective drug available for patients with severe nodulocystic acne, but warned that depression, suicidality, myalgia, hypertriglyceridemia, and other adverse effects can occur. One of our readers objected to our listing depression and suicidality, which are the subject of a prominent warning in the package insert, in the same sentence as indisputable side effects such as hyperlipidemia and myalgia.Depression and suicidal ideation have been reported in patients with...
Onzetra Xsail - Sumatriptan Nasal Powder
The Medical Letter on Drugs and Therapeutics • Jul 18, 2016 (Issue 1499)
) have
been available for many years.
Table 1. Pharmacology
Route Intranasal
Cmax 21 ng/mL (22-mg dose)
Tmax 45 ...
The FDA has approved Onzetra Xsail (Avanir), a nasal
powder formulation of sumatriptan, for acute treatment
of migraine in adults. Nasal spray formulations of
sumatriptan (Imitrex) and zolmitriptan (Zomig) have
been available for many years.
Brivaracetam (Briviact) for Epilepsy
The Medical Letter on Drugs and Therapeutics • Jul 18, 2016 (Issue 1499)
approved initially only as adjunctive
treatment for partial seizures.1
Pronunciation Key
Brivaracetam ...
Brivaracetam (Briviact – UCB), an analog of
levetiracetam (Keppra, and others), has been approved
by the FDA for adjunctive treatment of partial-onset
seizures in patients ≥16 years old. New drugs for
epilepsy are often approved initially only as adjunctive
treatment for partial seizures.
Buprenorphine Implants (Probuphine) for Opioid Dependence
The Medical Letter on Drugs and Therapeutics • Jul 18, 2016 (Issue 1499)
after
insertion of 4 Probuphine implants (0.5-1 ng/mL)
are comparable to those achieved with 8 mg/day ...
The FDA has approved subdermal implants of the partial
opioid agonist buprenorphine (Probuphine – Titan) for
maintenance treatment of opioid dependence in patients
stabilized on low to moderate doses of transmucosal
buprenorphine. Probuphine was designed to provide
continuous low levels of buprenorphine for 6 months
and to safeguard against illicit use of the drug.
SGLT2 Inhibitors and Renal Function
The Medical Letter on Drugs and Therapeutics • Jul 18, 2016 (Issue 1499)
) and dapagliflozin
(Farxiga, and others),1 a study was published showing
that the third SGLT2 inhibitor ...
At the same time that the FDA announced it was
strengthening existing warnings about the risk of acute
kidney injury in patients with type 2 diabetes treated with
the sodium-glucose co-transporter 2 (SGLT2) inhibitors
canagliflozin (Invokana, and others) and dapagliflozin
(Farxiga, and others), a study was published showing
that the third SGLT2 inhibitor, empagliflozin (Jardiance,
and others), slowed the progression of renal dysfunction
in patients with type 2 diabetes.
Asfotase Alfa (Strensiq) for Hypophosphatasia (online only)
The Medical Letter on Drugs and Therapeutics • Jul 18, 2016 (Issue 1499)
3 times
weekly or 1 mg/kg SC 6 times weekly. The dosage can be
increased to 3 mg/kg SC 3 times ...
The FDA has approved asfotase alfa (Strensiq – Alexion),
a recombinant form of tissue-nonspecific alkaline
phosphatase, for subcutaneous treatment of perinatal-,
infantile-, and juvenile-onset hypophosphatasia.
Asfotase alfa is the first treatment to be approved in
the US for this rare genetic metabolic disorder.
In Brief: Cabozantinib (Cabometyx) for Advanced Renal Cell Carcinoma (online only)
The Medical Letter on Drugs and Therapeutics • Jul 18, 2016 (Issue 1499)
inhibitors have become the standard of care for
treatment of unresectable or metastatic renal cell cancer.1 ...
The FDA has approved the oral tyrosine kinase inhibitor cabozantinib (Cabometyx – Exelixis) for treatment of patients with advanced renal cell carcinoma previously treated with antiangiogenic therapy. Cabozantinib was first approved in 2012 as Cometriq for treatment of progressive, metastatic medullary thyroid cancer.Anti-VEGF antibodies, tyrosine kinase inhibitors, and mTOR kinase inhibitors have become the standard of care for treatment of unresectable or metastatic renal cell cancer.1FDA approval was based on the results of a randomized open-label trial (METEOR) comparing cabozantinib to...
In Brief: Uridine Triacetate (Vistogard) for Fluorouracil Overdose
The Medical Letter on Drugs and Therapeutics • Jul 04, 2016 (Issue 1498)
of treatment is $75,000.1
1. Approximate WAC. WAC = wholesaler acquisition cost or manufacturer’s
published ...
The FDA has approved the pyrimidine analog uridine triacetate (Vistogard – Wellstat Therapeutics) for emergency treatment of a fluorouracil (5-FU) or capecitabine (Xeloda, and generics) overdose or severe toxicity that occurs within 96 hours following administration of one of these drugs. Fluorouracil is a cytotoxic antimetabolite used to treat breast, colorectal, and other cancers; capecitabine is an oral prodrug of fluorouracil.Uridine triacetate, a prodrug, is deacetylated to uridine after oral administration. Excess circulating uridine is converted into uridine triphosphate, which...
Spritam - A New Formulation of Levetiracetam for Epilepsy
The Medical Letter on Drugs and Therapeutics • Jun 20, 2016 (Issue 1497)
absence
seizures and seizures of Lennox-Gastaut syndrome.1
Pronunciation Key
Levetiracetam : lee” ve ...
The FDA has approved a rapidly disintegrating tablet
formulation of the antiepileptic drug levetiracetam
(Spritam – Aprecia) for adjunctive treatment of partialonset,
myoclonic, and primary generalized tonicclonic
seizures. Oral and intravenous formulations
of levetiracetam (Keppra, and generics) have been
available for years. Although approved by the FDA only
as adjunctive therapy, levetiracetam is commonly used
as monotherapy for partial-onset and generalized
seizures and may also be effective in treating absence
seizures and seizures of Lennox-Gastaut syndrome.