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Searched for vol. Results 551 to 560 of 1447 total matches.
Safety of Testosterone Replacement Therapy
The Medical Letter on Drugs and Therapeutics • Mar 14, 2016 (Issue 1490)
-2769
34
The Medical Letter ® Vol. 58 (1490) March 14, 2016
≥1.0 ng/mL occurred in 23 men treated ...
Three coordinated double-blind, placebo-controlled
clinical trials have evaluated the efficacy of one year of
testosterone replacement therapy in improving sexual
function, physical function, and vitality in a total of
790 men ≥65 years old with moderately low serum
testosterone concentrations and symptoms suggesting
hypoandrogenism. Sexual function improved
modestly, and there appeared to be marginal benefits
in some areas of physical function and vitality as well.
The trials were not designed to evaluate the safety of
testosterone replacement therapy.
Zarxio - A Filgrastim Biosimilar
The Medical Letter on Drugs and Therapeutics • Mar 14, 2016 (Issue 1490)
. www.fdbhealth.com/policies/drug-pricing-policy.
35
The Medical Letter ® Vol. 58 (1490) March 14, 2016
ADVERSE ...
The FDA has approved filgrastim-sndz (Zarxio –
Sandoz), a biosimilar of the recombinant human
granulocyte colony-stimulating factor filgrastim
(G-CSF; Neupogen), which has been available in the
US since 1991. Zarxio is the first biosimilar product to
be approved in the US; it has been available in Europe
as Zarzio since 2009.
Isavuconazonium Sulfate (Cresemba) - A New Antifungal
The Medical Letter on Drugs and Therapeutics • Mar 14, 2016 (Issue 1490)
dose may be increased to 70 mg if response is inadequate.
38
The Medical Letter ® Vol. 58 (1490 ...
The FDA has approved isavuconazonium sulfate
(Cresemba – Astellas) for intravenous and oral treatment
of invasive aspergillosis and invasive mucormycosis
in adults. Isavuconazonium sulfate is a prodrug of
isavuconazole, a broad-spectrum triazole antifungal.
Low-Dose Meloxicam (Vivlodex) for Osteoarthritis Pain
The Medical Letter on Drugs and Therapeutics • Mar 14, 2016 (Issue 1490)
The Medical Letter ® Vol. 58 (1490) March 14, 2016
excessive alcohol intake, and advanced age increase ...
The FDA has approved Vivlodex (Iroko), a low-dose
formulation of the nonsteroidal anti-inflammatory drug
meloxicam (Mobic, and generics), for management of
osteoarthritis pain. According to the manufacturer, the
new formulation aligns with stronger FDA warnings
about the cardiovascular risks of NSAIDs and the
recommendation to use the lowest possible doses of
these drugs.
Elbasvir/Grazoprevir (Zepatier) for Hepatitis C
The Medical Letter on Drugs and Therapeutics • Feb 29, 2016 (Issue 1489)
).
26
The Medical Letter ® Vol. 58 (1489) February 29, 2016
tients, but lower for treatment ...
The FDA has approved Zepatier (Merck), a fixed-dose
combination of two direct-acting antiviral
agents — elbasvir, an NS5A inhibitor, and grazoprevir,
an NS3/4A protease inhibitor — for oral treatment
of chronic hepatitis C virus (HCV) genotype 1 or 4
infection.
Olaparib (Lynparza) for Advanced Ovarian Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Feb 29, 2016 (Issue 1489)
inhibitors
are being tried for use alone and as part of combination
e33
The Medical Letter ® Vol. 58 (1488 ...
The FDA has approved the oral poly (ADP-ribose) polymerase
(PARP) inhibitor olaparib (Lynparza – Astra-Zeneca) as monotherapy for treatment of women with
advanced ovarian cancer who have BRCA1/2 germline
mutations and have received at least 3 prior lines of
chemotherapy. Olaparib is the first PARP inhibitor to
be approved in the US. It is approved outside the US
for maintenance treatment of relapsed BRCA-mutated
ovarian cancer.
Sonidegib (Odomzo) for Basal Cell Carcinoma
The Medical Letter on Drugs and Therapeutics • Feb 29, 2016 (Issue 1489)
The Medical Letter ® Vol. 58 (1489) February 29, 2016
Serum creatine kinase and creatinine levels should ...
The FDA has approved the hedgehog pathway
inhibitor sonidegib (Odomzo – Novartis) for oral
treatment of locally advanced basal cell carcinoma
that cannot be treated with surgery or radiation or
has recurred following such treatment. Vismodegib
(Erivedge), another oral hedgehog pathway inhibitor,
was approved earlier for the same indication and also
for treatment of metastatic basal cell carcinoma.
Selexipag (Uptravi) for Pulmonary Arterial Hypertension
The Medical Letter on Drugs and Therapeutics • Feb 15, 2016 (Issue 1488)
® Vol. 58 (1488) February 15, 2016
Table 2. Some Drugs for Treatment of Pulmonary Arterial Hypertension ...
The FDA has approved selexipag (Uptravi – Actelion),
an oral selective prostacyclin IP receptor agonist, for
treatment of pulmonary arterial hypertension (PAH).
Treprostinil (Orenitram), an oral prostacyclin analog,
was approved earlier for this indication.
Genvoya - A New 4-Drug Combination for HIV
The Medical Letter on Drugs and Therapeutics • Feb 15, 2016 (Issue 1488)
improvements in BMD at the spine
(+1.56% vs -0.44%) and hip (+1.47% vs -0.34%).7
20
The Medical Letter ® Vol ...
The FDA has approved Genvoya (Gilead), a fixed-dose
combination of the integrase strand transfer
inhibitor (INSTI) elvitegravir, the pharmacokinetic
enhancer cobicistat, and the nucleoside/nucleotide
reverse transcriptase inhibitors (NRTIs) emtricitabine
and tenofovir alafenamide, for treatment of HIV-1 infection in patients ≥12 years old. This is the first
approval for tenofovir alafenamide (TAF), a tenofovir
prodrug. Stribild, a fixed-dose combination of
elvitegravir, cobicistat, emtricitabine, and tenofovir
disoproxil fumarate (TDF), was approved in 2012.
Patiromer (Veltassa) for Hyperkalemia
The Medical Letter on Drugs and Therapeutics • Feb 15, 2016 (Issue 1488)
in serum potassium levels after
24
The Medical Letter ® Vol. 58 (1488) February 15, 2016
8 weeks ...
The FDA has approved patiromer (Veltassa –
Relypsa), an oral potassium binder, for treatment
of hyperkalemia. It is the first drug to be approved
for this indication since the cation-exchange resin
sodium polystyrene sulfonate (Kayexalate, and others)
in 1958. Patiromer is not indicated for emergency
correction of life-threatening hyperkalemia. Sodium
zirconium cyclosilicate, another oral potassium binder,
is currently being reviewed by the FDA; a decision on
its approval is expected in May 2016.