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Auvi-Q Epinephrine Auto-Injector Returns
The Medical Letter on Drugs and Therapeutics • Feb 27, 2017 (Issue 1515)
to potential inaccurate dosage delivery,1 has
become available once more. According to Kaléo,
improvements ...
Auvi-Q (Kaléo; previously manufactured and
marketed by Sanofi), the epinephrine auto-injector
approved by the FDA in 2012 for emergency treatment
of anaphylaxis and voluntarily withdrawn in 2015
due to potential inaccurate dosage delivery, has
become available once more. According to Kaléo,
improvements in the manufacturing process have
addressed the concerns that led to its recall.
Extended-Release Calcifediol (Rayaldee) for Secondary Hyperparathyroidism
The Medical Letter on Drugs and Therapeutics • Feb 27, 2017 (Issue 1515)
vitamin D to calcitriol
(1,25-dihydroxyvitamin D3). Reduced synthesis of
calcitriol leads to low levels ...
The FDA has approved extended-release (ER)
calcifediol (25-hydroxyvitamin D3; Rayaldee –
Opko), a prohormone of calcitriol, the active form of
vitamin D3. It is indicated for treatment of secondary
hyperparathyroidism (SHPT) in adults with stage 3 or
4 chronic kidney disease (CKD) who have serum total
25-hydroxyvitamin D levels <30 ng/mL.
Drug Interaction: Clopidogrel and PPIs
The Medical Letter on Drugs and Therapeutics • Feb 27, 2017 (Issue 1515)
may interfere with the activation of clopidogrel and
diminish its antiplatelet effect.1 FDA-approved labeling ...
The antiplatelet drug clopidogrel (Plavix, and others)
reduces major cardiovascular events, but can cause
bleeding. Proton pump inhibitors (PPIs) are often
used with clopidogrel to prevent gastrointestinal
bleeding, however, some evidence suggests that PPIs
may interfere with the activation of clopidogrel and
diminish its antiplatelet effect. FDA-approved labeling
recommends avoiding concurrent use of the PPIs
omeprazole and esomeprazole with clopidogrel.
Atezolizumab (Tecentriq) for Bladder Cancer and NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • Feb 27, 2017 (Issue 1515)
programmed death-ligand 1 (PD-L1) blocking
antibody to become available in the US. Two other
immune ...
The FDA has approved the immune checkpoint
inhibitor atezolizumab (Tecentriq – Genentech) for
treatment of locally advanced or metastatic urothelial
carcinoma and metastatic non-small cell lung cancer
(NSCLC) that have progressed during or following
platinum-based chemotherapy. Atezolizumab is the
first programmed death-ligand 1 (PD-L1) blocking
antibody to become available in the US. Two other
immune checkpoint inhibitors, the programmed death
receptor-1 (PD-1) inhibitors nivolumab (Opdivo) and
pembrolizumab (Keytruda), are also approved for
treatment of metastatic NSCLC, and...
Lixisenatide for Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • Jan 30, 2017 (Issue 1513)
The FDA has approved lixisenatide (Sanofi), a short-acting
injectable GLP-1 (glucagon-like peptide ...
The FDA has approved lixisenatide (Sanofi), a short-acting
injectable GLP-1 (glucagon-like peptide-1)
receptor agonist, for once-daily treatment of adults
with type 2 diabetes, both alone (Adlyxin) and in a
fixed-ratio combination with insulin glargine (Soliqua
100/33). Lixisenatide has been available since 2013 in
many other countries as Lyxumia. It is the fifth GLP-1
receptor agonist to be approved in the US.
Inflectra - An Infliximab Biosimilar
The Medical Letter on Drugs and Therapeutics • Jan 30, 2017 (Issue 1513)
colonystimulating
factor, was the first.1
Pronunciation Key
Infliximab: in flix' i mab Inflectra: in flek' tra ...
The FDA has approved infliximab-dyyb (Inflectra –
Pfizer; marketed as Remsima in some countries), as a
biosimilar of the TNF inhibitor infliximab (Remicade).
Infliximab-dyyb was approved in the European Union
(EU) in 2013 and in Canada in 2014. It is the second
biosimilar to be approved by the FDA. Filgastrim-sndz
(Zarxio), a recombinant human granulocyte colony-stimulating
factor, was the first.
Drug Interaction: Dabigatran (Pradaxa) and Statins
The Medical Letter on Drugs and Therapeutics • Jan 30, 2017 (Issue 1513)
) increases the
risk of major hemorrhage.1
POSSIBLE MECHANISMS — The mechanism for this
potential ...
The results of a recently published study suggest that
taking the oral direct thrombin inhibitor dabigatran
etexilate (Pradaxa) with either simvastatin (Zocor, and
others) or lovastatin (Altoprev, and others) increases the
risk of major hemorrhage.
Pembrolizumab (Keytruda) for First-Line Treatment of Metastatic NSCLC
The Medical Letter on Drugs and Therapeutics • Jan 30, 2017 (Issue 1513)
the immune checkpoint inhibitor
pembrolizumab (Keytruda – Merck), a programmed
death receptor-1 (PD-1 ...
The FDA has approved the immune checkpoint inhibitor
pembrolizumab (Keytruda – Merck), a programmed
death receptor-1 (PD-1) inhibitor, for first-line treatment
of patients with metastatic non-small cell lung cancer
(NSCLC) that highly expresses programmed death-ligand
1 (PD-L1) and has no epidermal growth factor
receptor (EGFR) mutations or anaplastic lymphoma
kinase (ALK) translocations. About 25% of patients with
advanced NSCLC have tumors with high levels of PD-L1
expression (PD-L1 expressed on ≥50% of tumor cells).
Pembrolizumab was approved earlier for treatment...
Yosprala - A Combination of Aspirin and Omeprazole
The Medical Letter on Drugs and Therapeutics • Jan 30, 2017 (Issue 1513)
Yosprala: yo spra' lah
SECONDARY PREVENTION — Aspirin irreversibly
acetylates cyclooxygenase-1, blocking ...
The FDA has approved Yosprala (Aralez), a fixed-dose
combination of delayed-release aspirin and
immediate-release omeprazole, for secondary
prevention of cardiovascular and cerebrovascular
events in patients who are at risk of developing aspirin-associated
gastric ulcers (≥55 years old or history of
gastric ulcers). Yosprala is the first product to become
available in the US that combines aspirin and a proton
pump inhibitor (PPI).
Corrections: Drugs for Diabetes & Another Insulin Glargine (Basaglar) for Diabetes
The Medical Letter on Drugs and Therapeutics • Jan 30, 2017 (Issue 1513)
Corrections
Drugs for Diabetes (Med Lett Drugs Ther 2017; 59:9)
In the 4th paragraph of the GLP-1 ...
Drugs for Diabetes (Med Lett Drugs Ther 2017; 59:9)In the 4th paragraph of the GLP-1 receptor agonists section, we mistakenly stated that Xultophy 100/3.6 is a combination of insulin degludec and albiglutide; Xultophy 100/3.6 is a combination of insulin degludec and liraglutide.Another Insulin Glargine (Basaglar) for Diabetes (Med Lett Drugs Ther 2017; 59:3)In the Dosage and Administration section, we removed the word "syringe" to describe Basaglar's KwikPen device. Basaglar is not available as a prefilled syringe; it is only available as a KwikPen.Download complete U.S. English...