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Choose An Archived Content Update

While Clinical Pharmacology OnHand's content is updated daily, we post
content and feature updates to this website for review on a quarterly basis.

Content Updates
Version 2.26, May 2009

WHAT'S NEW:

None at this time.

NEW DRUG MONOGRAPHS INCLUDE:

  • c1 inhibitor, human (Cinryze™) – plasma-derived product for prophylaxis of hereditary angioedema attacks
  • eltrombopag (Promacta®) – oral thrombopoietin receptor agonist for thrombocytopenia in patients with idiopathic thrombocytopenic purpura
  • fenofibric acid (TriLipix™) – oral fibrate for hyperlipidemia; can be used with HMG-CoA reductase inhibitors ('statins')
  • plerixafor (Mozobil®) – novel inhibitor of stromal-derived factor-1 and CXC receptor 4 for mobilization of hematopoietic stem cells for autotransplantation
  • rufinamide (Banzel™) – anticonvulsant for seizures associated with Lennox-Gastaut syndrome
UPDATED DRUG MONOGRAPHS INCLUDE:

  • amiodarone (Nexterone™) – monograph updated for new FDA-approved IV formulation that does not contain polysorbate 80 or benzyl alcohol

  • anthrax vaccine, adsorbed (Biothrax®) – monograph updated for new FDA-approved dosage, including intramuscular administration

  • antithrombin (ATryn®) – monograph updated for new FDA-approved recombinant product genetically engineered in goats

  • aprepitant (Emend®) – ADRs updated for post-marketing reports of pruritis, rash, urticaria, and anaphylaxis

  • ascorbic acid, vitamin C – monograph updated for off-label use for reduction of resuscitation fluid volume requirements in patients with severe burns

  • bendamustine (Treanda®) – indications/dosage updated for off-label, front-line use in mantle cell lymphoma and indolent NHL

  • bevacizumab (Avastin™) – monograph updated for off-label intravitreal use for diabetic macular edema

  • bimatoprost (Latisse™) – monograph updated for new FDA-approved ophthalmic solution for hypotrichosis

  • bosentan (Tracleer™) – ADRs updated for post-marketing reports of overdose, oligospermia, and anemia requiring transfusion

  • budesonide; formoterol (Symbicort ®) – monograph updated for new FDA-approved use in COPD

  • bupropion (Aplenzin™) – monograph updated for new FDA-approved oral formulation for major depressive disorder in adults and for cautious use in patients with moderate to severe renal impairment

  • ceftibuten (Cedax®) – ADRs updated for post-marketing reports of Stevens-Johnson syndrome

  • celecoxib (Celebrex®) – indications/dosage and precautions updated for use in patients that are poor CYP2C9 metabolizers

  • cisplatin (Platinol®) – indications/dosage updated for use in gastric cancer

  • clopidogrel (Plavix®) – monograph updated for possible decreased clinical response in patients who are carriers of reduced function CYP2C19 alleles

  • codeine – precautions updated for risk of altered codeine metabolism in different races

  • codeine; phenylephrine; promethazine (Phenergan® VC with Codeine, Prometh® VC with Codeine) – monograph updates include use in children and use in patients with different CYP2D6 phenotypes

  • codeine; promethazine (Phenergan® with Codeine) – monograph updates include use in children and use in patients with different CYP2D6 phenotypes

  • denileukin diftitox (Ontak®) – monograph updated for black box warnings for risk of serious infusion reactions, capillary leak syndrome, and visual changes

  • dexamethasone; tobramycin (Tobradex ST®) – monograph updated with new product formulation information

  • docetaxel (Taxotere®) – indications/dosage updated for use in metastatic malignant melanoma

  • dorzolamide (Trusopt®) – monograph updated for an increased risk of corneal edema and for cautious use in patients with low endothelial cell counts

  • doxylamine (Doxytex ®) – indications/dosage updated to include treatment of allergic rhinitis and precautions updated for use during pregnancy and lactation
  • drotrecogin alfa (Xigris®) – ADRs and precautions updated for bleeding risk

  • entecavir (Baraclude®) – ADRs updated with post-marketing reports of alopecia and rash

  • erlotinib (TarcevaTM) – ADRs and precautions updated for reports of fatalities when used in patients with advanced NSCLC and moderate hepatic impairment

  • erythromycin (A/T/S®, Akne-Mycin®, E-Mycin®) – dosage and indications updated for off-label use to facilitate GI motility in ICU patients

  • fludarabine (Fludara®) – monograph updated for risk of neurologic complications and for new FDA-approved oral capsules for treatment of CLL

  • fosaprepitant (Emend®) – ADRs updated for post-marketing reports of pruritis, rash, urticaria, and anaphylaxis

  • fulvestrant (Faslodex®) – indications/dosage updated for off-label use of loading dose in metastatic breast cancer

  • glatiramer (Copaxone®) – monograph updated for new FDA-approved use after a first clinical episode in patients with MRI results consistent with multiple sclerosis

  • glimepiride (Amaryl®) – precautions updated for use in patients with G6PD deficiency secondary to a risk of hemolytic anemia

  • imatinib (Gleevec®) – indications and dosage updated for new FDA-approved use in gastrointestinal-stromal tumor

  • infliximab (Remicade®) – ADRs and contraindications updated for risk of infection and severe hypersensitivity reactions

  • itraconazole (Sporonox®) – ADRs and precautions updated for risk of hearing loss and heart failure

  • lenalidomide (Revlimid®) – monograph updated of risk for angioedema and for dose adjustment guidelines in patients with moderate or severe renal impairment

  • metaproterenol (Alupent®) – indications/dosage updated for acute bronchospasm in children

  • metoclopramide (Reglan®) – monograph updated for new black box warning for risk of tardive dyskinesia associated with use more than 3 months or with high doses

  • mitotane (Lysodren®) –administration updated for new recommendations for handling tablets

  • moxifloxacin (Avelox®) – monograph updated for new pre-mixed IV solution data and for cautious use in patients with hepatic disease or risk factors for QT interval prolongation

  • natalizumab (Tysabri®) – ADRs updated for infusion-releated reactions, myalgia, hypertension, dyspnea, anxiety, and tachycardia

  • nicotine (NicodermCQ™) – precautions updated to warn of burns when using transdermal patches during magnetic resonance imaging (MRI) scans

  • nitrofurantoin (Furadantin®) – contraindications updated to avoid use in patients with cholestatic jaundice due to previous nitrofurantoin therapy

  • omeprazole (Prilosec®) – monograph updated for newly formulated, FDA-approved oral suspension

  • oxybutynin (Gelnique™) – monograph updated for new FDA-approved topical gel formulation for overactive bladder.

  • pegaptanib (Macugen®) – monograph updated for off-label intravitreal use for diabetic macular edema

  • peginterferon alfa-2b (PegIntron®) – indications and dosage updated for use with ribavirin in previously untreated, compensated, chronic hepatitis C patients

  • peginterferon alfa-2b (PegIntron®) – indications/dosage updated for use with ribavirin in hepatitis C and for off-label use in nonresponders or relapsers with chronic hepatitis C

  • ramelteon (Rozerem®) – precautions updated for cautious use in patients with schizophrenia and bipolar disorder

  • ranibizumab (Lucentis™) – monograph updated for off-label intravitreal use for diabetic macular edema

  • ribavirin (Rebetol®) – indications and dosage updated for use with peginterferon alfa-2b in previously untreated, compensated, chronic hepatitis C patients

  • rituximab (Rituxan®) – indications/dosage updated for off-label, combination use with dexamethasone in ITP

  • rotavirus vaccine (RotaTeq®, Rotarix®) – monograph updates include dosing information for premature infants

  • rotigotine (Neupro®) – precautions updated to warn of burns when wearing transdermal patches during magnetic resonance imaging (MRI) scans

  • selective norepinephrine reuptake inhibitors (SNRIs) – ADRs section for all drugs in class updated for risk of neuroleptic malignant syndrome-like reactions

  • selective serotonin reuptake inhibitors (SSRIs) – ADRs section for all drugs in class updated for risk of neuroleptic malignant syndrome-like reactions

  • solifenacin (Vesicare®) – ADRs updated for post-marketing reports of headache

  • tacrolimus (Prograf®, Protopic®) – indications/dosage updated for off-label use for moderate-to-severe atopic dermatitis; ADRs updated for posterior reversible encephalopathy syndrome, interstitial lung disease, and BK-virus associated nephropathy

  • temozolomide (Temodar®) – monograph updated for new FDA-approved injectable formulation for newly diagnosed glioblastoma multiforme and refractory anaplastic astrocytoma

  • thiazolidinediones – ADRs updated for risk of bone fractures in females

  • tigecycline (Tygacil®) – monograph updated for cautious use in ventilator-associated and hospital-acquired pneumonias; ADRs updated for anaphylaxis and hepatic failure

  • topotecan (Hycamtin®) – monograph updated for post-marketing reports of interstitial lung disease

  • tramadol (Ryzolt ™) – monograph updated for new FDA-approved extended release formulation for chronic pain requiring around-the-clock management

  • triamcinolone - monograph updated for off-label intravitreal use for diabetic macular edema

  • varenicline (Chantix®) – monograph updated for recent warnings of serious neuropsychiatric adverse effects, including suicidal ideation and behaviors

  • voriconazole (Vfend®) – monograph updated for cardiac toxicities including torsades de pointe and QT interval prolongation

  • zolpidem (Zolpimist®) – monograph updated for new FDA-approved oral spray dosage form

  • zonisamide (Zonegran®) – monograph updated for risk of metabolic acidosis
IV COMPATIBILITY:
None at this time.
SPECIFIC CONTENT ISSUES:
Selected content issues include, but are not limited to:
More than 2,307 content changes were performed, including:
  • Drug interactions: Over 366 revised and new entries

  • FDA MedWatch: Drug Safety Alerts and Label Changes

  • Osteogenic sarcoma – indications and dosage of select monographs updated to reflect current dosing recommendations
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