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CLINICAL CONTENT UPDATES
Selected New Drug Approvals - New Monographs and Patient Medication Instructions
U.S. Food and Drug Administration (FDA)
Blinatumomab (Blincyto™): Approved to treat relapsing or refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia. Blinatumomab is the first drug approved to engage the body's T cells to target leukemia cells.
Carbidopa/levodopa (Duopa™): New enteral suspension dose form approved to treat motor fluctuations in advanced Parkinson disease. Duopa™ is administered directly into the small intestine for 16 continuous hours.
Carbidopa/levodopa (Rytary™): An extended-release capsule form approved to treat Parkinson disease, postencephalitic parkinsonism, and parkinsonism associated with carbon monoxide or manganese intoxication in adults.
Ceftolozane/tazobactam (Zerbaxa™): Approved as monotherapy for complicated urinary tract infections or as combination therapy with metronidazole for complicated intraabdominal infections. Indicated for adults, ceftolozane/tazobactam was designated a qualified infectious disease product and granted FDA priority review.
Dapagliflozin/metformin (Xigduo™): Approved to treat type 2 diabetes. It is the first and only once-daily sodium-glucose co transporter 2 and extended-release metformin combination tablet to gain US approval.
Diclofenac (Dyloject™): Approved for pain management in adults and injected as an IV bolus over 15 seconds. It carries boxed warnings for NSAIDs and the increased risk of serious cardiovascular or gastrointestinal events.
Edoxaban (Savaysa™): Approved to help prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation and also to treat DVT and pulmonary embolism following 5 to 10 days of parenteral anticoagulant therapy.
Finafloxacin (Xtoro™): Approved to treat acute otitis externa, also known as swimmer’s ear, in patients 1 year of age or older. The ear drops are effective in treating ear infections caused by Pseudomonas aeruginosa and Staphylococcus aureus.
Fluocinolone acetonide (Iluvien®): Approved as the first long-term diabetic macular edema treatment. Endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments have occurred with its use.
Hydrocodone (Hysingla™ ER): Approved to manage long-term pain when other medications did not provide adequate relief. It is a once-daily oral opioid that is formulated to deter abuse.
Human papillomavirus 9-valent vaccine, recombinant (Gardasil® 9): Approved to prevent HPV-associated cancers (cervical, vulvar, vaginal, and anal) and genital warts caused by 9 strains of HPV in females aged 9 to 26 years and in males aged 9 to 15 years.
Idelalisib (Zydelig®): Approved, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.
Influenza virus vaccine (Fluzone® Intradermal Quadrivalent): Approved to prevent influenza type A and B in adults aged 18 to 64 years. It is the first and only four-strain flu vaccine option for intradermal administration.
Ivermectin (Soolantra®): Approved as a once-daily topical treatment for adult rosacea.
Ledipasvir/sofosbuvir (Harvoni®): Approved to treat chronic hepatitis C genotype 1 infection in adults, including patients with cirrhosis. Ledipasvir/sofosbuvir is the first approved hepatitis C regimen that does not require coadministration with interferon or ribavirin.
Liraglutide (Saxenda®): Approved as an adjunct to diet and exercise for chronic weight management in overweight adults have at least one weight-related condition. Liraglutide is already marketed under the brand name of Victoza® for type 2 diabetes.
Memantine/donepezil (Namzaric™): Approved for treatment of moderate to severe dementia in patients with Alzheimer disease who are already stabilized on memantine and donepezil.
Meningococcal group B vaccine (Trumenba™): Granted accelerated approval as breakthrough therapy to prevent serogroup B meningococcal disease in patients 10 to 25 years of age. Meningococcal vaccines for all 5 main serogroups of N. meningitidis bacteria (A, B, C, W, and Y) now have US availability.
Netupitant/palonosetron (Akynzeo®): Approved to treat nausea and vomiting in cancer patients receiving chemotherapy treatment.
Nintedanib (Ofev®) and Pirfenidone (Esbriet®): Approved 2 new drugs to treat idiopathic pulmonary fibrosis. Both formulations are oral capsules that reduce the decline in forced vital capacity and block pathways involved in the scarring of lung tissue.
Nivolumab (Opdivo™): Approved to treat patients with unresectable or metastatic melanoma who were unresponsive to treatment with ipilimumab and, if positive for BRAF V600 mutation, a BRAF inhibitor.
Olaparib (Lynparza™): Approved to treat advanced ovarian cancer associated with defective BRCA genes, which are identified by the FDA-approved test BRACAnalysis CDx.
Ombitasvir/paritaprevir/ ritonavir and dasabuvir (Viekira Pak™): Approved to treat adult patients with genotype 1 chronic hepatitis C virus infection, including those with compensated cirrhosis. It is administered orally with or without ribavirin and is an interferon-free treatment.
Peramivir (Rapivab™): Approved to treat acute uncomplicated influenza in adult patients who have been showing symptoms for no more than 2 days. Peramivir is administered as a single-dose IV infusion.
Recombinant antihemophilic factor, porcine sequence (Obizur): Approved to treat bleeding in patients with acquired hemophilia A. This drug contains a recombinant analog of pig factor VIII (FVIII), which can effectively clot human blood but is not targeted by antibodies against human FVIII.
Simeprevir (Olysio®): Approved as an all-oral treatment in combination with sofosbuvir for genotype 1 chronic hepatitis C infection in adults.
Sotalol hydrochloride (Sotylize™): Approved a new oral solution dose form of sotalol to treat ventricular arrhythmias and maintain normal sinus rhythm in patients with a history of atrial fibrillation or flutter. This will be beneficial as pharmacists will no longer need to prepare a solution using tablets.
European Medicines Agency Approvals (not already approved by the FDA) - New Monographs
Aclidinium bromide/formoterol fumarate (Brimicar Genuair, Duaklir Genuair): Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.
Darunavir/cobicistat (Rezolsta): Indicated in combination with other antiretroviral medicinal products to treat HIV-1 infection in adults.
Insulin degludec/liraglutide (Xultophy): Indicated to treat adults with type 2 diabetes mellitus to improve glycemic control in combination with oral glucose-lowering medicinal products when these alone or combined with basal insulin do not provide adequate glycemic control.
New FDA-Approved Indications - Revised Monographs and Patient Medication Instructions
Alemtuzumab (Lemtrada™): Now approved to treat relapsing forms of multiple sclerosis (MS) in patients who had an inadequate response to 2 or more MS treatment drugs. Alemtuzumab is available only through a REMS program and carries a black box warning that serious, sometimes fatal, autoimmune conditions, infusion reactions, and malignancies may occur.
Beclomethasone dipropionate (QNASL™): Expanded approval to include use in children 4 years or older who have seasonal and perennial allergic rhinitis. This low-dose formulation of beclomethasone is the first waterless nasal allergy spray approved for children under the age of 12 years.
Bevacizumab (Avastin®): Approved in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan to treat platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Denosumab (Xgeva®): Now approved to treat hypercalcemia of malignancy refractory to biphosphonate therapy.
Gadobutrol (Gadavist®): Expanded approval to include use in patients younger than 2 years, including term neonates. Gadobutrol is the first gadolinium-based contrast agent approved for this age group.
Influenza virus vaccine (Flublok®): Granted accelerated approval of Flublok® for use in adults 50 years and older. Flublok® is the only 100% egg-free and highly purified influenza virus vaccine available.
Meningococcal group B vaccine (Trumenba™): Now approved to prevent serogroup B meningococcal disease in patients 10 to 25 years old. The FDA granted accelerated approval for Trumenba™ as a breakthrough therapy providing US availability for all 5 main serogroups of N. meningitidis bacteria (A, B, C, W, and Y).
Ramucirumab (Cyramza®): Now approved in combination with paclitaxel to treat advanced gastric and gastroesophageal junction (GEJ) adenocarcinomas and approved in combination with docetaxel to treate metastatic non-small cell lung cancer
Ruxolitinib (Jakafi®): Now approved as the first treatment for polycythemia vera in patients with a history of poor response or tolerance to hydroxyurea. The US FDA approved ruxolitinib under priority review and orphan product designation.
Technetium Tc 99m tilmanocept (Lymphoseek®): Expanded approval now includes sentinel lymph node detection for breast cancer and melanoma. It is the only FDA-approved radiopharmaceutical agent for sentinel lymph node detection and lymphatic mapping of solid tumors.
Drug Safety – Revised Monographs and Patient Medication Instructions
Antiplatelet therapy: The US FDA announced it is reviewing recent data that suggests an increased risk of death associated with long-term antiplatelet therapy following drug-eluting coronary stent implantation. While the FDA reviews the data, it urges health care professionals not to change the way they prescribe antiplatelet medication.
Dimethyl fumarate (Tecfidera®): The US FDA reported that a patient being treated with dimethyl fumarate for multiple sclerosis for more than 4 years developed progressive multifocal leukoencephalopathy (PML). Therefore, lymphocyte counts should be monitored in all dimethyl fumarate-treated patients. If PML is suspected, the drug should be immediately discontinued.
Ziprasidone (Geodon®): New warning alerts clinicians that ziprasidone is associated with a rare but potentially fatal adverse reaction, drug reaction with eosinophilia and systemic symptoms (DRESS), and a new warning is being added to the prescribing information. If DRESS is suspected, ziprasidone should be discontinued immediately.
New Off-Label Indications
Celecoxib for postoperative pain, acute (Class IIb, recommended in some):
In a systematic review of 10 randomized trials (9 dental, 1 orthopedic; N=1785 patients), significantly more patients treated with a single postoperative dose of celecoxib 400 mg achieved at least 50% pain relief at 4 to 6 hours (43%) compared with celecoxib 200 mg (34%) or placebo (4.7%). The need for rescue medication was reduced in both celecoxib groups (400 mg: 63%; 200 mg: 74%; placebo: 91%).
Montelukast for seasonal allergic conjunctivitis (Class IIb, recommended in some):
In a meta-analysis of patients with seasonal allergic rhinoconjunctivitis, significant differences in the mean change from baseline for the ocular symptom score (3-point scale) were 0.1 in favor of montelukast compared with placebo (6 studies; N=3940) and 0.08 in favor of oral antihistamines compared with montelukast (3 studies; N=1491). Combination treatment with both agents produced a significant between-treatment difference of 0.3 in favor of the combination compared with placebo (2 studies; N=610). The clinical significance of these changes is unknown. Treatment lasted for 2 weeks and included patients 15 years or older.
Oxycodone/naloxone for restless legs syndrome (RLS; severe), after failure of prior therapy (Class IIb, recommended in some):
In a randomized 12-week trial (N=276) of patients with no history of regular opioid use who failed prior therapy, oxycodone hydrochloride/naloxone hydrochloride extended-release tablets significantly reduced the mean International RLS Study Group rating scale sum score by -16.5 compared with -9.4 for placebo. The reduction was also maintained in the 40-week open-label extension phase (n=197). Adverse events were more common in the treatment group (73% vs 43%), and included fatigue, constipation, and nausea, with 13% and 7% discontinuing because of intolerability.
Tenecteplase for pulmonary embolism, intermediate risk due to right ventricular dysfunction and myocardial injury (Class IIb, recommended in some):
Tenecteplase in conjunction with heparin significantly decreased the 7-day risk of death or hemodynamic decompensation by 56% compared with placebo in patients with acute pulmonary embolism who were at intermediate risk for adverse outcomes because of right ventricular dysfunction and myocardial injury (N=1006). The benefit was primarily driven by decreased rates of hemodynamic decompensation, which occurred in 1.6% of patients treated with tenecteplase and 5% with placebo. Mortality rates were similar between treatments at 7 and 30 days. As expected with any fibrinolytic treatment, the rates of major extracranial bleeding (6.3% vs 1.2%) and stroke (2.4% vs 0.2%) were significantly increased with tenecteplase.
ACC/AHA 2014 Non-ST-elevation acute coronary syndrome guidelines: Find updated information regarding treatment of non-ST-elevation acute coronary syndrome throughout drug monographs and the ACC/AHA 2014 Non-ST-Elevation Acute Coronary Syndrome Guidelines Drug Consult. In Micromedex: Search non-ST-elevation acute coronary syndromes in the search box to access related drug content.
Other Significant Updates - Drug Content
Doxazosin: Added breast milk doxazosin concentration information Estradiol vs conjugated equine estrogen Compare the cardiovascular events risk between estradiol and conjugated equine estrogen.
Hydrocortisone sodium succinate: Added information on the use of hydrocortisone via the subQ route of administration for emergency use in adrenal insufficiency
Ibandronate vs zoledronic acid: Added comparative efficacy for oral ibandronate versus IV zoledronic acid in the treatment of bone metastases from breast cancer.
Morphine/naltrexone (Embeda®): Approved new abuse-deterrent labeling for Embeda®, an oral extended-release opioid used for long-term, around-the-clock pain relief. When the capsule is used correctly, the naltrexone is not released and the morphine works as expected.
Tinzaparin: Added dosage adjustment for tinzaparin sodium in hemodialysis patients
Other Significant Updates - CareNotes
70 New Care Notes: New patient instructions cover topics in the areas of cardiology, critical care, dental health, dermatology, endocrinology & metabolic disease, gastroenterology, infectious diseases, neonatology, neurology, OB/GYN, oncology, ophthalmology, orthopedics, otolaryngology, pain management, pediatrics, primary care, public health, pulmonology, radiology, spinal cord injury, surgery, and urology.
34 Revised Care Notes: Topics have been revised to incorporate new evidence and new and updated clinical guideline recommendations from the American Academy of Pediatrics, American College of Gastroenterology, American Diabetes Association, Infectious Diseases Society of America, the Centers for Disease Control and Prevention and other leading guideline developers.
Other Significant Updates: Toxicology Content
Ceritinib is indicated for the treatment of metastatic, anaplastic lymphoma kinase-positive non-small cell lung cancer. Overdose has not been reported. The most common adverse events include: diarrhea, nausea, elevated liver enzymes, vomiting, abdominal pain, fatigue, decreased appetite, and constipation. Concomitant use of ceritinib (a CYP3A4 substrate) and strong CYP3A4 inhibitors may increase ceritinib exposure and adverse effects. Overdose events are anticipated to be an extension of adverse events. Treatment is symptomatic and supportive. Correct any significant fluid and/or electrolyte abnormalities. Therapeutic doses of ceritinib may cause prolongation of the QT interval. Concomitant use of ceritinib and other drugs that prolong the QT interval may increase the risk of torsades de pointes.
Sofosbuvir is indicated for the treatment of chronic hepatitis C viral (HCV) infection. Adverse events may include fatigue, headache, nausea, insomnia, and anemia, pruritus, rash, myalgia, diarrhea, neutropenia, asthenia, irritability, fever, and influenza-like illness. Signs and symptoms of an acute overdose are anticipated to be similar to excessive pharmacologic adverse events. Treatment is symptomatic and supportive. Monitor serial CBC with differential. For severe neutropenia, administer colony stimulating factors. In clinical trials, creatine kinase elevations of more than 10 times ULN occurred in 1% of patients treated for 12 weeks with sofosbuvir in combination with ribavirin and peginterferon alpha. Monitor creatine kinase levels.
Sucroferric oxyhydroxide, a phosphate binder, is used for the control of serum phosphorus levels in patients with chronic kidney disease that are on dialysis. Exposure may occur, but the risk of severe toxicity is not anticipated. Absorption of iron from sucroferric oxyhydroxide is low and the risk of severe systemic effects of iron toxicity is minimal. Adverse events are likely to include nausea and diarrhea. Hypophosphatemia can develop. Treatment is symptomatic and supportive. Significant toxicity is not anticipated because the drug is minimally absorbed. Obtain a baseline phosphate level; repeat as indicated. Hypophosphatemia can develop. Severe hypophosphatemia (serum phosphate concentration of less than 1 mg/dL over 2 or more days) can produce rhabdomyolysis, respiratory failure, acute hemolytic anemia and dysrhythmias. Replace phosphorus as indicated.
GHB withdrawal: Gamma hydroxybutyrate (GHB) and its analogs including gamma-butyrolactone (GBL), 1,4-butanediol (1,4-BD) and gamma-valerolactone (GVL) are common drugs of abuse. There is increasing evidence that chronic, frequent (multiple times daily) abuse can lead to physical tolerance.
Hydroxocobalamin: An antidote approved for the treatment of known or suspected cyanide poisoning.
Epoxy Resins and Polyamines: These are widely used as adhesives, moulding resins, surface coatings and reinforced plastics. Polyamine hardeners are extremely basic (pH 13 to 14) and have irritant and caustic alkaline properties.
New Monographs and Calculators: C1 esterase inhibitor (human), C1 esterase inhibitor (recombinant), calcitriol, duloxetine, immune globulin (bovine), taliglucerase alfa
New Enteral Formulas: Preterm human milk + Enfamil® liquid human milk fortifier 22, Preterm human milk + Enfamil® liquid human milk fortifier 24, Preterm human milk + Enfamil® liquid human milk fortifier 26, Preterm human milk + Similac® human milk fortifier extensively hydrolyzed protein concentrated liquid, Similac® advance® stage 2, Similac® advance® stage 1 (19 cal/fl oz), Similac® soy isomil® (19 cal/fl oz), Similac® total comfort, Similac® with iron 24 cal.
Revised Monographs: acyclovir, adalimumab, adenosine, alglucosidase alfa, atomoxetine, atropine, bosentan, cefuroxime, clonidine, cyclosporine, darbepoetin alfa, dexmedetomidine, didanosine, dolasetron, doxycycline, DT/Td vaccine, epoetin alfa, epoprostenol, etravirine, factor VIII (recombinant), Fc fusion protein, fluconazole, fluticasone, fondaparinux, furosemide, glucagon, heparin, hyaluronidase, hydrocortisone, hypertonic saline, immune globulin (human), indomethacin, influenza virus vaccine, insulin, ivacaftor, levetiracetam, lisdexamfetamine, lorazepam, methotrexate, micafungin, miltefosine, mometasone, morphine, mupirocin, mycophenolate mofetil, oseltamivir, oxcarbazepine, palivizumab, palonosetron, peginterferon alfa-2b, penicillin g, phenobarbital, sertraline, sodium polystyrene sulfonate, somatropin, vasopressin, venlafaxine, zanamivir
Revised Enteral Formulas: Enfamil® enfacare® powder, Enfamil® enfacare® liquid, Enfamil® infant, Enfamil® prosobee®, Neocate® infant DHAh/ARA, Nutramigen®, preterm human milk + Prolact+10 h(2)MF®, Preterm human milk + Prolact+4 H(2)MF®, Preterm human milk + Prolact+6 H(2)MF®, Preterm human milk + Prolact+8 H(2)MF®, Prolact+ H(2) MF® human milk fortifier, Similac® advance® organic, Similac® advance® stage 1 (20 cal/fl oz), Similac® expert care® alimentum®, Similac® for spit-up®, Similac® go and grow® milk-based formula, Similac® go and grow® soy-based formula, Similac® pm 60/40, Similac® sensitive®, Similac® soy isomil® (20 cal/floz).
New Monographs and Calculators: bosentan, calcitriol, Poly-Vi-Sol® with iron MVI drops
Revised Monographs: acyclovir, adenosine, alglucosidase alfa, atropine, bosentan, clonidine, darbepoetin alfa, didanosine, DT/Td vaccine, epoetin alfa, fluconazole, furosemide, glucagon, heparin, hyaluronidase, hydrocortisone, ibuprofen lysine, immune globulin (human), indomethacin, insulin, levetiracetam, lorazepam, micafungin, morphine, mupirocin, oseltamivir, palivizumab, penicillin g, phenobarbital, sodium polystyrene sulfonate
Revised Enteral Formulas: Prolact+ H(2) MF® human milk fortifier
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