NEW DRUGS Generic Adderall XR - P&T Communitysublingual tablets for the maintenance treatment of...
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196 P&T® • April 2013 • Vol. 38 No. 4 NEW DRUGS Kadcyla in Breast Cancer Ado-trastuzumab emtansine (Kadcyla, Genentech) has been approved for patients with HER-2–positive, metastatic breast cancer who previously used the company’s trastuzumab (Herceptin) and taxanes. A boxed warning mentions a risk of liver and heart toxicities, death, and life-threatening birth defects. Pregnancy status should be verified before treatment. Sources: FDA and GlobalData, Febru- ar y 22, 2013 Osphena for Painful Intercourse Ospemifene (Osphena, Shionogi) has been approved for women experiencing pain during sexual intercourse. The pain is often a symptom of vulvar and vaginal atrophy, attributed to declining levels of estrogen hormones during menopause. A boxed warning mentions that the drug acts like estrogen on vaginal tissues, making them thicker and less fragile and stimulating the endometrium. In post- menopausal women, however, a stimu- lated endometrium is not the normal con- dition. The boxed warning also states a risk of stroke and deep vein thrombosis. Sources: FDA and GlobalData, Febru- ar y 26, 2013 Generic Approvals Buprenorphine/Naloxone Amneal Pharmaceuticals, LLC, has received the FDA’s approval for one of the first generic versions of Suboxone sublingual tablets for the maintenance treatment of patients with opioid drug dependence. Generic buprenorphine HCl/naloxone HCl dihydrate tablets are available in strengths of 2 mg/0.5 mg and 8 mg/2 mg, both in 30-count bottles. Suboxone is made by Reckitt Benckiser. The drug was approved under a Risk Evaluation and Mitigation Strategy (REMS) program, and it is classified as a Schedule III controlled substance. Source: Amneal, February 25, 2013 Generic Adderall XR The FDA has approved Teva’s Abbre- viated New Drug Application (ANDA) for a generic version of Shire’s Adderall XR for the treatment of attention defi- cit/hyperactivity disorder (ADHD). The capsules will be available in strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg. Adderall XR is a once-daily, ex- tended-release, amphetamine product. It is a Schedule II controlled substance. Sources: Teva, February 14, 2013; www.news-medical.net Generic Zoledronic Acid Agila Specialties, a subsidiary of Strides Arcolab Ltd., has received ANDA approval for zoledronic acid injection 4 mg (base)/5 mL, packaged in single- dose vials. On March 6, Sagent Pharma- ceuticals, Inc., also announced the appro- val and launch of zoledronic acid injection 4 mg in a latex-free plastic vial. Zoledronic acid is the generic form of Zometa (Novartis), which was scheduled to lose its patent in March 2013. It is used to treat hypercalcemia of malignancy and bone complications that may occur with chemotherapy for other cancers. Sources: PharmaBiz.com, March 6, 2013; www.stridesarco.com; http://inves- tor.sagentpharma.com Generic Doxorubicin Doxorubicin HCL liposome injection HCl (Doxil, Janssen) has been approved via a priority review to help offset cur- rent drug shortages. The injection is used to treat leukemia and other cancers as monotherapy or in combination with other therapies. It is sold in 20-mg and 50-mg vials by Sun Pharma Global. Source: MedPage Today, February 4, 2014 Lymphoseek Maps Lymph Nodes Navidea’s L ymphoseek Injection (tech- netium Tc 99m tilmanocept) is used to locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. The physician injects the drug into the tumor area, and using a hand-held radiation detector, finds lymph nodes that have taken up the drug’s radioactivity. This diagnostic imaging agent is not a cancer-imaging drug. L ymphoseek is the first new drug used for lymph node mapping to be approved in more than 30 years. Similar agents include sulfur colloid and isosulfan blue. Source: FDA, March 13, 2013 NEW INDICATIONS Zortress to Prevent Liver Rejection Everolimus (Zortress, Novartis) has been approved to prevent liver transplant rejection in adults. It was previously approved for preventing rejection in kidney transplant recipients. This is the first approval for a mammalian target of rapamycin (mTOR) inhibitor in liver transplantation. Everolimus is a deriva- tive of sirolimus (rapamycin, Rapamune, Wyeth/Pfizer). Source: MedPage Today, February 18, 2013 Stivarga for Advanced GISTs Regorafenib (Stivarga, Bayer) is now approved to treat patients with inoperable gastrointestinal stromal tumors (GISTs) that no longer respond to imatinib (Gleevec, Novartis) or sunitinib (Sutent, Pfizer). Regorafenib was first approved in September 2012 to treat colorectal cancer. Source: FDA, February 25, 2013 Epiduo for Acne in Children Adapalene 0.1%/benzoyl peroxide 2.5% gel (Epiduo, Galderma) has been approved for the topical treatment of acne in children as young as 9 years of age. The drug was originally intended for patients 12 years of age and older. Treating younger patients could help to prevent future scarring.
Transcript of NEW DRUGS Generic Adderall XR - P&T Communitysublingual tablets for the maintenance treatment of...
196 P&T® • April2013 • Vol.38No.4
NEWDRUGSKadcylainBreastCancer
Ado-trastuzumab emtansine (Kadcyla, Genentech) has been approved for patients with HER-2–positive, metastatic breast cancer who previously used the company’s trastuzumab (Herceptin) and taxanes. A boxed warning mentions a risk of liver and heart toxicities, death, and life-threatening birth defects. Pregnancy status should be verified before treatment.
Sources: FDA and GlobalData, Febru-ary 22, 2013
OsphenaforPainfulIntercourseOspemifene (Osphena, Shionogi) has
been approved for women experiencing pain during sexual intercourse. The pain is often a symptom of vulvar and vaginal atrophy, attributed to declining levels of estrogen hormones during menopause.
A boxed warning mentions that the drug acts like estrogen on vaginal tissues, making them thicker and less fragile and stimulating the endometrium. In post-menopausal women, however, a stimu-lated endometrium is not the normal con-dition. The boxed warning also states a risk of stroke and deep vein thrombosis.
Sources: FDA and GlobalData, Febru-ary 26, 2013
GenericApprovalsBuprenorphine/Naloxone
Amneal Pharmaceuticals, LLC, has received the FDA’s approval for one of the first generic versions of Suboxone sublingual tablets for the maintenance treatment of patients with opioid drug dependence. Generic buprenorphine HCl/naloxone HCl dihydrate tablets are available in strengths of 2 mg/0.5 mg and 8 mg/2 mg, both in 30-count bottles. Suboxone is made by Reckitt Benckiser.
The drug was approved under a Risk Evaluation and Mitigation Strategy (REMS) program, and it is classified as a Schedule III controlled substance.
Source: Amneal, February 25, 2013
GenericAdderallXRThe FDA has approved Teva’s Abbre-
viated New Drug Application (ANDA) for a generic version of Shire’s Adderall XR for the treatment of attention defi-cit/hyperactivity disorder (ADHD). The capsules will be available in strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg. Adderall XR is a once-daily, ex- tended-release, amphetamine product. It is a Schedule II controlled substance.
Sources: Teva, February 14, 2013; www.news-medical.net
GenericZoledronicAcidAgila Specialties, a subsidiary of
Strides Arcolab Ltd., has received ANDA approval for zoledronic acid injection 4 mg (base)/5 mL, packaged in single-dose vials. On March 6, Sagent Pharma-ceuticals, Inc., also announced the appro-val and launch of zoledronic acid injection 4 mg in a latex-free plastic vial.
Zoledronic acid is the generic form of Zometa (Novartis), which was scheduled to lose its patent in March 2013. It is used to treat hypercalcemia of malignancy and bone complications that may occur with chemotherapy for other cancers.
Sources: PharmaBiz.com, March 6, 2013; www.stridesarco.com; http://inves-tor.sagentpharma.com
GenericDoxorubicinDoxorubicin HCL liposome injection
HCl (Doxil, Janssen) has been approved via a priority review to help offset cur-rent drug shortages. The injection is used to treat leukemia and other cancers as monotherapy or in combination with other therapies. It is sold in 20-mg and 50-mg vials by Sun Pharma Global.
Source: MedPage Today, February 4, 2014
LymphoseekMapsLymphNodesNavidea’s Lymphoseek Injection (tech-
netium Tc 99m tilmanocept) is used to locate lymph nodes in patients with breast
cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. The physician injects the drug into the tumor area, and using a hand-held radiation detector, finds lymph nodes that have taken up the drug’s radioactivity. This diagnostic imaging agent is not a cancer-imaging drug.
Lymphoseek is the first new drug used for lymph node mapping to be approved in more than 30 years. Similar agents include sulfur colloid and isosulfan blue.
Source: FDA, March 13, 2013
NEWINDICATIONSZortresstoPrevent LiverRejection
Everolimus (Zortress, Novartis) has been approved to prevent liver transplant rejection in adults. It was previously approved for preventing rejection in kidney transplant recipients. This is the first approval for a mammalian target of rapamycin (mTOR) inhibitor in liver transplantation. Everolimus is a deriva-tive of sirolimus (rapamycin, Rapamune, Wyeth/Pfizer).
Source: MedPage Today, February 18, 2013
StivargaforAdvancedGISTsRegorafenib (Stivarga, Bayer) is now
approved to treat patients with inoperable gastrointestinal stromal tumors (GISTs) that no longer respond to imatinib (Gleevec, Novartis) or sunitinib (Sutent, Pfizer). Regorafenib was first approved in September 2012 to treat colorectal cancer.
Source: FDA, February 25, 2013
EpiduoforAcneinChildrenAdapalene 0.1%/benzoyl peroxide
2.5% gel (Epiduo, Galderma) has been approved for the topical treatment of acne in children as young as 9 years of age. The drug was originally intended for patients 12 years of age and older. Treating younger patients could help to prevent future scarring.
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Sources: Dermatology Times, February 19, 2013; drugdevelopment-technology.com, February 20, 2013; www.epiduo.com
NEWFORMULATIONInjectableAbilify
An extended-release injectable suspen-sion of the antipsychotic drug aripiprazole (Abilify Maintena, Otsuka/Lundbeck) is now approved. This is the first dopamine D2 partial agonist given once monthly via intramuscular injection. Starting and main-tenance doses are 400 mg monthly. This is the sixth FDA-approved, long-acting injectable antipsychotic medication, along with fluphenazine (Proloxin, Apothecon), haloperidol (Haldol, Janssen), risperidone (Risperdal, Janssen), paliperidone (In-vega Sustenna, Janssen), and olanzapine (Zyprexa Relprevv, Eli Lilly).
Sources: Otsuka and MedPage Today, March 2, 2013
DRUGNEWSRecalls
OmontysInjectionAffymax and Takeda have voluntarily
recalled all lots of peginesatide (Omontys) injection because of reports of anaphylaxis. Peginesatide is an erythropoiesis-stimulat-ing agent used to treat anemia in adults on dialysis. It was approved in March 2012. Serious and fatal hypersensitivity reactions occurred after some patients received their first IV dose, sometimes within 30 minutes. Affymax reported 19 cases of anaphylaxis from dialysis centers in the U.S. and three deaths.
Sources: FDA and Takeda, February 23, 2013
VistideforCMVRetinitisOne lot of cidofovir (Vistide, Gilead)
(B120217A; expiration date, May 2015) has been voluntarily recalled because particulate matter was found in some vials. Cidofovir is used to treat cyto- megalovirus retinitis, an opportunistic eye infection that affects AIDS patients.
Sources: FDA, February 15, 2013; MedPage Today, February 18, 2013
WarningsArrhythmiaswithZithromax
Life-threatening cardiac arrhythmias may affect patients taking azithro- mycin (Zithromax, Pfizer). Patients with a prolonged QT interval, bradycardia, or low serum levels of magnesium or potas-sium may be at risk. The warnings and precautions section of the drug’s label is being strengthened to highlight the risk of QT prolongation and torsades de pointes, a potentially lethal arrhythmia.
Sources: N Engl J Med 2012;366:1881–1890; MedPage Today, March 12, 2013
NoCodeineAfterTonsillectomyProducts that contain codeine should
not be used in children to relieve pain after a tonsillectomy or an adenoidec- tomy because of a risk of serious adverse events, including death. A boxed warning is being added to the labels of all codeine products. This contraindication does not apply to other pain therapies for children.
Source: MedPage Today, February 21, 2013
NEWMEDICALDEVICESMarvinM.Goldenberg,PhD,RPh,MS
Name: FerriScan R2-MRI Test for Iron Overload
Manufacturer: Inner Vision Biometrics/Resonance Health Ltd., Perth, Australia
Approval Date: January 28, 2013Purpose: FerriScan is an analysis
service that provides measurements of serum liver iron via noninvasive magnetic resonance imaging (MRI). It is a com- panion diagnostic device used with de-ferasirox (Exjade, Novartis) in patients with nontransfusion-dependent thalas-semia (NTDT). Deferasirox is used to remove excess iron from patients (2 years of age and older) with chronically
elevated levels of iron caused by repeat-ed blood transfusions. FerriScan aids physicians in selecting NTDT patients for deferasirox therapy and in monitor- ing their response to the drug.
Approximately 4 million people in the U.S. have iron overload disease. Hemo-chromatosis, a genetic disorder, causes iron deposition in the liver and in other organs, resulting in iron overload. Thal-assemia also results in iron overload as a result of frequent transfusions. NTDT patients are genetically predisposed to iron overload even if they are not receiv-ing transfusions regularly.
Description: Spin-density projection MRI technology is used to capture imag-es, which are transmitted to a FerriScan facility. A map of liver iron is produced, and the mean serum iron level is calcu-lated. Results are available in 48 hours.
Benefit: FerriScan has the highest sensitivity and specificity in measuring liver iron of any MRI-based method. Re-sults are as accurate as a liver biopsy.
Sources: www.resonancehealth.com; www.news-medical.net
Name: CADD-Solis Variable Infusion Profile Ambulatory Infusion System
Manufacturer: Smiths Medical, St. Paul, Minn.
Approval Date: February 6, 2013Purpose: The pump is used to deliver
analgesics, chemotherapy, hydration, antibiotics, immune globulin, and total parenteral nutrition to children and adults.
Description: Infusions can be continu-ous, intermittent, variable, or tapered. A smart infusion pump, medication safety software, and medication cassette reser-voirs are attached to the pump. The soft-ware alerts the operator to stop the infu-sion if a pump setting is misprogrammed. Smart pumps recognize prescription errors and dose misinterpretations.
Benefit: Data are displayed in a simple format to reduce training time. Clinicians can download the data from a personal
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computer into the pump and can view infusion reports to quickly assess the treatment. Holding up to 500 protocols, the pump’s color screens differentiate each delivery mode.
Sources: www.smiths-medical.com
Class I Cannula Recall
Bausch and Lomb’s 27G Sterile Cannula, which is used during ocular surgery, was recalled because of the possibility that viscoelastic material might leak or that the cannula might become detached from the syringe during injection. Detachment has resulted in serious patient injury. Affected lots include Amvisc 1.2% Sodium Hyaluronate (Model Nos. 59051, 59081, 59051L, and 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model Nos. 60081, 60051, 60051L, and 60081L) Ophthalmic Viscosurgical Device.
Source: FDA, www.fda.gov, January 23, 2013 n
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