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New Clinical Rx Forum Sept Oct 2017.Pub In This Issue Ipilimumab for Pediatric Unresectable or Metastatic Melanoma ®®® From the Department of Pharmacy Formulary Update September/October Issue 2017 Volume 5, Issue 5 Ipilimumab for Pediatric Unresectable or Metastatic Melanoma FDA Medication Safety Alert: Risk of VTE with Test osterone By: Ashley Fan, Pharm.D. Marcia J. Wyman, Pharm.D., BCPS Background: Melanoma in pediatric CTLA-4 blocking its interaction with its Drug Information Pharmacist patients, deLined by the National ligands, CD80 and CD86. Editor Cancer Institute as patients less than Key Clinical Trial: A phase 2 study Mandy C. Leonard, Pharm.D., BCPS 20 years old, is a rare but serious health System Director, Drug Use Policy and concern. 1 Melanoma accounts for 7.1% examined the efLicacy and safety of ipili- Formulary Management of cancers in patients ages 15 to mumab at doses of either 3 mg/kg Editor 19 years, affecting 5 to 6 per million (n=4) or 10 mg/kg (n=8) in pediatric patients ages 12 to 18 years, with stage Meghan K. Lehmann, Pharm.D., BCPS under the age of 20. Unresectable stage III or IV malignant melanoma. 5 For the Coordinator, Drug Information Services III and IV metastatic melanoma in pedi- Drug Information Specialist atric patients are difLicult to treat 3- and 10-mg/kg groups, the median Editor and lack curative options. 2 Ipilimumab age was 13- and 15-years, respectively. (Yervoy ®; Bristol-Meyers Squibb) is a After 1 year of treatment, three out of Marigel Constantiner, MSc, BCPS, CGP, CPh four patients on 3 mg/kg and Live out of Drug Information Specialist recombinant, fully human monoclonal Associate Editor antibody. 3 A study in adult patients eight patients on 10 mg/kg were alive. with metastatic melanoma demonstrat- Two patients on 10 mg/kg had partial Christopher Snyder, B.S., R.Ph. ed increased survival when treated responses and one patient from each Drug Information Pharmacist with ipilimumab, which led to its ap- group had stable disease. Treatment- Associate Editor related side effects were reported in proval by the Food and Drug Admin- Brian Hoffmaster, Pharm.D., BCPS istration (FDA) for adult patients in two of four and seven of eight patients Student Education Pharmacist 2011. 4 Since malignant melanoma tu- in the 3- and 10-mg/kg groups, respec- Associate Editor mors in children have similar immuno- tively. There was one grade 3-4 im- mune-related adverse event (irAE) with Maya Wai, Pharm.D. logic features as those in adults, Drug Information Pharmacist ipilimumab was studied in the pediatric 3 mg/kg dose and Live irAEs with the Associate Editor population and received FDA approval 10 mg/kg dose. The most common AEs for the treatment of unresectable or were hepatitis and pyrexia. Despite ear- Scott Knoer, MS, Pharm.D., FASHP ly termination due to low enrollment, Chief Pharmacy OfPicer metastatic melanoma in patients aged 12 and older in July 2017. 2,3 the authors concluded that ipilimumab was an effective treatment for melano- Mechanism of Action: Ipilimumab is ma in patients aged 12 to 18 years of a Lirst-in-class monoclonal antibody age with a safety proLile similar to that immune checkpoint inhibitor. 3 Cancer observed in adults. cells evade the immune system by using Safety: The most common AEs (>5%) checkpoint proteins, such as pro- associated with ipilimumab include fa- grammed death receptor 1 (PD1) or tigue, diarrhea, pruritus, rash, and coli- Cytotoxic T Lymphocyte Antigen 4 3 From the Department of Pharmacy tis. At higher doses of 10 mg/kg, AEs (CTLA-4) to “turn off” the immune sys- Drug Information Service include nausea, vomiting, headache, tem’s T cells preventing them from at- weight loss, pyrexia, decreased appe- (216) 444-6456, option #1 tacking carcinogenic tissue. Immune tite, and insomnia. It is important to checkpoint inhibitors prevent T cell de- note that ipilimumab carries a Boxed Comprehensive information about activation by interfering with these Warning for severe and fatal irAEs, medications, biologics, nutrients, checkpoint proteins. For example, ipili- which may involve any organ system. and drug therapy mumab helps to maintain T cell anti- Similar to adults, pediatric patients re- tumor immune response by binding to (Continued on page 2) (Continued from page 1) ceiving ipilimumab may develop drug-related entero- References: 1. Cambell LB, Kreicher KL, Gittleman HR, Strodtbeck K, Barn- colitis, hepatitis, dermatitis (including toxic epidermal holtz-Sloan J, Bordeaux JS. Melanoma incidence in children 2 necrolysis), neuropathy, and endocrinopathy. Pa- and adolescents: decreasing trends in the United States. J tients should be assessed for these disease states and Pedatr 2015;166(6):1505-13. be evaluated at baseline and before each dose. 3 If a 2. Mechant MS, Wright M, Baird K, Wexler LH, Rodriquez-Galindo severe irAE occurs, ipilimumab should be permanently C, Bernstein D et al. Phase I clinical trial of ipilimumab in pedi- atric patients with advanced solid tumors. Clin Cancer Res discontinued and systemic high-dose corticosteroid 2016;22(6):1364-70. therapy should be initiated. Additionally, ipilimumab 3. Yervoy ® [package insert]. Princeton NJ: Bristol-Myers Squibb can cause fetal harm; patients should be advised to use Company; July 2017. contraception. 4. Hodi FA, O’Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB et al. Improved survival with ipilimumab in pa- Dosing and Administration: The recommended tients with metastatic melanoma. N Engl J Med 2010;363: dose of ipilimumab for adult and pediatric patients 711-23. 5. Pappa AS, Bergeron C, Gore L, Sender LS, Dunke IJ, Herzog CE with unresectable or metastatic melanoma is 3 mg/kg et al. Phase II study of ipilimumab (IPI) in children and ado- given intravenously over 90 minutes every 3 weeks for lescents with unresectable stage III or IV malignant melanoma a maximum of four doses. 3 If toxicities occur, doses (MEL). J Clin Oncol 2017;Abstract e21006. may be delayed; however all treatment must be 6. Lexi-Comp Online. Lexi-Drugs Online, Hudson, Ohio: Lexi- Comp Inc; 2017: August 2017. administered within 16 weeks of the Lirst dose. 7. Melanoma: Treatment Options: American Society of Clinical Ipilimumab should be diluted in normal saline or Oncology. 2016 July. Available from: http://www.cancer.net/ dextrose 5% and water to a Linal concentration be- cancer-types/melanoma/treatment-options Accessed: August tween 1 to 2 mg/mL and administered through a low- 8, 2017. protein-binding in-line Lilter. 3 Availability and Cost: Ipilimumab is available as a 5 mg/mL intravenous solution in 10- or 40-mL vials.3 The suggested wholesale price of the 50 mg/10 mL vial is about $8,350 and the 200 mg/40 mL vial is about 6 $33,420. Therefore, the cost for a 70 kg patient to complete the therapy consisting of 3 mg/kg every 3 weeks for four cycles would be approximately $140,000. Role in Therapy: Currently, ipilimumab is the only FDA-approved treatment for unresectable or metastat- ic carcinoma in pediatric patients. Although its ap- proval was based on limited pediatric data from a very small clinical trial, it remains a viable therapy for a dis- ease state with very few effective treatment options. 7 Formulary Status: Ipilimumab is on the Pediatric CCHS Formulary restricted to the Department of He- matology and Oncology for outpatient use only in pa- tients ≥ 12 years of age with unresectable or metastat- ic melanoma using its FDA-approved dosing (3 mg/kg every 3 weeks for four doses). It is also on the Adult CCHS Formulary restricted to the Depart- ment of Hematology and Medical Oncology for adult outpatient use only using the FDA-approved dosing (3 mg/kg every 3 weeks for four doses). 2 Additions to the Adult CCHS Formulary Pharmacologic Drug Formulary Use Restrictions/Comments Class Restricted to the Department of Hematology and Medical Oncology for outpatient use only in patients with AML Enasidenib Antineoplastic and identiLied IDH mutation AML (IDHIFA ®) Agent Note: Patients are instructed to bring home supply or ob- tain outpatient prescription if admitted to the hospital as an inpatient. Restricted to Staff Anesthesia in the setting of severe post- Fibrinogen postpartum hemorrhage in Blood Product Severe Post-Partum concentrate conjunction with the Massive Derivative Hemorrhage (RiaSTAP ®) Transfusion Protocol and to the Department of Hematolo- gy and Medical Oncology Restricted to the Department Inotuzumab Antineoplastic of Hematology and Medical ozogamicin ALL Agent Oncology for patients with (Besponsa ®) ALL Naltrexone Restricted to physicians certi- extended-release Lied in Addiction Medicine for Opioid Management of Alcohol injectable use in outpatients for the Antagonist and Opioid Dependence suspension management of alcohol and (Vivitrol ®) opioid dependence Rituximab and Restricted to the Department CLL hyaluronidase Antineoplastic of Hematology and Medical subcutaneous injection Agent Oncology for outpatient use Lymphoma (Rituxan Hycela ™) only For use in liver lesions restricted to patients who: 1) Cannot have an MRI or CT Sulfur hexaLluoride contrast (e.g., allergies or lipid-type A Cardiac Imaging Diagnostic poor renal function) microspheres for Agent 2) Cannot have an MRI due injectable suspension Hepatic Imaging to implanted device(s) (Lumason ®) 3) Need to avoid or minimize ionizing radia- tion exposure Tranxemic acid Restricted to the Department AntiLibrinolytic Orthopedic (oral) of Orthopedic Surgery Agent Surgery (Lysteda ®) Note: Added to CCHS Formu- Neuromuscular Vecuronium Neuromuscular lary due to the inconsistent Blocker
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