Home in time for supper: Humanized Anti-GD2 antibody in the outpatient setting Melanie Cohen, RN, BSN, CPHON and Katherine Alessi, RN, BSN, CPHON Pediatric Ambulatory Care Center; New York, New York What is Naxitamab? Sample Schedule Standard Operating Naxitamab (hu3F8) is a humanized monoclonal antibody that Days 1,3,5: Monday/Wednesday/Friday* Procedures (SOPs) adheres to GD2 on neuroblastoma cells. Naxitamab has shown 0800: Room/emergency equipment set-up stronger binding to GD2 than other known anti-GD2 antibodies. A specific set of practices initiated and followed 0815: Patient arrives to clinic, parent/patient education, obtain vital signs, when particular circumstances arise Potential advantages over murine antibodies such confirm/obtain IV access, draw labs as mu3F8 0900: Administer SQ GM-CSF (Sargramostim)500µg/m2/day Infusion Hypertension Allergic reaction 1. Low immunogenicity allowing repeat 0915: Premedications (analgesic, antihistamines, antipyretic, etc.) Onset of pain Hypotension Significant reaction treatments 2. Improved antibody-dependent cell-mediated 0930: Emergency medication preparation, history & physical by Nurse Practitioner cytotoxicity (ADCC) potency 1015: Begin Naxitamab infusion over ~35min 3. Longer serum half-life reducing the necessity 1100: Post Naxitamab monitoring -pain, hyper/hypotension, tachycardia, fever, hives, of daily infusions Response by MIBG imaging 4. Reduction of pain side effects, anaphylaxis nausea/vomiting, respiratory distress; vital signs q 1hr or as clinically indicated and anaphylactoid reactions as well as 1400: Discharge; instruction to patient/family 3 yr old girl (primary refractory) before and after 2 cycles immune complex disease Y-mAbs Therapeutics, Inc. *example schedule of Naxitamab/GM-CSF Phase II Study Design Side Effects Given in patients with high risk neuroblastoma. Grade 1-2 Pain . Cough Each cycle is started with 5 days of GM-CSF . Tachycardia . Wheezing/Stridor . Hypotension . Hypertension (Sargramostim) administered at 250µg/m2/day in Before After advance of the start of Naxitamab administration. Nausea . Anaphylaxis . Urticaria . Peripheral Neuropathy GM-CSF is thereafter administered at 500µg/m2/day . Fever . Posterior Reversible on days 1 through 5. As standard treatment, Encephalopathy Sydrome (PRES) Anterior view Posterior view Anterior view Posterior view Naxitamab 3mg/kg/day is given on days 1,3, and 5 ch14.18 totalling 9mg/kg per cycle. Cycles are repeated Discharge Criteria mu3F8 Naxitamab (Dinutuximab) every 2-4 weeks. -Minimum of one hour post hu3F8 treatment/IV intervention Dosage Standard 2.5 x standard standard Schedule M-Tue-W-Th-F M-W-F 4 consecutive days -Oxygen saturations ≥95% on Room Air Outpatient Outpatient inpatient or ICU Hospital stay -Blood pressure normotensive and ≤99th % per NIH guidelines (30 min) (30 min) (10-20 hr) Cytokine GMCSF GMCSF GMCSF + IL2 -Afebrile/vital signs stable # patients treated 894^ 160^ 1021* -Pain well controlled Toxicities -No acute allergic reaction Transverse myelitis None None Occasional* -Medication reconciliation Capillary leak syndrome None** None** 23%* Medication Management PRES (RPLS) 0.6% (HBP related) 2% (HBP related) Rare* -Verbalized understanding of discharge instruction HUS, severe sensory and None None Rare* motor neuropathy Premedications Supportive Medications Neurologic disorders of eye; Rare Rare Common* GM-CSF (Sargramostim) myelosuppression • IV Hydromorphone Death None None Rare* • Loratadine • EpiPen® * Based on FDA Boxed Warning Label • Acetaminophen ** Occasional patients receiving mu3F8+IL2 had symptoms and signs • Diphenhydramine consistent with capillary leak syndrome • Hydroxyzine • Levalbuterol ^ January 2017 census, MSKCC • Ondansetron • Racemic Epinephrine Multicenter Study Expansion: • Famotidine • Naloxone Clinicaltrials.gov NCT03363373 • Oxycodone • Normal Saline Bolus 2.bp.blogspot.com. N.P., 2016. Web. 20 Sept. 2016..