Resources

Achieving optimal efficacy

Amanda reports that her symptoms have improved, but she still has difficulty with focus and forgetfulness.

After another week, Amanda’s daily dose is increased to 60 mg.

Dose is increased to 60 mg/day

Amanda tells her HCP that her symptoms are well controlled while she is at work. However, she feels the effect wear off later in the day when she needs to focus on her family.

To Achieve Optimal Efficacy

Individual results may vary.

IMPORTANT SAFETY INFORMATION (CONTINUED) WARNINGS AND PRECAUTIONS (CONTINUED)

JORNAY PM can cause serious adverse reactions and patients should be monitored for the following:

Priapism: Patients should seek immediate medical attention.
Peripheral Vasculopathy, including Raynaud’s Phenomenon: Observe patients for digital changes during treatment.
Weight Loss and Long-Term Suppression of Growth in Pediatric Patients: Monitor height and weight.
Increased Intraocular Pressure (IOP) and Glaucoma: Patients at risk for acute angle closure glaucoma should be evaluated by an ophthalmologist. Closely monitor patients with a history of abnormally increased IOP or open angle glaucoma.
Onset or Exacerbation of Motor and Verbal Tics, and Worsening of Tourette’s Syndrome.

Please see Important Safety Information and Full Prescribing Information, including Boxed Warning.

References

References: 1. JORNAY PM^® [package insert]. Ironshore Pharmaceuticals & Development, Inc. 2. Childress AC, Cutler AJ, Marraffino A, et al. A randomized, double-blind, placebo-controlled study of HLD200, a delayed-release and extended-release methylphenidate, in children with attention-deficit/hyperactivity disorder: an evaluation of safety and efficacy throughout the day and across settings. J Child Adolesc Psychopharmacol. 2020;30(1):2-14. 3. Pliszka SR, Wilens TE, Bostrom S, et al. Efficacy and safety of HLD200, delayed-release and extended-release methylphenidate, in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2017;27(6):474-482. 4. Gomeni R, Komolova M, Incledon B, Faraone SV. Model-based approach for establishing the predicted clinical response of a delayed-release and extended-release methylphenidate for the treatment of attention-deficit/hyperactivity disorder. J Clin Psychopharmacol. 2020;40(4):350-358. 5. Childress AC, Uchida CL, Po MD, DeSousa NJ, Incledon B. A post hoc comparison of prior ADHD medication dose and optimized delayed-release and extended-release methylphenidate dose in a pivotal phase III trial. Clin Ther. 2020;42(12):2332-2340. 6. Childress A, Mehrotra S, Gobburu J, McLean A, DeSousa NJ, Incledon B. Single-dose pharmacokinetics of HLD200, a delayed-release and extended-release methylphenidate formulation, in healthy adults and in adolescents and children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2018;28(1):10-18. 7. Gomeni R, Tan D, Sallee R, Incledon B. A model-based pharmacokinetic comparison of delayed-release/extended-release methylphenidate to extended-release methylphenidates with immediate-release supplementation. Poster presented at: The American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting; January 15-17, 2021. 8. Liu T, Gobburu JVS, Po MD, et al. Pharmacokinetics of HLD200, a delayed-release and extended-release methylphenidate: evaluation of dose proportionality, food effect, multiple-dose modeling, and comparative bioavailability with immediate-release methylphenidate in healthy adults. J Child Adolesc Psychopharmacol. 2019;29(3):181-191. 9. Katzman A, Otcheretko V, Po M, et al. Adverse events during dosing of delayed-release/extended-release methylphenidate: learnings from the open-label phase of a registration trial and a real-world postmarketing surveillance program. Clin Ther. 2023;45:1212-1221. 10. Faraone SV, DeSousa NJ, Komolova M, et al. Functional impairment in youth with ADHD: normative data and norm-referenced cutoff points for the Before School Functioning Questionnaire and the Parent Rating of Evening and Morning Behavior Scale, Revised. J Clin PsychiatryJ. 2020;81(1):19m12956. 11. APTENSIO XR [package insert]. Rhodes Pharmaceuticals; 2019. 12. AZSTARYS [package insert]. Corium, Inc.; 2021. 13. CONCERTA [package insert]. Janssen Pharmaceuticals, Inc.; 2021. 14. COTEMPLA XR-ODT [package insert]. Aytu BioPharma, Inc.; 2023. 15. FOCALIN XR [package insert]. Novartis Pharmaceuticals Corporation; 2021. 16. METADATE CD [package insert]. UCB, Inc.; 2013. 17. METADATE ER [package insert]. UCB, Inc.; 2014. 18. QUILLIVANT XR [package insert]. NextWave Pharmaceuticals, Inc.; 2021. 19. QUILLICHEW ER [package insert]. NextWave Pharmaceuticals, Inc.; 2021. 20. RITALIN LA [package insert]. Novartis Pharmaceuticals Corporation; 2021. 21. ADZENYS XR-ODT [package insert]. Aytu BioPharma, Inc.; 2022. 22. ADDERALL XR [package insert]. Shire US Inc.; 2013. 23. DEXEDRINE [package insert]. GlaxoSmithKline; 2007. 24. DYANAVEL XR [package insert]. Tris Pharma Inc.; 2022. 25. MYDAYIS [package insert]. Takeda Pharmaceuticals U.S.A., Inc.; 2022. 26. VYVANSE [package insert]. Takeda Pharmaceuticals U.S.A., Inc.; 2022. 27. Incledon B, Incledon C, Gomeni R, et al. Effect of colonic absorption on the pharmacokinetic properties of delayed-release and extended-release methylphenidate: in vivo, in vitro, and modeling evaluations. Clin Pharm Drug Dev. 2022;11(8):966-975. 28. Data on file. HLD200-108; Ironshore Pharmaceuticals & Development, Inc.; 2016. 29. Data on file. HLD200-107; Ironshore Pharmaceuticals & Development, Inc.; 2016. 30. Wigal SB, Gupta S, Guinta D, Swanson JM. Reliability and validity of the SKAMP rating scale in a laboratory school setting. Psychopharmacol Bull. 1998;34(1):47-53. 31. DuPaul GJ, Power TJ, Anastopoulos AD, Reid R. ADHD Rating Scale-IV: Checklists, norms, and clinical interpretation. New York: Guilford; 1998.