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IMPORTANT SAFETY INFORMATION (CONTINUED) ADVERSE REACTIONS

The most common (≥5% and twice the rate of placebo) adverse reactions with methylphenidate are decreased appetite, insomnia, nausea, vomiting, dyspepsia, abdominal pain, decreased weight, anxiety, dizziness, irritability, affect lability, tachycardia, and increased blood pressure.
Additional adverse reactions (≥5% and twice the rate of placebo) in JORNAY PM-treated pediatric patients 6 to 12 years are headache, psychomotor hyperactivity, and mood swings.

DRUG INTERACTIONS

Antihypertensive Drugs: Monitor blood pressure; adjust dosage of antihypertensive drug as needed.

To report SUSPECTED ADVERSE REACTIONS, contact Collegium Pharmaceutical, Inc. at 1-877-938-4766 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for 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.