2.1 Important Information Prior to Initiating Treatment

Prior to initiating treatment with DYANAVEL XR, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)].

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for DYANAVEL XR use [see Warnings and Precautions (5.1), and Drug Abuse and Dependence (9)].

Recommended Dosage

The recommended starting dosage is 2.5 mg or 5 mg once daily in the morning. The dosage may be increased in increments of 2.5 mg to 10 mg per day every 4 to 7 days based on clinical response. The maximum recommended dosage is 20 mg once daily.

Pharmacological treatment of ADHD may be needed for extended periods. Healthcare providers should periodically re-evaluate the long-term use of DYANAVEL XR, and adjust dosage as needed.

Administration Information

​Administer DYANAVEL XR orally once daily in the morning with or without food.

​DYANAVEL XR Extended-Release Oral Suspension

Instruct patients to read the “Instructions for Use” for complete administration instructions.

• ​Ensure that the bottle adapter is firmly inserted into the bottle and do not remove once inserted.
• ​Shake the bottle of DYANAVEL XR extended-release oral suspension well before every administration.
• ​Use with the oral dosing dispenser provided by the pharmacist.

​DYANAVEL XR Extended-Release Tablets

• ​May be chewed or swallowed whole [see Clinical Pharmacology (12.3)].
• ​The 5 mg extended-release tablet is functionally scored and may be divided into equal halves (2.5 mg) at the score line.

Switching from Other Amphetamine Products

​DYANAVEL XR extended-release oral suspension can be substituted with DYANAVEL XR extended-release tablets on a milligram-per-milligram basis [see Clinical Pharmacology (12.3)].

If switching from other amphetamine products, discontinue that treatment, and titrate with DYANAVEL XR using the above titration schedule. Do not substitute for other amphetamine products on a milligram-per-milligram basis, because of different amphetamine salt compositions and differing pharmacokinetic profiles [see Description (11), Clinical Pharmacology (12.3)].

Dosage Modifications due to Drug Interactions

Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust DYANAVEL XR dosage accordingly [see Drug Interactions (7.1)].