Pre-treatment Screening

Prior to treating patients with EVEKEO ODT, 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 EVEKEO ODT use [see Warnings and Precautions (5.1), and Drug Abuse and Dependence (9)].

Dosage Information

Administer EVEKEO ODT orally in the morning with or without food or liquid.

​The recommended starting dosage for pediatric patients 6 to 17 years of age is 5 mg once or twice daily. If necessary, administer an additional dose after 4 to 6 hours. Titrate the dosage in increments of 5 mg at weekly intervals depending on response and tolerability.

Only in rare cases will it be necessary to exceed a total of 40 mg daily.

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Amphetamine should be administered at the lowest effective dosage and dosage should be individually adjusted.

Administration Instructions

Instruct the patient or caregiver on the following administration instructions:

• Do not remove the tablet from the blister pack until just prior to dosing. Do not store the tablet for future use.
• Use dry hands to open the blister.
• Remove the tablet by pushing it through the back of the foil-lined blister pack.
• As soon as the blister is opened, remove the tablet and place the tablet on the patient's tongue.
• Place the whole tablet on the tongue and allow it to disintegrate without chewing or crushing.
• The tablet will disintegrate in saliva so that it can be swallowed. No liquid is needed to take the tablet. The tablet can be actively moved around between the tongue and the roof of the mouth until it disintegrates.

Switching from Other Amphetamine Products

Switching from EVEKEO to EVEKEO ODT can be done on a milligram-per-milligram basis.

When switching from other amphetamine products, discontinue treatment and titrate with EVEKEO ODT using the titration schedule above. 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 EVEKEO ODT dosage accordingly [see Drug Interactions (7.1)].