This website is intended for UK healthcare professionals.
The Adverse Event Reporting and a link to the Prescribing Information can be found at the bottom of the page.

Elvanse could open up a world of new opportunities:

Elvanse^® (lisdexamfetamine dimesylate) is indicated as part of a comprehensive treatment programme for ADHD in children aged 6 years and over when response to previous methylphenidate treatment is considered clinically inadequate.²

Treatment must be under the supervision of a specialist in childhood and/or adolescent behavioural disorders.²

Request a call from a Takeda representative to discuss Elvanse

NICE Guidelines

NICE recommends LDX for children and young people who have had a 6-week trial of MPH at an adequate dose and not derived enough benefit in terms of reduced ADHD symptoms and associated impairment¹

NICE recommends that…

… when prescribing stimulants for ADHD, think about
modified-release once-daily preparations for the following reasons:¹

convenience

improving adherence

their pharmacokinetic profiles

reducing problems of storing and administering controlled drugs at school

the risk of stimulant misuse and diversion associated with immediate-release preparations

reducing stigma (because there is no need to take medication at school or in the workplace)

Elvanse is the only ADHD treatment
with prodrug technology^2*

Watch the Mode of Action video

*The therapeutic mode of action of amfetamine in ADHD is not fully established

Elvanse provides 13 hours of sustained and consistent core symptoms control in children^2,3

Elvanse significantly reduced the core symptoms of ADHD at all measured time points from 1.5 hours up to 13 hours post-dose vs. placebo (p<0.005)*

*Assessed by SKAMP sub-scales.

SKAMP: THE SKAMP consists of 6 department items (interacting with other children, interacting with adults, remaining quiet, staying seated, complying the teacher’s directions, and following the classroom rules) and 7 attention items (getting started, sticking with tasks, attending to an activity, making activity transitions, completing assigned tasks, performing work accurately, and being neat and careful while writing or drawing).³

When taken at 7:00 am, Elvanse provided symptom control up to 8:00 pm (13 hours)³

Primary outcome: Elvanse provided signiﬁcant improvement on the SKAMP-D subscale at 1.5 hours, compared with placebo (p<0.005)
Secondary outcomes: Elvanse demonstrated signiﬁcant improvements in SKAMP-A and SKAMP-D subscales at all time points up to and including 13 hours postdose

Graph - LS mean change in SKAMP-D and SKAP-A vs. placebo

*p<0.005. **p<0.001 vs. placebo.
LS= least squares; SKAMP=Swanson, Kotkin, Agler, M-Flynn and Pelham scale, D=deportment, A=attention
Adapted from Wigal SB et al. Child Adolesc Psychiatry Ment Health 2009;3(1):17

Significant improvement in core ADHD symptoms compared with placebo⁵

Primary outcome: >50% reduction in ADHD-RS-IV total score with Elvanse from baseline to endpoint (p<0.001 vs. placebo)

Secondary outcome: LS mean changes (±SE) in ADHD-RS-IV mean total scores from baseline at each study visit (full analysis set)

Graph - Significant improvement in core ADHD symptoms compared with placebo

*p<0.01, **p<0.001 based on difference in LS mean change (active drug – placebo). ^†The study design was validated by use of a reference arm to establish study sensitivity. No comparisons can be drawn between the active treatment arm and the reference arm. Endpoint is the last on-treatment, post-baseline visit of the dose-optimisation or dose-maintenance period with a valid ADHD-RS-IV total score. Visit 7 was the last day of treatment; the interval between visits 7 and 8 was a 1-week post-treatment washout period. A decrease from baseline in the ADHD-RS-IV total score indicates an improvement in ADHD symptomatology. ADHD-RS-IV=ADHD Rating Scale version IV; LS=least-squares; SE=standard error.

Adapted from Coghill DR et al. Eur Neuropsychopharmacol 2013;23:1208–18

The recommended starting dose of Elvanse is 30 mg taken once daily, in the morning²

The dose may be increased by 10 or 20 mg increments, at approximately weekly intervals

Elvanse should be administered at the lowest effective dosage

*For illustrative purposes only. Based on % of total weight and a 100% full capsule.

Simple and flexible to take²

Elvanse only needs to be taken once every morning:

Safety profile of Elvanse is supported by 2-year data⁵

Summary of TEAEs reported with Elvanse over 2 years (safety population, N=314)

*Severe TEAE defined as an adverse event that interrupted usual activities of daily living, significantly affected clinical status, or may require intensive therapeutic intervention.
†Serious TEAE defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalisation or prolonged existing hospitalisation, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, or was an important medical event. Important medical events may have been considered as serious TEAEs when, based upon medical judgement, they may have jeopardized the patient and may have required medical or surgical intervention to prevent one of the outcomes listed above. Any new onset of seizures, syncope, or loss of consciousness was required by the sponsor to be reported as a serious TEAE.
‡As determined by the investigator.
TEAE=treatment-emergent adverse event.
Adapted from Coghill DR et al. CNS Drugs 2017;31:625–38

Symptom control was maintained over 2 years with Elvanse⁵

Secondary outcome: Change in ADHD-RS-IV total score from baseline to last on-treatment assessment was -25.8 (95% Cl -27.0 to -24.5, p<0.001)

ADHD-RS-IV=ADHD Rating Scale version IV; BL=baseline; LOTA=last on-treatment assessment; SD=standard deviation
Adapted from Coghill DR et al. CNS Drugs 2017;31:625–38

References

NICE. Attention deficit hyperactivity disorder: diagnosis and management. NG87.
Available at nice.org.uk/guidance/NG87 (accessed March 2023).
Elvanse. Summary of Product Characteristics.
Wigal SB et al. Child Adolesc Psychiatry Ment Health 2009;3(1):17.
Banaschewski T et al. CNS Drugs; 28(12): 1191-203.
Coghill DR et al. CNS Drugs. 2017; 31(7): 625-38.
Soutullo C et al. CNS Drugs. 2013;27(9):743-5.

Elvanse^® Prescribing Information

Equasym^® XL Prescribing Information

Intuniv^® Prescribing Information

For Adverse Event Reporting related to
Elvanse and Equasym XL:

Adverse events should be reported to the Medicines and Healthcare products Regulatory Agency.
Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Takeda at: AE.GBR‑IRL@takeda.com.

For Adverse Event Reporting related to
Intuniv:

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Takeda at: AE.GBR‑IRL@takeda.com.

C-APROM/GB/ELVS/0042 | March 2023

Elvanse could open up a world of new opportunities:

NICE Guidelines

NICE recommends LDX for children and young people who have had a 6-week trial of MPH at an adequate dose and not derived enough benefit in terms of reduced ADHD symptoms and associated impairment1

NICE recommends that…

… when prescribing stimulants for ADHD, think about modified-release once-daily preparations for the following reasons:1

Elvanse is the only ADHD treatment with prodrug technology2*

Elvanse provides 13 hours of sustained and consistent core symptoms control in children2,3

Elvanse significantly reduced the core symptoms of ADHD at all measured time points from 1.5 hours up to 13 hours post-dose vs. placebo (p<0.005)*

Significant improvement in core ADHD symptoms compared with placebo5

Primary outcome: >50% reduction in ADHD-RS-IV total score with Elvanse from baseline to endpoint (p<0.001 vs. placebo) Secondary outcome: LS mean changes (±SE) in ADHD-RS-IV mean total scores from baseline at each study visit (full analysis set)

The recommended starting dose of Elvanse is 30 mg taken once daily, in the morning2