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The Adverse Event Reporting and a link to the Prescribing Information can be found at the bottom of the page.

Intuniv: A different approach to ADHD treatment

Offer Intuniv as a treatment choice for children and young people if they cannot tolerate MPH or LDX, or their symptoms have not responded to separate 6-week trials of MPH and LDX, having considered alternative preparations and adequate doses1

MPH=methylphenidate; LDX=lisdexamfetamine; NICE=National Institute for Health and Care Excellence

intuniv logo

Intuniv® (guanfacine) prolonged-release tablets is indicated for the treatment of ADHD in children and adolescents 6-17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective.2

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

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NICE recommendations for non-stimulants1

NICE recommendations for non-stimulants

*The therapeutic mode of action of these drugs are not fully established.3
†The therapeutic mode of action of Intuniv (guanfacine) is not fully established.2,3
‡In terms of reduced ADHD symptoms and associated impairment.1
§Having considered alternative preparations and adequate doses.1
ATX=atomoxetine; DEX=dexamfetamine; GXR=guanfacine; LDX=lisdexamfetamine; MPH=methylphenidate; NICE=National Institute for Health and Care Excellence.

Intuniv works differently to stimulants and atomoxetine2-4*

Intuniv mode of action
Intuniv mode of action

A different MoA may offer additional treatment strategies for those not suitable for or responding to stimulants3

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Intuniv binds to post-synaptic alpha2A adrenergic receptors in the prefrontal cortex, mimicking noradrenaline2-4

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Stimulants and atomoxetine are thought to modulate the pre-synaptic reuptake/release of dopamine and/or noradrenaline3,4

*The therapeutic mode of action of Intuniv (guanfacine) is not fully established.2,3
MoA=Mode of Action; cAMP=cyclic adenosine monophosphate; HCN=hyperpolarisation-activated cyclic nucleotide-gated.
Adapted from: Wang M et al. 2007.

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Intuniv provides significant improvements in core symptom control5

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Significant improvement vs. placebo at week 10 or 135

Primary endpoint: Significant reduction in core ADHD symptoms from baseline, as measured by ADHD-RS-IV total score at endpoint (p<0.001 vs. placebo; FAS)5

Mean reduction in ADHD=RS-IV total score from baseline to endpoint (week 10 for ages 6-12 years, week 13 for ages 13-17)5

Intuniv symptom control chart

Approximately half of the patients (n=163) had previously used stimulants5

LOCF, N=337.
The study was validated by use of a reference arm to establish study sensitivity (ATX 10–100 mg/day);
No comparisons can be drawn between the treatment and reference arms.5

ADHD-RS-IV=Attention-Deficit Hyperactivity Disorder Rating Scale IV;
ATX=atomoxetine; FAS=full analysis set; ITT=intention-to-treat; LOCF=last observation carried forward.

School bag

Intuniv gets to work quickly5,6

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Onset of efficacy begins after 1 week5

Ad-hoc analysis: Onset of efficacy (first LOCF statistical difference in ADHD-RS-IV total score between active treatment and placebo)5

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Intuniv vs. placebo

Onset of efficacy with Intuniv was seen at week 1, with a placebo-adjusted difference in LS mean for ADHD-RS-IV total score of –2.6 (95% CI: –4.3, –0.9, p=0.003)5

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Reference arm (ATX) vs. placebo

For the reference arm (ATX) a significant placebo-adjusted difference in LS mean for ADHD-RS-IV total score was first detected at week 3 (–2.7, p=0.024)5

FAS, N=337.
The study was validated by use of a reference arm to establish study sensitivity (ATX 10–100 mg/day); no comparisons can be drawn between the treatment and reference arms.5
Adapted from: Hervas A et al. 2014.

ADHD-RS-IV=Attention-Deficit Hyperactivity Disorder Rating Scale IV;
ATX=atomoxetine; FAS=full analysis set; ITT=intention-to-treat; LOCF=last observation carried forward; LS=least-squares.

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Approaching full effect by 3 weeks6

Primary endpoint: Significant reduction in mean ADHD-RS-IV total score from baseline to endpoint (p≤0.0002 vs. placebo; ITT)6

Post hoc analysis: Analysis of change in ADHD-RS-IV total score per study week (vs. placebo)6

Graph - Intuniv efficacy
Legend

ITT population, N=345.
*Placebo-adjusted LS mean changes from baseline were significant at week 2 for the Intuniv 2 mg/day group (p<0.05), at all Intuniv dose groups at visits 3 through 5 (p<0.05 for all), and at the endpoint (p<0.001 for all). The numbers of patients included in the placebo, GXR 2 mg, GXR 3 mg and GXR 4 mg groups were 86, 87, 86 and 86, respectively.6
Adapted from: Biederman J et al. 2008.

Legend

Flexible, once-daily dosing2

Intuniv dosing chart
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The recommended starting dose is 1 mg/day2

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Dose may be adjusted, based on body weight, by a maximum of 1 mg/week2

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The maximum dose is 7 mg/day - depending on age, weight and response to Intuniv2

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The effect may not be immediate - some patients notice an improvement after the first week, although it may take longer5

BMI=body mass index.

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Monitoring

During dose titration:
weekly monitoring for signs and symptoms of somnolence and sedation, hypotension and bradycardia should be performed2

Effect on BMI: Intuniv may cause an increase in BMI. Monitoring of height, weight and BMI should be done prior to initiation of therapy and then every 3 months for the first year, taking into consideration clinical judgement2

Downward dose titration: blood pressure and pulse should be monitored in all patients during downward dose titration (decrements of no more than 1 mg every 3–7 days) and following discontinuation2

Efficacy and safety profile supported by 2-year data7

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Intuniv was generally well tolerated during 2 years of treatment7

Summary of TEAEs reported with Intuniv over 24 months (safety population, N=240)

Intuniv safety profile

Intuniv safety profile

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Sustained improvement vs. baselines in ADHD core symptoms for up to 2 years as measured using ADHD-RS-IV total score (p<0.001; ITT population, N=228)7

The most common side effect with Intuniv is somnolence. The occurrence of somnolence/sedation and hypotension was most prominent in the first few weeks of treatment and diminished gradually thereafter.2

*Serious TEAE defined as any untoward medical occurrence that is life-threatening or results in hospitalisation, prolongation of hospitalisation, significant disability or death; three serious TEAEs were considered possibly or probably related to the study drug (one event of orthostatic hypotension and two events of syncope).7
†Severe TEAE defined as incapacitating with inability to work or to complete usual activities.7
AE=adverse event; NOS=not otherwise specified; TEAE=treatment-emergent adverse event; URTI=upper respiratory tract infection.
Adapted from Biederman J et al. 2008.

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References

  1. NICE. Attention deficit hyperactivity disorder: diagnosis and management. NG87. Available at nice.org.uk/guidance/NG87 (accessed March 2023).
  2. Intuniv. Summary of Product Characteristics.
  3. Huss M et al. Clin Drug Investig 2016; 36(1): 1–25.
  4. Alamo C et al. Actas Esp Psiquiatr. 2016; 44(3): 107–12.
  5. Hervas A et al. Eur Neuropsychopharmacol. 2014; 24(12): 1861–72.
  6. Biederman J et al. Pediatrics 2008; 121(1): e73-84.
  7. Biederman J et al. CNS Spectr. 2008; 13(12): 1047–55.
  8. Arnold LE. J Attent Disord 2000;
  9. Wang M et al. Cell 2007; 129(2): 397- 410.

Takeda

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.

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