Shire plc has launched Elvanse Adult® - the first licensed stimulant indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adults.1 This provides clinicians involved in the treatment of adults with ADHD with an additional treatment option in an environment where choice is currently limited.
While commonly thought of as a childhood condition, ADHD persists to adulthood in a reported 50-66% of individuals diagnosed with the disorder in childhood.2-5 In the UK adult ADHD is thought to affect between 3 and 4% of adults.6
"As a psychiatrist working with adult ADHD for 20 years, I recognise the many ways that ADHD impacts on the lives of adults and the importance of optimising treatment - fine-tuning medication to the unique characteristics and treatment response of each individual with ADHD. The availability of therapies, such as Elvanse Adult is a welcome addition to the options available to prescribers to help adults with ADHD effectively control their symptoms" said Professor Philip Asherson, Professor in Molecular Psychiatry at King's College London and Honorary Consultant Psychiatrist at The Maudsley Hospital.
Unlike other treatments currently available for ADHD in adults, the prodrug technology of Elvanse Adult means that the inactive molecule is gradually converted in the blood, making the active part of the medicine, d-amfetamine (d-AMF), available in the body over a period of time. As a result of the prodrug technology, Elvanse Adult capsules cannot be mechanically manipulated (e.g. crushed) to release d-AMF. 1,7-10
"Shire is answering the need for a wider choice of effective medications for adults living with ADHD, who previously have had limited options" said Peter Gillberg, Acting Head of Medical Affairs, Shire UK. "We are committed to improving access to Elvanse Adult, ensuring that adults with ADHD continue to benefit from advances in treatment."
About Elvanse Adult
Elvanse Adult is indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adult patients.1
Elvanse Adult is not indicated in all adult patients and the decision to use the medicinal product must take into consideration the profile of the patient, including a thorough assessment of the severity and chronicity of the patient's symptoms, the potential for abuse, misuse or diversion and clinical response to any previous pharmacotherapies for the treatment of ADHD.1 Treatment must be under the supervision of a specialist in behavioural disorders.
The active part of Elvanse Adult, d-amfetamine (d-AMF), is thought to work by increasing the neurotransmitters, dopamine and noradrenaline, in the synaptic space between neurons. These chemicals are stored in nerve cells in the brain, and their presence in the synaptic space controls the transmission of messages. This process is responsible for efficient activity, attention and concentration.11
Elvanse Adult safety information
Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient's cardiovascular status including blood pressure and heart rate. A comprehensive history should document concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death, and accurate recording of pre-treatment weight. Consistent with other stimulants, the potential for abuse, misuse or diversion of Elvanse Adult should be considered prior to prescribing.1
Psychiatric and cardiovascular status should be continually monitored. Patients should be monitored for the risk of diversion, misuse, and abuse of Elvanse Adult.1
Pharmacological treatment of ADHD may be needed for extended periods. The physician who elects to use Elvanse Adult for extended periods (over 12 months) should re-evaluate the usefulness of Elvanse Adult at least yearly, and consider trial periods off medication to assess the patient's functioning without pharmacotherapy.1
Hypersensitivity to sympathomimetic amines or any of the excipients, concomitant use of monoamine oxidase inhibitors (MAOI) or within 14 days after MAOI treatment (hypertensive crisis may result), hyperthyroidism or thyrotoxicosis, agitated states, symptomatic cardiovascular disease, advanced arteriosclerosis, moderate to severe hypertension, glaucoma.1
Special warnings and precautions for use
Stimulants including Elvanse Adult have a potential for abuse, misuse, or diversion that physicians should consider when prescribing this product. The risk of misuse may be greater in adults (especially young adults) than in paediatric use. Stimulants should be prescribed cautiously to patients with a history of substance abuse or dependence.1
Please consult the Elvanse Adult Summary Product Characteristics (SPC) before prescribing, particularly in relation to abuse and dependence, cardiovascular adverse events, psychiatric adverse events, tics, long-term effect on weight, seizures, visual disturbance, prescribing and dispensing, and use with other sympathomimetic drugs.1
Very common (frequency ≥1/10):
Common (≥1/100 to <1/10):
Agitation, anxiety, libido decreased, psychomotor hyperactivity, bruxism, dizziness, restlessness, tremor, tachycardia, palpitation, dyspnoea, diarrhoea, constipation, upper abdominal pain, nausea, hyperhidrosis, erectile dysfunction, irritability, fatigue, feeling jittery, blood pressure increased and weight decreased.1
Uncommon (≥1/1000 to <1/100):
Hypersensitivity, logorrhea, depression, tic, affect lability, dysphoria, euphoria, dermatillomania, mania, somnolence, dyskinesia, vision blurred, vomiting, urticaria, rash and pyrexia.1
Please consult the SPC for rare (≥1/10000 to <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data) side effects with Elvanse Adult.1