ELVANSE Capsule, hard Ref.[7642] Active ingredients: Lisdexamfetamine

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

Pre-treatment evaluation

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 height and weight on a growth chart (see section 4.3 and section 4.4).

Consistent with other stimulants, the potential for abuse, misuse or diversion of Elvanse should be considered prior to prescribing (see section 4.4).

Ongoing monitoring

Growth, psychiatric, and cardiovascular status should be continually monitored (see also section 4.4).

• Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and at least every six months.
• Height, weight, and appetite should be recorded at least six-monthly with maintenance of a growth chart.
• Development of de novo or worsening of pre-existing psychiatric disorders should be monitored at every adjustment of dose and then at least every six months and at every visit.

Patients should be monitored for the risk of diversion, misuse, and abuse of Elvanse.

Posology

Dosage should be individualised according to the therapeutic needs and response of the patient. Careful dose titration is necessary at the start of treatment with Elvanse.

The starting dose is 30 mg taken once daily in the morning. When in the judgment of the clinician a lower initial dose is appropriate, patients may begin treatment with 20 mg once daily in the morning.

The dose may be increased by 10 or 20 mg increments, at approximately weekly intervals. Elvanse should be administered orally at the lowest effective dosage.

The maximum recommended dose is 70 mg/day; higher doses have not been studied.

Treatment must be stopped if the symptoms do not improve after appropriate dosage adjustment over a 1-month period. If paradoxical aggravation of symptoms or other intolerable adverse events occur, the dosage should be reduced or discontinued.

Method of administration

Elvanse may be taken with or without food.

Elvanse may be swallowed whole, or the capsule opened and the entire contents emptied and mixed with a soft food such as yogurt or in a glass of water or orange juice. If the contents include any compacted powder, a spoon may be used to break apart the powder in the soft food or liquid. The contents should be stirred until completely dispersed. The patient should consume the entire mixture of soft food or liquid immediately; it should not be stored. The active ingredient dissolves completely once dispersed; however, a film containing the inactive ingredients may remain in the glass or container once the mixture is consumed.

The patient should not take anything less than one capsule per day and a single capsule should not be divided.

In the event of a missed dose, Elvanse dosing can resume the next day. Afternoon doses should be avoided because of the potential for insomnia.

Long-term use

Pharmacological treatment of ADHD may be needed for extended periods. The physician who elects to use Elvanse for extended periods (over 12 months) should re-evaluate the usefulness of Elvanse at least yearly, and consider trial periods off medication to assess the patient’s functioning without pharmacotherapy, preferably during times of school holidays.

Adults

In adolescents whose symptoms persist into adulthood and who have shown clear benefit from treatment, it may be appropriate to continue treatment into adulthood (see sections 4.4 and 5.1).

Children Under 6 years

Elvanse should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established.

Patients with renal impairment

Due to reduced clearance in patients with severe renal insufficiency (GFR 15 to <30 mL/min/1.73 m² or CrCl <30 mL/min) the maximum dose should not exceed 50 mg/day. Further dosage reduction should be considered in patients undergoing dialysis. Lisdexamfetamine and dexamfetamine are not dialysable.

Patients with hepatic impairment

No studies have been conducted in patients with hepatic impairment.

The prolonged release of dexamfetamine after administration of Elvanse should be considered when treating patients with overdose.

Manifestations of acute overdosage with amfetamines include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia, and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhoea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

Management of acute amfetamine intoxication is largely symptomatic and includes gastric lavage, administration of activated charcoal, administration of a cathartic, and sedation. Acidification of the urine increases amfetamine excretion but is believed to increase risk of acute renal failure if myoglobinuria is present. If acute severe hypertension complicates amfetamine overdosage, administration of intravenous phentolamine has been suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved.

Lisdexamfetamine and dexamfetamine are not dialysable.

3 years.

Do not store above 25°C.

High density polyethylene bottle and a polypropylene child resistant cap with a foil inner seal.

Pack sizes: 28 or 30.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.