Lisdexamfetamine

There are no adequate and well controlled studies of lisdexamfetamine in pregnant women. Dexamfetamine, the active metabolite of lisdexamfetamine, crosses the placenta.

Lisdexamfetamine dimesylate had no effect on embryofoetal development or survival when administered orally to pregnant rats and rabbits. Administration of lisdexamfetamine dimesylate to juvenile rats was associated with reductions in growth measurements at clinically relevant exposures.

The physician should discuss lisdexamfetamine treatment with female patients who have started menstruation. Lisdexamfetamine should only be used during pregnancy if the potential benefit justifies the potential risk to the foetus.

Amfetamines are excreted in human milk. Lisdexamfetamine should not be used during breast-feeding.

Fertility

Amfetamine has shown no harmful effects on fertility in a rat study. The effect of Lisdexamfetamine on human fertility has not been investigated.

Lisdexamfetamine can cause dizziness, drowsiness and visual disturbances including difficulties with accommodation and blurred vision. These could have a moderate influence on the ability to drive and use machines. Patients should be warned of these possible effects and advised that if affected, they should avoid potentially hazardous activities such as driving or operating machinery.

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

• The medicine is likely to affect your ability to drive.
• Do not drive until you know how the medicine affects you.
• It is an offence to drive while under the influence of this medicine.
• However, you would not be committing an offence (called ‘statutory defence’) if:
  • The medicine has been prescribed to treat a medical problem and
  • You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
  • It was not affecting your ability to drive safely.