Treatment with Sativex must be initiated and supervised by a physician with specialist expertise in treating this patient population.1
Sativex is intended as treatment for symptom improvement in adult patients with moderate to severe spasticity due to MS who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.1
A thorough evaluation of the severity of spasticity related symptoms, and of the response to standard anti-spasticity medication, should be performed before treatment with Sativex is started. If a clinically significant improvement in spasticity related symptoms is not seen during an initial trial of therapy, treatment should be stopped.1
No routine monitoring (e.g. blood tests, blood pressure) is required for patients taking Sativex. However, the value of long-term treatment should be re-evaluated periodically.1
Sativex is contraindicated in patients:1
- With hypersensitivity to cannabinoids or to any of the excipients.
- With any known or suspected history or family history of schizophrenia, or other psychotic illness; history of severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
- Who are breast feeding (in view of the considerable likely levels of cannabinoids in maternal breast milk and the potential adverse developmental effects in infants).
NB. Sativex should not be used during pregnancy unless the potential risks to the fetus and/or embryo are considered to be outweighed by the benefit of treatment. Men and women of child-bearing age should take reliable contraceptive precautions for the duration of the treatment and for three months after discontinuation of therapy.1 Patients on hormonal contraceptives should be advised to use an additional alternative, non-hormonal/ reliable barrier method of birth control during Sativex therapy.1