Sativex® (nabiximols) (NEW)

 

Sativex® is approved by Medsafe for “use as an add-on treatment for symptom improvement in patients with moderate to severe spasticity due to Multiple Sclerosis 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”.

Use of Sativex® is not listed by Medsafe as approved for any other reason (www.medsafe.govt.nz/profs/RIss/Sativex.asp).

Sativex®is the only product cannabis based product that has made a therapeutic claim and regulated by Medsafe.

 

Accessing Sativex®

Only specialists can prescribe Sativex®.

Sativex® is not currently funded by PHARMAC and costs upwards of $1200 + GST per month. Prices may vary.

Applications for funding can be made under PHARMAC’s Named Patient Pharmaceutical Assessment system but to date no applications have been approved. Evidence must show that all other options have been tried but have failed to provide benefit or are contraindicated. To apply visit https://www.pharmac.govt.nz/tools-resources/forms/exceptional-circumstances/

 

What is Sativex®?

Sativex® (nabiximols) is a cannabis-based product classified as a Schedule 2, Part 1 (Class B1) controlled drug product under the Misuse of Drugs Act 1975.

Sativex® is an oromucosal (mouth) spray administering a metered, actuated dose containing the cannabis extracts delta-9-tetrahydrocannabinol (THC) (2.7 mg/spray) and cannabidiol (CBD) (2.5 mg/spray).

 

How is Sativex® administered?

Sativex® is a mouth (oromucosal) spray containing two chemical extracts derived from the cannabis plant: delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD). It might take up to two weeks to find the optimal dose. A titration period is required to reach optimal dose with timing and numbers of sprays varying between users.

 

Side effects

Common side effects include dizziness, drowsiness, diarrhea, fatigue, nausea, headache and a dry mouth. More information on the side effects can be found on the recommend reading The New Zealand Sativex® data sheet

Side effects are commonly observed in the titration period. Side effects and concerns should be reported to your prescribing health professional.

 

Contraindications

Sativex® is contraindicated in patients:

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 levels of cannabinoids likely in maternal breast milk and the potential adverse developmental effects in infants).

 

Sativex®, pregnancy and lactation

There is insufficient evidence to provide conclusive recommendations on the effects of Sativex® on reproduction.  Reliable contraceptive precautions for the duration of therapy and for three months after discontinuation of therapy are recommended.

Pregnancy 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.

Sativex® is contraindicated in breast feeding mothers.

 

Sativex® and Driving

Sativex® can cause dizziness and somnolence, impaired judgement and inhibited performance of skilled tasks. If using Sativex® it is recommended not drive, operate machinery or engage in any hazardous activity. Sativex® has been known to cause a few cases of loss of consciousness.

Sativex® may impair the mental and/or physical abilities required for certain potentially hazardous activities such as driving a car. People who experience any significant side effects should not drive, operate machinery or take part in any activity that could prove hazardous.

 

Age Restrictions

Sativex® is not recommended for use in children or adolescents below 18 years of age due to lack of safety and efficacy data.

 

What are the concerns surrounding Sativex®?

Regulatory bodies caution that the long-term usefulness of this medicine has not been established and recommend that extended periods of treatment should be periodically re-evaluated to examine the long-term safety and efficacy of the medicine for the individual patient.

 

Feedback from other patients

It is often helpful to review how other people with MS have liked or tolerated a treatments and the benefits and side effects they have experienced.

Patients Like Me – Sativex

 

Research

Sativex® has been studies for its use in MS symptoms which include: pain, spasticity, tremors, bladder issues and sleep disturbance.

 

Information for prescribers, Pharmacists and patients

The New Zealand Sativex® data sheet (PDF 125 KB, 14 pages)

Sativex® Supply Information for Prescribers

Sativex® Supply Information for Pharmacies

Sativex® Supply Information for Patients

Information on the prescribing of cannabis-based products is available on the Ministry of Health website (www.health.govt.nz/our-work/regulation-health-and-disability-system/medicines-control/prescribing-cannabis-based-products).

 

What to do about a bad reaction to medication

Reports from health professionals are preferred as doctors and other prescribers, pharmacists and nurses usually are able to provide more detailed information about the medications in use and other medical history from patient records that are helpful in evaluating the adverse reaction. However anyone may report a suspected adverse event or reaction to medication taken to the Centre for Adverse Reactions Monitoring (CARM).

For instructions and further information https://nzphvc.otago.ac.nz/reporting/