Thursday, 2 February 2017

Sativex dosage

Dear all,
We just got Sativex but are not certain about the dosage. Has anyone used it? how many puffs ? Shold there be dosage escalation? Thanks!

12 comments:

  1. In the trial testing Sativex in combination with temozolomide for recurrent GBM, Sativex was "Administered orally as a spray to the cheek according to a standard dose titration regimen, until patients reach a maximum tolerated dose (maximum 12 sprays per day). Each spray delivers 100 μl (Δ9tetrahydrocannabinol (THC), 27 mg/ml: Cannabidiol (CBD), 25 mg/ml)."

    In the information from GW Pharma (maker of Sativex) it states "There is limited experience with doses higher than 12 sprays per day. Some patients may require and may tolerate a higher number of sprays."

    However the current dosing recommendations for Sativex are based on the approved indications for multiple sclerosis and cancer pain management, not as an actual cancer treatment, so 12 sprays per day is not necessarily the optimal dose as a cancer therapy.

    This document also recommends a gradual increase in dose:

    "This medication is administered as a self-titration regimen, with gradual increase in dose as needed and tolerated until satisfactory pain relief is achieved. During the initial self-titration period, patients may experience adverse CNS effects. These can be used to guide self-titration to establish a satisfactory dosage regime. Patients should be advised that it
    might take a week or more to find the optimal dosing level. In patients with multiple sclerosis, the median daily dosage of SATIVEX® in the extension phase of the 4-week clinical trial was 5 sprays per day. The majority of patients required 12 sprays or less; dosage should be adjusted as needed and tolerated. There is limited experience with doses higher than 12 sprays per day. Some patients may require and may tolerate a higher number of sprays. In patients with pain in cancer, the median daily dosage of SATIVEX® was 8 actuations (sprays)."

    http://omr.bayer.ca/omr/online/sativex-dhcpl-lapds-08-01-2007-en.pdf

    ReplyDelete
    Replies
    1. Thank you so much, Stephen!

      Delete
    2. You're welcome, and just to fill in the math a little more, 12 sprays at 100 uL (microliters) per spray amounts to 1200 uL or 1.2 milliliters (mL) total per day. At a THC and CBD concentration of 27 and 25 mg per mL, the 1.2 mL daily dose of Sativex would deliver 32.4 mg of THC and 30 mg of CBD.

      Delete
  2. In our experience, we started using a 1-1 ratio of THC-CBD spray, 3 sprays, 5x a day. We found out this is considered only a maintenance dose. With further reading, some have recommended up to a gram of THC-CBD. This has often been called RSO (Rick Simpson Oil or Full Extract Cannabis Oil (FECO)). We've also read that smoking does not work.

    ReplyDelete
    Replies
    1. Keep in mind that cannabis oil isn't 100% THC + CBD. So a 1 gram dose of cannabis oil could contain significantly less than 1 gram of THC+CBD. And every oil preparation likely differs in terms of percentage of THC and CBD.

      Delete
  3. The Sativex + temozolomide trial in the UK, sponsored by GW pharmaceuticals (maker of Sativex) has released the first preliminary outcomes in a press release dated February 7 (two days ago).

    12 GBM patients at first recurrence were randomized to dose intense temozolomide + Sativex, and 9 patients were randomized to dose intense TMZ + placebo. One year survival in the Sativex arm was 83% (median 18 months), while one year survival in the placebo arm was 53% (median 12.1 months).

    Although this was only a small phase 1/2 trial, the results of the trial led GW Pharma's CEO, Justin Gover, to state that "These data are a catalyst for the acceleration of GW's oncology research interests and over the coming months, we expect to consult with external experts and regulatory agencies on a pivotal clinical development program for THC:CBD in GBM and to expand our research interests in other forms of cancer."

    http://ir.gwpharm.com/releasedetail.cfm?ReleaseID=1010672

    https://clinicaltrials.gov/ct2/show/NCT01812603

    ReplyDelete
    Replies
    1. Thank you so much for this great info!

      Delete
  4. Could anyone shed any light on how to get hold of sativex for someone with GMB in the UZk?

    ReplyDelete
    Replies
    1. At the moment, the only lead we have is from a private clinic in Hampshire.

      Delete