SATIVEX is a brand name for Cannabidiol, supplied as a spray. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SATIVEX® (delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)) is indicated as: • an adjunctive treatment for symptomatic relief of spasticity in patients with multiple sclerosis (MS) who have not responded adequately to other therapy and who demonstrate meaningful improvement during an initial trial of therapy.…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • SATIVEX® is for buccal use only. • The spray should be directed to below the tongue, or towards the inside of the cheeks. The site should be varied. • The patient should be advised not to direct the spray towards the pharynx and not to inhale the spray.
It must not be sprayed into the nose. 2 Recommended Dose and Dosage Adjustment Treatment initiation and stabilization • On day one of treatment, patients should take one spray during the morning and one spray during the afternoon/evening.
The morning dose can be taken at any time between waking up and 12 noon and the afternoon dose can be taken at any time between 4 pm and bedtime. • On subsequent days the patient may gradually increase the total number of sprays, by one spray each day, as needed and tolerated.
There should be at least a 15 minute gap between sprays. During initial titration, sprays should be evenly spread out over the day. • If unacceptable adverse reactions such as dizziness or other CNS-type reactions develop at any time, dosing should be suspended until they have resolved.
Some patients may be able to continue therapy at the dose reached by increasing the interval between doses; others may require their subsequent doses reduced. Patients should then carefully re- titrate to a tolerated dosage regimen that gives acceptable relief.
Page 5 of 38 Protected B / Protégé B Following the titration period, patients are advised to maintain the optimal dose achieved. Re- titration upwards or downwards may be appropriate if there are any changes in the severity of the patient’s conditions, changes in his/her concomitant medication or if unacceptable side effects develop.
The usual dose ranges between 4-8 sprays daily. The majority of patients require 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.
1 Priming 1. Shake the vial gently before use. 2. Remove the protective cap. 3. Holding the vial in an upright position, prime the SATIVEX® vial by pressing on the actuator two or three times firmly and quickly, directing into a tissue until a fine spray appears.
Important - Point the spray safely away when priming it into a tissue. Do not prime it near children, pets or an open flame. 2 Administration 1. Shake the vial gently before use. 2. Remove the protective cap. 3. Hold the vial in the upright position and direct into the mouth.
1 Adverse Reaction Overview SATIVEX® has been administered to 805 multiple sclerosis patients in placebo-controlled studies and to 1016 patients during long-term open-extension studies. Over 300 subjects with MS have more than six months exposure, and 231 subjects with MS have been exposed to SATIVEX® for over one year.
9%). 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from Page 12 of 38 Protected B / Protégé B clinical trials is useful for identifying drug-related adverse events and for approximating rates. The following data summarise the adverse events in patients in clinical trials with various neurological conditions.
7% on placebo. In most patients, adverse events have resolved without treatment, and some on a reduction of dosage of SATIVEX®. The studies from which these figures are derived incorporate a period of titration to optimal therapeutic and/or maximum tolerated dose during which unwanted effects are likely to be maximal.
Because SATIVEX® is self-titrated to effect, patients are likely to experience a higher incidence of adverse events during the titration period than when the optimal dose is established. Treatment-emergent adverse events that occurred in 1% or more of patients treated with SATIVEX®, and at an incidence greater than (or equal to) 1% more frequently than placebo, in the acute phase in all Phase III trials, are given below in Tables 1 and 2.
Table 1 includes all adverse events related to the application site, as the placebo used in studies contained the same excipients (ethanol and propylene glycol) as used in SATIVEX®. 1 Application Site Application site type events were reported by approximately 14% of patients receiving SATIVEX® or placebo.
Please see the Serious Warnings and Precautions Box at the beginning of Part I:
Health Professional Information. General During the initial self-titration period, patients may experience unacceptable adverse events, including dizziness. These should resolve with down-titration or interruption of treatment (see “OVERDOSAGE, Signs and Symptoms”).
Careful dose titration and monitoring are advised if SATIVEX® is used in patients on a drug product containing fentanyl, or its analogues such as alfentanil and sufentanil (see DRUG INTERACTIONS). Care should be taken with sedatives, drugs with sedating or psychotropic effects and hypnotics as co-administration with SATIVEX® may have an additive effect.
Buccal Mucosa Regular inspection of the oral mucosa is advised. Patients should be advised not to continue spraying on to sore or inflamed mucosa. Administration site irritation was common both during short-term and long-term use of SATIVEX®.
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Buccal Buccal spray delta-9-tetrahydrocannabinol 27mg/mL (from Tetranabinex® - Cannabis sativa L. extract) and cannabidiol 25mg/mL (from Nabidiolex® - Cannabis sativa L.
extract) Ethanol anhydrous Peppermint oil Propylene glycol Page 8 of 38 Protected B / Protégé B Carcinogenesis and Mutagenesis See Part II – TOXICOLOGY. Cardiovascular Cannabinoids have cardiovascular effects that include tachycardia, and transient changes in blood pressure, including episodes of postural hypotension.
Use of SATIVEX® is contraindicated in patients with pre-existing cardiovascular disease, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure. Dependence/Tolerance Recreational cannabis is known to produce dependence in some users.
THC is a psychotropic agent which may produce physical and psychological dependence and has the potential to be abused. SATIVEX® contains THC and should be used with caution in patients with a history of substance abuse, including alcohol abuse or dependence.
SATIVEX® is contraindicated in: • patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
• patients with cardiovascular diseases, such as ischemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure • patients with a history of schizophrenia or any other psychotic disorder • children under 18 years of age • women of child-bearing potential not on a reliable contraceptive or fertile men not on a reliable contraceptive (see “Use in Women of Child-Bearing Potential”) • pregnant or nursing women (see “Use in Women of Child-Bearing Potential”).
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Press firmly and quickly towards the buccal surface in the following regions: below the tongue or towards the inside of the cheeks. The site should be varied. Never aim at the throat, as SATIVEX® can cause irritation. 4. Replace the protective cap.
5. Keep away from sources of heat and direct sunlight. 4 Missed Dose SATIVEX® is a self-titration regime to be used “as required” therefore, “missed dose” is not applicable. Page 6 of 38 Protected B / Protégé B
These included glossodynia, mouth ulceration, oral discomfort, oral pain, application site irritation, application site pain, pharyngitis, throat irritation and dysgeusia. The incidences were similar for SATIVEX® treated patients and placebo appearing to indicate that some application site type reactions may be due to the excipients (50% ethanol and 50% propylene glycol).
The majority of these reactions consisted of mild to moderate stinging at the time of application. 8% in placebo. Two cases of possible leukoplakia were reported as related to SATIVEX®, but neither was confirmed histologically; a third case was unrelated.
Patients who complain of discomfort should be advised to vary the site of application within the mouth, and should not continue spraying onto sore or inflamed mucus membranes. Regular inspection of the oral mucosa is strongly recommended in […]
Multiple substance abuse is common and marijuana, which contains the same active compounds, is a frequently abused substance. Therefore, SATIVEX® is not recommended in patients with addiction and drug abuse liability. In a study designed to identify its liability for abuse, SATIVEX® at a dose of 4 sprays taken at one time, showed no more liability for abuse than placebo.
Higher doses of SATIVEX® of 8 to 16 sprays taken at one time showed a greater liability for abuse than placebo. In long-term open-label studies with SATIVEX®, no increase in the dosing level of SATIVEX® was observed. Driving and Operating Machinery SATIVEX® may impair the mental and/or physical abilities required for certain potentially hazardous activities such as driving a car or operating machinery.
Patients should be warned not to drive or engage in activities requiring unimpaired judgement and coordination. Patients should also be cautioned about the additive/synergistic effects of SATIVEX® with other CNS depressants, including opioids, GABA inhibitors, sedative/hypnotics, and alcohol.
SATIVEX® may produce undesirable effects such as dizziness and somnolence which may impair judgement and performance of skilled tasks. Patients should be aware that SATIVEX® has been known to cause cases of loss of consciousness. This medicine can also impair perception and cognitive function and can affect a patient’s ability to drive safely.
Hematologic Clinical laboratory investigations did not reveal any trends of clinical significance in haematological parameters. Hepatic/Biliary/Pancreatic Data from a single dose of 4 sprays of SATVEX® in individuals with normal hepatic function and Page 9 of 38 Protected B / Protégé B those with mild, moderate, and severe hepatic impairment are available.
SATIVEX® can be administered to patients with mild hepatic impairment with caution, especially at doses higher doses. Administration to patients with moderate or severe hepatic impairment is not advised due to higher peak concentration and exposure to THC, CBD, and their metabolites (see Special Populations and Conditions).
No data with multiple dosing is available in subjects with hepatic impairment. SATIVEX® contains approximately 50% v/v of ethanol. 04 g of ethanol. 2 g ethanol. Ethanol may be harmful for those suffering from alcoholism. This should also be taken into account in high-risk groups such as patients with liver disease.
Immune No clinically significant abnormalities of immune function have been observed in clinical trials with SATIVEX®. Monitoring and Laboratory Tests Routine laboratory monitoring, appropriate for the patient’s disease condition and concomitant medication, is recommended.
Due to accumulation of cannabinoids in the body fat, trace amount of cannabinoids may be detected in the blood and urine for some weeks after SATIVEX® is discontinued. Neurologic In clinical studies with SATIVEX®, an increase in the number of falls has been observed.
Whether this is due to dizziness, orthostatic hypotension or reduced spasticity has not been established. Patients should be made aware that care should be taken to avoid falls. There is not sufficient information to characterize the effect of SATIVEX® on the seizure threshold.
Caution should be used in treating patients with a history of epilepsy or recurrent seizures. Fainting episodes have been observed with use of SATIVEX®. CNS effects, with dizziness being the most frequent (see Table 2), appear to be dose-related, increasing in frequency with higher dosages, and subject to great inter-patient variability.
They usually resolve on reduction of doses, increasing the interval between doses or interruption of SATIVEX® (see “OVERDOSAGE”) Peri-Operative Considerations SATIVEX® may produce transient minor changes in blood pressure and heart rate.
The central and peripheral effects of […]