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Sixmo is a brand name for Buprenorphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment must be under the supervision of a healthcare professional experienced in the management of opioid dependence/addiction. Insertion and removal of the implants must be performed by a physician who is competent in minor surgery and has been trained to conduct the insertion and removal procedure.
Appropriate precautions, such as the conduct of patient follow-up visits according to the patient's needs and the treating physician’s clinical judgement, should be taken during the treatment. Patients previously treated with sublingual buprenorphine or sublingual buprenorphine + naloxone, must be on stable doses between 2 to 8 mg/day for at least 30 days and deemed clinically stable by the treating healthcare professional.
The following factors should be considered when determining clinical stability and suitability for Sixmo treatment: • period free from opioid drug abuse • stability of living environment • participation in a structured activity/job • consistency in participation in recommended behavioural therapy/peer support programme • consistency in compliance with clinic visit requirements • minimal to no desire or need to abuse opioids • period without episodes of hospitalisations (addiction or mental health issues), emergency room visits, or crisis interventions • social support system Medicinal product no longer authorised 3 Posology Sixmo should be used only in patients who are opioid tolerant.
Each dose consists of four implants, for subcutaneous insertion in the inner side of the upper arm. The implants are intended to be in place for 6 months of treatment and provide a sustained delivery of buprenorphine. They are removed by the end of the sixth month.
Treatment Sublingual buprenorphine should be discontinued 12 to 24 hours prior to subcutaneous insertion of the implants. g. at times of personal stress or crisis. g. sweating, lacrimation, yawning, nausea, vomiting, tachycardia, hypertension, piloerection, dilated pupils; • in case of patient’s self-reported heroin use, other opioid use or craving and/ or urine samples positive for opioids Although some patients may require occasional supplemental dosing with buprenorphine, patients should not be provided with prescriptions for sublingual buprenorphine-containing products for as- needed use.
Instead, patients who feel the need for supplemental dosing should be seen and evaluated promptly. e. the dose from which they were transferred prior to starting Sixmo treatment). The dissociation of buprenorphine from the μ-opioid receptors is expected to take up to several days after discontinuation of Sixmo treatment, which will prevent withdrawal symptoms immediately after removal of the implants.
8. The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy and death. In many cases the presence of pre-existing hepatic impairment (genetic disease, liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, alcohol abuse, anorexia, concomitant use of other potentially hepatotoxic medicinal products) and ongoing injecting drug use may have a causative or contributory role.
These underlying factors including confirmation of viral hepatitis status must be taken into consideration before prescribing Sixmo and during treatment. When a hepatic event is suspected, liver function evaluation is required, including consideration whether to discontinue treatment with Sixmo.
If the treatment is continued, hepatic function should be monitored closely. Hepatic impairment Buprenorphine is extensively metabolized in the liver. 2). 2). 3). Treatment of acute pain during therapy While on Sixmo, situations may arise where patients need acute pain management or anaesthesia.
Treat these patients with a non-opioid analgesic whenever possible. Patients requiring opioid therapy for analgesia may be treated with a high-affinity full opioid analgesic under the supervision of a healthcare professional, with particular attention to respiratory function.
Higher doses may be required for analgesic effect. Therefore, a higher potential for toxicity exists with opioid administration. If opioid therapy is required as part of anaesthesia, patients should be continuously monitored in an anaesthesia care setting by persons not involved in the conduct of the surgical or diagnostic procedure.
The opioid therapy must be provided by healthcare professionals trained in the use of anaesthetic medicinal products and the management of the respiratory effects of potent opioids, specifically the establishment and maintenance of a patent airway and assisted ventilation.
7). The insertion site should be examined one week following implant insertion and regularly thereafter for signs of infection or any problems with wound healing, including evidence of implant extrusion from the skin as well as misuse or abuse.
The recommended visit schedule for most patients is a frequency of no less than once-monthly for continued counselling and psychosocial support. 8). Additional complications may include local migration, protrusion, expulsion and implant breakage after insertion or during removal.
Surgical intervention is necessary for removing an implant that has migrated. Subcutaneous insertion is essential to confirm proper placement by palpation. If implants are placed too deeply (intramuscular or in the fascia) this may lead to neural or vascular injury upon insertion or removal.
Infection may occur at the site of the insertion or removal. Excessive palpation shortly after insertion of the implants may increase the chance of infection. Improper removal carries risk of implant-site infection and implant breakage.
2). Expulsion of the implant If spontaneous expulsion of the implant occurs after insertion, the following steps should be taken: • An appointment for the patient should be scheduled to return to the inserting healthcare professional as soon as possible.
• The patient should be instructed to place the implant in a glass jar with a lid, store it safely away from others, especially children, and bring it to the healthcare professional to determine whether the full implant has been expelled.
Buprenorphine can cause severe, possibly fatal, respiratory depression in children who are accidentally exposed to it. 5 mm in length). • The incision site should be inspected for infection. If infected, it should be treated appropriately and be determined if remaining implants need to be removed.
1. Severe respiratory insufficiency. Severe hepatic impairment. 5). 5). 4). Patients who have contraindications for MRI.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Buprenorphine in European Union.
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Retreatment If continued treatment is desired at the end of the first six-month treatment cycle, a new set of 4 implants may be administered following removal of the old implants for one additional treatment cycle of six months. The experience of a second treatment cycle is limited.
There is no experience of re-implantation beyond 12 months. Implants should be inserted in the inner side of the opposite upper arm, following the insertion steps below to locate the appropriate insertion site. Implants for repeat treatment should be inserted subcutaneously as soon as possible after removal of the previous implants, preferably on the same day.
If implants for repeat treatment are not inserted on the same day as removal of previous implants, individuals should be maintained on a fixed dose of 2 to 8 mg/day of sublingual buprenorphine, as clinically indicated, until repeat treatment occurs.
Sublingual buprenorphine should be discontinued 12 to 24 hours prior to insertion of four Sixmo implants. e. the dose from which they were transferred to Sixmo treatment) for continued treatment. There are no prospective data with Sixmo beyond two treatment cycles, and there is no experience with inserting the implants into other sites of the arm, sites other than the upper arm or re-insertion into previously-used sites.
Special populations Elderly Clinical studies of Sixmo did not include patients over 65 years and, therefore, the use of the product in this population is not recommended. The efficacy and safety of buprenorphine in elderly patients > 65 years has not been established.
No recommendation on posology can be made. 2). Patients with mild to moderate hepatic impairment (Child-Pugh A and B) should be monitored for signs and symptoms of toxicity or overdose caused by increased levels of […]
Renal impairment Renal elimination may be prolonged since 30% of the administered dose is eliminated by the renal route. Metabolites of buprenorphine accumulate in patients with renal failure. 2). Medicinal product no longer authorised 15 CYP3A inhibitors Medicinal products that inhibit the enzyme CYP3A4 may give rise to increased concentrations of buprenorphine.
g. protease inhibitors like ritonavir, nelfinavir or indinavir, or azole antifungals such as ketoconazole and itraconazole, or macrolide antibiotics). 5). General precautions relevant to the administration of opioids Opioids may produce orthostatic hypotension in ambulatory patients.
Opioids may elevate cerebrospinal fluid pressure, which may cause seizures, so opioids should be used with caution in patients with head injury, intracranial lesions, other circumstances where cerebrospinal pressure may be increased, or history of seizure.
Opioids should be used with caution in patients with hypotension, prostatic hypertrophy or urethral stenosis. Opioid-induced miosis, changes in the level of consciousness, or changes in the perception of pain as a symptom of disease may interfere with patient evaluation or obscure the diagnosis or clinical course of concomitant disease.
g. Addison's disease). Opioids have been shown to increase intracholedochal pressure, and should be used with caution in patients with dysfunction of the biliary tract. Opioids should be administered with caution to elderly or debilitated patients.
5). 5). If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.
If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms. g. scleroderma) or history of recurrent methicillin-resistant Staphylococcus aureus infections.
Sixmo is contraindicated in patients with a history of keloid or hypertrophic scar formation at the site where Sixmo would be implanted, as difficulties in retrieving the implant are […]
Medicinal product no longer authorised 13 • If the expelled implant is not intact, the healthcare professional should palpate the insertion location to identify the location of any remaining partial implant. 2. 2. • The healthcare professional must carefully monitor the patient until the implant is replaced to evaluate for withdrawal or other clinical indicators suggesting that supplemental sublingual buprenorphine may be needed.
• The replacement implant(s) should be inserted in same arm either medially or laterally to in situ implants. Alternatively, replacement implant(s) may be inserted in the contralateral arm. Misuse and diversion Buprenorphine has the potential to be abused and is prone to criminal diversion.
Sixmo is formulated as a diversion and abuse deterrent formulation. Nevertheless, it is possible to extract the buprenorphine from the implant. These risks and the patient’s stability in treatment for opioid dependence should be considered when determining whether Sixmo is appropriate for the patient.
Abuse of buprenorphine poses a risk of overdose and death. This risk is increased with the concomitant abuse of buprenorphine and alcohol and other substances, especially benzodiazepines. All patients receiving Sixmo should be monitored for conditions indicative of diversion, or progression of opioid dependence and addictive behaviours suggesting the need for more intensive and structured treatment for substance use.
Dependence Buprenorphine is a partial agonist at the μ (mu)-opioid receptor and chronic administration produces dependence of the opioid type. g. morphine. If the implants are not immediately replaced upon removal, patients should be maintained on sublingual buprenorphine (2 to 8 mg/day), as clinically indicated, until Sixmo treatment is resumed.
Patients who elect to discontinue Sixmo treatment should be monitored for withdrawal syndrome, with consideration given to use of a tapering dose of sublingual buprenorphine. Precipitation of opioid withdrawal syndrome The partial opioid agonist properties of buprenorphine may precipitate opioid withdrawal signs and symptoms in persons who are currently physically dependent on full opioid agonists - such as heroin, morphine, or methadone - before the effects of the full opioid agonist have subsided.
2). 5) or when buprenorphine was not used according to prescribing information. 5) or other opioids. If […]