Buprenorphine hydrochloride implant
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Implant containing buprenorphine.
Substitution treatment for opioid drug dependence
Substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8mg/day of sublingual buprenorphine, and who are also receiving medical, social and psychological support.
Patients that have had previous treatment with sublingual buprenorphine or sublingual buprenorphine and naloxone, must be on stable doses of between 2 to 8mg/day for at least 30 days and deemed clinical stable by the treating healthcare professional.
The buprenorphine implant should only be used in patients who are opioid tolerant.
Four implants are inserted subcutaneously according to manufacturer's instructions. The implants must be removed at the end of the sixth month.
Sublingual buprenorphine should be discontinued 12 to 24 hours prior to subcutaneous insertion of buprenorphine implants.
Additional Dosage Information
Supplemental sublingual buprenorphine
Some patients may require occasional supplemental sublingual buprenorphine support to obtain full control of opioid withdrawal symptoms and cravings. Additional sublingual buprenorphine doses should be considered by the physician if the patient experiences withdrawal symptoms, or, if patient's self-reported heroin use, other opioid use or craving and/or urine samples positive for opioids. Prescriptions for sublingual buprenorphine-containing products should not be given for as-needed use. Patients who feel the need for supplemental dosing should be seen and evaluated promptly.
Patients who discontinue treatment should be switched back to their previous dose of sublingual buprenorphine within 12 to 24 hours following removal of the implant.
If further 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. New implants must be inserted 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 of the removal, patients should be maintained on a fixed dose of 2 to 8mg/day of sublingual buprenorphine, as clinically indicated, until repeat treatment occurs. There is little available data regarding the use of second implant cycle and no data available for re-implantation beyond 12 months.
To be administered by a healthcare professional who has been appropriately trained and accredited in the procedure. Ultrasound and MRI facilities need to be available to the clinical site at which the insertion and removal of the implants occurs.
Four implants are inserted subcutaneously according to manufacturer's instructions in the inner side of the upper arm approximately 8 to 10cm above the medial epicondyle, in the sulcus between the biceps and triceps muscle.
Immediately after insertion, verify the presence of the implant by palpation. If it cannot be palpated, or its presence is doubtful, confirm its presence with other methods to confirm the presence of the implant.
When removing the implant verify the location by palpation of the arm. After removal of all implants, confirm that the entire 26.5mm long implant has been removed by measuring its length.
Children under 18 years
History of keloid formation
Raised intracranial pressure
Severe hepatic impairment
Severe respiratory impairment
Precautions and Warnings
Females of childbearing potential
History of recurrent methicillin-resistant Staphylococcus aureus infections
Patients over 65 years
Benign prostatic hyperplasia
Biliary tract disorder
Connective tissue disorder
History of seizures
Mild hepatic impairment
Renal impairment - creatinine clearance below 30 ml/minute
Before initiating screen all patients for viral hepatitis
Advise ability to drive/operate machinery may be affected by side effects
Pre-treatment medical history and clinical examination
Treatment to be initiated and supervised by a specialist
Aseptic technique should be used throughout
Expulsion may occur if inserted incorrectly
Evaluate treatment efficacy regularly
Examine insertion site one week after implant and regularly thereafter
Monitor for signs of dependence
Monitor liver function. Withdraw if evidence of hepatotoxic reaction
Potential for drug abuse
Abuse may cause serious adverse events, dependence and withdrawal symptoms
Advise patient to seek advice at first indications of pregnancy
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient grapefruit products may increase plasma level
Female: Ensure adequate contraception during treatment
Remind patient of importance of carrying Alert Card with them at all times
There may be situations during treatment with buprenorphine where patients need acute pain management or anaesthesia. Patients should be treated with a non-opioid analgesic whenever possible. Patients requiring opioid therapy for analgesic 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 there is a higher risk of toxicity 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.
Patients with mild to moderate hepatic impairment or patients that develop hepatic impairment during treatment should be monitored for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine (miosis, lip cyanosis, sedation, bradycardia, hypotension, respiratory depression). If toxicity or overdose is observed, buprenorphine implants should be removed and transition to a medicinal product that allows dose adjustment are required.
The insertion site should be examined one week following insertion and regularly thereafter for signs of infections, any problems with wound healing, including evidence of implant extrusion from the skin as well as misuse or abuse. Recommended visit schedule for most patients is no less than once a month for continued counselling and psychosocial support.
Nerve damage and migration, resulting in embolism and death, may occur after improper insertion of drug implants in the upper arm. Other complications include, local migration, protrusion, expulsion and implant breakage after insertion or during removal. Surgical intervention is necessary for removing an implant that has migrated. Implants that have been placed too deeply may lead to neural or vascular injury upon insertion or removal.
Insertion and removal of the buprenorphine implants must be performed by a physician who is competent in minor surgery and has had the relevant training to conduct the insertion and removal procedure.
Pregnancy and Lactation
Buprenorphine is contraindicated during pregnancy.
The manufacturer does not recommend using buprenorphine during pregnancy and in women of child bearing potential not using contraception. There is limited available data regarding the use of buprenorphine in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown.
Long-term administration of buprenorphine during the last three months of pregnancy may cause withdrawal syndrome in the neonate. The syndrome is generally delayed for several hours to several days after birth. Due to the long half-life of buprenorphine, neonatal monitoring should be considered at the end of pregnancy to prevent the risk of respiratory depression or withdrawal syndrome in neonates.
Buprenorphine is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst using the buprenorphine implant. Buprenorphine and its metabolites are excreted in human milk, therefore effects on breastfed infants are likely.
Alanine aminotransferase increased
Discomfort in limb
Implant site abscess
Implant site erythema
Implant site haematoma
Implant site haemorrhage
Implant site infection
Implant site pain
Implant site pruritus
Implant site rash
Lacrimal gland disorder
Urinary tract infections
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: June 2021
Summary of Product Characteristics: Sixmo 74.2 mg implant. L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A. Revised January 2021.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.