Many patients suffering from narcotic addiction and dependency are familiar with Suboxone tablets, film and Subutex. These are various form of Buprenorphine that is used to control the withdrawal symptoms associated with addiction to narcotics. Suboxone is a partial agonist and antagonist medication. What that means is that it acts as a narcotic and also has protection against excessive narcotic intake. Sublocade is a new FDA approved form of Buprenorphine that is extended- release and activated by injection into a subcutaneous area of the abdomen. When injected, it forms an implant that slowly released the Buprenorphine over a period of one month or longer.
Sublocade is administered only by a healthcare provider that is familiar with the injection process. It is used to tread adults with moderate to severe addiction to opioid drugs regardless of obtained by prescription or illegally. The medication is injected as a liquid under the skin of the abdomen (stomach). It forms an implant under the skin known as a “depot”. The “depot” may be felt as a small bump under the sin for about several weeks. As with all addiction, Sublocade is only a part of a complete treatment plan that will also require counseling.
INDICATION AND USAGE
SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by a dose adjustment period for a minimum of seven days.
SUBLOCADE should be used as part of a complete treatment program that includes counseling and psychosocial support.
WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY
• Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life threatening pulmonary emboli, if administered intravenously.
• Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program called the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements.
IMPORTANT SAFETY INFORMATION
Prescription use of this product is limited under the Drug Addiction Treatment Act.
SUBLOCADE should not be administered to patients who have been shown to be hypersensitive to buprenorphine or any component of the ATRIGEL® delivery system
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.
Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE.
Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome is an expected and treatable outcome of prolonged use of opioids during pregnancy.
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
Risk of Opioid Withdrawal With Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately.
Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment.
Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine before injecting SUBLOCADE.
Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect.
Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain.
About Opioid Use Disorder
OUD, commonly referred to as opioid addiction8, is a chronic, relapsing disease that changes the brain9. According to the DSM–5, opioid use disorder is characterized by signs and symptoms that reflect compulsive, prolonged self-administration of opioid substances that are used for no legitimate medical purpose or, if another medical condition is present that requires opioid treatment, they are used in doses greatly in excess of the amount needed for that medical condition13.
Based on 2016 data from the most recent National Survey on Drug Use and Health report, nearly 12 million Americans (age 12+ years) engaged in misuse of opioids in the last year6. Between 1999 and 2014 the rate of deadly opioid overdoses quadrupled14, and in the United States alone, an average of four people die of opioid overdose every hour of every day7. In 2015 opioids accounted for 70 percent of the negative health impact associated with drug use disorders worldwide15. Approximately 2.5 million American adults (age 18+ years old) met criteria for opioid use disorder in the past year10. The same report suggested that 935,000 adults have used heroin in the past year and 471,000 used in the past month. There were approximately 625,000 adults who had a heroin use disorder in the past year6. In a recent report by the White House Council of Economic Advisers, estimated economic costs of the opioid crisis in the U.S. were $504 billion in 201512.
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Dr. Jagodowicz provided this service and has found that treatment with Sublocade can provide a long term solution to gradual withdrawal from opioids with a series of a few injections that are performed in the office setting. The abdominal injection of the Sublocade is relatively painless and results In blockade of the receptor sites for other narcotics such as “Heroin”. With proper counseling, this may offer a solution for some patients with moderate to severe addiction.
For more information, Contact our office at (818) 360-4949
Morris Jagodowicz, M.D.