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` Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal
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`syndrome (NOWS) is an expected and treatable outcome of prolonged
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`use of opioids during pregnancy (5.5)
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` Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of
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`corticosteroids, and wean patient off of the opioid. (5.6)
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` Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment is
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`temporarily interrupted or discontinued, monitor patients for withdrawal
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`and treat appropriately. (5.7)
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` Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to
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`initiation and during treatment and evaluate suspected hepatic events.
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`(5.8)
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` Precipitation of Opioid Withdrawal Signs and Symptoms: An opioid
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`withdrawal syndrome is likely to occur with parenteral misuse of
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`SUBOXONE sublingual film by individuals physically dependent on full
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`opioid agonists, or by sublingual or buccal administration before the
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`agonist effects of other opioids have subsided. (5.10)
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` Risk of Overdose in Opioid‐Naïve Patients: SUBOXONE sublingual film is
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`not appropriate as an analgesic. There have been reported deaths of
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`opioid naïve individuals who received a 2 mg sublingual dose. (5.11)
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`‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ADVERSE REACTIONS‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
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`Adverse events commonly observed with the sublingual/buccal
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`administration of the SUBOXONE sublingual film are oral hypoesthesia,
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`glossodynia, oral mucosal erythema, headache, nausea, vomiting,
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`hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia,
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`pain, and peripheral edema. (6)
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`To report SUSPECTED ADVERSE REACTIONS, contact Indivior Inc. at 1‐877‐
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`782‐6966 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch.
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`‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐DRUG INTERACTIONS‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
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` Benzodiazepines: Use caution in prescribing SUBOXONE sublingual film
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`for patients receiving benzodiazepines or other CNS depressants and
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`warn patients against concomitant self‐administration/misuse. (7)
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` CYP3A4Inhibitors and Inducers: Monitor patients starting or ending
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`CYP3A4 inhibitors or inducers for potential over‐ or under‐ dosing. (7)
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` Antiretrovirals: Patients who are on chronic buprenorphine treatment
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`should have their dose monitored if NNRTIs are added to their treatment
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`regimen. Monitor patients taking buprenorphine and atazanavir with and
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`without ritonavir. Dose reduction of buprenorphine may be warranted
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`(7).
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`Serotonergic Drugs: Concomitant use may result in serotonin syndrome.
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`Discontinue SUBOXONE sublingual film if serotonin syndrome is
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`suspected. (7)
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`‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐USE IN SPECIFIC POPULATIONS‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
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`Lactation: Buprenorphine passes into mother’s milk. (8.2)
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`Geriatric Patients: Monitor for sedation and respiratory depression.
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`(8.5)
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` Moderate or Severe Hepatic Impairment: Buprenorphine/naloxone
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`products are not recommended in patients with severe hepatic
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`impairment and may not be appropriate for patients with moderate
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`hepatic impairment. (8.6)
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`See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
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`Revised: 12/2023
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` HIGHLIGHTS OF PRESCRIBING INFORMATION
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` These highlights do not include all the information needed to use
` SUBOXONE sublingual film safely and effectively. See full prescribing
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` information for SUBOXONE sublingual film.
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`SUBOXONE® (buprenorphine and naloxone) sublingual film, for sublingual
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`or buccal use, CIII
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`Initial U.S. Approval: 2002
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`‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐INDICATIONS AND USAGE‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
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`SUBOXONE® sublingual film contains buprenorphine, a partial‐opioid agonist,
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`and naloxone, an opioid antagonist, and is indicated for treatment of opioid
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`dependence. (1)
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`SUBOXONE sublingual film should be used as part of a complete treatment
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`plan that includes counseling and psychosocial support. (1)
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`‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐DOSAGE AND ADMINISTRATION‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
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` Administer SUBOXONE sublingual film as a single daily dose. (2.1)
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` Strongly consider prescribing naloxone at the time SUBOXONE sublingual
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`film is initiated or renewed because patients being treated for opioid use
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`disorder have the potential for relapse, putting them at risk for opioid
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`overdose. (2.2)
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` To avoid precipitating withdrawal, induction with SUBOXONE sublingual
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`film should be undertaken when objective and clear signs of withdrawal
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`are evident and SUBOXONE sublingual film should be administered in
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`divided doses when used as initial treatment. (2.3)
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` For patients dependent on short‐acting opioid products who are in opioid
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`withdrawal; on Day 1, administer up to 8 mg/2 mg SUBOXONE sublingual
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`film (in divided doses). On Day 2, administer up to 16 mg/4 mg of
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`SUBOXONE sublingual film as a single dose. (2.3)
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` For patients dependent on methadone or long‐acting opioid products,
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`induction onto sublingual buprenorphine monotherapy is recommended
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`on Days 1 and 2 of treatment. (2.3)
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` For maintenance treatment, the target dosage of SUBOXONE sublingual
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`film is usually 16 mg/4 mg as a single daily dose. (2.4)
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` Sublingual Administration: Place one film under the tongue, close to the
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`base on the left or right side, and allow to completely dissolve.
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`Buccal Administration: Place one film on the inside of the left or right
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`cheek and allow to completely dissolve. (2.5)
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` SUBOXONE sublingual film must be administered whole. Do not cut,
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`chew, or swallow SUBOXONE sublingual film (2.5)
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` When discontinuing treatment, gradually taper to avoid signs and
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`symptoms of withdrawal. (2.8)
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`‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐DOSAGE FORMS AND STRENGTHS‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
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`Sublingual film:
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`buprenorphine 2 mg/ naloxone 0.5 mg,
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`buprenorphine 4 mg/ naloxone 1 mg,
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`buprenorphine 8 mg/ naloxone 2 mg and
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`buprenorphine 12 mg/ naloxone 3 mg. (3)
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`‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐CONTRAINDICATIONS‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
`Hypersensitivity to buprenorphine or naloxone. (4)
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`‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐WARNINGS AND PRECAUTIONS‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
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` Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar
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`manner to other opioids. Monitor patients for conditions indicative of
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`diversion or progression of opioid dependence and addictive behaviors.
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`Multiple refills should not be prescribed early in treatment or without
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`appropriate patient follow‐up visits. (5.1)
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` Respiratory Depression: Life‐threatening respiratory depression and
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`death have occurred in association with buprenorphine use. Warn
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`patients of the potential danger of self‐administration of benzodiazepines
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`or other CNS depressants while under treatment with SUBOXONE
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`sublingual film. (5.2, 5.3)
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` Unintentional Pediatric Exposure: Store SUBOXONE sublingual film safely
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`out of the sight and reach of children. Buprenorphine can cause severe,
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`possibly fatal, respiratory depression in children. (5.4)
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`Reference ID: 5294257
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`
`DRUG INTERACTIONS
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`USE IN SPECIFIC POPULATIONS
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`8.1
`Pregnancy
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`8.2
`Lactation
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`8.3
`Females and Males of Reproductive Potential
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`8.4
`Pediatric Use
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`8.5 Geriatric Use
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`8.6 Hepatic Impairment
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`8.7
`Renal Impairment
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`DRUG ABUSE AND DEPENDENCE
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`9.1
`Controlled Substance
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`9.2
`Abuse
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`9.3 Dependence
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`OVERDOSAGE
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`DESCRIPTION
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`CLINICAL PHARMACOLOGY
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`12.1 Mechanism of Action
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`12.2 Pharmacodynamics
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`12.3 Pharmacokinetics
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`NONCLINICAL TOXICOLOGY
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`13.1 Carcinogenesis, Mutagenesis, Impairment of
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`Fertility
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`HOW SUPPLIED / STORAGE AND HANDLING
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`PATIENT COUNSELING INFORMATION
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`Storage and Disposal
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`Safe Use
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`*
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`Sections or subsections omitted from the full
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`prescribing information are not listed.
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`7
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`8
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`9
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`10
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`11
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`12
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`13
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`16
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`17
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` FULL PRESCRIBING INFORMATION: CONTENTS*
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`
` 1
` INDICATIONS AND USAGE
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` 2
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` DOSAGE AND ADMINISTRATION
`
` Important Dosage and Administration
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`
` 2.1
` Information
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` Patient Access to Naloxone for the Emergency
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` Treatment of Opioid Overdose
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` 2.3
` Induction
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` 2.4 Maintenance
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` 2.5 Method of Administration
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` 2.6
` Clinical Supervision
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` 2.7 Unstable Patients
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` 2.8 Discontinuing Treatment
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` 2.9
` Switching Between Buprenorphine or
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` Buprenorphine and Naloxone Sublingual Tablets
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` and SUBOXONE Sublingual Film
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` 2.10 Switching Between SUBOXONE Sublingual Film
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` Strengths
` 2.11 Switching Between Sublingual and Buccal Sites
`
` of Administration
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`
` DOSAGE FORMS AND STRENGTHS
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` CONTRAINDICATIONS
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` WARNINGS AND PRECAUTIONS
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` Addiction, Abuse, and Misuse
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`
` 5.1
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`
` 5.2
` Risk of Life‐Threatening Respiratory and Central
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` Nervous System (CNS) Depression
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` 5.3 Managing Risks from Concomitant Use of
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` Benzodiazepines or Other CNS Depressants
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` 5.4 Unintentional Pediatric Exposure
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` 5.5 Neonatal Opioid Withdrawal Syndrome
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` 5.6
` Adrenal Insufficiency
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` 5.7
` Risk of Opioid Withdrawal with Abrupt
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` Discontinuation
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` Risk of Hepatitis, Hepatic Events
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` 5.8
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` 5.9 Hypersensitivity Reactions
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` 5.10 Precipitation of Opioid Withdrawal Signs and
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` Symptoms
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` 5.11 Risk of Overdose in Opioid Naïve Patients
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` 5.12 Use in Patients with Impaired Hepatic Function
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` 5.13 Dental Adverse Events
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` 5.14 QTc Prolongation
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` 5.15
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` Impairment of Ability to Drive or Operate
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` Machinery
` 5.16 Orthostatic Hypotension
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` 5.17 Elevation of Cerebrospinal Fluid Pressure
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` 5.18 Elevation of Intracholedochal Pressure
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` 5.19 Effects in Acute Abdominal Conditions
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` ADVERSE REACTIONS
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` 6.1
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` Clinical Trials Experience
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` 6.2
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` Postmarketing Experience
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` 2.2
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` 3
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` 4
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` 5
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` 6
`
`Reference ID: 5294257
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`
`
`
`
` FULL PRESCRIBING INFORMATION
`
`
`
`
`
` 1
`
`
`
`
` INDICATIONS AND USAGE
`
`
`
`
`
`
`
`
`
` SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should
`
`
`
`
` be used as part of a complete treatment plan that includes counseling and psychosocial support.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` DOSAGE AND ADMINISTRATION
`
`
`
`
` 2
`
`
` 2.1
` Important Dosage and Administration Information
`
`
`
`
`
`
`
`
`
`
` SUBOXONE sublingual film is administered sublingually or buccally as a single daily dose.
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`
`
` Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not
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`
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` advised early in treatment or without appropriate patient follow‐up visits.
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` 2.2
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`
` Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose
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`
` Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and
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` caregiver. Because patients being treated for opioid use disorder have the potential for relapse, putting them
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` at risk for opioid overdose, strongly consider prescribing naloxone for the emergency treatment of opioid
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` overdose, both when initiating and renewing treatment with SUBOXONE sublingual film. Also consider
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` prescribing naloxone if the patient has household members (including children) or other close contacts at risk
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` for accidental ingestion or opioid overdose [see Warnings and Precautions (5.2)].
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`Advise patients and caregivers that naloxone may also be administered for a known or suspected overdose
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`with SUBOXONE sublingual film itself. Higher than normal doses and repeated administration of naloxone may
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`be necessary due to the long duration of action of SUBOXONE sublingual film and its affinity for the mu‐opioid
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`receptor [see Overdosage (10)].
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`Inform patients and caregivers of their options for obtaining naloxone as permitted by individual state
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`naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a
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`pharmacist, or as part of a community‐based program) [see Patient Counseling Information (17)].
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`Induction
`2.3
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`Prior to induction, consideration should be given to the type of opioid dependence (i.e., long‐ or short‐acting
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`opioid products), the time since last opioid use, and the degree or level of opioid dependence.
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`Patients dependent on heroin or other short‐acting opioid products
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`Patients dependent on heroin or other short‐acting opioid products may be inducted with either SUBOXONE
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`sublingual film or with sublingual buprenorphine monotherapy. At treatment initiation, the first dose of
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`SUBOXONE sublingual film should be administered when objective signs of moderate opioid withdrawal appear,
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`not less than six hours after the patient last used opioids.
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`It is recommended that an adequate treatment dose, titrated to clinical effectiveness, be achieved as rapidly as
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`possible. In some studies, a too‐gradual induction over several days led to a high rate of drop‐out of
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`buprenorphine patients during the induction period.
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`On Day 1, an induction dosage of up to 8 mg/2 mg SUBOXONE sublingual film is recommended. Clinicians
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`should start with an initial dose of 2 mg/0.5 mg or 4 mg/1 mg buprenorphine/naloxone and may titrate
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`upwards in 2 or 4 mg increments of buprenorphine, at approximately 2‐hour intervals, under supervision, to
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`8 mg/2 mg buprenorphine/naloxone based on the control of acute withdrawal symptoms.
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`On Day 2, a single daily dose of up to 16 mg/4 mg SUBOXONE sublingual film is recommended.
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`Because the exposure to naloxone is somewhat higher after buccal than after sublingual administration, it is
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`recommended that the sublingual site of administration be used during induction to minimize exposure to
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`Reference ID: 5294257
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` naloxone, to reduce the risk of precipitated withdrawal.
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` Patients dependent on methadone or long‐acting opioid products
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` Patients dependent upon methadone or long‐acting opioid products may be more susceptible to precipitated
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` and prolonged withdrawal during induction than those on short‐acting opioid products.
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` Buprenorphine/naloxone combination products have not been evaluated in adequate and well‐controlled
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` studies for induction in patients who are physically dependent on long‐acting opioid products, and the
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` naloxone in these combination products is absorbed in small amounts by the sublingual route and could cause
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` worse precipitated and prolonged withdrawal. For this reason, buprenorphine monotherapy is recommended
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` in patients taking long‐acting opioids when used according to approved administration instructions. Following
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` induction, the patient may then be transitioned to once‐daily SUBOXONE sublingual film.
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` 2.4 Maintenance
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` For maintenance, SUBOXONE sublingual film may be administered buccally or sublingually.
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` The dosage of SUBOXONE sublingual film from Day 3 onwards should be progressively adjusted in
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` increments/decrements of 2 mg/0.5 mg or 4 mg/1 mg buprenorphine/naloxone to a level that holds the
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` patient in treatment and suppresses opioid withdrawal signs and symptoms.
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` After treatment induction and stabilization, the maintenance dose of SUBOXONE sublingual film is generally
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` in the range of 4 mg/1 mg buprenorphine/naloxone to 24 mg/6 mg buprenorphine/naloxone per day
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` depending on the individual patient and clinical response. The recommended target dosage of SUBOXONE
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` sublingual film during maintenance is 16 mg/4 mg buprenorphine/naloxone/day as a single daily dose.
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` Dosages higher than 24 mg/6 mg daily have not been demonstrated to provide a clinical advantage.
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` When determining the prescription quantity for unsupervised administration, consider the patient’s level of
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`stability, the security of his or her home situation, and other factors likely to affect the ability to manage
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`supplies of take‐home medication.
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` There is no maximum recommended duration of maintenance treatment. Patients may require treatment
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` indefinitely and should continue for as long as patients are benefiting and the use of SUBOXONE sublingual
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` film contributes to the intended treatment goals.
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`2.5 Method of Administration
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`SUBOXONE sublingual film must be administered whole. Do not cut, chew, or swallow SUBOXONE sublingual film.
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`Advise patients not to eat or drink anything until the film is completely dissolved.
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`Sublingual Administration
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`Place one film under the tongue, close to the base on the left or right side. If an additional film is necessary to
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`achieve the prescribed dose, place an additional film sublingually on the opposite side from the first film. Place
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`the film in a manner to minimize overlapping as much as possible. The film must be kept under the tongue until
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`the film is completely dissolved. If a third film is necessary to achieve the prescribed dose, place it under the
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`tongue on either side after the first 2 films have dissolved.
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`Buccal Administration
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`Place one film on the inside of the right or left cheek. If an additional film is necessary to achieve the prescribed
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`dose, place an additional film on the inside of the opposite cheek. The film must be kept on the inside of the
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`cheek until the film is completely dissolved. If a third film is necessary to achieve the prescribed dose, place it on
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`the inside of the right or left cheek after the first two films have dissolved.
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`SUBOXONE sublingual film should NOT be moved after placement.
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`To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of
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`Reference ID: 5294257
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`the product. Proper administration technique should be demonstrated to the patient.
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`Advise patients to do the following after the product has completely dissolved in the oral mucosa: take a sip of
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`water, swish gently around the teeth and gums, and swallow. Advise patients to wait for at least one hour after
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`taking SUBOXONE before brushing teeth [see Warnings and Precautions (5.13), Postmarketing Experience (6.2),
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`Information for Patients (17), and the Medication Guide].
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`Clinical Supervision
`2.6
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`Treatment should be initiated with supervised administration, progressing to unsupervised administration as
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`the patient’s clinical stability permits. SUBOXONE sublingual film is subject to diversion and abuse. When
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`determining the prescription quantity for unsupervised administration, consider the patient’s level of stability,
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`the security of his or her home situation, and other factors likely to affect the ability to manage supplies of
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`take‐home medication.
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`Ideally patients should be seen at reasonable intervals (e.g., at least weekly during the first month of
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`treatment) based upon the individual circumstances of the patient. Medication should be prescribed in
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`consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without
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`appropriate patient follow‐up visits. Periodic assessment is necessary to determine compliance with the dosing
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`regimen, effectiveness of the treatment plan, and overall patient progress.
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`Once a stable dosage has been achieved and patient assessment (e.g., urine drug screening) does not indicate
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`illicit drug use, less frequent follow‐up visits may be appropriate. A once‐monthly visit schedule may be
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`reasonable for patients on a stable dosage of medication who are making progress toward their treatment
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`objectives. Continuation or modification of pharmacotherapy should be based on the healthcare provider’s
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`evaluation of treatment outcomes and objectives such as:
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`1. Absence of medication toxicity.
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`2. Absence of medical or behavioral adverse effects.
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`3. Responsible handling of medications by the patient.
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`4. Patient’s compliance with all elements of the treatment plan (including recovery‐oriented activities,
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`psychotherapy, and/or other psychosocial modalities).
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`5. Abstinence from illicit drug use (including problematic alcohol and/or benzodiazepine use).
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`If treatment goals are not being achieved, the healthcare provider should re‐evaluate the appropriateness of
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`continuing the current treatment.
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`Unstable Patients
`2.7
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`Healthcare providers will need to decide when they cannot appropriately provide further management for
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`particular patients. For example, some patients may be abusing or dependent on various drugs, or
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`unresponsive to psychosocial intervention such that the healthcare provider does not feel that he/she has the
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`expertise to manage the patient. In such cases, the healthcare provider may want to assess whether to refer
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`the patient to a specialist or more intensive behavioral treatment environment. Decisions should be based on a
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`treatment plan established and agreed upon with the patient at the beginning of treatment.
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`Patients who continue to misuse, abuse, or divert buprenorphine products or other opioids should be provided
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`with, or referred to, more intensive and structured treatment.
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`Discontinuing Treatment
`2.8
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`The decision to discontinue therapy with SUBOXONE sublingual film after a period of maintenance should be
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`made as part of a comprehensive treatment plan. Advise patients of the potential to relapse to illicit drug use
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`following discontinuation of opioid agonist/partial agonist medication‐assisted treatment. Taper patients to
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`reduce the occurrence of opioid withdrawal signs and symptoms [See Warnings and Precautions (5.7)].
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`Reference ID: 5294257
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`
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` 2.9
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` Switching Between Buprenorphine or Buprenorphine and Naloxone Sublingual Tablets and
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` SUBOXONE Sublingual Film
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` Patients being switched between buprenorphine and naloxone or buprenorphine only sublingual tablets and
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` SUBOXONE sublingual film should be started on the same dosage of the previously administered product.
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` However, dosage adjustments may be necessary when switching between buprenorphine products. Not all
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` strengths and combinations of the SUBOXONE sublingual films are bioequivalent to SUBOXONE® sublingual
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` tablets as observed in pharmacokinetic studies [see Clinical Pharmacology (12.3)]. Therefore, systemic
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` exposures of buprenorphine and naloxone may be different when patients are switched from tablets to film or
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` vice‐versa. Patients should be monitored for symptoms related to over‐dosing or under‐dosing.
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` Switching Between SUBOXONE Sublingual Film Strengths
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` 2.10
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` As indicated in Table 1, the sizes and the compositions of the four units of SUBOXONE sublingual films, i.e.,
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` 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg and the 12 mg/3 mg units, are different from one another. If patients
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` switch between various combinations of lower and higher strength units of SUBOXONE sublingual films to
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` obtain the same total dose, (e.g., from three 4 mg/1 mg units to a single 12 mg/3 mg unit, or vice‐versa),
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` systemic exposures of buprenorphine and naloxone may be different and patients should be monitored for
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` over‐dosing or under‐dosing. For this reason, pharmacist should not substitute one or more film strengths for
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` another without approval of the prescriber.
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` Table 1. Comparison of Available SUBOXONE Sublingual Film Strengths by Dimensions and Drug
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` Concentrations.
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` SUBOXONE sublingual film unit strength
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` (buprenorphine/naloxone)
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` SUBOXONE sublingual
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` film unit dimensions
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` Buprenorphine
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` Concentration
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` % (w/w)
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` Naloxone
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` Concentration
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` % (w/w)
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` 2 mg/0.5 mg
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` 22.0 mm x 12.8 mm
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` 22.0 mm x 25.6 mm
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` 5.4
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` 5.4
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` 1.53
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` 1.53
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` 4 mg/1 mg
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` (2 times the length of the 2 mg/0.5 mg unit)
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` 8 mg/2 mg
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` 12 mg/3 mg
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` (1.5 times the length of the 8 mg/2 mg unit)
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` 22.0 mm x 12.8 mm
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` 22.0 mm X 19.2 mm
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` 17.2
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` 17.2
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` 4.88
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` 4.88
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` Switching Between Sublingual and Buccal Sites of Administration
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` 2.11
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` The systemic exposure of buprenorphine between buccal and sublingual administration of SUBOXONE
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` sublingual film is similar. Therefore, once induction is complete, patients can switch between buccal and
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` sublingual administration without significant risk of under or overdosing.
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` DOSAGE FORMS AND STRENGTHS
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` 3
` SUBOXONE sublingual film is supplied as an orange rectangular film with a white printed logo in four dosage
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` strengths:
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` Buprenorphine 2 mg/naloxone 0.5 mg,
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` Buprenorphine 4 mg/naloxone 1 mg,
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`Reference ID: 5294257
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` Buprenorphine 8 mg/naloxone 2 mg and
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` Buprenorphine 12 mg/naloxone 3 mg
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` 4
` CONTRAINDICATIONS
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` SUBOXONE sublingual film is contraindicated in patients with a history of hypersensitivity to buprenorphine or
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` naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and
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` Precautions (5.9)].
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` WARNINGS AND PRECAUTIONS
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` 5
` 5.1
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` Addiction, Abuse, and Misuse
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` SUBOXONE sublingual film contains buprenorphine, a schedule III controlled substance that can be abused in a
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` manner similar to other opioids, legal or illicit. Prescribe and dispense buprenorphine with appropriate
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` precautions to minimize risk of misuse, abuse, or diversion, and ensure appropriate protection from theft,
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` including in the home. Clinical monitoring appropriate to the patient’s level of stability is essential. Multiple
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` refills should not be prescribed early in treatment or without appropriate patient follow‐up visits [see Drug
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` Abuse and Dependence (9.2)].
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