SUBLOCADE buprenorphine 100 mg Solution, 1 pouch

1 INDICATIONS AND USAGE SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support. SUBLOCADE contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

( 1 ) SUBLOCADE should be used as part of a complete treatment program that includes counseling and psychosocial support. ( 1 )

2 DOSAGE AND ADMINISTRATION SUBLOCADE is for healthcare provider preparation and administration only. ( 2.1 ) SUBLOCADE is administered only by subcutaneous injection in the abdomen, thigh, buttock, or back of the upper arm. ( 2.1 ) Strongly consider prescribing naloxone at the time SUBLOCADE is initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose.

( 2.2 ) Patients not currently taking buprenorphine should receive an initial dose (e.g. 4 mg) of transmucosal buprenorphine before administering the first injection of SUBLOCADE. Monitor patients in a healthcare setting after injection with SUBLOCADE to assess for symptoms of worsening withdrawal or sedation.

Patients' symptoms should be stable or improving prior to release from the healthcare setting. ( 2.3 ) The second injection of SUBLOCADE may be administered as early as one week after the first injection. ( 2.3 ) Injection sites should be rotated between doses.

( 2.3 ) The recommended dose of SUBLOCADE is two initial doses of 300 mg followed by 100 mg monthly maintenance doses. ( 2.3 ) Increasing the maintenance dose to 300 mg monthly may be considered for patients in which the benefits outweigh the risks. ( 2.3 ) Examine the injection site for signs of infection or evidence of tampering or attempts to remove the depot.

( 2.4 ) See Full Prescribing Information for administration instructions. ( 2.5 )

2.1Important Dosing and Administration Information FOR SUBCUTANEOUS INJECTION ONLY. DO NOT ADMINISTER SUBLOCADE INTRAVENOUSLY, INTRAMUSCULARLY OR INTRADERMALLY [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.1 , 5.6 )] . SUBLOCADE is for healthcare provider preparation and administration only.

SUBLOCADE must be injected into the subcutaneous tissue of the abdomen, thigh, buttock, or back of the upper arm. Patients not currently taking buprenorphine should receive an initial dose (e.g. 4 mg) of transmucosal buprenorphine before administering the first injection of SUBLOCADE.

Monitor patients in a healthcare setting after injection with SUBLOCADE to assess for symptoms of worsening withdrawal or sedation. Patients' symptoms should be stable or improving prior to release from the healthcare setting. The second injection of SUBLOCADE may be administered as early as one week after the first injection.

Injection sites should be rotated between doses. Administer maintenance injections at least 26 days apart. A patient who misses a maintenance dose should receive the next dose as soon as possible.

Administer each injection only using the syringe and safety needle included with the product [see Dosage and Administration ( 2.5 )] .

2.2Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver. Because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose, strongly consider prescribing naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with SUBLOCADE. Also consider prescribing naloxone if the patient has household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose [see Warnings and Precautions ( 5.4 )] .

Advise patients and caregivers that naloxone may also be administered for a known or suspected overdose with buprenorphine itself. Higher than normal doses and repeated administration of naloxone may be necessary due to the long duration of action of buprenorphine and its affinity for the mu-opioid receptor [see Overdosage ( 10 )] . Inform patients and caregivers of their options for obtaining naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based p…

3 DOSAGE FORMS AND STRENGTHS SUBLOCADE injection is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each injection is a sterile, clear, colorless to yellow to amber solution provided in a single-dose, prefilled syringe with a 19 gauge 5/8-inch needle. Injection: 100 mg/0.5 mL and 300 mg/1.5 mL provided in a prefilled, single-dose syringe with a 19 Gauge 5/8-inch needle. ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). SUBLOCADE Risk Evaluation and Mitigation Strategy (REMS) Advise patients that because of the risk of serious harm or death due to intravenous self-administration, SUBLOCADE is available only through a restricted program called the SUBLOCADE REMS Program. Healthcare settings and pharmacies are certified and only dispense SUBLOCADE directly to a healthcare provider for administration by healthcare providers [see Warnings and Precautions ( 5.2 )] .

Life Threatening Respiratory Depression Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions 5.4 )] . Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Because patients being treated for opioid use disorder are at risk for relapse, discuss the importance of having access to naloxone with the patient and caregiver.

Also discuss the importance of having access to naloxone if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose. Inform patients and caregivers of the options for obtaining naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program). Educate patients and caregivers on how to recognize the signs and symptoms of an opioid overdose.

Explain to patients and caregivers that naloxone's effects are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered. Repeat administration may be necessary, particularly for overdose involving buprenorphine, because naloxone is often not effective at the doses available for patient access [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.4 ), Overdosage ( 10 )] . If naloxone is prescribed, also advise patients and caregivers: How to treat with naloxone in the event of an opioid overdose To tell family and friends about their naloxone and to keep it in a place where family and friends can easily access it in an emergency To read the Patient Information (or other educational material) that will come with their naloxone.

Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do Interaction With Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if SUBLOCADE is used with benzodiazepines or other CNS depressants, including alcohol. Counsel patients that such medications should not be used concomitantly unless supervised by a healthcare provider [see Warnings and Precautions ( 5.4 , 5.5 ), Drug Interactions ( 7 )].

Serotonin Syndrome Inform patients that SUBLOCADE could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications [see Drug Interactions ( 7 )].

Adrenal Insufficiency Inform patients that SUBLOCADE could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions ( 5.8 )].

Anaphylaxis Inform patients that anaphylaxis has been reported with buprenorphine. Advise patients how…

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 02/2025 MEDICATION GUIDE SUBLOCADE (SUB-lo-kade) (buprenorphine extended-release) injection, for subcutaneous use, (CIII) What is the most important information I should know about SUBLOCADE?

Because of the serious risk of potential harm or death from self-injecting SUBLOCADE into a vein (intravenously), it is only available through a restricted program called the SUBLOCADE REMS Program. SUBLOCADE is not available in retail pharmacies. Your SUBLOCADE injection will only be given to you by a certified healthcare provider.

SUBLOCADE contains a medicine called buprenorphine. Buprenorphine is an opioid that can cause serious and life-threatening breathing problems, especially if you take or use certain other medicines or drugs. Talk to your healthcare provider about naloxone.

Naloxone is a medicine that is available to people for the emergency treatment of an opioid overdose. If naloxone is given, you must call 911 or get emergency medical help right away to treat overdose or accidental use of an opioid. SUBLOCADE may cause serious and life-threatening breathing problems.

Get emergency medical help right away if you : feel faint feel dizzy are confused feel sleepy or uncoordinated have blurred vision have slurred speech are breathing slower than normal cannot think well or clearly Do not take SUBLOCADE with certain medicines. Taking SUBLOCADE with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. In an emergency, have family members tell emergency department staff that you are physically dependent on an opioid and are being treated with SUBLOCADE.

You may have detectable levels of SUBLOCADE in your body for several months after stopping treatment with SUBLOCADE. What is SUBLOCADE? SUBLOCADE is a prescription medicine used to treat adults with moderate to severe addiction (dependence) to opioid drugs (prescription or illegal) who: have started treatment with a single dose of a buprenorphine medicine in the form of a sublingual tablet or buccal film (transmucosal) or are already being treated with buprenorphine.

SUBLOCADE is part of a complete treatment plan that should include counseling and psychosocial support. Who should not receive SUBLOCADE? Do not receive SUBLOCADE if you are allergic to buprenorphine or any ingredients in the prefilled syringe (ATRIGEL® delivery system).

See the end of this Medication Guide for a list of ingredients in SUBLOCADE. Before receiving SUBLOCADE, tell your healthcare provider about all your medical conditions, including if you have: trouble breathing or lung problems a curve in your spine that affects your breathing Addison's disease an enlarged prostate (men) problems urinating liver, kidney, or gallbladder problems alcoholism a head injury or brain problem mental health problems adrenal gland or thyroid gland problems Tell your healthcare provider if you are: pregnant or plan to become pregnant.

If you receive SUBLOCADE while pregnant, your baby may have symptoms of opioid withdrawal at birth that could be life-threatening if not recognized and treated. Talk to your healthcare provider if you are pregnant or plan to become pregnant. breastfeeding or plan to breastfeed. SUBLOCADE can pass into your breast milk and harm your baby.

Talk to your healthcare provider about the best way to feed your baby during treatment with SUBLOCADE. Monitor your baby for increased drowsiness and breathing problems if you breastfeed during treatment with SUBLOCADE. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Talk with your healthcare provider before starting any new medicines during or after stopping treatment with SUBLOCADE. How will I receive SUBLOCADE? You will rec…