SUBLOCADE 300 mg/1

buprenorphine · SOLUTION · Indivior Inc.

No Recall History

Plain English

SUBLOCADE is a solution containing buprenorphine at 300 mg/1, taken subcutaneous. Manufactured by Indivior Inc..

Key Facts

Brand Name: SUBLOCADE
Generic Name: buprenorphine
NDC Code (Product): 12496-0300
Manufacturer: Indivior Inc.
Strength: 300 mg/1
Dosage Form: SOLUTION
Route: SUBCUTANEOUS
Marketing Status
DEA Schedule: Schedule III (Controlled)
Application #: NDA209819
Drug Class: Partial Opioid Agonist [EPC]
Marketing Start: 02/26/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug dependence4,412 reports

drug withdrawal syndrome2,318 reports

drug abuse2,200 reports

overdose2,175 reports

pain2,050 reports

toxicity to various agents1,589 reports

death1,548 reports

drug ineffective1,512 reports

nausea1,388 reports

emotional distress1,249 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 )

Dosage & Administration

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 recommending or prescribing an opioid overdose reversal agent (e.g., naloxone, nalmefene) 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 maintenanc…

Contraindications

4 CONTRAINDICATIONS SUBLOCADE should not be administered to patients who have been shown to be hypersensitive to buprenorphine or any component of the ATRIGEL ® delivery system [see Warnings and Precautions ( 5.11 )] . Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 5 includes clinically significant drug interactions with SUBLOCADE. Table 5 Clinically Significant Drug Interactions Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. Intervention: Cessation of benzodiazepines or other CNS depressants is preferred in most cases of concomitant use. In some cases, monitoring in a higher level of care for taper may be appropriate. In others, gradually tapering a patient off of a prescribed benzodiazepine or other CNS depressant or decreasing to the lowest effective dose may be appropriate. Similarly, cessation of other CNS depressants is preferred when possible. Before co-prescribing benzodiazepines for anxiety or insomnia, ensure that patients are appropriately diagnosed and consider alternative medications and non-pharmacologic treatments [see Warnings and Precautions ( 5.4 , 5.5 )] . If concomitant use is warranted, strongly consider recommending or prescribing an opioid overdose reversal…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.3 )] Respiratory and CNS Depression [see Warnings and Precautions ( 5.4 )] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.7 )] Adrenal Insufficiency [see Warnings and Precautions ( 5.8 )] Opioid Withdrawal [see Warnings and Precautions ( 5.9 , 5.12 )] Hepatitis, Hepatic Events [see Warnings and Precautions ( 5.10 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.11 )] Orthostatic Hypotension [see Warnings and Precautions ( 5.18 )] Elevation of Cerebrospinal Fluid Pressure [see Warnings and Precautions ( 5.19 )] Elevation of Intracholedochal Pressure [see Warnings and Precautions ( 5.20 )] 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. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Indivior Inc. at 1-877-782-6966 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinic…

Frequently Asked Questions

What is SUBLOCADE used for?

SUBLOCADE contains buprenorphine. It is a solution taken subcutaneous. Consult your doctor for specific uses.

Is SUBLOCADE a controlled substance?

Yes, SUBLOCADE is classified as CIII under the DEA Controlled Substances Act.

What is the generic name for SUBLOCADE?

The generic name for SUBLOCADE is buprenorphine. There are 12 other brand versions of buprenorphine.

What is the NDC code for SUBLOCADE 300 mg/1?

The NDC (National Drug Code) for SUBLOCADE 300 mg/1 is 12496-0300, listed by Indivior Inc..

Product NDC

12496-0300

Package NDC

12496-0300-1

Other Buprenorphine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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