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Sublocade

Last reviewed on RxList: 4/27/2021
Sublocade Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Sublocade?

Sublocade (buprenorphine extended-release) Injection 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 transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days. Sublocade should be used as part of a complete treatment program that includes counseling and psychosocial support.

What Are Side Effects of Sublocade?

Common side effects of Sublocade include:

  • constipation,
  • headache,
  • nausea,
  • injection site itching or pain,
  • vomiting,
  • increased liver enzymes,
  • and fatigue.

Dosage for Sublocade

The recommended dose of Sublocade is two monthly initial doses of 300 mg followed by 100 mg monthly maintenance doses.

What Drugs, Substances, or Supplements Interact with Sublocade?

Sublocade may interact with:

Tell your doctor all medications and supplements you use.

Sublocade During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Sublocade; it is unknown how it would affect a fetus. Neonatal opioid withdrawal syndrome may occur in newborn infants of mothers who are receiving treatment with Sublocade. Sublocade passes into breast milk in small amounts. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Sublocade.

Additional Information

Our Sublocade (buprenorphine extended-release) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sublocade Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
  • slow heartbeat or weak pulse;
  • blue lips or fingernails;
  • severe constipation;
  • confusion, feelings of extreme happiness;
  • little or no urination; or
  • low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

  • drowsiness;
  • constipation;
  • dizziness, spinning sensation;
  • nausea, vomiting;
  • increased sweating;
  • headache; or
  • blurred vision, double vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sublocade (Buprenorphine Injection for Subcutaneous Use)

Sublocade Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
  • Respiratory and CNS Depression [see WARNINGS AND PRECAUTIONS]
  • Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
  • Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
  • Opioid Withdrawal [see WARNINGS AND PRECAUTIONS]
  • Hepatitis, Hepatic Events [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
  • Elevation of Cerebrospinal Fluid Pressure [see WARNINGS AND PRECAUTIONS]
  • Elevation of Intracholedochal Pressure [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of SUBLOCADE was evaluated in 848 opioid-dependent subjects (see Table 1). In these studies, there was a total of 557 subjects who received at least 6 monthly SC injections of SUBLOCADE and 138 subjects who received 12 monthly SC injections. Adverse events led to premature discontinuation in 4% of the group receiving SUBLOCADE compared with 2% in the placebo group (13-0001, NCT02357901).

In the Phase 3 open-label study (13-0003, NCT02510014), adverse events leading to drug dose reductions were reported in 7.3% of subjects receiving SUBLOCADE.

Table 1: Total Subjects Exposed to SUBLOCADE

Study 13-0001 (NCT02357901) Up to 6 InjectionsStudy 13-0003 (NCT02510014)Total Subjects Exposed To SUBLOCADE
Roll-Over Up to 6 InjectionsDe-Novo Up to 12 Injections
SUBLOCADE 300/100 mgSUBLOCADE 300/300 mgPlaceboFrom SUBLOCADE 300/100 mg To SUBLOCADE 300/Flex†From SUBLOCADE 300/300 mg To SUBLOCADE 300/Flex†From Placebo To SUBLOCADE 300/Flex†SUBLOCADE 300/Flex
N = 203N = 201N = 100*N = 112‡N = 113‡N= 32N = 412N = 848
*Not included in total subjects exposed to SUBLOCADE
† FLEX = 300 mg initial dose with an option to receive either 100 mg or 300 mg for subsequent dosing per clinician's discretion
‡ = Not included in total unique subjects exposed to SUBLOCADE, already accounted for in Study 13-0001 section of table

Table 2 shows the non-injection site-related adverse reactions (ADRs) for the groups receiving SUBLOCADE 300/300 mg (6 doses of 300 mg SC injections) 300/100 mg (300 mg SC injections for the first two doses followed by 4 doses of 100 mg SC injections) and placebo (volume-matched ATRIGEL® delivery system subcutaneous injections) reported following administration in the 6 month, doubleblind, placebo-controlled study. The systemic safety profile for SUBLOCADE, given by a healthcare provider in clinical trials, was consistent with the known safety profile of transmucosal buprenorphine. Common adverse reactions associated with buprenorphine included constipation, nausea, vomiting, abnormal liver enzymes, headache, sedation and somnolence. Dose dependent hepatic effects observed in the Phase 3, double-blind study (13-0001, NCT02357901) included the incidence of ALT more than 3 times the upper limit of normal (> 3 x ULN) in 12.4%, 5.4%, and 4.0% of the SUBLOCADE 300/300-mg, SUBLOCADE 300/100-mg, and placebo groups, respectively. The incidence of AST > 3 x ULN was 11.4%, 7.9%, and 1.0%, respectively. Adverse drug reactions [by MedDRA Preferred Terms (PT)] reported in at least 2% of subjects receiving SUBLOCADE are grouped by System Organ Class (SOC).

Table 2: Adverse Reactions for Phase 3 Double-Blind Study: ≥2% of Subjects Receiving SUBLOCADE

System Organ Class Preferred TermPLACEBO Count(%)SUBLOCADE 300/100 mg Count(%)SUBLOCADE 300/300 mg Count(%)
TotalN = 100N = 203N = 201
Gastrointestinal disorders12 (12%)51 (25.1%)45 (22.4%)
Constipation019 (9.4)16 (8)
Nausea5 (5)18 (8.9)16 (8)
Vomiting4 (4)19 (9.4)11 (5.5)
General disorders and administration site conditions17 (17%)40 (19.7%)49 (24.4%)
Fatigue3 (3)8(3.9)12 (6)
Investigations*2 (2%)21 (10.3%)19 (9.5%)
Alanine aminotransferase increased (ALT)02 (1)10 (5)
Aspartate aminotransferase increased (AST)07 (3.4)9 (4.5)
Blood creatine phosphokinase increased (CPK)1 (1)11 (5.4)5 (2.5)
Gamma-glutamyl transferase increased (GGT)1 (1)6 (3)8 (4)
Nervous system disorders7 (7%)35 (17.2%)25 (12.4%)
Headache6 (6)19 (9.4)17 (8.5)
Sedation07 (3.4)3 (1.5)
Dizziness2 (2)5 (2.5)3 (1.5)
Somnolence010 (4.9)4 (2)
*There were no cases of serious liver injury attributed to study drug.

Table 3 shows the injection site-related adverse events reported by ≥2 subjects in the Phase 3 studies. Most injection site adverse drug reactions (ADRs) were of mild to moderate severity, with one report of severe injection site pruritus. None of the injection site reactions were serious. One reaction, an injection site ulcer, led to study treatment discontinuation.

Table 3: Injection Site Adverse Drug Reactions Reported by ≥2 Subjects in the Phase 3 Studies

Preferred term, n (%)13-0001 (Ph3DB)13-0003 (Ph3OL)All Phase 3*
Roll-overDe-novo
SUBLOCADE 300/300
(N = 201)
SUBLOCADE 300/100
(N = 203)
Placebo
(N = 100)
SUBLOCADE 300 → SUBLOCADE 300/Flex
(N = 113)
SUBLOCADE 100 → SUBLOCADE 300/Flex
(N = 112)
Placebo → SUBLOCADE 300/Flex
(N = 32)
SUBLOCADE 300/Flex
(N = 412)
Total SUBLOCADE
(N = 848)
Subjects with any injection site reactions38 (18.9%)28 (13.8%)9 (9.0%)6 (5.3%)13 (11.6%)2 (6.3%)61 (14.8%)140 (16.5%)
Injection site pain12 (6.0%)10 (4.9%)3 (3.0%)4 (3.5%)2 (1.8%)2 (6.3%)33 (8.0%)61 (7.2%)
Injection site pruritus19 (9.5%)13 (6.4%)4 (4.0%)2 (1.8%)6 (5.4%)1 (3.1%)17 (4.1%)56 (6.6%)
Injection site erythema6 (3.0%)9 (4.4%)01 (0.9%)4 (3.6%)021 (5.1%)40 (4.7%)
Injection site induration2 (1.0%)2 (1.0%)001 (0.9%)07 (1.7%)12 (1.4%)
Injection site bruising2 (1.0%)2 (1.0%)00002 (0.5%)6 (0.7%)
Injection site swelling1 (0.5%)2 (1.0%)01 (0.9%)1 (0.9%)01 (0.2%)6 (0.7%)
Injection site discomfort1 (0.5%)1 (0.5%)00003 (0.7%)5 (0.6%)
Injection site reaction1 (0.5%)0003 (2.7%)01 (0.2%)5 (0.6%)
Injection site cellulitis01 (0.5%)00002 (0.5%)3 (0.4%)
Injection site infection1 (0.5%)01 (1.0%)0002 (0.5%)3 (0.4%)
*Patients received SUBOXONE film for a run-in period before they switched to SUBLOCADE injection.

Longer-Term Experience

In an interim analysis of the ongoing open-label long-term safety study (13-0003), safety was evaluated for up to 12 injections over the course of a year (see Table 1). Adverse events were reported for 432 of 669 subjects during the treatment period. The overall adverse event profile was similar to the doubleblind trial described above.

Postmarketing Experience

The most frequently reported systemic postmarketing adverse event observed with buprenorphine sublingual tablets was drug misuse or abuse. The most frequently reported systemic postmarketing adverse event with buprenorphine/naloxone sublingual tablets and film was peripheral edema.

The following adverse reactions have been identified during post-approval use of buprenorphine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Serotonin Syndrome

Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis

Anaphylaxis has been reported with ingredients contained in SUBLOCADE.

Androgen Deficiency

Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Sublocade (Buprenorphine Injection for Subcutaneous Use)

Related Resources for Sublocade

© Sublocade Patient Information is supplied by Cerner Multum, Inc. and Sublocade Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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