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:
- injection site itching or pain,
- 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:
- other central nervous system depressants (alcohol, non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids),
- macrolide antibiotics,
- azole antifungals,
- protease inhibitors,
- selective serotonin reuptake inhibitors (SSRIs),
- serotonin and norepinephrine reuptake inhibitors (SNRIs),
- tricyclic antidepressants (TCAs),
- 5-HT3 receptor antagonists,
- drugs that affect the serotonin neurotransmitter system,
- monoamine oxidase inhibitors (MAOIs),
- muscle relaxants,
- and anticholinergic drugs.
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.
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.
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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:
- 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)
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 2). 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 2: Total Subjects Exposed to SUBLOCADE
|Study 13-0001 (NCT02357901) Up to 6 Injections||Study 13-0003 (NCT02510014)||Total Subjects Exposed To SUBLOCADE|
|Roll-Over Up to 6 Injections||De-Novo Up to 12 Injections|
|SUBLOCADE 300/100 mg||SUBLOCADE 300/300 mg||Placebo||From 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 = 203||N = 201||N = 100*||N = 112‡||N = 113‡||N= 32||N = 412||N = 848|
|*Not included in total subjects exposed to SUBLOCADE
† FLEX = 300 mg inial dose with an opon to receive either 100 mg or 300 mg for subsequent dosing per clinician's discreon
‡ = Not included in total unique subjects exposed to SUBLOCADE, already accounted for in Study 13-0001 section of table
Table 3 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, double-blind, 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 3: Adverse Reactions for Phase 3 Double-Blind Study: ≥2% of Subjects Receiving SUBLOCADE
|System Organ Class Preferred Term||PLACEBO Count(%)||SUBLOCADE 300/100 mg Count(%)||SUBLOCADE 300/300 mg Count(%)|
|Total||N = 100||N = 203||N = 201|
|Gastrointestinal disorders||12 (12%)||51 (25.1%)||45 (22.4%)|
|Constipation||0||19 (9.4)||16 (8)|
|Nausea||5 (5)||18 (8.9)||16 (8)|
|Vomiting||4 (4)||19 (9.4)||11 (5.5)|
|General disorders and administration site conditions||17 (17%)||40 (19.7%)||49 (24.4%)|
|Fatigue||3 (3)||8 (3.9)||12 (6)|
|Investigations*||2 (2%)||21 (10.3%)||19 (9.5%)|
|Alanine aminotransferase increased (ALT)||0||2 (1)||10 (5)|
|Aspartate aminotransferase increased (AST)||0||7 (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 disorders||7 (7%)||35 (17.2%)||25 (12.4%)|
|Headache||6 (6)||19 (9.4)||17 (8.5)|
|Sedation||0||7 (3.4)||3 (1.5)|
|Dizziness||2 (2)||5 (2.5)||3 (1.5)|
|Somnolence||0||10 (4.9)||4 (2)|
|*There were no cases of serious liver injury attributed to study drug.|
Table 4 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 4: 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*|
(N = 201)
(N = 203)
(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 reactions||38 (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 pain||12 (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 pruritus||19 (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 erythema||6 (3.0%)||9 (4.4%)||0||1 (0.9%)||4 (3.6%)||0||21 (5.1%)||40 (4.7%)|
|Injection site induration||2 (1.0%)||2 (1.0%)||0||0||1 (0.9%)||0||7 (1.7%)||12 (1.4%)|
|Injection site bruising||2 (1.0%)||2 (1.0%)||0||0||0||0||2 (0.5%)||6 (0.7%)|
|Injection site swelling||1 (0.5%)||2 (1.0%)||0||1 (0.9%)||1 (0.9%)||0||1 (0.2%)||6 (0.7%)|
|Injection site discomfort||1 (0.5%)||1 (0.5%)||0||0||0||0||3 (0.7%)||5 (0.6%)|
|Injection site reaction||1 (0.5%)||0||0||0||3 (2.7%)||0||1 (0.2%)||5 (0.6%)|
|Injection site cellulitis||0||1 (0.5%)||0||0||0||0||2 (0.5%)||3 (0.4%)|
|Injection site infection||1 (0.5%)||0||1 (1.0%)||0||0||0||2 (0.5%)||3 (0.4%)|
|*Patients received SUBOXONE film for a run-in period before they switched to SUBLOCADE injection.|
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 2). Adverse events were reported for 432 of 669 subjects during the treatment period. The overall adverse event profile was similar to the double-blind trial described above.
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].
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].
If concomitant use is warranted, strongly consider prescribing naloxone for the emergency treatment of opioid overdose, as is recommended for all patients in treatment for opioid use disorder [see WARNINGS AND PRECAUTIONS].
|Examples:||Alcohol, benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids.|
|Inhibitors of CYP3A4|
|Clinical Impact:||The effects of co-administered CYP3A4 inhibitors on buprenorphine exposure in subjects treated with SUBLOCADE have not been studied and the effects may be dependent on the route of administration; however, such interactions have been established in studies using transmucosal buprenorphine. Buprenorphine is metabolized to norbuprenorphine primarily by CYP3A4; therefore, potential interactions may occur when SUBLOCADE is given concurrently with agents that affect CYP3A4 activity.
The concomitant use of sublingual buprenorphine and CYP3A4 inhibitors (e.g., ketoconazole) can increase the plasma concentration of buprenorphine, resulting in increased or prolonged opioid effects.
|Intervention:||Patients who transfer to SUBLOCADE treatment from a regimen of transmucosal buprenorphine used concomitantly with CYP3A4 inhibitors [e.g., azole antifungals such as ketoconazole, macrolide antibiotics such as erythromycin, and HIV protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)] should be monitored to ensure that the plasma buprenorphine level provided by SUBLOCADE is adequate. If patients already on SUBLOCADE require newly-initiated treatment with CYP3A4 inhibitors, the patients should be monitored for signs and symptoms of over-medication. Within 2 weeks of SUBLOCADE administration, if signs and symptoms of buprenorphine toxicity or overdose occur but the concomitant medication cannot be reduced or discontinued, it may be necessary to remove the depot and treat the patient with a formulation of buprenorphine that permits dose adjustments. Conversely, if a patient has been stabilized on SUBLOCADE in the setting of concomitant medication that is a CYP3A4 inhibitor, and the concomitant medication is discontinued, the patient should be monitored for withdrawal. If the dose of SUBLOCADE is not adequate in the absence of the concomitant medication, that patient should be transitioned back to a formulation of buprenorphine that permits dose adjustments.|
|Examples:||Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir)|
|Clinical Impact:||The effects of co-administered CYP3A4 inducers on buprenorphine exposure in subjects treated with SUBLOCADE have not been studied.
Buprenorphine is metabolized to norbuprenorphine primarily by CYP3A4; therefore, potential interactions may occur when SUBLOCADE is given concurrently with agents that affect CYP3A4 activity.
CYP3A4 inducers may induce the metabolism of buprenorphine and, therefore, may cause increased clearance of the drug which could lead to a decrease in buprenorphine plasma concentrations, lack of efficacy or, possibly, development of an abstinence syndrome.
|Intervention:||Patients who transfer to SUBLOCADE treatment from a regimen of transmucosal buprenorphine used concomitantly with CYP3A4 inducers should be monitored to ensure that the plasma buprenorphine level provided by SUBLOCADE is adequate. If patients already on SUBLOCADE require newly-initiated treatment with CYP3A4 inducers, the patients should be monitored for withdrawal. If the dose of SUBLOCADE is not adequate in the absence of the concomitant medication, and the concomitant medication cannot be reduced or discontinued, that patient should be transitioned back to a formulation of buprenorphine that permits dose adjustments. Conversely, if a patient has been stabilized on SUBLOCADE in the setting of concomitant medication that is a CYP3A4 inducer, and the concomitant medication is discontinued, the patient should be monitored for signs and symptoms of over-medication. Within 2 weeks of SUBLOCADE administration, if the dose provided by SUBLOCADE is excessive in the absence of the concomitant inducer, it may be necessary to remove the SUBLOCADE and treat the patient with a formulation of buprenorphine that permits dose adjustments [see CLINICAL PHARMACOLOGY].|
|Examples:||Rifampin, carbamazepine, phenytoin, phenobarbital|
|Antiretrovirals: Non-nucleoside reverse transcriptase inhibitors (NNRTIs)|
|Clinical Impact:||Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are metabolized principally by CYP3A4. Efavirenz, nevirapine, and etravirine are known CYP3A inducers, whereas delavirdine is a CYP3A inhibitor. Significant pharmacokinetic interactions between NNRTIs (e.g., efavirenz and delavirdine) and sublingual buprenorphine have been shown in clinical studies, but these pharmacokinetic interactions did not result in any significant pharmacodynamic effects.|
|Intervention:||Patients who are on chronic treatment with SUBLOCADE should be monitored for increase or decrease in therapeutic effects if NNRTIs are added to their treatment regimen.|
|Examples:||Efavirenz, nevirapine, etravirine, delavirdine|
|Antiretrovirals: Protease inhibitors (PIs)|
|Clinical Impact:||Studies have shown some antiretroviral protease inhibitors (PIs) with CYP3A4 inhibitory activity (nelfinavir, lopinavir/ritonavir, ritonavir) have little effect on sublingual buprenorphine pharmacokinetic and no significant pharmacodynamic effects. Other PIs with CYP3A4 inhibitory activity (atazanavir and atazanavir/ritonavir) resulted in elevated levels of buprenorphine and norbuprenorphine after sublingual administration, and patients in one study reported increased sedation. Symptoms of opioid excess have been found in postmarketing reports of patients receiving sublingual buprenorphine and atazanavir with and without ritonavir concomitantly.|
|Intervention:||If treatment with atazanavir with and without ritonavir must be initiated in a patient already treated with SUBLOCADE, the patient should be monitored for signs and symptoms of over-medication. It may be necessary to remove the depot and treat the patient with a sublingual buprenorphine product that permits rapid dose adjustments.|
|Antiretrovirals: Nucleoside reverse transcriptase inhibitors (NRTIs)|
|Clinical Impact:||Nucleoside reverse transcriptase inhibitors (NRTIs) do not appear to induce or inhibit the P450 enzyme pathway, thus no interactions with buprenorphine are expected.|
|Clinical Impact:||The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.|
|Intervention:||If concomitant use is warranted, carefully monitor the patient for signs and symptoms of serotonin syndrome, particularly during treatment initiation, and during dose adjustment of the serotonergic drug.|
|Examples:||Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).|
|Monoamine Oxidase Inhibitors (MAOIs)|
|Clinical Impact:||MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma).|
|Intervention:||The use of SUBLOCADE is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.|
|Examples:||Phenelzine, tranylcypromine, linezolid|
|Clinical Impact:||Buprenorphine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.|
|Intervention:||Monitor patients receiving muscle relaxants and SUBLOCADE for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of the muscle relaxant as necessary. Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids, strongly consider prescribing naloxone for the emergency treatment of opioid overdose [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].|
|Clinical Impact:||Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.|
|Intervention:||Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.|
|Clinical Impact:||The concomitant use of anticholinergic drugs may increase the risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.|
|Intervention:||Monitor patients for signs of urinary retention or reduced gastric motility when SUBLOCADE is used concomitantly with anticholinergic drugs.|
Drug Abuse And Dependence
SUBLOCADE contains buprenorphine, a Schedule III substance under the Controlled Substances Act.
Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.
SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused similar to other opioids. Patients who continue to misuse, abuse, or divert buprenorphine products or other opioids should be provided with or referred for more intensive and structured treatment. Abuse of buprenorphine poses a risk of overdose and death. This risk is increased with the abuse of buprenorphine and alcohol and other substances, especially benzodiazepines.
SUBLOCADE is distributed through a restricted distribution system, which is intended to prevent the direct distribution to a patient. SUBLOCADE should only be dispensed directly to a healthcare provider for administration by a healthcare provider. It is supplied in prefilled syringes and is intended for administration only by subcutaneous injection by a healthcare provider. The entire contents of the prefilled syringe should be administered. After administration, a small amount (approximately 0.1 mL) of SUBLOCADE will remain in the needle and syringe and should be properly disposed of [see HOW SUPPLIED/Storage And Handling].
SUBLOCADE is injected as a liquid, and the subsequent precipitation of the poly (DL-lactide-co-glycolide) polymer creates a solid depot which contains buprenorphine. After initial formation of the depot, buprenorphine is released via diffusion from, and the biodegradation of, the depot. Clinical monitoring for evidence at the injection site of tampering or attempting to remove the depot should be ongoing throughout treatment. No accounts of subjects removing or attempting to remove the depot after administration of SUBLOCADE were reported in premarketing studies.
Buprenorphine is a partial agonist at the mu-opioid receptor and chronic administration produces physical dependence of the opioid type, characterized by moderate withdrawal signs and symptoms upon abrupt discontinuation. The withdrawal syndrome is typically milder than seen with full agonists and may be delayed in onset [see WARNINGS AND PRECAUTIONS].
Due to the long-acting nature of SUBLOCADE, withdrawal signs and symptoms may not be evident immediately following the discontinuation of treatment.
Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy [see WARNINGS AND PRECAUTIONS].
Read the entire FDA prescribing information for Sublocade (Buprenorphine Injection for Subcutaneous Use)
© 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.