Sublocade Dosage

Generic name: BUPRENORPHINE 100mg
Dosage form: subcutaneous injection

Medically reviewed by Drugs.com. Last updated on Feb 28, 2025.

Important Dosing and Administration Information

FOR SUBCUTANEOUS INJECTION ONLY. DO NOT ADMINISTER SUBLOCADE INTRAVENOUSLY, INTRAMUSCULARLY OR INTRADERMALLY.

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.

Patient 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.

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.

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 program).

Recommended Dosage

Induction in patients not already receiving buprenorphine

Treatment with buprenorphine should be initiated when objective and clear signs of opioid withdrawal are evident in order to minimize the risk of precipitating withdrawal.

Patients should receive an initial dose (e.g. 4 mg) of transmucosal buprenorphine and be observed for one hour to confirm tolerability before administering the first injection of SUBLOCADE. The recommended starting dose of SUBLOCADE is 300 mg. 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. On induction day, up to an additional 8 mg of transmucosal buprenorphine could be administered to manage withdrawal symptoms.

The recommended dose for the second injection is 300 mg. The second injection may be administered as early as 1 week and up to 1 month after the initial injection, based on patient need.

Transition of patients already receiving transmucosal buprenorphine

Patients who have been on 8 mg to 24 mg daily of transmucosal buprenorphine may be transitioned directly to the recommended starting dose of 300 mg of SUBLOCADE. The recommended dose for the second injection is 300 mg. The second injection may be administered as early as 1 week and up to 1 month after the initial injection, based on patient need.

Patients established on long-term treatment and whose symptoms are controlled with 8 mg to 18 mg daily of transmucosal buprenorphine may receive 100 mg of SUBLOCADE as their second dose if symptoms remain controlled following the initial dose of 300 mg.

Maintenance dosage

After the first two injections, the recommended maintenance dosage of SUBLOCADE is 100 mg monthly. A monthly maintenance dosage of 300 mg may be considered in patients who tolerate 100 mg of SUBLOCADE monthly, but do not demonstrate a satisfactory clinical response. Maintenance doses should be administered with at least 26 days between injections.

Table 1 Recommended Dosing Schedule
TM BUP, transmucosal buprenorphine; NA, not applicable
a The second injection may be administered as early as 1 week and up to 1 month after the initial injection based on patient need.
b A monthly maintenance dosage of 300 mg may be considered in patients who tolerate SUBLOCADE, but do not demonstrate a satisfactory clinical response.
c On induction day, additional transmucosal buprenorphine may be administered as needed to manage withdrawal symptoms. Monitor patients for 1 hour to confirm tolerability before administering the first injection of SUBLOCADE.
d Patients established on long-term treatment and whose symptoms are controlled with 8 mg to 18 mg daily of transmucosal buprenorphine may receive 100 mg of SUBLOCADE as their second dose if symptoms remain controlled following the initial dose of 300 mg.
Previous Dose of TM BUP	TM BUP	SUBLOCADE
	Initial Dose	Injection #1	Injection #2a	Maintenance Doseb
Initiation in patients not already receiving buprenorphine
NA	4 mgc	300 mg	300 mg	100 mg
Transition of patients already receiving transmucosal buprenorphine
8 – 24 mg/day	NA	300 mg	300 mgd	100 mg

Missed doses

A patient who misses a maintenance dose should receive the next dose as soon as possible, with the following dose given at least 26 days later. Occasional delays in dosing up to 2 weeks are not expected to have a clinically significant impact on treatment effect.

For patients in established treatment of 100 mg monthly, there may be instances when allowance for a two-month dosing interval may be appropriate (e.g., extended travel); in those instances, a single 300 mg dose may be given to cover a two-month period. Thereafter, the 100 mg monthly regimen would resume. Patients should be cautioned that the peak plasma level after injection of a 300 mg dose will be higher than their usual monthly dose and that they may experience sedation or other buprenorphine- related effects.

Clinical Supervision

Periodic assessment is necessary to determine effectiveness of the treatment plan and overall patient progress. When evaluating the patient, examine the injection site for signs of infection or evidence of tampering or attempts to remove the depot.

Due to the chronic nature of opioid use disorder, the need for continuing medication-assisted treatment should be re-evaluated periodically. There is no maximum recommended duration of maintenance treatment. For some patients, treatment may continue indefinitely. If considering stopping treatment, the clinical status of the patient should be considered.

If SUBLOCADE is discontinued, its extended-release characteristics should be considered and the patient should be monitored for several months for signs and symptoms of withdrawal and treated appropriately. After steady-state has been achieved (4-6 months), patients discontinuing SUBLOCADE may have detectable plasma and urine levels of buprenorphine for twelve months or longer.

Instructions for Use

IMPORTANT INFORMATION:

For subcutaneous injection only. Do not inject intravenously, intramuscularly, or intradermally.
To be prepared and administered by a healthcare provider only.
Read the instructions carefully before handling the product.
As a universal precaution, always wear gloves.
SUBLOCADE must be injected into the subcutaneous tissue of the abdomen, thigh, buttock, or back of the upper arm.
Remove SUBLOCADE from the refrigerator prior to administration. The product requires at least 15 minutes to reach room temperature. Do not open the foil pouch until the patient has arrived for his or her injection.
Discard SUBLOCADE if left at room temperature for longer than 12 weeks.
Do not attach the needle until time of administration.

STEP 1: GETTING READY

Remove the foil pouch and safety needle from the carton. Open the pouch and remove the syringe.

Discard the oxygen absorber pack. It is not needed.

Figure 1

STEP 2: CHECK THE LIQUID CLARITY

Check that the medication does not contain contaminants or particles. SUBLOCADE ranges from colorless to yellow to amber. Variations of color within this range do not affect the potency of the product.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Figure 2

STEP 3: ATTACH THE SAFETY NEEDLE

Remove the cap from the syringe and the safety needle supplied in the carton from its sterile package.

Gently twist the needle clockwise until it is tight and firmly attached.

Do not remove the plastic cover from the needle.

Figure 3

STEP 4: PREPARE THE INJECTION SITE

Choose one of the following body regions for subcutaneous injection (see Figure 4):

Abdomen between the transpyloric and transtubercular planes
Back of the upper arm
Buttock
Thigh

Ensure that the selected injection site has adequate subcutaneous tissue that is free of skin conditions (e.g., nodules, lesions, excessive pigment).

Do not inject into an area where the skin is irritated, reddened, bruised, infected or scarred in any way.

To avoid irritation, rotate injection sites.

Clean the injection site well with an alcohol swab.

Figure 4

STEP 5: REMOVE EXCESS AIR FROM SYRINGE

Hold the syringe upright for several seconds to allow air bubbles to rise. Due to the viscous nature of the medication, bubbles will not rise as quickly as those in an aqueous solution.

Remove needle cover and slowly depress the plunger to push out the excess air from the syringe.

Small bubbles may remain in the medication. Large air gaps, however, can be minimized by pulling back on the plunger rod to pop air bubbles prior to expelling the air very slowly. Air should be expelled very carefully to avoid loss of medication.

If medication is seen at the needle tip, pull back slightly on the plunger to prevent medication spillage.

Figure 5

STEP 6: PINCH THE INJECTION SITE

Pinch the skin around the injection area. Be sure to pinch enough skin to accommodate the size of the needle. Lift the adipose tissue from the underlying muscle to prevent accidental intramuscular injection.

Figure 6

STEP 7: INJECT THE MEDICATION

SUBLOCADE is for subcutaneous injection only. Do not inject intravenously, intramuscularly, or intradermally.

Insert needle fully into the subcutaneous tissue. Actual angle of injection will depend on the amount of subcutaneous tissue.

Use a slow, steady push to inject the medication. Continue pushing until all of the medication is given.

Figure 7

STEP 8: WITHDRAW THE NEEDLE

Withdraw the needle at the same angle used for insertion and release the pinched skin.

Do not rub the injection area after the injection. There may be a small amount of blood or fluid at the injection site; wipe with a cotton ball or gauze before applying a gauze pad or bandage using minimal pressure.

Figure 8

STEP 9: LOCK THE NEEDLE GUARD AND DISCARD THE SYRINGE

Lock the needle guard into place by pushing it against a hard surface such as a table (Figure 9).

Dispose of all syringe components in a secure sharps disposal container.

Figure 9

STEP 10: INSTRUCT THE PATIENT

Advise the patient that they may have a lump for several weeks that will decrease in size over time. Instruct the patient not to rub or massage the injection site and to be aware of the placement of any restrictive clothing, such as belts, waistbands, or sleeves.

Limits on Distribution

SUBLOCADE is subject to a risk evaluation and mitigation strategy (REMS) program that includes, among other elements, a restricted distribution system. The purpose of the restricted distribution system is to ensure that SUBLOCADE is only administered by a health care provider.

Removal of the Depot

In the event the depot must be removed, it can be surgically excised under local anesthesia within 14 days of injection. Only the most recently-injected depot can be removed.

The removed depot should be handled with adequate security, accountability, and proper disposal, per facility procedure for a Schedule III drug product and pharmaceutical biohazardous waste, and per applicable federal, state, and local regulations.

The residual plasma concentrations from previous injections will decrease gradually over subsequent months.

Patients who have the depot removed should be monitored for signs and symptoms of withdrawal and treated appropriately.