Sublocade®/Brixadi™ Informed Consent

Informed Consent to Participate in Treatment with Sublocade® or Brixadi™
What are Sublocade® and Brixadi™?

Sublocade® (buprenorphine extended-release) injection, for subcutaneous use, CIII, is a prescription medicine used to treat adults with moderate to severe opioid addiction (dependence) to opioid drugs (prescription or illegal). It is part of a complete treatment plan that should include counseling.

Brixadi™ (buprenorphine extended-release) injection, for subcutaneous use, is another prescription medicine used similarly to Sublocade® for treating opioid dependence in adults as part of a treatment program that includes counseling.

Both medications are used after receiving an oral transmucosal (under the tongue or inside the cheek) buprenorphine-containing medicine at a dose that controls withdrawal symptoms for at least 7 days.

Important Information About Sublocade® and Brixadi™

Do not take other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants while on Sublocade® or Brixadi™, as it can cause serious side effects, including severe drowsiness, respiratory depression, coma, or death.

Because of the risk of severe harm or death from injecting Sublocade® or Brixadi™ into a vein, both are only available through restricted programs (Sublocade® REMS Program or Brixadi™ Risk Management Program). These medications are not available in retail pharmacies and must be administered by certified healthcare providers.

Pregnancy Warning

Both Sublocade® and Brixadi™ have not been thoroughly studied in pregnant women. Therefore, it is not known if these medications are safe in pregnancy. Your healthcare provider will decide whether the benefits of treatment outweigh any potential risks to your unborn child.

Potential Side Effects / Risks

Like all medicines, Sublocade® and Brixadi™ can cause serious side effects, including allergic reactions such as hives, angioedema, or anaphylaxis. Local symptoms may include slight tenderness, itching, or swelling at the injection site. These reactions usually begin 6 to 12 hours after the injection and can persist for a few days. Immediate allergic reactions such as hives, angioedema, allergic asthma, or systemic anaphylaxis are rare.

In the case of a severe reaction such as high fever, behavioral changes, or flu-like symptoms, please contact your provider and head to the nearest emergency room.

Signs of an allergic reaction can include difficulty breathing, hoarseness, hives, paleness, weakness, a fast heartbeat, or dizziness within a few minutes to a few hours after the injection.
Pre-treatment Questionnaire
1. Have you received treatment with an oral transmucosal (under the tongue or inside the cheek) buprenorphine-containing medicine for at least 7 days? (e.g., Suboxone/buprenorphine films or tablets, Subutex)*

YesNo
2. Have you been taking a dose of buprenorphine that controls cravings and withdrawal symptoms for at least 7 days?*

YesNo
3. Have you ever fainted or felt dizzy after receiving an immunization?

YesNo
4. Are you pregnant, planning to become pregnant, or is there a chance you may be pregnant during the next month?*

YesNo
5. Have you ever received a Sublocade® or Brixadi™ injection before?*

YesNo, skip next section
For Previous Injection Patients:
When did you receive your last SUBLOCADE® injection?

MonthDayYear
Date
Name of your previous clinic/treatment center where you received your last Sublocade® or Brixadi™ injection
Did you experience any adverse reaction(s) to the Sublocade® or Brixadi™ injection?

YesNo
If yes, please list adverse reactions
Are you allergic to latex?

YesNo
Age Disclaimer

Sublocade® and Brixadi™ is intended for adult patients only. You must be 18 years of age or older to receive Sublocade. By signing this consent form, you confirm that you meet the minimum age requirement for treatment with Sublocade® and Brixadi™.
Patient Acknowledgment and Consent

I understand and agree that:
- I acknowledge that I have read the adverse reactions associated with the administration of Sublocade® and Brixadi™
- A copy of the manufacturer's drug information is available on request and/or by visiting the appropriate website (e.g., for Sublocade:Sublocade Patient Brochure; Brixadi: Brixadi Patient Brochure
- I voluntarily choose to proceed with Sublocade® and Brixadi™ treatment and assume full responsibility for any reactions that may result from my receipt of these injections. My medical record may be shared with my physician or other healthcare provider as necessary.
- I understand that I must receive these injections from a certified healthcare provider once per month for treatment to be effective. Certified healthcare providers may include Nurse Practitioners, Physician Assistants, Medical Doctors, Registered Nurses, or Licensed Practical Nurses.
- If I miss my scheduled injection or am more than two weeks late, I may need to restart daily transmucosal buprenorphine/naloxone (e.g., Suboxone) before transitioning back to Sublocade® and Brixadi™, which could carry a risk of relapse.
- I am requesting that Sublocade® and Brixadi™ be administered to me and release Aspire Medical Group and its affiliates, subsidiaries, divisions, directors, contractors, agents, and employees from any and all claims arising from my receipt of the injection.
- I acknowledge that I am a client of the Aspire Medical Group Medication Assisted Treatment (MAT) Program. I have discussed my treatment plan with the treatment team and have had the opportunity to ask questions about Sublocade and Brixadi, which I fully understand, including the associated risks.
- I understand that Aspire Medical Group will use and disclose my personal and health information for treatment, payment, and other healthcare operations, and I have received a copy of the Notice of Privacy Practices.
- By signing this form, I certify that I have read, understand, and agree to all the conditions indicated on the Sublocade® Consent Form. I certify that I have full authority to sign this consent.
- I affirm that I have been provided ample opportunity to seek clarification. I understand and accept the terms of this agreement and am signing this document voluntarily.
Electronic Signatures
By providing my electronic signature below, I agree to the terms and conditions outlined in this agreement. I agree to the use of electronic records and signatures. I acknowledge that I have read the related consumer disclosure.

The parties acknowledge and agree that this financial agreement form may be executed by electronic signature, which shall be considered as an original signature for all purposes and shall have the same force and effect as an original signature. Without limitation, “electronic signature” shall include faxed versions of an original signature or electronically scanned and transmitted versions (e.g., via PDF) of an original signature.
Print Name*

First NameLast Name
Date of Birth*

MonthDayYear
Date
Patient Signature*

Clear
Date Signed*

MonthDayYear
Date
If the patient is not legally competent to provide consent, the signature of legal guardian or representative is required
Signature of Legal Guardian or Representative

Clear
Print Name

First NameLast Name
Date Signed

MonthDayYear
Date
Relationship to Patient (Guardian or Legal Representative)
Should be Empty:

Informed Consent to Participate in Treatment with Sublocade® or Brixadi™

Pre-treatment Questionnaire

For Previous Injection Patients:

Age Disclaimer

Patient Acknowledgment and Consent

Electronic Signatures

If the patient is not legally competent to provide consent, the signature of legal guardian or representative is required