Vivitrol® Consent

Informed Consent to Participate in Treatment with Vivitrol®
What is VIVITROL®?

VIVITROL® is a prescription injectable extended-release, microsphere formulation of naltrexone used to treat alcohol & opioid dependence, after opioid detoxification.
Important:
- You should stop drinking alcohol and stop using opioids or opioid-containing medicines before starting Vivitrol.
- Vivitrol should be combined with other recovery programs such as counseling.
- Vivitrol may not work for everyone.
- Inform any healthcare provider treating you that you are receiving Vivitrol injections, especially if you need pain, cough, or diarrhea medications containing opioids.
How will I receive Vivitrol?
- Vivitrol is administered as an injection by a healthcare provider into a muscle in your buttocks using a special needle once every 3-4 weeks, depending on your treatment plan.
- After the injection, Vivitrol remains in your body for one month and cannot be removed.
Patient Information
Patient Name

First NameLast Name
Date of Birth

MonthDayYear
Date
Contact Number
Please enter a valid phone number.
Email
example@example.com
Address

Street Address

Street Address Line 2

CityState / Province

Postal / Zip Code
Primary Care Provider (PCP)
Medical History
Height (inches)
Weight (pounds)
Do you have any allergies? (If yes, please list them)
List all current supplements, OTC & prescription medications, dose and and how often you take them*
Current medical problems
Pre-treatment Questionnaire
1. Have you received a Vivitrol® injection before? Skip Question 2 & 3 if you answer NO*

YesNo
2. When did you receive your last Vivitrol® injection?

MonthDayYear
Skip if you answered NO to question 1
3. Name of your previous clinic/treatment center where you received your last VIVITROL® injection
skip if you answered NO to question 1
4. Have you used opiates, buprenorphine, or methadone within the last 14 days?*

YesNo
5. Are you currently experiencing acute opioid withdrawal?

YesNo
6. Have you used alcohol within the last 24 hours?*

YesNo
7. Have you failed the naloxone challenge test before?*

YesNo
8. Have you exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent?*

YesNo
9. Have you ever been diagnosed with Hepatitis, liver cirrhosis, or other liver problems?*

YesNo
10. Are you pregnant or is there a chance you could be pregnant during the next month?*

YesNo
11. Are you allergic to latex?*

YesNo
What is the most important information I should know about VIVITROL®?
Precipitated Opioid Withdrawal Warning:
You must avoid all opioid use for at least 7-14 days before starting Vivitrol. Taking opioids within this time frame can result in severe precipitated opioid withdrawal, characterized by nausea, vomiting, diarrhea, muscle aches, anxiety, and increased heart rate. If unsure whether you’ve been opioid-free for this period, contact your provider immediately.

Overdose Risk:
Vivitrol blocks opioid effects, and attempting to overcome this by taking large amounts of opioids (such as heroin or prescription pain pills) can cause serious injury, coma, or death.

Liver Damage:
Naltrexone, the active ingredient in Vivitrol, may cause liver damage or hepatitis. Contact your healthcare provider if you experience symptoms such as stomach pain, dark urine, yellowing of the whites of your eyes, or unusual fatigue.

Injection Site Reactions:
Reactions at the site of injection include necrosis, pain, tenderness, swelling, redness, bruising, or itching.

Common Side Effects:
Mild nausea, tiredness, headache, vomiting, decreased appetite, and joint/muscle pain are possible. These side effects usually resolve within a few days.

Dizziness:
Vivitrol may cause dizziness. Avoid driving or operating heavy machinery until you know how Vivitrol affects you.

Allergic Pneumonia:
Vivitrol may cause allergic pneumonia. Seek medical attention if you develop breathing difficulties, coughing, or wheezing.

Depression:
Vivitrol may cause depression. Contact your provider if you experience depressive symptoms.

For detailed information, refer to the Vivitrol Medication Guide
Age Disclaimer

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

By signing this form, I certify that:
- I have read and understand all the conditions on the Vivitrol® Consent Form.
- I agree to electronic records and signatures.
- I acknowledge that I must return for follow-up injections every 3-4 weeks as directed by my provider.
- I will avoid opioids for at least 7-14 days before treatment to avoid serious withdrawal.
- I understand the risks and benefits of Vivitrol, including the possibility of liver damage, overdose, and injection site reactions.
- I will inform my provider if I become pregnant or am breastfeeding.
- I release Aspire Medical Group from any and all liability related to my receipt of the Vivitrol injection.
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.
Patient Name*

First NameLast Name
Date of Birth*

MonthDayYear
Date
Age (years)*
Patient Signature*

Clear
Date Signed*

MonthDayYear
Date
If the patient is not competent to give consent, the signature of a guardian, or other legal representative is required
Signature of Guardian or Legal 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 Vivitrol®

What is VIVITROL®?

Patient Information

Medical History

Pre-treatment Questionnaire

What is the most important information I should know about VIVITROL®?

Age Disclaimer

Patient Acknowledgment and Consent

Electronic Signatures

If the patient is not competent to give consent, the signature of a guardian, or other legal representative is required