Naltrexone: Oral to Depot

[whopper]

In several depot guidelines they have a clear rule. ALWAYS TRY THE ORAL FIRST! ONLY GIVE THE DEPOT IF THERE WERE NO SIGNIFICANT PROBLEMS WITH THE ORAL VERSION.

Here's my problem. I see no such guidelines on Vivitrol.
Here's what the FDA guidelines say.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s015lbl.pdf

2.2 Switching From Oral Naltrexone There are no systematically collected data that specifically address the switch from oral naltrexone to VIVITROL.

Wow now that was helpful....NOT.

Anyone know of any existing guidelines FDA or otherwise on making the switch from oral to depot?

I am going to make a rule at an addiction clinic where I work that oral has to be tried first but want to see if there's people who know more than I who can enlighten me on any existing policies I may not be aware of, and how long of a trial would you recommend before depot?

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[littlefred]

In several depot guidelines they have a clear rule. ALWAYS TRY THE ORAL FIRST! ONLY GIVE THE DEPOT IF THERE WERE NO SIGNIFICANT PROBLEMS WITH THE ORAL VERSION.

Here's my problem. I see no such guidelines on Vivitrol.
Here's what the FDA guidelines say.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s015lbl.pdf

Wow now that was helpful....NOT.

Anyone know of any existing guidelines FDA or otherwise on making the switch from oral to depot?

I am going to make a rule at an addiction clinic where I work that oral has to be tried first but want to see if there's people who know more than I who can enlighten me on any existing policies I may not be aware of, and how long of a trial would you recommend before depot?

PCSS has example inductions. I can sesrch for resources if you'd like, but it might take me some time 😄

 

[whopper]

Please! I'll join PCSS.

 

[calvnandhobbs68]

I think it just makes intuitive sense. If you have some severe reaction or side effects to IM depot naltrexone you’re kinda f’d…you just gave them a months worth. Better to try oral for at least some time to make sure the patient doesn’t feel terrible on it or have some reaction.

 

[michaelrack]

On a side note, I had trouble getting a script for vivitrol covered (to bring back to clinic for injection), do you guys prescribe it, or have some in stock in the clinic?

 

[Merovinge]

On a side note, I had trouble getting a script for vivitrol covered (to bring back to clinic for injection), do you guys prescribe it, or have some in stock in the clinic?

For what indication? I've had pretty good luck with Opioid and Alcohol use disorders thus far. Patients acquire and bring to the program (at an IOP/PHP) where a nurse administers it.

 

[clozareal]

In the CMHCs in my area, the policy is to give one test oral dose of 25mg for 30 minutes and if no reaction (allergic or precipitated withdrawal), then proceed with injection.

Ideally, you would get them to a steady state concentration (2-3 days) of the oral first and then check LFTs sometime after that, then do the injection. Makes theoretical sense but I'm not aware of the data on this. The cons of this would be delaying treatment and increasing cumulative exposure to drinking alcohol.

 

[littlefred]

Please! I'll join PCSS.

Register, it's free.

Here's the link:

PCSS Learning: Buprenorphine and Naltrexone Induction

Page 32 on the presentation

I remember a more succinct presentation about induction, off the top of my head it was a graph where it timed the induction process. 7-10 days since last opioid use then oral challenge for 2 days with Naltrexone 25 mg day 1 and 50 mg day 2(can do IM Naloxone which is not very feasible in many treatment centers), if tolerated then XR-Naltrexone (Vivitrol)

 

[michaelrack]

For what indication? I've had pretty good luck with Opioid and Alcohol use disorders thus far. Patients acquire and bring to the program (at an IOP/PHP) where a nurse administers it.

alcohol use d/o

 

[FlowRate]

then check LFTs sometime after that

I was reading that it is no longer recommended to check or monitor LFT's absent other specific clinical indications (comorbidities.)

https://pcssnow.org/wp-content/uploads/2014/10/PCSS-MAT-NTX-Liver-Safety-Guideline1.pdf

 

[Sushirolls]

I've found a local pharmacy that is willing to administer the injection and keep on stock. But I've had so few people, that the few times I've tried, insurance didn't cover, or patients wishes changed and never connected up to get the injection.

I have so few its not worth dealing with injections, storage or sharps disposal in my office.

 

[whopper]

NPR had a piece of a court injecting people with Naltrexone without a physician's prescription and a guy did get an allergic reaction to the depot shot. I can't find the article and checked NPR's website, but I do remember thinking to myself "Idiots." there's no doctor prescribing it so how is this legal and #2 they gave a depot without oral first.

Edit: Found the article.

To Grow Market Share, A Drugmaker Pitches Its Product To Judges

The pharmaceutical company Alkermes is trying to increase the number of people taking Vivitrol for their opioid addiction by marketing the drug to judges, who have the power to influence treatment.

www.npr.org

 

[whopper]

So it would seem despite my best efforts I can't find anything on this other than the above and thank you for the contributions. What I'm going to do, and this will be above the standard of care since it's not even in the FDA package insert, is to give oral first, recommend at least 3 days worth but 1 day will have to do if the patient wants.

Despite the above this will only rule out Type 1 hypersensitivity since the other types could happen weeks down the road. If we have more time we'll use it, but the odds of an allergic reaction are already so low I believe the risk/benefit ratio is justified and especially if the patient is warned they could spend more time on the oral.

Frankly I'm shocked there's no FDA guidelines on trying oral first especially given that there's clear oral-first guidelines on other depot-medications.

 

[clozareal]

I wonder if it's because naltrexone is a much safer medication than antipsychotics that the FDA didn't see a need for oral tolerance prior to depot. You don't have issues like EPS or NMS that could be life threatening.

 

[whopper]

I don't know the reasoning myself but I have seen several, about double-digits get bad side effects from Naltrexone. The most I've seen reported is dizziness and fatigue.

Also I've seen people who do well on Naltrexone but at much lower or higher dosages than the standard 50 mg pill daily. E.g. I had a lady who was fatigued on 50 mg daily, but on 25 mg daily she didn't want to drink and had no side effects. I had another on 75 mg daily it curbed her impulse eating but not at lower dosages.

When you give Vivitrol it's only one dosage.

In short I don't like this lack of oral trial first and don't think it's safe, but since it's not on the FDA guidelines it is standard of care. I figure if I simply have the patient try oral for at least a 1 time use it's now technically above standard of care but use for several weeks would be the optimal challenge since types 2-4 hypersensitivity start during those durations.