InvegaPagesIndex

This is essentially everything we know about Invega (paliperidone) on two big-ass pages. On this page is brand / trade names to odds of working and comparisons with other meds, or pretty much everything most people want to know. Page two is pharmacokinetics to the bibliography, or: I’m sure somebody wants to read it.

The titles for most sections link to the pages for those sections. While all the information is on these two comprehensive pages, the individual section pages go into a little more detail about what it all means.

1.  Names, Availability, Brand vs. Generic Issues, Forms

1.1  US brand name: Invega

Just because a drug is available in one country doesn’t mean you can get it everywhere. Even if a medication is available elsewhere, it won’t necessarily have the same brand, or trade name everywhere it is sold.

1.2  Available as Invega in these countries¹

• European Union
• Ireland
• United Kingdom

1.3  Other trade name(s) for Invega used in these countries¹

1.4  Generic Name and Availability

A drug’s generic, or international nonproprietary name (INN) is how it is uniquely identified around the world⁴. The generic version of a med is are often available in other countries long before they are in the US.

Generic name/INN:	paliperidone
US Generic available?	No

1.5  paliperidone is available in these countries²

1.6  Branded generic names³

1.7  Specific generics with complaints, or preferred generics manufacturers

In theory the generic version of a med is the same as the brand-name version. In practice that is usually, but not always the case. Especially with crazy meds. If we know of any problems with particular generics, or if some generics are better than others, we’ll let you know.

1.8  Generics with independently-tested bioequivalence

1.9  Forms and Classes

Available/supplied as:

• 1.5 mg, 3 mg, 6 mg, and 9 mg OROS trilayer capsules. (OROS stands for Osmotic Release Oral System).
• Invega Sustenna (paliperidone palmitate) extended-release injection. Comes in prefilled syringes with dosages being in 39mg, 78mg, 117mg, 156mg, and 234mg.

Primary Drug Class:	Antipsychotics
Additional Drug Categories:
	MoodStabilizers

2.  Approved and Off-Label Uses

Drugs are officially approved to be used for certain things, and they may be approved for one thing in one country but something else entirely in another.⁵

2.1  US FDA approved use(s)

• Short-term (acute) or long-term (maintenance) treatment of schizophrenia
• Short-term treatment of schizoaffective disorder as monotherapy (by itself)
• Short-term treatment of schizoaffective disorder as an adjunct to mood stabilizers and/or antidepressants (used with other meds)
• Invega is the first, and so far only med with FDA approval to treat all aspects of schizoaffective disorder. Clozaril is approved only to treat recurrent suicidal behavior.
• Invega Sustenna the long-lasting injections, is approved to treat acute and maintenance treatment of schizophrenia in adults.

2.2  Invega is approved elsewhere for

2.3  Common off-label uses

Meds are often prescribed for conditions or people they aren’t approved to treat. This is known as off-label prescribing. Some off-label prescribing is so common that lots of people think the medication is a first-line treatment for the condition it’s prescribed to treat.

Invega Oral

• Treatment of bipolar spectrum disorders. (Most likely for management of psychotic symptoms such as hallucinations, delusions, distortions.)
• And probably everything Risperdal is used to treat, with or without official approval.

Invega Sustenna

• Schizoaffective disorder
• Schizophrenia in people under 18

2.4  Less common/experimental off-label uses

When all else fails and you’ve run out of other options, the experimental use of some drug may be your best chance at treating something. Be careful! Otherwise safe meds can be downright dangerous when used for some things.

2.5  Failed off-label uses

2.6  Potentially dangerous off-label uses

2.7  When / why you should take Invega

Just because a medication is approved or commonly prescribed for a particular condition doesn’t necessarily mean you should be taking it for that condition. There could be a drug that might be better to try first, or at least talk to your doctor about trying first, or the condition you have isn’t bad enough to warrant medication at all.

Risperdal is/was working for you, but:

• you had to switch to Paxil from another SSRI or had a similar CYP2D6-related drug-drug interaction
• you kept having lots of GI problems
• your insurance plan is from the Bizarro Dimension and will cover Invega but won’t cover Risperdal or generic risperidone

2.8  When / why you should not take Invega

• You’ve taken Risperdal before and it just didn’t work, or sorta worked but you had to stop taking it for a severe side effect like tardive dyskinesia or it made you lactate.
• You can’t tolerate anything above 0.5mg of Risperdal, because the lowest dosage of Invega is 1.5mg, and that’s the equivalent of 0.75mg of Risperdal.

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3.  Chances of Working & Comparisons with Other Meds

Two of the most important things to know when deciding on which med is the best for a particular condition⁶: how likely is it to work and how long will it take.
The odds of a med working for a particular condition and how long it generally takes to work should be fairly easy to nail down, and not need to be summed up by the Internet shorthand YMMV (Your Mileage May Vary). Unfortunately because no one is quite sure exactly what causes various conditions - further complicated when everything is a spectrum disorder - and they’re never really sure about how a med works in the first place, especially when there are lots of contradictory and/or questionable studies,⁷ we can only give you an idea somewhat less vague than support groups and PI sheets, but certainly more accurate than the implied “it fixes everything all the time!” promises of pharmaceutical advertising.
See our page on the tests researchers use to measure the efficacy of medications, including during clinical trials to get FDA approval.

3.1  How long until Invega starts working:

• Like all antipsychotics you’ll feel something the next day. By the time you reach a steady state, usually in 4 to 5 days, you’ll pretty much know if Invega is going to do anything for you. Various studies and trials have shown positive results in 2 to 7 days, with 2 to 4 days being typical.
• Invega Sustenna: In the clinical trial there were positive results shown at 4 days with further improvement by 8 days. That’s without any other meds, and you probably wouldn’t be starting Invega Sustenna if you weren’t already taking Invega, or at least RisperdalConsta.

3.2  Likelihood Invega will work for its approved indications:

• As the only drug with FDA approval to treat schizoaffective disorder - other than Clozaril’s approval to treat recurrent suicidal behavior - it doesn’t have a lot of competition.
• According to Stahl, between five and 15% of people who take Risperdal or Invega respond well enough to hold down real jobs and live independently.
• Here’s something we always like to see: the clinical trial results for Invega Sustenna with lots of data. What’s that down at the bottom? Everyone whose name is on the paper is an employee of Johnson & Johnson (parent company of Invega’s manufacturer) and four out of five of them are stockholders. But that wouldn’t have influenced anything, would it? We just don’t have enough real world data to give you good odds.

3.3  For off-label applications:

3.4  Invega versus other Antipsychotics for approved treatments:

It’s just a case report, but Risperdal gave this lady hepatitis and it went away after they switched her to Invega.

3.5  For off-label uses:

4.  Dosage, Titration, and Discontinuation

One of the most important aspects of any medication is how to go about taking it. This includes:

• how much to take (the dosage or dose)
• when and how often to take it (dosing schedule or doses)
• how much to start with and how to increase the dose/dosage until you’re taking the target amount (titration or titration schedule).

This information is always in the PI sheet, is usually in the information for patients leaflets, most doctors will give you some idea of what it will be like, and this is what every pharmacist is trained and paid to tell you.
We here at Crazy Meds often disagree with the official schedules found in the PI sheets. We usually advocate starting at a lower dosage than recommended. One of our core philosophies is increasing the dosages as slowly as one’s condition allows, and staying at the dosage that works instead of a target dosage⁸. More and more doctors are agreeing with us⁹. You and your doctor can always discuss increasing the dosage when you need to in advance.

4.1  Dosage and doses:

Invega:One 6mg tablet in the morning. There, you’re done. Once a day and you’ve started at the recommended dosage. It doesn’t get any freaking easier in the world of crazy meds.
Of course you and your doctor could determine that 3mg a day would be a good starting point. Sure, why not? I’m all about starting at lower dosages. And if you need to you can go up to 12mg a day. Three, six, nine and twelve milligrams. I think for many people freedom from choice makes their lives much, much simpler, and simpler is way better.
This is where Invega and Risperdal really differ, as Invega comes in only three dosages and you start right out with what you’re probably going to be taking.

Invega Sustenna: One shot, you’re done for the month. Invega Sustenna comes in prefilled syringes with dosages being in 39mg, 78mg, 117mg, 156mg, and 234mg. Shots are given into the muscle either in the arm or the rear. In an ideal world there would be a trial run with regular Invega or Risperdal to make sure you don’t have any reactions to the medication but according to invegasustenna.com it says that your doctor “may give you a test dose”.

4.2  Best time / way to take Invega:

If you’re converting from Risperdal, and aren’t taking a potent inhibitor of CYP2D6 (or weren’t when you were taking the Risperdal), or otherwise have CYP2D6 issues, it’s a 1:2 Risperdal-to-Invega ratio. So..

0.75mg Risperdal = 1.5mg Invega
1.5mg Risperdal = 3mg Invega
3mg Risperdal = 6mg Invega
4.5mg Risperdal = 9mg Invega
6mg Risperdal = 12mg Invega

That’s per The Pharmacokinetics of Paliperidone Versus Risperidone.

See our page on Pharmacokinetics and CYP450 enzymes for information about CYP2D6 and why it can be a big deal for some people.

4.3  Titration schedule:

At whatever dosage you start, Janssen recommends increasing the dosage by 3mg, and waiting at least 5 days between each increase.

Again: sure, why not? They also make a 1.5mg capsule, and as long as you’re not completely flipping out try waiting as long as you’re comfortable before raising the dosage. Five days is the absolute minimum amount of time to wait.

For Invega Sustenna the PI sheet says the recommended dosing schedule is to start with a 234mg dose on day 1 then one week later to give a second dose of 156mg. After the second dose, the shots will be given monthly with a recommended dose of 117mg. That seems pretty high, especially since they recommend that you should have already taken Invega or Risperdal first but not be taking either when you start. That sounds like a fun few days.

4.4  How to discontinue Invega:

One thing PI sheets and doctors infrequently discuss, and don’t go into enough detail about, is how to discontinue a medication. With some meds it’s not too bad, but with others it can be a nightmare.
That’s a good question. When you start at the recommended dosage one would just have to stop taking the one pill a day. Janssen reports not a heck of a lot as happening in Invega’s PI sheet/the PDR. If you were taking 9mg, 12mg (or more) a day, or actually increased from 3mg a day, talk to your doctor about a 3mg a day reduction every five days. Who really knows? This stuff is new. The five days is based on Invega’s half-life of 23 hours.

How to stop taking Invega Sustenna is an even better question. With a half-life of 25–49 days¹⁰ it can take between four and nine months to fully clear from your system. While that makes for a theoretically easy answer of “Just don’t get another shot,” what to do if you’re having a bad reaction makes things a bit tricky.

4.5  Discontinuation symptoms:

• It’s an antipsychotic, so unless you’re taking another antipsychotic at the same time you’ll probably have a headache, feel spacy (or more so than usual).
• Depending on your condition, why you’re taking Invega, why you’re stopping, and if you’re taking another med or not, your symptoms may return.
• Sometimes when symptoms return they’re worse than before (rebound), but that’s almost always temporary. It’s really rare for rebound symptoms to hang around for longer than one or two weeks.
• The best information we have so far comes from Schizophrenia.emed.tv.com’s page. They list all of two things to be concerned about:
  • Insomnia
  • Return of symptoms

4.6  Notes, tips, etc. about discontinuing Invega:

Although the once-a-month injection of Invega Sustenna is really easy, you should probably see how you do with regular Invega for a year or so before switching to the injection.

The equivalency ratio of Invega Sustenna to oral Invega is:
Invega Sustenna - 39, 78, 117, 156, and 234 mg
Invega oral - 25, 50, 75, 100, and 150 mg

Not that you’d be taking 25mg a day, or more, of Invega. That’s just to give you an idea of how much a month you’re getting.

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5.  Pros, Cons, and Interesting Information

Every med has its good points and its bad points. This is what we think those are.
Doctors don’t have the time to tell you everything about a drug. Patient information leaflets leave out a lot. Even if the PI sheet covers everything the language is so dense and obtuse that the good stuff is often lost in information overload. Most meds have something interesting about them.

5.1  Pros

• Far fewer drug-drug interactions than Risperdal.
• Between the lessened metabolization by the liver (most of Invega gets pissed away) and its being packaged in an OROS trilayer capsule, the people in the trials reported far fewer tummy troubles. Not much from the field. What has been reported confirms what is on the PI sheet, you are less likely to puke with Invega than anything else you’ll see listed on Crazy Meds.
• You have to take it only once a day, compared with taking Risperdal one to four times a day.
• No titration is needed, in that you don’t have to work up to the recommended dosage.
• Invega Sustenna: Once a month dosing, no more pills to forget.

5.2  Cons

• Invega comes in four dosages: 1.5mg, 3mg, 6mg and 9mg. Thus you have a lot less wiggle room when it comes to fine-tuning your dosage than you do with Risperdal.
• While Risperdal tablets are small, Invega tablets are about the size of a multivitamin. So if you have trouble swallowing larger tablets (e.g. Depakote, Keppra, Neurontin 800mg tablets, and the larger dosages of Seroquel) you might have problems taking Invega.
• As you should never, ever cut an extended-release tablet of any medication, you can’t get a price break on buying the 6mg tablets and splitting them in half as you can with buying larger dosage tablets of Risperdal and splitting them in half. Let alone to try to help you swallow them.
• Invega is just way more expensive than Risperdal. As many doctors are subject to “if a drug is new it must be better” syndrome, you may be better off with Risperdal, or even a dirt-cheap standard antipsychotic than Invega.
• Invega Sustenna: If you get a side effect you’re stuck waiting for the med to wear off.

5.3  Interesting stuff your doctor probably didn’t tell you:

The capsule will pass out looking whole so don’t be surprised by that - it’s what OROS does. Like many of the other atypical antipsychotics, Invega can cause QT interval prolongation. Also, in the clinical trials 12% - 14% of patients receiving Invega reported tachycardia (rapid heartbeat). So if you have a history of heart problems Invega probably isn’t a good idea. Otherwise if you develop cardiac wackiness, an EKG / ECG is a good idea to find out if you have something that is a problem or just annoying.

6.  Side Effects and Pregnancy Category

Potential side effects are used as a rationalization to not take a medication. Many people will stop taking an otherwise working drug because of one or more relatively minor, or often temporary side effects. There may even be ways to counter or mitigate side effects.
It all comes down to a very important question: which sucks less?
No matter what crazy med you take, it will probably make you feel spacey and generally out of it for the first few days (i.e. don’t operate heavy machinery), as well as make you drowsy. Even stimulants can make you drowsy. Invega will probably affect your dreams as well, and there’s no way to tell if that will be a temporary or permanent side effect. Don’t be surprised if your stomach and/or other parts of your GI system complain for at least the first few days.

6.1  Typical side effects

Most everyone gets at least one or two of these.
Invega Oral:

• Headache
• Drowsiness (Somnolence)
• Dizziness
• Feeling lightheaded
• Weight gain
• Restlessness and trouble sitting still (Akathisia)
• Anxiety
• Faster or irregular heartbeat (Tachycardia and QT interval prolongation respectively)
• And if you are incredibly stupid and drink alcohol you will get drunker

Invega Sustenna:
Many side effects are somewhat less likely except:

• Injection site reactions (around 10% of people get these).
• EPS and TD rates are higher.

6.2  Uncommon side effects

You may or may not get one or more of these.

• Trouble walking or standing (Dystonia and “coordination abnormal”)
• Drooling
• Fainting (Orthostatic hypotension)
• Extrapyramidal symptoms (probability and severity of EPS increases along with dosage)
• “Unusual eye movements”. - A direct quote from the pharmacy handout.

6.3  Potentially dangerous side effects:

If you have these, call your doctor ASAP. Or now. Or get the hell off of the Internet and go to the ER. NOW!

6.4  Freaky rare side effects:

You won’t get these. Unless you already have and that’s why you’re here.
Lactation anyone? Guys, you too can experience the joys of new motherhood. Which isn’t even all that freaky (to anyone who it doesn’t happen to), let alone rare as far as antipsychotics are concerned, but Invega still doesn’t have any weird-ass side effects.

6.5  Ways to counter / minimize / mitigate / deal with some side effects

6.6  Pregnancy category

C-Use with caution Expanded pregnancy category explanation.

Invega Index

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¹ EU: European Union. Currently Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom. Not all drugs approved in any one EU country are approved in all, but most crazy meds approved in several EU countries are at least obtainable in all EU countries on the European mainland. I'm not sure about Britain, Cyprus, Ireland, and Malta.
The UK and Ireland are listed separately because we're a primarily English-language site. Plus the UK tends to be more independent on more matters than any other EU member state, so it should probably be listed separately no matter what language a site like this is in.
While the EU is moving toward one brand name for the same med, that's not going to happen overnight. And people will still refer to meds by old brand names. So we'll list old brand names until they vanish.

² Generic availability isn't fully harmonized in the EU. Sometimes a drug is available everywhere as a generic, sometimes it's available only in a few member states. We'll provide the best information we have.

³ The term "branded generic" has three meanings:
1) A generic drug produced by a generics manufacturer that is a wholly-owned subsidiary of the company that makes the branded version. E.g. Greenstone Pharmaceuticals makes gabapentin**, and they are owned by Pfizer***, who also own Parke-Davis, the makers of Neurontin.
2) A branded generic is also a generic drug given a 'brand' name by the manufacturer (e.g. Teva's Budeprion), but otherwise has the same active ingredient as the original branded version (Wellbutrin).
3) A branded generic is also a generic drug given a 'brand' name by the manufacturer (e.g. Sanofi-Aventis' Aplenzin, which is bupropion hydrobromide) and uses a salt of the active ingredient that is different from the original branded version and other generics (Wellbutrin, Budeprion and all the others are bupropion hydrochloride). We aren't sure if that really makes a difference or not. The FDA says they're the same thing. As usual, the data are contradictory, but most evidence indicates that the FDA is right and the differences are negligible.
For our purposes a "branded generic name" refers to the second and third definitions. We'll note if any preferred generics are manufactured by the pioneering company's subsidiary.

⁴ Except in Finland, where generic names are sometimes rendered into Finnish. This may happen elsewhere, but I haven't come across anyone else doing it.

⁵ Before Cymbalta (duloxetine) was approved as an antidepressant in the US it was already approved in the EU, but only for stress urinary incontinence and sold under the trade name Yentreve. Duloxetine is now sold in the EU as an antidepressant under the trade name Cymbalta.
A better known, if slightly different example is bupropion. According to the 2007 edition of Mosby's Drug Consult, in the US, Canada and Singapore you can get both Wellbutrin (bupropion) as an antidepressant or Zyban (bupropion) to stop smoking. In Korea, Thailand and most of South America (but not Brazil) you can get bupropion (under various trade names) only as an antidepressant. In Brazil, the EU & UK, Israel, India, Australia and New Zealand it's only available as Zyban to help you stop smoking.

⁶ Assuming you were correctly diagnosed in the first place.

⁷ Keep in mind that according to one study, most drug studies will skew in favor of the med made by the company that sponsored the study.***** That's one of my favorite "no shit Sherlock" studies, although it did help in getting conflicts of interest showing up on papers.
Two additional papers along similar lines are Why Current Publication Practices May Distort Science******* and Why Most Published Research Findings Are False********. So in addition to the books we use as source material, this is why we also factor a lot of anecdotal evidence (personal experience, experiences of people we know, case reports, what people have sent us in e-mail, and what is posted all over the Internet) into our conclusions regarding the likelihood of meds working, the prevalence of various side effects, etc.
While the drug companies are getting a lot more transparent and publishing more data in the PI sheets regarding the results of the clinical trials, they still don't publish how many times a drug failed a clinical trial.********

⁸ Although not everyone has the luxury of stopping at a dosage when the symptoms abate and not increasing it unless the return. Sometimes you just have to keep going up until you reach that target dosage. E.g. you have a history of seizures that haven't yet responded to several medications.

⁹ Most notably Dr. Edward Faught, founder and Director of the Epilepsy Center, and vice chairman of the Department of Neurology, at the University of Alabama School of Medicine in Birmingham. His article on new antiepileptic drugs in Volume 7 issue 1 of Peer Review in Review stressed starting at low dosages, doing a slow titration, and stopping at the dosage where symptoms were under control. In Topiramate in the treatment of partial and generalized epilepsy****, the one free, full-text article I could find (that's not about geriatric patients), he again stresses the low and slow approach to avoid or lessen most side effects, while still achieving seizure control in the same amount of time.

¹⁰ Over twice as long as the longest-lasting Depot injections of first generation antipsychotics. Invega Sustenna has the longest half-life we've seen in all crazy meds.

*Article I, Section 8 of the US Constitution
**Greenstone Pharmaceuticals, makers of gabapentin
***Pfizer, owner of Parke-Davis and Greenstone
****Topiramate in the treatment of partial and generalized epilepsy
*****Drug studies favoring sponsors the study.
******Why Current Publication Practices May Distort Science
*******Why Most Published Research Findings Are False
********unpublished clinical trials

Date created 10 Jun 2011 - 17:09 Page Creator: girrl88? Last edited by:

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Crazy Meds’ Comprehensive Pages on Invega is copyright 2011 girrl88?

Page design and explanatory material by Jerod Poore, copyright © 2004 - 2012. All rights reserved.

Almost all of the material on this site is by Jerod Poore and is copyright © 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, and 2012 Jerod Poore. Except, of course, the PI sheets - those are the property of the drug companies who developed the drugs the sheets are about - and any documents that are written by other people which may be posted to this site will remain the property of the original authors. You cannot reproduce this page or any other material on this site outside of the boundaries of fair use copying without the express permission of the copyright holder. That’s usually me, so just ask first. That means if want to print out a few pages to take to your doctor, therapist, counselor, support group, non-understanding family members or something like that - then that’s OK to just do. Go for it! Please. As long as you include this copyright notice and the following disclaimer, I’m usually cool with it.

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¹ While there are plenty of books to help you with hypochondria, for some reason there’s not much in the way of websites. Then again, staying off of the Internet is a large part of curing/managing the disorder.

² Have I mentioned how open source operating systems for commercial applications is one of the dumbest ideas in the history of dumb ideas?
[begin rant] I rent a dedicated server for Crazy Meds. It’s sitting on a rack somewhere in Southern California along with a bunch of other servers that other people have rented. The hardware is identical, but no two machines have exactly the same operating systems. I don’t even need to see what is on any of the others to know this. If somebody got their server at the exact same time, with the exact same features as I did, I’m confident that there would be noticeable differences in some aspects of the operating systems. So what does this mean? For one thing it means that no two computers in the same office of a single company have the same operating system, and the techs can spend hours figuring out what the fuck the problem could be based on that alone. It also means that application software like IP board that runs the forum here has to have so many fucking user-configurable bells and whistles that even when I read the manual I can’t find every setting, or every location that every flag needs to be set in order for a feature to run the way I want it to run. And in the real world it means you can get an MBA not only with an emphasis on resource planning, but with an emphasis on using SAP - a piece of software so complex there are now college programs on how to use it. You might think, “But don’t people learn how to use Photoshop or Adobe Illustrator in college?” Sure, in order to create stuff. And in a way you’re creating stuff with SAP. But do you get a Bachelor of Fine Arts degree with an emphasis on Photoshop?
Back in the Big Iron Age the operating systems were proprietary, and every computer that took up an entire room with a raised floor and HVAC system, and had less storage and processing power than an iPhone, had the same operating system as every other one, give or take a release level. But when a company bought application software like SAP, they also got the source code, which was usually documented and written in a way to make it easy to modify the hell out of it. Why? Because accounting principles may be the same the world over, and tax laws the same across each country and state, but no two companies have the same format for their reports, invoices, purchase orders and so forth. Standards existed and were universally ignored. If something went wrong it went wrong the same way for everyone, and was easy to track down. People didn’t need to take a college course to learn how to use a piece of software.
I’m not against the open source concept entirely. Back then all the programmers read the same magazines, so we all had the same homebrew utilities. We even had the forerunner to QR Code to scan the longer source code. Software vendors and computer manufacturers sponsored conventions so we could, among other things, swap recipes for such add-ons and utilities. While those things would make our lives easier, they had nothing to do with critical functions of the operating system. Unless badly implemented they would rarely cause key application software to crash and burn. Whereas today, with open source everything, who the hell knows what could be responsible some part of a system failing. [/end rant]