Quantcast

Subscribe to:
POZ magazine
Newsletters
Join POZ: Facebook MySpace Twitter Pinterest
Tumblr Google+ Flickr Instagram
POZ Personals
Sign In / Join
Username:
Password:
Welcome, Guest. Please login or register.
October 22, 2014, 06:52:57 AM

Login with username, password and session length


Members
Stats
  • Total Posts: 643028
  • Total Topics: 48926
  • Online Today: 196
  • Online Ever: 585
  • (January 07, 2014, 02:31:47 PM)
Users Online
Users: 3
Guests: 168
Total: 171

Welcome


Welcome to the POZ/AIDSmeds Community Forums, a round-the-clock discussion area for people with HIV/AIDS, their friends/family/caregivers, and others concerned about HIV/AIDS.  Click on the links below to browse our various forums; scroll down for a glance at the most recent posts; or join in the conversation yourself by registering on the left side of this page.

Privacy Warning:  Please realize that these forums are open to all, and are fully searchable via Google and other search engines. If you are HIV positive and disclose this in our forums, then it is almost the same thing as telling the whole world (or at least the World Wide Web). If this concerns you, then do not use a username or avatar that are self-identifying in any way. We do not allow the deletion of anything you post in these forums, so think before you post.

  • The information shared in these forums, by moderators and members, is designed to complement, not replace, the relationship between an individual and his/her own physician.

  • All members of these forums are, by default, not considered to be licensed medical providers. If otherwise, users must clearly define themselves as such.

  • Forums members must behave at all times with respect and honesty. Posting guidelines, including time-out and banning policies, have been established by the moderators of these forums. Click here for “Am I Infected?” posting guidelines. Click here for posting guidelines pertaining to all other POZ/AIDSmeds community forums.

  • We ask all forums members to provide references for health/medical/scientific information they provide, when it is not a personal experience being discussed. Please provide hyperlinks with full URLs or full citations of published works not available via the Internet. Additionally, all forums members must post information which are true and correct to their knowledge.

  • Product advertisement—including links; banners; editorial content; and clinical trial, study or survey participation—is strictly prohibited by forums members unless permission has been secured from POZ.

To change forums navigation language settings, click here (members only), Register now

Para cambiar sus preferencias de los foros en español, haz clic aquí (sólo miembros), Regístrate ahora

Finished Reading This? You can collapse this or any other box on this page by clicking the symbol in each box.

Author Topic: FDA Approves Heat-Stable Norvir Tablets  (Read 7475 times)

0 Members and 1 Guest are viewing this topic.

Online Miss Philicia

  • Member
  • Posts: 24,209
  • celebrity poster, faker & poser
FDA Approves Heat-Stable Norvir Tablets
« on: February 12, 2010, 12:05:12 PM »
I'm not sure why they make the comment about taking this new tablet with food, because as far as I know the gel cap requires food too, at least that is how my bottles are labeled.  I never found the fridge issue to be a problem so I can't say I care that much about this, but I know others here seemed to take issue with it.

link

FDA Approves Heat-Stable Norvir Tablets

A tablet version of Norvir (ritonavir) has been approved by the U.S. Food and Drug Administration (FDA), according to notices from the agency and Norvirís manufacturer Abbott Laboratories. The film-coated tabletís prime advantage over Norvir capsules is its heat-stable formulation that doesnít require refrigeration. It is unclear if Norvir tablets will cause fewer side effects than Norvir capsulesóin fact, it may cause a spike in gastrointestinal side effects among those switching from the capsules to the tablets. In addition, unlike the capsules, the new tablets must be taken with food.

Abbott also announced it will launch the Norvir tablet at the same wholesale acquisition (WAC) price as Norvir capsules. Additionally, the company will make Norvir tablets and capsules available through a co-pay support program for people with private insurance. Once a patient has paid $25 in co-pays, the program will cover up to $75 per month in patient co-pays within the first 12 months.

Norvir tablets, like Kaletra (lopinavir/ritonavir) tablets before them, were developed using Abbottís Meltrex, or melt-extrusion, technology. This helped Abbott develop formulations of both drugs that can withstand heat fluctuations and donít require refrigerationóa significant advantage, notably in parts of the world where refrigeration and climate control are not widely available.

"Approximately one-third of all HIV-positive patients in treatment use Norvir in combination with other antiretroviral medicines. The heat-stable tablet formulation may allow these patients greater flexibility to store and carry their medication with them," said Renslow Sherer, MD, professor of medicine, section of infectious diseases and global health and director, International HIV Training Center, University of Chicago Hospitals. "For patients who may not have access to refrigeration, this new formulation is also important."

Each Norvir tablet contains 100 mg of ritonavir, similar to each Norvir capsule. However, the drug in the tablet formulation is absorbed differently, hence it must be taken with foodóthe clinic trials included meals consisting of about 850 calories and a mix of protein, fat and carbohydrates. Even with food, the maximum amount (Cmax) of ritonavir in the bloodstream is 26 percent higher when using tablets compared with the capsules.

Because of the increased Cmax, the FDA warns that people switching from the capsules to the tablets may experience more gastrointestinal side effects, such as nausea, vomiting, abdominal pain or diarrhea. However, this is based on data involving those using the full dose of Norvir (600 mg twice daily). Norvir is most often used at much lower doses to boost the blood levels and effectiveness of other protease inhibitors. It is unclear whether people switching booster doses of Norvir capsules for Norvir tablets are likely to experience more gastrointestinal side effects.

Though the FDA did not require that Norvir capsules be taken with food, it did recommend doing so to reduce the risk and severity of gastrointestinal side effects.

As with Norvir capsules, the tablet formulation is expected to interact with many other medications used to treat HIV, HIV-related complications and other diseases.

The Norvir co-pay support program will be available through Norvir.com. Abbott is also committed to continuing its patient assistance program to make sure any patient without prescription coverage can get both Kaletra and Norvir for free. To learn more about Abbottís patient assistance programs, click here.
"Iíve slept with enough men to know that Iím not gay"

Offline GSOgymrat

  • Member
  • Posts: 5,037
  • HIV+ since 1993. INTJ
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #1 on: February 12, 2010, 12:09:45 PM »
Good news! :)

Offline leatherman

  • Member
  • Posts: 6,272
  • Google and HIV meds are Your Friends
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #2 on: February 12, 2010, 01:18:31 PM »
all of my norvir has always said to take with food (even when it was in the uber-disgusting liquid version) and the AM drug chart info says "Norvir, even if low doses are used with another protease inhibitor, should be taken with a meal or light snack". To be honest, I wouldn't consider taking it without food. For me, that's a guaranteed way to induce barfing and great intestinal distress!

Next week is my next appt with the doc and I'll be asking when I can be switching over ;)
thanks for passing that along!
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Offline tednlou2

  • Member
  • Posts: 4,979
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #3 on: February 13, 2010, 12:54:21 AM »
Good news.  Norvir is part of the regimen that has been picked out for me.  I always wondered what would happen when ya travel and can't refrigerate.

Offline leatherman

  • Member
  • Posts: 6,272
  • Google and HIV meds are Your Friends
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #4 on: February 13, 2010, 01:10:02 AM »
Good news.  Norvir is part of the regimen that has been picked out for me.  I always wondered what would happen when ya travel and can't refrigerate.
norvir actually travels fine without refrigeration. However, high temps for extended periods will "melt" the gelcaps and they'll stick together. The heat (also extreme cold - as in frozen) actually breaks down the chemical making it less effective (which could also lead to resistance along with putting less med into your system).

I advise people to learn to deal with their monthly supply in the refrigerator if it gets above 75 degrees for an extended time in your locale. That way you don't accidentally lose a month's supply if it reaches 90+ in your house in the summer and you "forget" to move them from your regular storage spot to the frig. Using the frig as the storage spot eliminates this problem. As the frig is chilled but more temperature-controlled than your house, it prevents freezing and/or heating issues and holds the med at a more stable temperature year round.

When you carry meds traveling, or out for a day or a dinner, don't carry the med near your body (as in your pocket) as it can overheat and melt there too! I use a pill fob on my key chain to keep a spare set of "dinner meds" (my norvir, reyataz, viread, etc). I use this "set of meds" once a week and replace them, so they'll don't get old but are always available, if I'm not at home at dinner time to take my meds.

this tablet will eliminate all those precautions (and from ever having a bottle of globbed up gelcaps when they get hot, melt together and burst!). I'm hoping too, that even though it needs to still be taken with food, that having it as a tablet and not a gelcap bursting in my stomach will eliminate most of my monthly puking. ;)
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Offline Grasshopper

  • Member
  • Posts: 454
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #5 on: February 13, 2010, 05:06:57 AM »
In the past I had terrible stomach problems after taking my meds (as instructed WITH some sort of food). Eversince I started taking them on an empty stomach, approx. 7 years ago, it has been an easy ride for me. My ID doc knows about this from the start. I have maintained excellent numbers ever since. Currently on Kaletra (Tablets!) & Truvada.

*note* :  what works for me doesn't necessarily work for you, consult your doctor before attempting this !

Offline MBK

  • Member
  • Posts: 19
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #6 on: February 13, 2010, 02:28:50 PM »
Any idea when it will be available?

Offline Hellraiser

  • Member
  • Posts: 4,136
  • Semi-misanthropic
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #7 on: February 13, 2010, 03:41:21 PM »
In the past I had terrible stomach problems after taking my meds (as instructed WITH some sort of food). Eversince I started taking them on an empty stomach, approx. 7 years ago, it has been an easy ride for me. My ID doc knows about this from the start. I have maintained excellent numbers ever since. Currently on Kaletra (Tablets!) & Truvada.

*note* :  what works for me doesn't necessarily work for you, consult your doctor before attempting this !

Norvir has to be taken with food because your body won't absorb it unless there is stomach acid currently in your stomach to break it down (I think).

Offline Dsd09

  • Member
  • Posts: 29
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #8 on: February 19, 2010, 02:44:16 AM »
In the past I had terrible stomach problems after taking my meds (as instructed WITH some sort of food). Eversince I started taking them on an empty stomach, approx. 7 years ago, it has been an easy ride for me. My ID doc knows about this from the start. I have maintained excellent numbers ever since. Currently on Kaletra (Tablets!) & Truvada.

*note* :  what works for me doesn't necessarily work for you, consult your doctor before attempting this !

How long have you taken the Kaletra / Truvada combo Grasshopper?
07/2009 - Diagnosis
08/2009 - CD4 354 / VL 4700
09/2009 - CD4 286 / VL 3200
10/2009 - CD4 249 / VL n/a - Started Truvada / Sustiva
12/2009 - CD4 318 / VL <40
01/2010 - CD4 316 / VL <40 - Switched Atripla
04/2010 - CD4 370 / VL <40
12/2010 - CD4 342 / VL <40

Offline leatherman

  • Member
  • Posts: 6,272
  • Google and HIV meds are Your Friends
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #9 on: February 19, 2010, 07:41:12 AM »
Next week is my next appt with the doc and I'll be asking when I can be switching over ;)
Of course  ::) sadly, my doctor here in SC had no clue about the new Norvir tablet.  :'( He thinks he'll know more after he attends some conference next month  :P

He also talked to me about switching some other meds to make my regimen easy (videx ed and viread to truvada which is viread and emtriva). However, now that I'm checking into my own records (and I've got a call in back to my old doc in OH to confirm), a genotype test in 2002 shows that I have resistance to epivir which would also mean emtriva wouldn't be effective. Dang. that would have changed my regimen to one less pill and all taken at the same time. Double dang! for having to do my own "due deligience" and double-check the doctor's recommendation. I mean he's the one with the paperwork from my last doctor and should see the genotype test. Just proof once again, that you can't blindly trust any of these guys since it's your health and you life. ;)
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Offline mpositive

  • Member
  • Posts: 298
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #10 on: February 19, 2010, 09:03:27 AM »
My only concern is the size.  I have a lap-band and am having a tough time because of Norvir.

Offline Matty the Damned

  • Member
  • Posts: 12,228
  • Ninja Please
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #11 on: February 19, 2010, 09:13:24 AM »
My only concern is the size.  I have a lap-band and am having a tough time because of Norvir.

I believe that ritonavir was available in liquid formulation at one time. That may still be the case.

MtD

Offline mpositive

  • Member
  • Posts: 298
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #12 on: February 19, 2010, 10:27:42 AM »
Yea, that's just too difficult to manage with my work schedule.  Plus, that is 100% required to refrigerate and I heard it tastes soooooo nasty.  But thanks.  Hoping the pill form is smaller and with any luck, might be able to be cut in half....please please please.

Offline WillyWump

  • Member
  • Posts: 7,196
  • Fall is in the air!
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #13 on: February 19, 2010, 11:02:02 AM »
I don't know, I've sorta become endeared to my pudgy little Norvir Capsule. I think I'm gonna sit in the bleachers on this one and monitor the posts of those who switch to the tablet form before I decide to switch. For me, the only thing that is an issue with the new tab is the possible gastrointestinal issues, albeit slight,  for those switching to the tab. I've never had any problems with rumbling gut and everything that comes with it so for now my thoughts are If it ain't broke, don't fix it.

Yes, the Norvir Capsule requires a little more "babysitting" when travelling, but for me it's not a deal breaker.

-Will
POZ since '08

Last Labs-
6/3/14 CD4- 736, UD 34%
6/25/13 CD4- 1036, UD,
2/4/13, CD4 - 489, UD, 28%

Current Meds: Prezista/Epzicom/ Norvir
.

Online Miss Philicia

  • Member
  • Posts: 24,209
  • celebrity poster, faker & poser
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #14 on: February 19, 2010, 11:14:57 AM »
I enjoy using Norvir as a suppository.
"Iíve slept with enough men to know that Iím not gay"

Offline WillyWump

  • Member
  • Posts: 7,196
  • Fall is in the air!
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #15 on: February 19, 2010, 11:20:30 AM »
I enjoy using Norvir as a suppository.

only have one cup of coffee in me, so at a loss for snappy comeback...will defer to others.

-Will
POZ since '08

Last Labs-
6/3/14 CD4- 736, UD 34%
6/25/13 CD4- 1036, UD,
2/4/13, CD4 - 489, UD, 28%

Current Meds: Prezista/Epzicom/ Norvir
.

Offline Assurbanipal

  • Member
  • Posts: 2,173
  • Taking a forums break, still see PM's
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #16 on: February 19, 2010, 11:25:46 AM »
I don't know, I've sorta become endeared to my pudgy little Norvir Capsule. ...
-Will

I enjoy using Norvir as a suppository.

It is butt ugly...
 :)

I'm looking forward to this -- the more robust the meds the less time I need to spend rearranging my life around them.
5/06 VL 1M+, CD4 22, 5% , pneumonia, thrush -- O2 support 2 months, 6/06 +Kaletra/Truvada
9/06 VL 3959 CD4 297 13.5% 12/06 VL <400 CD4 350 15.2% +Pravachol
2007 VL<400, 70, 50 CD4 408-729 16.0% -19.7%
2008 VL UD CD4 468 - 538 16.7% - 24.6% Osteoporosis 11/08 doubled Pravachol, +Calcium/D
02/09 VL 100 CD4 616 23.7% 03/09 VL 130 5/09 VL 100 CD4 540 28.4% +Actonel (osteoporosis) 7/09 VL 130
8/09  new regimen Isentress/Epzicom 9/09 VL UD CD4 621 32.7% 11/09 VL UD CD4 607 26.4% swap Isentress for Prezista/Norvir 12/09 (liver and muscle issues) VL 50
2010 VL UD CD4 573-680 26.1% - 30.9% 12/10 VL 20
2011 VL UD-20 CD4 568-673 24.7%-30.6%
2012 VL UD swap Prezista/Norvir for Reyataz drop statin CD4 768-828 26.7%-30.7%

Online Miss Philicia

  • Member
  • Posts: 24,209
  • celebrity poster, faker & poser
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #17 on: February 19, 2010, 12:14:10 PM »
only have one cup of coffee in me, so at a loss for snappy comeback...will defer to others.

-Will

I'm having organic Ethiopian Harrar.
"Iíve slept with enough men to know that Iím not gay"

Offline Matty the Damned

  • Member
  • Posts: 12,228
  • Ninja Please
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #18 on: February 19, 2010, 04:46:41 PM »
I enjoy using Norvir as a suppository.

Hm. Do you have a USB connexion?


MtD

Offline WillyWump

  • Member
  • Posts: 7,196
  • Fall is in the air!
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #19 on: February 19, 2010, 05:46:12 PM »
I'm having organic Ethiopian Harrar.

You Bitch! I had to use the Instant Folgers since I ran out of my Starbucks :(
POZ since '08

Last Labs-
6/3/14 CD4- 736, UD 34%
6/25/13 CD4- 1036, UD,
2/4/13, CD4 - 489, UD, 28%

Current Meds: Prezista/Epzicom/ Norvir
.

Online Miss Philicia

  • Member
  • Posts: 24,209
  • celebrity poster, faker & poser
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #20 on: February 19, 2010, 06:21:27 PM »
You Bitch! I had to use the Instant Folgers since I ran out of my Starbucks :(

I buy only the best from Old City Coffee at the Reading Terminal Market, where I can also flirt with innocent Amish boys selling honey and jelly.  Starbucks over-roasts their beans.
"Iíve slept with enough men to know that Iím not gay"

Offline secretgarden

  • Member
  • Posts: 6
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #21 on: April 16, 2010, 09:19:03 PM »
I enjoy using Norvir as a suppository.

Loving your posts!

Good news tablet form, cant wait..
19/03/2008       Cd4 340     VL 50000
07/05/2008       Cd4 340     VL 19000
12/08/2008   Cd4 319   VL 125000
12/11/2008   Cd4 312   VL 20000
28/01/2009   Cd4 271   VL 19500
Started Atripla

Online Miss Philicia

  • Member
  • Posts: 24,209
  • celebrity poster, faker & poser
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #22 on: April 16, 2010, 09:37:37 PM »
Oh, good on you bumping this up.  I actually scored my first bottle of the *new* Norvir last week.
"Iíve slept with enough men to know that Iím not gay"

Offline leatherman

  • Member
  • Posts: 6,272
  • Google and HIV meds are Your Friends
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #23 on: April 16, 2010, 09:50:23 PM »
was the new norvir giving you any issues, like you mentioned in another thread?

I'm supposed to be getting my non-gelcap norvir on tues. I'm very exicted! ;D I've hated norvir since i used to take it in liquid form and can't wait for this tablet version.
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Offline Jody

  • Member
  • Posts: 1,829
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #24 on: April 16, 2010, 10:58:24 PM »
I also began taking the Norvir tablet earlier this week and it is much nicer of course not to have to refrigirate it.

My whole regimen improved a while back in terms of less pills and slightly better overall results.  I went from 4 Prezista, 2 Norvir and 1Truvada a day at 2 different times to 2 Prezista, just 1 Norvir and 1 Truvada daily all at the same time after lunch during the week or after a late breakfast on weekends.

Jody
"Wake up to find out that you are the eyes of the world".
 "Try to discover that you are the song that the morning brings."

Grateful Dead

Offline leatherman

  • Member
  • Posts: 6,272
  • Google and HIV meds are Your Friends
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #25 on: April 21, 2010, 12:25:42 AM »
got my new norvir today and took it this evening  ;D
had to take a bunch of immodium too which I normally don't have to do :(
i'm hoping this is just the "getting adjusted" to it's greater strength phase  ;)

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm200179.htm
NORVIR tablets are not bioequivalent to NORVIR capsules. Under moderate fat conditions (857 kcal; 31% fat, 13% protein, 56% carbohydrates), when a single 100 mg NORVIR dose was administered as a tablet compared with a capsule, AUC(0- ∞) met equivalence criteria but mean Cmax [maximum plasma] was increased by 26%

my regimen has changed quite a bit now too. Now I'm doing a once daily dosing at dinner of Reyetaz, Norvir, Truvada, and Valtrex. After almost 20 yrs of meds, I've never had so few pills and such an easy schedule. I think I like this alot.  ;D
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Online Miss Philicia

  • Member
  • Posts: 24,209
  • celebrity poster, faker & poser
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #26 on: April 23, 2010, 10:49:30 AM »
I went back to the old gel caps and life instantly improved.  I gave the new Norvir 12 days.  Lame.
"Iíve slept with enough men to know that Iím not gay"

Offline WillyWump

  • Member
  • Posts: 7,196
  • Fall is in the air!
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #27 on: April 23, 2010, 10:56:58 AM »
I went back to the old gel caps and life instantly improved.  I gave the new Norvir 12 days.  Lame.

That's all I need to hear.

Glad your better.

-Will
POZ since '08

Last Labs-
6/3/14 CD4- 736, UD 34%
6/25/13 CD4- 1036, UD,
2/4/13, CD4 - 489, UD, 28%

Current Meds: Prezista/Epzicom/ Norvir
.

Offline Hellraiser

  • Member
  • Posts: 4,136
  • Semi-misanthropic
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #28 on: April 23, 2010, 10:58:38 AM »
I'll keep this in mind should I ever need to swap to Norvir.  Wonder if I would have the same Gastro-intestinal issues from the tablet.  Has anyone else had similar issues out of the tablet?

Offline leatherman

  • Member
  • Posts: 6,272
  • Google and HIV meds are Your Friends
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #29 on: April 23, 2010, 01:53:03 PM »
day 4 and still needing the immodium which I hadn't needed in years. ::) but much less, so many things are getting better today ;)

3 others at my clinic started it almost a week before me and only had issues the first few days. I so so so hate the gel caps (really, i just hate the norvir!), so I'm giving it a few more days with my very poz attitude that the tablet is going to end up being wonderful.

I was reading an update on meds over at another site (can't remember where exactly), and had to laugh at the description of norvir. at the end they mention that it is also available in liquid form but the taste was "unbelievably horrific".  :D Exactly!
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Offline chguy78

  • Member
  • Posts: 67
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #30 on: April 23, 2010, 02:24:20 PM »
Why do y'all dislike the gel caps so much? Is it the refrigeration requirement or how the gel caps stick together?  It's my understanding that, although recommended, refrigeration isn't required if gel caps are used w/in 2 months. See http://www.aidsmeds.com/archive/Norvir_1561.shtml.

Just wondering as I've been taking Norvir (gel caps) for about a year now and have no complaints.

EDIT: sorry, I reread some older posts and I see why leatherman wants to change (the fragility of the gel caps themselves).
« Last Edit: April 23, 2010, 02:28:30 PM by chguy78 »
01/11: CD4=753 (36%), VL=Undetectable
07/10: CD4=531 (33%), VL=Undetectable
04/10: CD4=746 (33%), VL=Undetectable
01/10: CD4=566 (35%), VL=Undetectable
10/09: CD4=436 (31%), VL=405
07/09: CD4=631 (27%), VL=847
06/09: Started: Truvada, Reyataz, Norvir
05/09: CD4=426 (28%), VL=38,300
04/09: Positive; CD4=466 (28%), VL=39,700
10/08: Negative

Online Miss Philicia

  • Member
  • Posts: 24,209
  • celebrity poster, faker & poser
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #31 on: April 23, 2010, 02:31:24 PM »
Why do y'all dislike the gel caps so much? Is it the refrigeration requirement or how the gel caps stick together?  It's my understanding that, although recommended, refrigeration isn't required if gel caps are used w/in 2 months. See http://www.aidsmeds.com/archive/Norvir_1561.shtml.

Just wondering as I've been taking Norvir (gel caps) for about a year now and have no complaints.

EDIT: sorry, I reread some older posts and I see why leatherman wants to change (the fragility of the gel caps themselves).

I think it's 30 days, not 2 months -- but yeah I'm the same way.  I have no issue with them really.  If I lived along the Amazon a heat stabilized version might prove useful, but I don't live there and I doubt anyone else here does either.
"Iíve slept with enough men to know that Iím not gay"

Offline madbrain

  • Member
  • Posts: 1,208
  • No longer an active member
    • My personal site
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #32 on: April 23, 2010, 02:46:48 PM »
norvir actually travels fine without refrigeration. However, high temps for extended periods will "melt" the gelcaps and they'll stick together.

For some definition of "travels fine". My bf and I drove from San Jose to San Diego once. We had a brand new Norvir refill bottle in the trunk since he was out of meds before the trip.  By the time we got there, the 30 gelcaps were all one nasty gooey mess. It was more than "stick together". You couldn't even tell they had been separate capsules :( We had AC on in the car during the drive and didn't get warm. But obviously the med did.

My bf's regimen no longer includes Norvir, fortunately . It was a huge PITA. It also required him to go in person to the pharmacy to pick up his meds - it couldn't be mailed.

Offline GSOgymrat

  • Member
  • Posts: 5,037
  • HIV+ since 1993. INTJ
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #33 on: April 23, 2010, 03:06:57 PM »
Thanks for being the Guinea pig, Miss P. After listening to your experience I'm going to stick with the old Norvir. I keep them in the fridge until I fill my weekly med dispenser and it is not that big a deal. When I travel I just make sure they stay with me in an air conditioned environment.

Offline Assurbanipal

  • Member
  • Posts: 2,173
  • Taking a forums break, still see PM's
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #34 on: April 23, 2010, 03:37:51 PM »
The new Norvir hasn't been particularly troublesome for me -- as  noted in Miss P's other thread, I noticed this much more moving onto Norvir in the first place (as gelcaps).  It was only a one day adjustment moving from the gelcaps to the tabs the first time I did it, and the subsequent times it has been not noticeable at all. (I've been using the tablets when out of town)

I'm looking forward to moving over permanently in a couple of days (having using up the last of the gelcaps)

5/06 VL 1M+, CD4 22, 5% , pneumonia, thrush -- O2 support 2 months, 6/06 +Kaletra/Truvada
9/06 VL 3959 CD4 297 13.5% 12/06 VL <400 CD4 350 15.2% +Pravachol
2007 VL<400, 70, 50 CD4 408-729 16.0% -19.7%
2008 VL UD CD4 468 - 538 16.7% - 24.6% Osteoporosis 11/08 doubled Pravachol, +Calcium/D
02/09 VL 100 CD4 616 23.7% 03/09 VL 130 5/09 VL 100 CD4 540 28.4% +Actonel (osteoporosis) 7/09 VL 130
8/09  new regimen Isentress/Epzicom 9/09 VL UD CD4 621 32.7% 11/09 VL UD CD4 607 26.4% swap Isentress for Prezista/Norvir 12/09 (liver and muscle issues) VL 50
2010 VL UD CD4 573-680 26.1% - 30.9% 12/10 VL 20
2011 VL UD-20 CD4 568-673 24.7%-30.6%
2012 VL UD swap Prezista/Norvir for Reyataz drop statin CD4 768-828 26.7%-30.7%

Online Miss Philicia

  • Member
  • Posts: 24,209
  • celebrity poster, faker & poser
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #35 on: April 23, 2010, 04:40:05 PM »
I'll just reiterate that this new med did not give me diarrhea, it game me fecal mucosa.  I've never gotten that from any other HIV med.
"Iíve slept with enough men to know that Iím not gay"

Offline leatherman

  • Member
  • Posts: 6,272
  • Google and HIV meds are Your Friends
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #36 on: April 23, 2010, 04:53:08 PM »
For some definition of "travels fine". ...We had a brand new Norvir refill bottle in the trunk since he was out of meds before the trip. 
well, Doh! I meant "travels fine" like in a suitcase inside the car or plane. Not much "travels fine" in the trunk of the car going through the desert.  ::) :D Hell toothpaste, or twinkies (the snack cake) or ding dongs (again, the snack cakes :D) wouldn't last in the truck of a car like that.

It also required him to go in person to the pharmacy to pick up his meds - it couldn't be mailed.
wonder what was up with that? Mine has been mailed to me for years. (wow off-n-on for nearly a decade!) It comes in a thermal mylar pack (great for re-using to wrap Christmas gifts. just slap a bow over the "keep refrigerated" sticker if it won't peel off), with two ice paks (great for using in the cooler in the summer instead of ice)


As to the other issues, no it's not about the refrigeration, though I do recommend that. Living in homes were I've been unable to afford air conditioning, keeping the pills in the frig all year round insures a stable environment. There would have been a big difference in storage issues, back in Ohio where I lived the past 25 yrs, between being on a closet shelf in -10 degree weather (45 inside the house) and 95 degrees (115 inside). That's why I've always recommended the frig - the temp is controlled and stable, and melted norvir gelcaps are a mess! LOL

and I hate norvir, in general! ever since I had to take 8 tblspns of the liquid every day back in the late 90s. Norvir is ethanol based and in my book that's gasoline.  :o and if you ever tasted it, you'd know that's just what it was. I've had issues with the gelcap melting too quickly and that rush of ethanol in my system is very puke-inducing. So I've been anxious for years for either one of the alternative booster or Norvir to be made without ethanol.
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Offline chguy78

  • Member
  • Posts: 67
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #37 on: April 24, 2010, 10:49:50 AM »
I think it's 30 days, not 2 months -- but yeah I'm the same way.

I think the literature for the pills themselves says 30 days but aidsmeds.com says 2 months (http://www.aidsmeds.com/archive/Norvir_1561.shtml).  The difference is irrelevant for me since I have no backup supply anyway.

Thanks for your reports on this, Miss Philicia:  I'll stick with the gel caps for a while - I like to take my pills chilled in the morning.  Now, if I could get it all in one pill to avoid the three copays, I'd be-a-changing.
01/11: CD4=753 (36%), VL=Undetectable
07/10: CD4=531 (33%), VL=Undetectable
04/10: CD4=746 (33%), VL=Undetectable
01/10: CD4=566 (35%), VL=Undetectable
10/09: CD4=436 (31%), VL=405
07/09: CD4=631 (27%), VL=847
06/09: Started: Truvada, Reyataz, Norvir
05/09: CD4=426 (28%), VL=38,300
04/09: Positive; CD4=466 (28%), VL=39,700
10/08: Negative

Offline madbrain

  • Member
  • Posts: 1,208
  • No longer an active member
    • My personal site
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #38 on: April 26, 2010, 04:42:49 AM »
well, Doh! I meant "travels fine" like in a suitcase inside the car or plane. Not much "travels fine" in the trunk of the car going through the desert.  ::) :D Hell toothpaste, or twinkies (the snack cake) or ding dongs (again, the snack cakes :D) wouldn't last in the truck of a car like that.

I never had issues with toothpaste which was also in the car. Food, sure.
None of the other meds we had melted, many in capsule form. Only the Norvir did.

Quote
wonder what was up with that? Mine has been mailed to me for years. (wow off-n-on for nearly a decade!) It comes in a thermal mylar pack (great for re-using to wrap Christmas gifts. just slap a bow over the "keep refrigerated" sticker if it won't peel off), with two ice paks (great for using in the cooler in the summer instead of ice)

It's Kaiser's policy, they force you to pick it up here due to the refrigeration need. How long would those icepacks last inside a mailbox in full sun on a hot day ? My mail usually gets delivered between 11 and noon. I rarely get home before 7pm . That may be long enough for the med to go bad, I think.  Also if you aren't there to open the mailbox on the day of delivery, it might be very bad. I'm guessing the HMO doesn't want to be responsible for expensive meds going bad.

Offline leatherman

  • Member
  • Posts: 6,272
  • Google and HIV meds are Your Friends
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #39 on: April 26, 2010, 10:09:04 AM »
None of the other meds we had melted, many in capsule form. Only the Norvir did.
that's cause it's filled with that ethanol mix.  :D just be glad it didn't explode ROFL

It's Kaiser's policy, they force you to pick it up here due to the refrigeration need. How long would those icepacks last inside a mailbox in full sun on a hot day ?
ah! yes my pharmacy does call to arrange a date so that I get it and it doesn't sit outside all day. However, the ice packs inside the mylar insulated bag have still been cold and slightly frozen (which IS most melted :D ) when I have missed the delivery by over 4 hours (and that's in SC sun and heat ;) )

the good news is that now on day 6, all of my issues have just about gone away. For a short time after taking my norvir at dinner last night I was just a little gassy but that passed quickly. No immodium in three days and no puking at all during the change-over. I also like the difference in the size of this pill. Being just a hair smaller than the truvada, now all my pills easily fit in a keychain pill fob, which sure makes carrying them when going out to eat, etc much easier.
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Offline bocker3

  • Member
  • Posts: 3,415
  • You gotta enjoy life......
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #40 on: April 26, 2010, 01:58:47 PM »
It's Kaiser's policy, they force you to pick it up here due to the refrigeration need. How long would those icepacks last inside a mailbox in full sun on a hot day ? My mail usually gets delivered between 11 and noon. I rarely get home before 7pm . That may be long enough for the med to go bad, I think.  Also if you aren't there to open the mailbox on the day of delivery, it might be very bad. I'm guessing the HMO doesn't want to be responsible for expensive meds going bad.

Aetna ships my Norvir via UPS -- Next Day Air Saver (on their dime).  They require a signature, so the package is never left in the hot sun.  They used to call me and ask me when I wanted it delivered -- this was very convenient.  Now they just ship and email the tracking number to me -- I see when it is due and try to be here -- or I make arrangements to go pick it up at the UPS customer center.

It's packed with cold packs in a styrofoam cooler (which is inside a box).  I've gone 4 days from ship to opening and the packs have still been plenty cold.  The capsules rattle around when shaken.

Mike
Atripla - Started 12/05
Reyataz/Norvir - Added 6/06
Labs - Pre-Meds
Sep05 T=350/25% VL98,559
Nov05 288/18%  47,564
Current Labs
May2013 691/31% <20

Offline Matty the Damned

  • Member
  • Posts: 12,228
  • Ninja Please
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #41 on: April 26, 2010, 04:11:31 PM »
Heh.

This is a classic case of "best is the enemy of better".

MtD


Offline madbrain

  • Member
  • Posts: 1,208
  • No longer an active member
    • My personal site
Re: FDA Approves Heat-Stable Norvir Tablets
« Reply #42 on: April 26, 2010, 07:25:34 PM »
Aetna ships my Norvir via UPS -- Next Day Air Saver (on their dime).  They require a signature, so the package is never left in the hot sun.  They used to call me and ask me when I wanted it delivered -- this was very convenient.  Now they just ship and email the tracking number to me -- I see when it is due and try to be here -- or I make arrangements to go pick it up at the UPS customer center.

It's packed with cold packs in a styrofoam cooler (which is inside a box).  I've gone 4 days from ship to opening and the packs have still been plenty cold.  The capsules rattle around when shaken.

Mike

I am glad I don't have your pharmacy, UPS will never come at the same time of the day twice, but it's always when I'm at work. They also don't do weekend delivery in my area. And not even weekend pickups - their office is closed, you can only come during office hours on weekdays to pick up. So either I would have to take a day off from work and wait for delivery, or take off work during the day to pick up from UPS, or have the package redirected to my office. I hate UPS !

 


Terms of Membership for these forums
 

© 2014 Smart + Strong. All Rights Reserved.   terms of use and your privacy
Smart + Strong® is a registered trademark of CDM Publishing, LLC.