Saturday, January 27, 2007

Novantrone...What's It All About, Alfy?...

     The long-awaited Novantrone lecture...filled with some actual medical data, a splash of opinion, and a drop of speculation...compiled just for YOU!  Please note, no references will be sited so that I cannot be sued by the Mega-Pharma companies...LOL  But you, too, could hit the search button on your Internet and find some equally "riveting" information I am sure...

     Novantrone...Mitoxantrone (pronounced "my toe zantrone"), was first approved by the FDA (Big Boy Federal Regulators) waaaay back in 1987 for the treatment of pain related to advanced hormone-refractory prostate cancer and acute nonlymphocytic leukemia...A little ol' company called, "IMMUNEX", developed it...it's been a money maker ever since.

     But did you know (and I quote an unreferenced source!) "Mitoxantrone, a DNA-reactive agent, intercalates into deoxyribonucleic acid (DNA) through hydrogen bonding, causing crosslinks and strand breaks.  It also interferes with ribonucleic acid (RNA) and is a potent inhibitor of topoisomerase II, an enzyme responsible for uncoiling and nonproliferating cultured human cells, suggesting lack of cell cycle phase specificity."

     Whew!!!  Now what the HECK does all that mean??  Well, frankly I don't really know either...LOL  But, in lay man's terms, it means Novantrone's mechanism of action is seen directly on cellular functioning, specifically the immune system and blood cells.  I added the last part as the above explanation doesn't point specifically to the immune system OR blood cells...but just trust me here...that's what the drug does!  It suppresses the immune system by interfering with how cells are made, specifically white blood cells (thus, it's effectiveness for treating specific types of leukemia...a blood cell disorder.)

     Anytime a drug interferes with or destroys cells in the body, it is often referred to as an "antineoplastic agent" or a "chemotherapy"...Novantrone falls into both of these categories (but, it's really just splitting hairs to separate them...not all chemotherapies are considered antineoplastic agents...minor detail!).

     We usually hear the word "Chemotherapy" used in reference to treating some type of horrible cancer which, in case you've forgotten, MULTIPLE SCLEROSIS IS NOT.  As we all recite over and over in our MS classes, Multiple Sclerosis is THOUGHT to be a disorder of the immune system that attacks the nervous system by destroying the myelin sheath surrounding the nerve tissues of the brain and spinal cord. 

     Blah blah blah...I do much better with a visual myself.  So, I like to think of MS as a nasty, little bunny that's hopping around in my brain and spine, leaving " poo pellets" randomly wherever it feels like it (AKA, plaques or lesions).  I HAD a mini-lop rabbit indoors for a pet...trust me...they defecate in random patterns and will leave you puzzled HOW they can do it so often!  But I digress...

     The current school of thought about the causative factor of MS (among MANY, MANY theories) is, the immune system/white blood cells cross over into the blood/brain barrier (that odd fantasy line of demarcation where blood and spinal fluid meet) and enter ready to do battle...but the white blood cells are confused, because they're not SUPPOSED to be there (kind of like the US in Iraq...I digress again) and all they know to do is to destroy what they've been pre-programmed to.  And for some unknown reason, these little buggars seem to think they've been programmed to destroy myelin (perhaps they only need a "Re-education Camp?!?).

     Sooo, if Novantrone inhibits the production of white blood cells and even destroys white blood cells in the body, the immune system of a screwed up MS patient has less "soldiers" floating around to do battle...rogue soldiers AND good soldiers...but I'll hit on this hot topic later.

     In 2003 (November, to be exact), Big Boy FDA reviewed a few studies that had been done using Novantrone to treat MS.  They liked what they saw and said, "Hey.  Why NOT give the approval for this drug to be sold for MS treatment as well?"  And that's really all their "approval" amounted to...giving IMMUNEX the go ahead to MARKET Novantrone for MS treatment...and, make some more money on another population of needy, ill people.  (Although I should probably check because I doubt it is JUST IMMUNEX making the money...I believe Mitoxantrone, the generic label, IS produced by more companies than IMMUNEX now...but that's only speculation and NOT speculated fact...LOL)

     The studies/drug trials the FDA reviewed actually had some mixed reviews.  The trials DID show that "it appeared mitoxantrone may have a beneficial effect on disease progression in patients with MS whose clinical condition is deteriorating" and it was "probable mitoxantrone reduces the clinical attack rate and reduces attack-related MRI outcomes in patients with relapsing MS".  They went on to say, "In general, however, this agent is of limited use and of potentially great toxicity and should, therefore, be reserved for patients with rapidly advancing disease who have failed other therapies".  The FDA approved the use of Novantrone for Secondary Progressive, Progressive Relapsing, and Worsening Relapsing and Remitting MS.

     Toxicity???  Did you catch that word in the last paragraph??  It was kind of "snuck" in there, wasn't it?  But, yes...Novantrone CAN be quite toxic...remember, it KILLS stuff in the body!  And, as we are learning in Iraq, you can't just go around killing things without consequences...

     So, currently Novantrone/Mitoxantrone is carefully administered to MS patients...to avoid TOXICITY.  There is a life time limit or amount of the drug any one person with MS SHOULD get...it's what the FDA recommends, so most doctors follow the Big Boys to avoid lawsuits later.  The FDA recommends no more than a life time dosing of 140mg/m2 (can't make that "2" hang higher, sorry!)...translated, it's based on body weight.  The usual course of treatment is somewhere between 2-3 years or 8-12 doses.  However, based on MY size, I could conceivably be on this "juice" for 10 years! (I'm kidding, really!)

     Novantrone for the treatment of MS, is usually given every three months via IV.  Don't ask me why because I don't know...I can only speculate (I love that word!) it has to do with the amount of time it takes the body to recover before being "immunosuppressed" again...which leads me back to that word TOXICITY.

     In the world of duality, all good things have an equally darker side.  Novantrone does not escape this fact.  Two of the primary problems or "extra" conditions Novantrone can cause are Congestive Heart Failure (CHF) and a specific leukemia called Secondary Acute Myelogenous Leukemia (AML)...You guessed it...AML IS a type of cancer (odd that a cancer-treating drug could CAUSE a cancer, but it can).

     So, because Novantrone carries its own potential demons, both the heart and blood work must be checked (by Big Boy FDA recommendation, so you KNOW it will happen) prior to each dose every three months.  An echocardiogram is usually used to monitor the heart's functioning and standard labs are drawn to monitor the suppression of the white and red blood cells as well as platelets.  If a problem shows up in either one of these tests, you might as well kiss your Novantrone goodbye...your drug days will be over...there's likely NO ONE, except Dr. Kevorkian, who will hook you up for an infusion at this point!

     And, of course, I shouldn't forget the other "adverse effects" Novantrone can cause...it just doesn't bring out the best in us!  Most references list the following as possible side effects...not everyone will have them and some lucky B-turds may have none:

*Nausea

*Hair thinning or hair loss

*Hypotension (low blood pressure)

*Rashes or mouth sores (stomatitis)

*Susceptibility to other infections such as urinary tract

*Menstrual disorders (seriously boys, no worries here)

*Diarrhea OR Constipation (because you can't win for losing here!)

     One of the other "potential" side effects, which I actually wouldn't mind having (as I think it might be "cool"), is a bluish discoloration of your urine...and even for some, a bluish discoloration of the whites of your eyes.  Neither is said to last more than 24-72 hours, but I seriously wouldn't mind a bit of robin egg tint to my pee...how exciting is THAT?!?  The discoloration is caused by the blue color of the liquid infusion...haven't seen a bag of it myself, but I've heard Novantrone referenced as the "blue juice" or "blue Kool-Aid".  I'm wondering if my personal bag could be tinted purple...it's a favorite color!

     Let's see...check, check, check, covered that, and that, and...Oh yeah...the most important part of this post (because it IS all about me) is, I have consented to the Novantrone...reluctantly...hesitantly...kicking and screaming-ly.  I've done my homework and I will admit begrudgingly, Dr. She Who Will Not Be Named is probably right...it makes more sense to try and stop this progression of my "aggressive" MS now, before I lose even more neurological functioning...before I can no longer refuse things "kicking and screaming-ly".

     Let's face it...I rather like my independence.  And my mother used to say, "That which doesn't kill us, makes us stronger".  I shared that statement with Corrine several weeks ago...but had to add, "My mother is dead now, however.  So she's lost a bit of credibility with me!"

     Now go find something more productive to do with your time...class dismissed...

2 comments:

pjorpeej said...

wow!  I'd read a lot of that before but it confused me so badly that it made my brain hurt.... THANKYOU for putting it in plain English!

Well, that settles the issue for me then... I don't have (knocking wood here!) aggressive MS.  Actually, other than this damned pain, my disease is kinda whimpy!   I think after reading this report I've come to the conclusion that I'd rather just deal with the illness I have rather than chance getting the ones that the little blue bag threatens to entertain us with.  :)

Thanks again Linda!  Good luck with your infusions!!  You're braver than I am.  :)



mdmhvonpa said...

"Diarrhea OR Constipation"

You know, I'm not entirely enticed by THAT combination.