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Frequently Asked Questions about Elmiron

October 1, 2006 - 6:03am — Jessica

What is Elmiron?

Elmiron is an FDA approved drug (since 1996) used in the treatment of Interstitial Cystitis (IC). Elmiron's chemical name is pentosan polysulfate sodium. It is manufactured in 100mg doses, taken in pill form. In the United States it is manufactured by Alza Pharmaceuticals.
Elmiron is a fairly new drug treatment for IC. At it's root Elmiron is a very weak anticoagulant (blood thinner) when administered through an IV, however taking it orally as IC patients do, has very little of this action.
Elmiron is typically considered to be a Heparinoid, which means that it is structurally similar to heparin sulfate an element found on the bladder surface mucin. Elmiron is excreted through the urine and therefore a small amount of it passes through the bladder unchanged. This action is thought to cause Elmiron to adhere to the bladder lining. Elmiron is metabolised through the liver, and therefore patients with pre-existing liver conditions may not be suitable for Elmiron.

What is Elmiron's chemical compound (name)?

β-D-Xylan (1->4) 2, 3 bis (hydrogen sulfate), sodium salt. It has a molecular weight of 4,000-6,000 Dalton. Elmiron is a white, odourless powder, which is soluble in water. It is a semi synthetic Heparin like drug (macromolecular carbohydrate) which resembles glycosaminoglycans chemically, and in it's overall structure.

What is the recommended dosage of Elmiron?

100mgs taken 3 times daily. Elmiron is manufactured in 100mg white capsules that have a hard gelatine coating. Some IC patients note an adverse reaction to gelatine and therefore opt to remove the medication from the capsule prior to consuming it.

How does Elmiron affect Interstitial Cystitis?

Though the medical community does not yet understand exactly how Elmiron works, the most likely reason is that it appears to coat the bladder and subsequently aid in the restoration of the bladder's surface or glycosaminoglycan (GAG) layer. This very important layer is often damaged/deteriorated in IC patients for whatever reason (no exact cause of IC is thus far known, so reasons as to why the GAG layer becomes damaged are also not precisely known at this point in time.)
This layer is thought to be responsible for guarding the bladder wall form the irritants in urine and from bacteria. When the GAG layer is damaged symptoms such as inflammation and pain often occur. Elmiron is thought to work like an artificial GAG layer, and thusly relief may be obtained as the bladder has a chance to be "protected" by this new GAG layer, while the original has time to regenerate and heal.

I have heard Elmiron referred to as an orphan drug why is this?

Elmiron is often referred to as an orphan drug primarily for two reasons. One is that it is the only drug of it's kind, in the sense that it's chemical properties are unique to it. Elmiron has no oral substitutes, and no similar drugs exist on the market at this time. As well it is the only FDA oral drug approved specifically for the treatment of IC.

Will Elmiron cure me?

As the cause/causes of IC are unknown, a definitive "cure" also eludes medical science, so the short answer is no, Elmiron will not cure you. However, it may help relieve your IC symptoms. Many patients find that Elmiron allows them to regain a sense of "normalcy" in their lives, as it may decrease many IC symptoms such as frequency, urgency and bladder/pelvic/lower abdominal pain.
Elmiron is quickly becoming the first line of defence when it comes to the treatment of IC with oral medications, despite the fact that it can take several months to see visible results. Numerous studies have shown that Elmiron is indeed beneficial to many IC patients.

Is Elmiron available worldwide?

No, Elmiron is currently available in only a handful of countries, despite its successful reputation and FDA (should it specify for people not from North America that the FDA is the United States Food and Drug Administration?) approval. To the best of the author's knowledge Elmiron is available for dispersion and distribution only in the following countries:

* Canada (Drug name; Elmiron)
* United States (Drug name; Elmiron)
* Italy (Drug name; Fibrase)
* Spain (Drug name; Fibrocid)
* Austria (Drug name; Polyanion)
* Germany (Drug name; Fibrezym)
* France (Drug name; Hemoclar)
* South Africa (Drug name; Tavan SP-54)

As the pharmaceutical laws and regulations vary greatly from country to country it may be possible to obtain Elmiron with the assistance of your doctor if you do not live in a country where it is currently available. Your doctor may apply to the Pharmaceutical (medicine) board or similar organization of your country for the right to bring in Elmiron. He or she will then have the Elmiron delivered to their office/clinic and in turn prescribe it to you. Please check with your doctor about this possibility if you require Elmiron but do not live in a country where it is available.
It is advised that you do not attempt to bring Elmiron into your country if it is not available there (for example having it shipped in the post), as you may be breaking the drug trafficking and importing laws of your country, and could face legal prosecution.

I am currently on Elmiron and I don't see/feel any benefits, why?

Many IC patients find that if they are going to see any positive effects of Elmiron it takes between 3-6 months, and some opt to keep trying for as long a year. A decrease in pain is often one of the first reported positive effects, with fewer frequency and urgency symptoms following. Clinical and open-label trials (tests) have shown that Elmiron does indeed improve symptoms of IC. Though the results of such studies vary it appears that about 35-40 percent of IC patients who take Elmiron notice marked improvement (some open label studies raise that number in the 60 percentile).
Part of the reason that Elmiron may take so long to work, is that it often has to work to undo months or years worth of "damage" to the bladder's GAG layer, resulting from IC. Elmiron itself does not heal the bladder wall, instead it offers a layer of protection to the bladder while it heals, which is often a drawn out process. As such it's best to stay on Elmiron for at least a six-month trial period (assuming no adverse reactions occur), as it may take that long to see any positive effects.

Why is it recommended to wait before taking Elmiron after eating?

In order for as much Elmiron to directly reach your bladder as possible it is recommended that you take it on an empty stomach. It is best to take Elmiron at least one hour before a meal or two hours after a meal (or drinking heavy beverages). Elmiron should be taken with at least 8 ounces of water.
The less stomach matter Elmiron has to navigate through the more that can reach the bladder's GAG layer. While some IC patients find this hard to adjust to at first (especially if they are used to frequently snacking) the effectiveness of Elmiron does appear to be greater if these guidelines are adhered to as best as possible.

Can I take Elmiron while I am pregnant or breast-feeding?

If you are considering getting pregnant or are pregnant or breast-feeding it is best to consult your doctor before continuing on Elmiron. While no birth defects have been seen in humans who take Elmiron, animal studies have shown Elmiron (pentosan) may pose a risk to the fetus.
It is not yet known if Elmiron is excreted through the breast milk, however most medications do (in small amounts) pass through the milk and into the baby's system. So again it is best to consult with your doctor about the pros and cons of taking Elmiron (or any other medications for that mater) when you are pregnant/breast feeding.

Is Elmiron safe for children with IC?

An FDA approved dosage of Elmiron for children has not been established yet. However many physicians will prescribe Elmiron to children with IC and no higher incidence of side effects have been reported.

How long does Elmiron remain in your body?

When taken orally Elmiron has a half-life of about 5 hours, and one single dosage is completely expelled by your body within 144 hours.

Is Elmiron expensive?

The cost of Elmiron is around $160-$200 American dollars per one month supply (90 capsules), and approximately $120 in Canada per one month supply. No generic form of Elmiron is available yet. So yes, it is more expensive than many other medications, however most drug schemes and health plans do cover Elmiron and may be able to help lower the cost.

Should I be aware of any possible (negative) drug interactions?

If you are taking Elmiron it is best to let your doctor know about all other medications and supplements that you are taking. In particular it is important that your doctor(s) know if you are taking Anticoagulants (blood thinners), Heparin, Alteplase, Streptokinase, or high doses of Aspirin as these medications may increase your risk of bleeding.
Likewise if you have any pre-existing medical conditions you should inform your doctor(s) of these, especially if they are conditions in which bleeding occurs such as stomach ulcers, blood vessel diseases, spleen problems and certain heart conditions.

Should Elmiron be taken in conjunction with other medications in the treatment of IC?

Increasingly Elmiron is being prescribed alongside other IC treatments (oral or intravesical). Combinations which are garnering positive results, are Elmiron and Hydroxyzine (Atarax, Vistaril), Elmiron and Elavil (and other antidepressants) and Elmiron and antispasmodics/anticonvulsants.

What are the side effects of Elmiron?

Overall most patients easily tolerate Elmiron. The most frequently occurring side effects are gastrointestinal issues such as diarrhoea and nausea. Other symptoms may include dizziness, headache, abdominal pain, nosebleed, sore throat, lethargy and rash.
Two serious side effects that have been reported are temporary hair loss, often in patches (hair re-grows when Elmiron is discontinued) and liver dysfunction. As Elmiron is a very weak blood thinner it is possible that it may cause you to be more susceptible to serious bleeding and/or increased bruisability (advise your dentist or medical care professionals if you are having any surgery that you take Elmiron). In these instances the medication should be discontinued. On average each of these symptoms occurs 1-4% of the time.

What are some good sources of further Elmiron information?

IC message boards such as those on ICadvice feature a section devoted to Elmiron. Here patients can discuss Elmiron and offer personal insight on the subject. As well you or your doctor may wish to call 1-888-ELMIRON, and/or check out credible online sources of information such as: