Elmiron (pentosan polysulfate sodium) dosing, indications, interations, adverse effects, and more

Sections

Sections pentosan polysulfate sodium
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

100mg

Interstitial Cystitis

Indicated for bladder pain associated with interstitial cystitis

100 mg PO q8hr

Administration: 1 hour before or 2 hours after meals with water

Reassess every 3 Months

Sickle Cell Disease (Orphan)

Orphan indication sponsors

Vanguard Therapeutics, Inc; Eagle Trace Dr; Half Moon Bay, CA 94019
TRF Pharma, Inc; 863 Mitten Road; Burlingame, CA 94010

Mucopolysaccharidosis (Orphan)

Brand name: Lysosan

Orphan designation for treatment of MPS type VI

Sponsor

Plexcera Therapeutics, LLC; 4445 North Highway A1A, Suite 241; Vero Beach, FL 32963

<16 years: Safety and efficacy not established

1-10%

Alopecia (4%)

Diarrhea (4%)

Nausea (4%)

Headache (3%)

Abdominal pain (2%)

Indigestion (2%)

Postmarketing Reports

Rectal hemorrhage

Elevated LFTs

Anemia

Leukopenia

Partial thromboplastin time increased

Prothrombin time increased

Thrombocytopenia

Optic neuritis

Retinal hemorrhage

Pigmentary changes in the retina

Contraindications

Hypersensitivity

Cautions

Alopecia is associated with pentosan polysulfate and with heparin products; alopecia began within the first 4 weeks of treatment in clinical trials; ninety-seven percent (97%) of cases of alopecia reported were alopecia areata, limited to a single area on the scalp

The drug has not been studied in patients with hepatic insufficiency; because there is evidence of hepatic contribution to elimination of drug, hepatic impairment may have an impact on pharmacokinetics of the drug; exercise caution when using drug in this patient population

Retinal pigmentary changes

Pigmentary changes in retina, reported as pigmentary maculopathy, identified with long-term use of drug
Although most cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use; while the etiology is unclear, cumulative dose appears to be a risk factor
Visual symptoms in reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision
Visual consequences of pigmentary changes are not fully characterized
Use caution in patients with retinal pigment changes from other causes in which examination findings may confound appropriate diagnosis, follow-up, and treatment
Obtain detailed ophthalmologic history in all patients prior to starting treatment; consider testing if there is a family history of hereditary pattern dystrophy, genetic
For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy
A baseline retinal examination (including OCT and autofluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment; if pigmentary changes in retina develop, re-evaluate risks and benefits of continuing treatment, since these changes may be irreversible
Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment

Anticoagulant effects

The drug is a weak anticoagulant (1/15 the activity of heparin) At a daily dose of 300 mg (n=128), rectal hemorrhage was reported as an adverse event in 6.3% of patients
Bleeding complications of ecchymosis, epistaxis, and gum hemorrhage reported
Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to other therapies such as coumarin anticoagulants, heparin, tPA, streptokinase, high dose aspirin, or nonsteroidal anti-inflammatory drugs) should be evaluated for hemorrhage.
Patients with diseases such as aneurysms, thrombocytopenia, hemophilia, gastrointestinal ulcerations, polyps, or diverticula should be carefully evaluated before starting therapy
Exercise caution when administering therapy in patients who have a history of heparin-induced thrombocytopenia

Pregnancy & Lactation

Pregnancy Category: B

Lactation: not known if excreted in breast milk, use caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Low molecular weight heparin-like compound; elicits weak anticoagulant (1/15 activity of heparin) and fibrinolytic effects

MOA in cystitis unknown; drug appears to attach to the bladder wall mucosa where it may act as a buffer to protect tissues from irritating substances in the urine

Pharmacokinetics

Absorption: 6%

Half-Life, Elimination: 4.8 hr

Distribution: Uroepithelium of the genitourinary tract with lesser amounts found in the liver, spleen, lung, skin, periosteum, and bone marrow

Metabolism: Spleen and liver; partial depolymerization in the kidney to a large number of metabolites

Excretion: Feces (58% as unchanged drug) Urine (6% primarily as metabolites)

BRAND	FORM.	UNIT PRICE	PILL IMAGE
Elmiron oral -	100 mg capsule

Patient Handout

PENTOSAN POLYSULFATE SODIUM - ORAL

(PEN-toe-san paw-lee-SULL-fate SO-dee-um)

COMMON BRAND NAME(S): Elmiron

USES: This medication is used to treat pain/discomfort from a certain bladder disorder (interstitial cystitis). It may work by forming a layer on the bladder wall and protecting it from harmful/irritating substances in the urine. It is also a weak "blood thinner" and therefore may increase the risk of bruising/bleeding (such as bleeding from the nose/gums).

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking pentosan polysulfate sodium and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth at least 1 hour before or 2 hours after meals as directed by your doctor, usually 3 times daily.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Do not increase your dose or take this medication more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.Tell your doctor if your condition worsens or does not improve after 3 months.

SIDE EFFECTS: Diarrhea, hair loss, nausea, headache, stomach upset, or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: unusual bruising/bleeding (such as blood in stool), vision changes (such as blurred vision), eye pain, mental/mood changes, heartburn, discomfort when swallowing, tiredness, fast/pounding heartbeat, shortness of breath.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking pentosan polysulfate sodium, tell your doctor or pharmacist if you are allergic to it; or to heparin or low molecular weight heparin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (such as hemophilia, thrombocytopenia), blood vessel disorders (such as aneurysm), eye disorders, liver disease, spleen disorders, stomach/intestinal disorders (such as stomach ulcers, polyps, diverticula).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (e.g., warfarin, heparin, tenecteplase, abciximab, clopidogrel, ticlopidine), mifepristone, sulfinpyrazone.Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, naproxen, ketorolac) that may increase your risk for side effects if taken together with this medication. Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually 81-162 milligrams a day). Ask your doctor or pharmacist for more details.This medication may interfere with certain laboratory tests (including prothrombin time/INR, factor Xa levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: unusual bruising/bleeding, nausea/vomiting.

NOTES: Do not share this medication with others.Lab and/or medical tests (such as eye exams, liver function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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