pentosan polysulfate sodium (Rx)

Brand and Other Names:Elmiron
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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

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Adverse Effects

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

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Warnings

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

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
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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.

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Pharmacology

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)

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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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.

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