Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING sfROWASA ® (mesalamine) rectal suspension is an off-white to tan colored suspension. Each disposable suspension bottle contains 4 grams of mesalamine in 60 mL aqueous suspension. Suspension bottles are supplied in boxed, foil-wrapped trays as follows: NDC 0037-0022-60 .................. Sample – 1 Bottle NDC 0037-0022-07 .................. Carton of 7 Bottles NDC 0037-0022-14 .................. Carton of 14 Bottles NDC 0037-0022-28 .................. Carton of 28 Bottles sfROWASA ® (mesalamine) rectal suspension is for rectal use only. Storage Store at controlled room temperature 20°C to 25°C (68°F to 77°F); Excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Once the foil wrapped unit of seven bottles is opened, all suspensions should be used promptly as directed by your physician. Contents of suspensions removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, suspensions with dark brown contents should be discarded.; PRINCIPAL DISPLAY PANEL – 4 g/60 mL NDC 0037-0022-07 7 X 60 mL Unit-Dose Bottles sfROWASA® (mesalamine) rectal suspension, 4 g/60 Ml Sulfite-Free Formulation 7 pack For Rectal Use Only Rx Only Each disposable unit contains: Mesalamine (5-aminosalicylic acid)........................................................4 grams in suspension containing carbomer 934P, edetate disodium, potassium acetate, purified water, sodium benzoate, and xanthan gum. USUAL DOSE: One unit-dose suspension in the evenings before going to bed. See package insert for complete prescribing information including usual dose. See enclosed directions for use. Use as directed by your physician. KEEP THIS AND ANY MEDICATION OUT OF REACH OF CHILDREN. SHAKE WELL BEFORE USING. FOIL WRAP PROTECTS PRODUCT FROM DISCOLORATION. DO NOT REMOVE PRODUCT FROM FOIL WRAP UNTIL READY TO USE. Once the foil-wrapped unit of seven bottles is opened, any bottles remaining after 14 days should be discarded. Product contents may darken with time. NOTE: product contents will cause staining of most direct contact surfaces. Store at controlled room temperature 20° to 25°C (68° to 77°F); brief excursions permitted 15° to 30°C (59° to 86°F) [See USP]. Dispensed in original foil-wrapped package. For medical inquiries, call toll-free 1-866-210-5950. SHAKE WELL BEFORE USING Distributed by: MEDA PHARMACEUTICALS® Canonsburg, PA 15317 U.S.A. © 2024 Viatris Inc SFROWASA is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company. U.S. Patent No. 7,645,801 UC-003207-05 Rev. 8/2024 Container Label 4 g/60 mL
- 16 HOW SUPPLIED/STORAGE AND HANDLING sfROWASA ® (mesalamine) rectal suspension is an off-white to tan colored suspension. Each disposable suspension bottle contains 4 grams of mesalamine in 60 mL aqueous suspension. Suspension bottles are supplied in boxed, foil-wrapped trays as follows: NDC 0037-0022-60 .................. Sample – 1 Bottle NDC 0037-0022-07 .................. Carton of 7 Bottles NDC 0037-0022-14 .................. Carton of 14 Bottles NDC 0037-0022-28 .................. Carton of 28 Bottles sfROWASA ® (mesalamine) rectal suspension is for rectal use only. Storage Store at controlled room temperature 20°C to 25°C (68°F to 77°F); Excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Once the foil wrapped unit of seven bottles is opened, all suspensions should be used promptly as directed by your physician. Contents of suspensions removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, suspensions with dark brown contents should be discarded.
- PRINCIPAL DISPLAY PANEL – 4 g/60 mL NDC 0037-0022-07 7 X 60 mL Unit-Dose Bottles sfROWASA® (mesalamine) rectal suspension, 4 g/60 Ml Sulfite-Free Formulation 7 pack For Rectal Use Only Rx Only Each disposable unit contains: Mesalamine (5-aminosalicylic acid)........................................................4 grams in suspension containing carbomer 934P, edetate disodium, potassium acetate, purified water, sodium benzoate, and xanthan gum. USUAL DOSE: One unit-dose suspension in the evenings before going to bed. See package insert for complete prescribing information including usual dose. See enclosed directions for use. Use as directed by your physician. KEEP THIS AND ANY MEDICATION OUT OF REACH OF CHILDREN. SHAKE WELL BEFORE USING. FOIL WRAP PROTECTS PRODUCT FROM DISCOLORATION. DO NOT REMOVE PRODUCT FROM FOIL WRAP UNTIL READY TO USE. Once the foil-wrapped unit of seven bottles is opened, any bottles remaining after 14 days should be discarded. Product contents may darken with time. NOTE: product contents will cause staining of most direct contact surfaces. Store at controlled room temperature 20° to 25°C (68° to 77°F); brief excursions permitted 15° to 30°C (59° to 86°F) [See USP]. Dispensed in original foil-wrapped package. For medical inquiries, call toll-free 1-866-210-5950. SHAKE WELL BEFORE USING Distributed by: MEDA PHARMACEUTICALS® Canonsburg, PA 15317 U.S.A. © 2024 Viatris Inc SFROWASA is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company. U.S. Patent No. 7,645,801 UC-003207-05 Rev. 8/2024 Container Label 4 g/60 mL
Overview
The active ingredient in sfROWASA ® (mesalamine) Rectal Suspension, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: sfROWASA is supplied as a suspension for rectal administration. Each rectal suspension unit contains 4 grams of mesalamine. The inactive ingredients are carbomer 934P, edetate disodium, potassium acetate, purified water, sodium benzoate and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product. mesalamine structural formula
Indications & Usage
sfROWASA is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. sfROWASA is an aminosalicylate indicated for treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. ( 1 )
Dosage & Administration
Evaluate renal function before initiating therapy with sfROWASA [see Warnings and Precautions (5.1) ] . Recommended Dosage The recommended dosage is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours for 3 to 6 weeks depending on symptoms and sigmoidoscopic findings. Administration Instructions • Shake the bottle to ensure the suspension is homogeneous. • Remove the protective sheath from the applicator tip. • Assume the correct body position: o Lie on the left side with the lower leg extended and the upper right leg flexed forward for balance. o Alternatively, sit in the knee to chest position. • Gently insert the applicator tip in the rectum pointing toward the umbilicus. • Steadily squeeze the bottle to discharge the medication. • Remain in the position for at least 30 minutes. Administer at bedtime with the objective of retaining it all night. • Drink an adequate amount of fluids during treatment [see Warnings and Precautions (5.7) ] . • Evaluate renal function prior to initiation of sfROWASA and periodically while on therapy. ( 2 , 5.1 ) • The recommended dosage is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours for 3 to 6 weeks depending on symptoms and sigmoidoscopic findings. ( 2 ) • Drink an adequate amount of fluids. ( 2 . 5.7 )
Warnings & Precautions
• Renal Impairment : Assess renal function at the beginning of treatment and periodically during treatment. Evaluate the risks and benefits of sfROWASA in patients with known renal impairment or taking nephrotoxic drug. Discontinue sfROWASA if renal function deteriorates while on therapy. ( 7.1 ) • Mesalamine-Induced Acute Intolerance Syndrome : Discontinue treatment if acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, sometimes fever, headache and rash) is suspected. ( 5.2 ) • Hepatic Failure : Evaluate the risks and benefits of using sfROWASA in patients with known liver impairment. ( 5.3 ) • Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other sings of hypersensitivity and consider further evaluation. ( 5.4 ) • Photosensitivity : Avoid sun exposure if pre-existing skin conditions. ( 5.5 ) • Nephrolithiasis : Cases of nephrolithiasis have been reported with the use of mesalamine. Mesalamine-containing stones are undetectable by standard radiography or computed tomography (CT). Ensure adequate hydration during treatment. ( 5.6 ) • Interference with Laboratory Tests : Mesalamine may lead to elevated urinary normetanephrine test results. ( 5.7 ) 5.1 Renal Impairment Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure have been reported in patients given sfROWASA or other products that contain mesalamine or are converted to mesalamine. In animal studies, the kidney was the principal organ of mesalamine toxicity [see Nonclinical Toxicology (13.2) ] . Evaluate the risks and benefits of using sfROWASA in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs. Evaluate renal function in all patients prior to initiation and periodically while on sfROWASA therapy. Discontinue sfROWASA if renal function deteriorates while on therapy [see Drug Interactions (7.1) , Use in Specific Populations (8.6)] . 5.2 Mesalamine-Induced Acute Intolerance Syndrome Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Although the exact frequency of occurrence cannot be ascertained, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. Monitor patients for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with sfROWASA. 5.3 Hepatic Failure There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered other products containing mesalamine. Evaluate the risks and benefits of using sfROWASA in patients with known liver impairment. 5.4 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of mesalamine [see Adverse Reactions (6) ] . Discontinue sfROWASA at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. 5.5 Photosensitivity Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Advise patients to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. 5.6 Nephrolithiasis Cases of nephrolithiasis have been reported with the use of mesalamine, including stones with 100% mesalamine content. Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate fluid intake during treatment. 5.7 Interference with Laboratory Tests Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection because of the similarity in the chromatograms of normetanephrine and the main metabolite of mesalamine, N‑acetyl‑5‑aminosalicylic acid (N‑Ac‑5‑ASA). Consider an alternative, selective assay for normetanephrine.
Contraindications
sfROWASA is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates or any other component of this medication [see Warnings and Precautions (5.3) ] . Known or suspected hypersensitivity to salicylates, aminosalicylates or any other of the ingredients in sfROWASA. ( 4 , 5.1 )
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: • Renal impairment [see Warnings and Precautions (5.1) ] • Mesalamine-induced acute intolerance syndrome [see Warnings and Precautions (5.2) ] • Hepatic failure [see Warnings and Precautions (5.3) ] • Severe cutaneous adverse reactions [see Warnings and Precautions (5.4) ] • Photosensitivity [see Warnings and Precautions (5.5) ] • Nephrolithiasis [see Warnings and Precautions (5.6) ] Most common adverse reactions (≥1%) are: gas/flatulence, flu, fever, leg/joint pain, hemorrhoids, rectal pain and hair loss. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc at 1-866-210-5949 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Table 1: Adverse Reactions reported in 1% or more of sfROWASA-treated patients and greater than placebo in Clinical Trials of sfROWASA in Adult Patients with Ulcerative Colitis, Proctosigmoiditis or Proctitis Adverse Reaction sfROWASA (N=815) % Placebo (N=128) % Gas/Flatulence 6 4 Flu 5 1 Fever 3 0 Leg/Joint pain 2 1 Hemorrhoids 1 1 Rectal pain 1 0 Hair loss 1 0 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of mesalamine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders: pancreatitis Hematologic Disorders: agranulocytosis, aplastic anemia, eosinophilia, leukopenia, neutropenia, pancytopenia, thrombocytopenia Hepatic Disorders: elevated liver enzymes, hepatic failure [see Warnings and Precautions (5.3) ] Nervous System: intracranial hypertension Renal and Urinary Disorders: acute renal failure, chronic renal failure, interstitial nephritis, nephrogenic diabetes insipidus, nephrolithiasis, nephrotoxicity [see Warnings and Precautions (5.1) , (5.6) ] • Urine discoloration occurring ex-vivo caused by contact of mesalamine including inactive metabolite, with surfaces or water treated with hypochlorite-containing bleach Reproductive System and Breast Disorders: reversible oligospermia Respiratory, Thoracic, and Mediastinal Disorders: fibrosing alveolitis, pleurisy/pleuritis Skin and Subcutaneous Tissue Disorders: AGEP, DRESS, SJS/TEN [see Warnings and Precautions (5.4) ]
Drug Interactions
• Nephrotoxic Agents including Non-Steroidal Anti-inflammatory Drugs (NSAIDs) : Increased risk of nephrotoxicity; monitor for changes in renal function and mesalamine-related adverse reactions. ( 7.1 ) • Azathioprine or 6-Mercaptopurine : Increased risk of blood dyscrasias; monitor complete blood cell counts and platelet counts. ( 7.2 ) 7.1 Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs), may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions [see Warnings and Precautions (5.2) ] . 7.2 Azathioprine or 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6‑mercaptopurine and/or any other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of sfROWASA and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts. 7.3 Interference with Urinary Normetanephrine Measurements Use of sfROWASA may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection [see Warnings and Precautions (5.7) ] . Consider an alternative, selective assay for normetanephrine.
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