Aminosalicylate

Mesalamine

Approved 16 Apr 2025RectalEnema

The FDA lists this product in 36 strengths and forms.

Indications

Mesalamine rectal suspension enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. Mesalamine rectal suspension enema is an aminosalicylate indicated for treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. (1)

Contraindications

Mesalamine rectal suspension enema is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, sulfites or any other component of this medication [see Warnings and Precautions (5.3)] . Known or suspected hypersensitivity to salicylates, aminosalicylates, sulfites or any other of the ingredients in mesalamine rectal suspension enema. (4, 5.1)

Warnings and precautions

Hypersensitivity Reactions : Sulfite-related reactions (mesalamine rectal suspension enema contains potassium metabisulfite) and sulfasalazine-associated reactions (myocarditis and pericarditis) can occur; evaluate patients immediately and discontinue mesalamine rectal suspension enema if a hypersensitivity reaction is suspected. (5.3) Renal Impairment : Assess renal function at the beginning of treatment and periodically during treatment.

Evaluate the risks and benefits of mesalamine rectal suspension enema in patients with known renal impairment or taking nephrotoxic drug. Discontinue mesalamine rectal suspension enema if renal function deteriorates while on therapy. (5.1, 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 mesalamine rectal suspension enema in patients with known liver impairment. (5.4) Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. (5.5) Photosensitivity : Avoid sun exposure if pre-existing skin conditions. (5.6) 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. (5.7) Interference with Laboratory Tests : Mesalamine may lead to elevated urinary normetanephrine test results. (5.8)

At a glance

Brand name: Mesalamine
Pharmacologic class: Aminosalicylate
Route: Rectal
Dosage form: Enema
Applicant: Novitium Pharma
Status: Prescription
FDA approval: 16 Apr 2025
Application: ANDA215269-001

Indications

Contraindications

Warnings and precautions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Published data from meta-analyses, cohort studies and case series on the use of mesalamine during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . There are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see Clinical Considerations) . In animal reproduction studies, rats and rabbits administered mesalamine during organogenesis at oral doses up to 5 and 8 times the maximum recommended human dose, respectively, did not reveal any evidence of harm to the embryo or the fetus (see Data) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and embryo/fetal risk Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with ulcerative colitis.

Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Data Human Data Published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety of mesalamine rectal suspension enema, during early pregnancy (first trimester) and throughout pregnancy have not reliably informed an association of mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes.

There is no clear evidence that mesalamine exposure in early pregnancy is associated with an increase risk in major congenital malformations, including cardiac malformations. Published epidemiologic studies have important methodological limitations which hinder interpretation of the data, including inability to control for confounders, such as underlying maternal disease, and maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products.

Animal Data Reproduction studies have been performed with mesalamine in rats and rabbits during organogenesis at oral doses up to 5 and 8 times respectively, the maximum recommended human dose, and have revealed no evidence of harm to the embryo or the fetus.

Adverse reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity reactions [see Warnings and Precautions (5.1)] Renal impairment [see Warnings and Precautions (5.2)] Mesalamine-induced acute intolerance syndrome [see Warnings and Precautions (5.3)] Hepatic failure [see Warnings and Precautions (5.4)] Severe cutaneous adverse reactions [see Warnings and Precautions (5.5)] Photosensitivity [see Warnings and Precautions (5.6)] Nephrolithiasis [see Warnings and Precautions (5.7)] 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 ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 * in Clinical Trials of Mesalamine Rectal Suspension Enema in Adult Patients with Ulcerative Colitis, Proctosigmoiditis or Proctitis Adverse Reaction Mesalamine Rectal Suspension Enema (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 * reported in 1% or more of mesalamine rectal suspension enema-treated patients and greater than placebo

6.2Postmarketing 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. Cardiac Disorders: myocarditis, pericarditis [see Warnings and Precautions (5.1)] Gastrointestinal Disorders: pancreatitis Hematologic Disorders: agranulocytosis, aplastic anemia, eosinophilia, leukopenia, neutropenia, pancytopenia, thrombocytopenia Hepatic Disorders: elevated liver enzymes, hepatic failure [see Warnings and Precautions (5.4)] 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 (5.2), (5.7)] 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 (5.5)]

Mesalamine

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Mesalamine

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Hypersensitivity Reactions Sulfite-Related Reactions

5.2Renal Impairment

5.3Mesalamine-Induced Acute Intolerance Syndrome

5.4Hepatic Failure

5.5Severe Cutaneous Adverse Reactions

5.6Photosensitivity Patients

5.7Nephrolithiasis Cases

5.8Interference with Laboratory Tests Use

Interactions

7.1Nephrotoxic Agents, Including Non-Steroidal Anti- Inflammatory Drugs

7.2Azathioprine or 6-Mercaptopurine

7.3Interference with Urinary Normetanephrine Measurements Use

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information