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Guide
Drug Safety-related Labeling Changes (SrLC) Database
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| CDER | Center for Drug Evaluation and Research |
| MG | Medication Guide |
| NDA | New Drug Application |
| PCI | Patient Counseling Information |
| PI | Patient Information |
| PLR | Physician Labeling Rule |
| PLLR | Pregnancy and Lactation Labeling Rule |
| Italics | For the most part, italics indicate an FDA comment such as:
Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. |
| Underlines | Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text. |
Sections
| BW | Box Warning |
| WP | Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format) |
| AR | Adverse Reactions (in pre-PLR format, this may be a subheading under precautions). |
| DI | Drug Interactions (in pre-PLR format, this may be a subheading under precautions). |
| USP | Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format. |
| PCI/PI/MG | Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. |
Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.
Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.
LIALDA (NDA-022000)
(MESALAMINE)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
10/24/2023 (SUPPL-27)
6 Adverse Reactions
6.2 Postmarketing ExperienceAdditions and/or
revisions underlined:
The
following adverse reactions have been identified during post-approval use of
LIALDA or other mesalamine-containing products. 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.
…
Renal Disorders: renal failure,
interstitial nephritis, nephrogenic diabetes insipidus, nephrolithiasis [see Warnings and Precautions (5.1, 5.8)]
Urine discoloration occurring ex-vivo caused by contact of mesalamine, including inactive metabolite, with surfaces or water treated with hypochlorite-containing bleach
...
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATIONAdditions and/or revisions underlined:
Administration Instruct patients:
- Swallow LIALDA tablets whole;
do not split or crush.
Take LIALDA tablets with food [see Clinical Pharmacology (12.3)].
Urine may become discolored reddish-brown while taking LIALDA when it comes in contact with surfaces or water treated with hypochlorite-containing bleach. If discolored urine is observed, advise patients to observe their urine flow. Report to the healthcare provider only if urine is discolored on leaving the body, before contact with any surface or water (e.g., in the toilet).
Drink an adequate amount of fluids [see Warnings and Precautions (5.8)].
…
11/16/2022 (SUPPL-25)
5 Warnings and Precautions
5.1 Renal ImpairmentNewly added information:
Discontinue LIALDA if renal function deteriorates while on therapy.
8 Use in Specific Populations
8.6 Renal ImpairmentNewly added information:
Discontinue LIALDA if renal function deteriorates while on therapy
11/01/2021 (SUPPL-23)
5 Warnings and Precautions
Newly added subsection:
5.5 Severe Cutaneous Adverse Reactions
Severe cutaneous adverse reactions, such as 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 (6.2)]. Discontinue LIALDA at the first appearance of signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
6 Adverse Reactions
Severe cutaneous adverse reactions, such as 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 (6.2)]. Discontinue LIALDA at the first appearance of signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
ADVERSE REACTIONS
Newly added to the bulleted line listing:
Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5)]
6.2 Postmarketing Experience
Additions and/or revisions underlined:
Respiratory/Pulmonary: Sinusitis, rhinitis, pharyngitis, asthma exacerbation, pleuritis/pleurisy, bronchitis, eosinophilic pneumonia, interstitial pneumonitis.
Skin: psoriasis, pyoderma gangrenosum, erythema nodosum, photosensitivity, SJS/TEN, DRESS, and AGEP [see Warnings and Precautions (5.5)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATIONNewly added information:
Severe Cutaneous Adverse Reactions
Inform patients of the signs and symptoms of severe cutaneous adverse reactions. Instruct patients to stop taking LIALDA and report to their healthcare provider at first appearance of a severe cutaneous adverse reaction or other sign of hypersensitivity [see Warnings and Precautions (5.5)].
05/25/2021 (SUPPL-22)
6 Adverse Reactions
6.2 Postmarketing Experience
(Additions and/or revisions underlined)
The following adverse reactions have been identified during post-approval use of LIALDA or other mesalamine-containing products. 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.
Body as a Whole: lupus-like syndrome, drug fever
Cardiac Disorders: pericarditis, pericardial effusion, myocarditis [see Warnings and Precautions (5.3)]
Gastrointestinal: cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer
Hepatic: jaundice, cholestatic jaundice, hepatitis, liver necrosis, liver failure, Kawasaki-like syndrome including changes in liver enzymes
Hematologic: agranulocytosis, aplastic anemia
Immune System Disorders: anaphylactic reaction, angioedema, Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), toxic epidermal necrolysis (TEN)
Musculoskeletal and Connective Tissue Disorders: myalgia, lupus-like syndrome
Neurological/Psychiatric: peripheral neuropathy, Guillain-Barré syndrome, transverse myelitis, intracranial hypertension
Renal Disorders: renal failure, interstitial nephritis, nephrogenic diabetes insipidus, nephrolithiasis [see Warnings and Precautions (5.1, 5.7)]
Respiratory, Thoracic and Mediastinal Disorders: interstitial lung disease, hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis), pleurisy/pleuritis
12/17/2020 (SUPPL-21)
6 Adverse Reactions
6.2 Postmarketing Experience(Additions and/or revisions underlined)
The following adverse reactions have been identified during post-approval use of LIALDA or other mesalamine-containing products. 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.
Body as a Whole: lupus-like syndrome, drug fever
Cardiac Disorders: pericarditis, pericardial effusion, myocarditis [see Warnings and Precautions (5.3)] Gastrointestinal: cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer
Hepatic: jaundice, cholestatic jaundice, hepatitis, liver necrosis, liver failure, hepatotoxicity, Kawasaki-like syndrome including changes in liver enzymes
Hematologic: agranulocytosis, aplastic anemia
Immune System Disorders: anaphylactic reaction, angioedema, Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS)
Musculoskeletal and Connective Tissue Disorders: myalgia, lupus-like syndrome
Neurological/Psychiatric: peripheral neuropathy, Guillain-Barré syndrome, transverse myelitis, intracranial hypertension
Renal Disorders: renal failure, interstitial nephritis, nephrogenic diabetes insipidus, nephrolithiasis [see Warnings and Precautions (5.1, 5.7)]
Respiratory, Thoracic and Mediastinal Disorders: interstitial lung disease, hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis)
Skin: psoriasis, pyoderma gangrenosum, erythema nodosum, photosensitivity
Urogenital: reversible oligospermia
10/01/2020 (SUPPL-20)
4 Contraindications
(Additions and/or revisions underlined)
LIALDA is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the ingredients of LIALDA [see Warnings and Precautions (5.3), Adverse Reactions (6.2), Description (11)].
5 Warnings and Precautions
Nephrolithiasis(Newly added section)
Cases of nephrolithiasis have been reported with the use of mesalamine, including stones with a 100% mesalamine content. Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate hydration during treatment with LIALDA.
(Additions and/or revisions underlined)
Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients given products such as LIALDA that contain mesalamine or are converted to mesalamine. In animal studies, the kidney was the principal organ of mesalamine toxicity [see Adverse Reactions (6.2), Nonclinical Toxicology (13.2)].
6 Adverse Reactions
(Additions and/or revisions underlined)
The following clinically significant adverse reactions are described elsewhere in labeling:
Renal impairment, including renal failure [see Warnings and Precautions (5.1)]
Mesalamine-induced acute intolerance syndrome [see Warnings and Precautions (5.2)]
Hypersensitivity reactions [see Warnings and Precautions (5.3)]
Hepatic failure [see Warnings and Precautions (5.4)]
Upper gastrointestinal tract obstruction [see Warnings and Precautions (5.5)]
Photosensitivity [see Warnings and Precautions (5.6)]
Nephrolithiasis [see Warnings and Precautions (5.7)]
(Additions and/or revisions underlined)
Renal Disorders: renal failure, interstitial nephritis, nephrogenic diabetes insipidus, nephrolithiasis [see Warnings and Precautions (5.1, 5.7)]
7 Drug Interactions
7.1 Interference with Urinary Normetanephrine Measurements(Section title revised)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Patient Counseling Information(Additions and/or revisions underlined)
Nephrolithiasis
Instruct patients to drink an adequate amount of fluids during treatment in order to minimize the risk of kidney stone formation and to contact their healthcare provider if they experience signs or symptoms of a kidney stone (e.g., severe side or back pain, blood in the urine) [see Warnings and Precautions (5.7)].
Administration
Instruct patients:
Swallow LIALDA tablets whole; do not split or crush.
Take LIALDA tablets with food [see Clinical Pharmacology (12.3)].
Drink an adequate amount of fluids [see Warnings and Precautions (5.7)].
06/26/2020 (SUPPL-19)
5 Warnings and Precautions
5.1 Renal Impairment(Additions and/or revisions underlined)
Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients given products such as LIALDA that contain mesalamine or are converted to mesalamine.
Evaluate renal function prior to initiation of LIALDA therapy and periodically while on therapy. Evaluate the risks and benefits of using LIALDA in patients with known renal impairment, history of renal disease, or taking concomitant nephrotoxic drugs [see Drug Interactions (7.1), Use in Specific Populations (8.6), Nonclinical Toxicology (13.2)].
(Additions and/or revisions underlined)
Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain, and bloody diarrhea, and sometimes fever, headache, and rash. Monitor patients closely for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with LIALDA.
(Additions and/or revisions underlined)
Hypersensitivity reactions have been reported in patients taking sulfasalazine. Some of these patients may have a similar reaction to LIALDA tablets or to other compounds that contain or are converted to mesalamine.
As with sulfasalazine, mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, and hematologic abnormalities. Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present. Discontinue LIALDA if an alternative etiology for the signs or symptoms cannot be established.
(Additions and/or revisions underlined)
There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Evaluate the risk and benefit of using LIALDA in patients with known liver impairment.
(Additions and/or revisions underlined)
Pyloric stenosis or other organic or functional obstruction in the upper gastrointestinal tract may cause prolonged gastric retention of LIALDA, which would delay mesalamine release in the colon. Avoid LIALDA in patients at risk of upper gastrointestinal tract obstruction.
(Additions and/or revisions underlined)
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.
(Additions and/or revisions underlined)
Use of LIALDA 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.
6 Adverse Reactions
6.1 Clinical Trials Experience(Extensive changes; please refer to label)
(Additions and/or revisions underlined)
In addition to the adverse reactions reported above in clinical trials involving LIALDA, the adverse reactions listed below have been identified during post-approval use of LIALDA and other mesalamine-containing products. 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.
Body as a Whole: lupus-like syndrome, drug fever
Cardiac Disorders: pericarditis, pericardial effusion, myocarditis [see Warnings and Precautions (5.3)] Gastrointestinal: cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer
Hepatic: jaundice, cholestatic jaundice, hepatitis, liver necrosis, liver failure, Kawasaki-like syndrome including changes in liver enzymes
Hematologic: agranulocytosis, aplastic anemia
Immune System Disorders: anaphylactic reaction, angioedema, Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS)
Musculoskeletal and Connective Tissue Disorders: myalgia, lupus-like syndrome
Neurological/Psychiatric: peripheral neuropathy, Guillain-Barré syndrome, transverse myelitis, intracranial hypertension
Renal Disorders: renal failure, interstitial nephritis, nephrogenic diabetes insipidus [see Warnings and Precautions (5.1)]
Respiratory, Thoracic and Mediastinal Disorders: interstitial lung disease, hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis)
Skin: psoriasis, pyoderma gangrenosum, erythema nodosum, photosensitivity
Urogenital: reversible oligospermia
7 Drug Interactions
7.1 Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs(Additions and/or revisions underlined)
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 (5.1)].
(Subsection title revised; Additions and/or revisions underlined)
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 LIALDA and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.
(Newly added subsection)
Use of LIALDA 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.
8 Use in Specific Populations
8.4 Pediatric Use(Additions and/or revisions underlined)
The safety and effectiveness of LIALDA have been established for the treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. Use of LIALDA in this population is supported by evidence from adequate and well-controlled trials in adults, a multicenter, randomized, double-blind, parallel group trial in 105 pediatric patients 5 to 17 years of age, and additional pharmacokinetic analyses. The safety profile in pediatric patients was similar to that observed in adults [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.2)].
The safety and effectiveness of LIALDA have not been established in patients weighing less than 24 kg.
(Additions and/or revisions underlined)
Clinical trials of LIALDA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia, and pancytopenia) in patients who were 65 years or older who were taking mesalamine-containing products such as LIALDA compared to younger patients. Monitor complete blood cell counts and platelet counts in elderly patients during treatment with LIALDA.
Systemic exposures are increased in elderly subjects [see Clinical Pharmacology (12.3)].
In general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients when prescribing LIALDA. Consider starting at the low end of the dosing range for induction in elderly patients [see Dosage and Administration (2)].
(Newly added subsection)
Mesalamine is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Evaluate renal function in all patients prior to initiation and periodically while on LIALDA therapy. Monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions. [see Warnings and Precautions (5.1), Drug Interactions (7.1), Adverse Reactions (6.2)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION(Additions and/or revisions underlined)
Renal Impairment
Inform patients that LIALDA may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, and periodic monitoring of renal function will be performed while they are on therapy. Advise patients to complete all blood tests ordered by their healthcare provider [see Warnings and Precautions (5.1)].
Mesalamine-Induced Acute Intolerance Syndrome and Other Hypersensitivity Reactions
Instruct patients to stop taking LIALDA and report to their healthcare provider if they experience new or worsening symptoms of acute intolerance syndrome (cramping, abdominal pain, bloody diarrhea, fever, headache, and rash) or other symptoms suggestive of mesalamine-induced hypersensitivity [see Warnings and Precautions (5.2, 5.3)].
Hepatic Impairment
Advise patients with known liver disease to contact their healthcare provider if they experience signs or symptoms of worsening liver function [see Warnings and Precautions (5.4)].
Upper Gastrointestinal Tract Obstruction
Advise patients to contact their healthcare provider if they experience signs and symptoms of upper gastrointestinal tract obstruction [see Warnings and Precautions (5.5)].
Photosensitivity
Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors [see Warnings and Precautions (5.6)].
Blood Disorders
Inform elderly patients and those taking azathioprine or 6-mercaptopurine of the risk for blood disorders and the need for periodic monitoring of complete blood cell counts and platelet counts while on therapy. Advise patients to complete all blood tests ordered by their healthcare provider [see Drug Interactions (7.2), Use in Specific Populations (8.5)].
Administration
Inform patients to swallow LIALDA delayed-release tablets whole, taking care not to break the outer coating.
07/18/2019 (SUPPL-18)
7 Drug Interactions
7.2 Azathioprine or 6-mercaptopurine(additions underlined)
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.
8 Use in Specific Populations
8.1 Pregnancy(PLLR conversion)
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, there were no adverse developmental outcomes with administration of oral mesalamine during organogenesis to pregnant rats and rabbits at doses 1.8 and 2.9 times, respectively, the maximum recommended human dose (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated populations 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 miscarriages 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 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 increased risk of 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, maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products.
Animal Data
Reproduction studies with mesalamine during organogenesis have been performed in rats at doses up to 1000 mg/kg/day (1.8 times the maximum recommended human dose based on a body surface area comparison) and rabbits at doses up to 800 mg/kg/day (2.9 times the maximum recommended human dose based on a body surface area comparison) and have revealed no evidence of harm to the fetus due to mesalamine.
(PLLR conversion)
Risk Summary
Data from published literature report the presence of mesalamine and its metabolite, N-acetyl- 5-aminosalicylic acid in human milk in small amounts with relative infant doses (RID) of 0.1% or less for mesalamine (see Data). There are case reports of diarrhea in breastfed infants exposed to mesalamine (see Clinical Considerations). There is no information on the effects of the drug on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of LIALDA to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LIALDA and any potential adverse effects on the breastfed child from LIALDA or from the underlying maternal condition.
Clinical Considerations
Advise the caregiver to monitor the breastfed infant for diarrhea. Data
In published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 4.8 g daily. The average concentration of mesalamine in milk ranged from non-detectable to 0.5 mg/L. The average concentration of N-acetyl-5-aminosalicylic acid in milk ranged from 0.2 to 9.3 mg/L. Based on these concentrations, estimated infant daily dosages for an exclusively breastfed infant are 0 to 0.075 mg/kg/day (RID 0% to 0.1%) of mesalamine and 0.03 to 1.4 mg/kg/day of N-acetyl-5-aminosalicylic acid.
05/23/2018 (SUPPL-17)
5 Warnings and Precautions
5.6 Photosensitivity(Newly Added Subsection)
Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions.
6 Adverse Reactions
6.2 Postmarketing Experience(Additions and/or revisions are underlined)
Skin: psoriasis, pyoderma gangrenosum, erythema nodosum, photosensitivity
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION(Additions and/or revisions are underlined)
- Inform patients to let their physicians know all medications they are taking and if they:
- have increased sensitivity of the skin to sun and ultraviolet light
08/22/2017 (SUPPL-15)
6 Adverse Reactions
6.2 Postmarketing Experience(additions underlined)
In addition to the adverse reactions reported above in clinical trials involving LIALDA, the adverse reactions listed below have been identified during post-approval use of LIALDA and other mesalamine- containing products. 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.
…
Musculoskeletal and Connective Tissue Disorders: myalgia, lupus-like syndrome
…
Respiratory, Thoracic and Mediastinal Disorders: interstitial lung disease, hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis
…
07/27/2017 (SUPPL-16)
6 Adverse Reactions
6.2 Postmarketing Experience(additions underlined)
…
Neurological/Psychiatric: peripheral neuropathy, Guillain-Barre syndrome, transverse myelitis, intracranial hypertension
Renal Disorders: interstitial nephritis, nephrogenic diabetes insipidus