Drug Safety-related Labeling Changes (SrLC)

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ESOMEPRAZOLE STRONTIUM (NDA-202342)

(ESOMEPRAZOLE STRONTIUM)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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03/04/2022 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

Newly added subsection:

5.5 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 in association with the use of PPIs [see Adverse Reactions (6.2)].

Discontinue ESOMEPRAZOLE STRONTIUM at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.

Additions and/or revisions underlined:

5.9 Hypomagnesemia and Mineral Metabolism

… Serious adverse events include tetany, arrhythmias, and seizures. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [see Adverse Reactions (6.2)].

Consider monitoring magnesium and calcium levels prior to initiation of ESOMEPRAZOLE STRONTIUM and periodically while on treatment in patients with a preexisting risk of hypocalcemia (e.g., hypoparathyroidism). Supplement with magnesium and/or calcium as necessary. If hypocalcemia is refractory to treatment, consider discontinuing the PPI.

6 Adverse Reactions

Additions and/or revisions to the bulleted line listing:

• Severe Cutaneous Adverse Reactions [see Warning and Precautions (5.5)]

• Hypomagnesemia and Mineral Metabolism [see Warning and Precautions ( 5.9)]

6.2 Postmarketing Experience

Additions and/or revisions underlined:

Metabolism and Nutritional Disorders: hypomagnesemia; hypocalcemia, hypokalemia [Warnings and Precautions 5.8]; hyponatremia

Skin and Subcutaneous Tissue: alopecia, erythema multiforme, hyperhidrosis, photosensitivity, SJS/TEN, DRESS and AGEP [see Warnings and Precautions (5.5)], cutaneous lupus erythematosus.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

What should I tell my doctor before taking esomeprazole strontium?

Before you take esomeprazole strontium tell your doctor if you:

Additions and/or revisions underlined:

• have been told that you have low magnesium levels, calcium levels and low potassium levels in your blood

  What are the possible side effects of esomeprazole strontium?

  Esomeprazole strontium can cause serious side effects, including:

  Newly added information:

• Severe skin reactions. Esomeprazole strontium can cause rare but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:

  • Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet).

  • You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes.

Stop taking Esomeprazole Strontium and call your doctor right away. These symptoms may be the first sign of a severe skin reaction.

PATIENT COUNSELING INFORMATION

Adverse Reactions:

Additions and/or revisions underlined:

• Severe Cutaneous Adverse Reactions [see Warning and Precautions (5.5)]

• Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.9)]

• Fundic Gland Polyps [see Warnings and Precautions (5.13)]

11/27/2020 (SUPPL-6)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined

• Esomeprazole strontium is contraindicated in patients with known hypersensitivity to proton pump inhibitors. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6)].

…

5 Warnings and Precautions

5.2 Acute Tubulointerstitial Nephritis

Additions and/or revisions underlined

Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia). Discontinue ESOMEPRAZOLE STRONTIUM and evaluate patients with suspected acute TIN [see Contraindications (4)].

6 Adverse Reactions

Additions and/or revisions underlined

…

• Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)]

…

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Additions and/or revisions underlined

…

Esomeprazole strontium can cause serious side effects, including:

• A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including esomeprazole strontium, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with esomeprazole strontium. Call you doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.

  …

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined

…

Adverse Reactions:

Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:

…

• Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)]

…

06/07/2018 (SUPPL-5)

Approved Drug Label (PDF)

5 Warnings and Precautions

Newly created subsection:

5.12 Fundic Gland Polyps

PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use,

especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated.

6 Adverse Reactions

Addition of the following:

• Fundic Gland Polyps

6.2 Postmarketing Experience

Gastrointestinal Disorders:

Addition of: fundic gland polyps

10/24/2016 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Presence of Gastric Malignancy

In adults, symptomatic response to therapy with ESOMEPRAZOLE does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy. (additions and/or revisions underlined)

5.5 Cutaneous and Systemic Lupus Erythematosus (additional section)

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE.

The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement.

Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.

Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving ESOMEPRAZOLE, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.

6 Adverse Reactions

The following serious adverse reactions are described below and elsewhere in labeling:

• Acute Interstitial Nephritis
• Clostridium difficile-Associated Diarrhea
• Bone Fracture
• Cutaneous and Systemic Lupus Erythematosus
• Cyanocobalamin (Vitamin B-12) Deficiency
• Hypomagnesemia

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ESOMEPRAZOLE:

Immune System: anaphylactic reaction/shock; systemic lupus erythematosus

Skin and Subcutaneous Tissue: alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens- Johnson syndrome, toxic epidermal necrolysis (some fatal), cutaneous lupus erythematosus.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

What is the most important information I should know about ESOMEPRAZOLE?

ESOMEPRAZOLE may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

ESOMEPRAZOLE can cause serious side effects, including: (additions below)

• A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including ESOMEPRAZOLE, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with ESOMEPRAZOLE. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.
• Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including ESOMEPRAZOLE, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.

General information about esomeprazole strontium

… For more information, contact R2 Pharma, LLC at 1-866-633-9033. (addition underlined)

PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide) Adverse Reactions:

• Advise patients to report to their healthcare provider if they experience any signs or symptopms consistent with:

• Hypersensitivity Reactions

• Acute Interstitial Nephritis

• Clostridium difficile-Associated Diarrhea

• Bone Fracture

• Cutaneous and Systemic Lupus Erythematosus

• Cyanocobalamin (Vitamin B-12) Deficiency

• Hypomagnesemia

  Drug Interactions (new subheading title)

• Advise patients to let you know if they are taking …

Administration (new subheading title)

• Advise patients to take esomeprazole strontium delayed-release capsules…

• For patients who are advised to open the esomeprazole strontium delayed-release capsules before taking them, instruct them in the proper technique for administration and tell them to follow the dosing instructions, as found in the Medication Guide. (additions and/or revisions underlined)