Drug Safety-related Labeling Changes (SrLC)

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NEXIUM (NDA-021153)

(ESOMEPRAZOLE MAGNESIUM)

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

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07/18/2023 (SUPPL-60)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

...

Reproductive System and Breast: gynecomastia, erectile dysfunction;

03/04/2022 (SUPPL-59)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Severe Cutaneous Adverse Reactions

New subsection added

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

5.9 Hypomagnesemia and Mineral Metabolism

Additions and/or revisions underlined

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. 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 NEXIUM 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 underlined

…

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

  …

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

  …

  6.2 Postmarketing Experience

  …

  Skin and Subcutaneous Tissue: alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), cutaneous lupus erythematosus.

  …

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

MEDICATION GUIDE

Additions underlined

…

What are the possible side effects of NEXIUM?

NEXIUM can cause serious side effects, including:

…

• Severe skin reactions. NEXIUM 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 NEXIUM and call your doctor right away. These symptoms may be the first sign of a severe skin reaction.

…

PATIENT COUNSELING INFORMATION

Additions underlined

…

Severe Cutaneous Adverse Reactions

Advise the patient or caregiver to discontinue NEXIUM and immediately call the patient’s healthcare provider for at first appearance of a severe cutaneous adverse reaction or other sign of hypersensitivity signs or symptoms associated with Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5)].Cutaneous and Systemic Lupus Erythematosus

…

Hypomagnesemia and Mineral Metabolism

Advise the patient or caregiver to report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, and/or hypokalemia to the patient’s healthcare provider, if they have been receiving NEXIUM for at least 3 months [see Warnings and Precautions (5.9)].

…

08/25/2021 (SUPPL-56)

Approved Drug Label (PDF)

4 Contraindications

Newly added information:

• Proton pump inhibitors (PPIs), including NEXIUM, are contraindicated in patients receiving rilpivirine­ containing products [see Drug Interactions (7)].

6 Adverse Reactions

6.1 Clinical Trials Information

Additions and/or revisions underlined:

… The safety in the treatment of healing of EE in adults was assessed in four randomized comparative clinical trials, which included 1,240 patients who received NEXIUM 20 mg once daily, 2,434 patients on NEXIUM 40 mg once daily, and 3,008 patients on omeprazole 20 mg once daily. The most frequently occurring adverse reactions (at least 1%) in all three groups were headache (5.5%, 5%, and 3.8%, respectively) and diarrhea (no difference among the three groups) …

Less common adverse reactions with an incidence of less than 1% are listed below by body system …

… The incidence of adverse reactions during 6-month trials for the maintenance of healing of EE with NEXIUM 20 mg once daily was similar to placebo. There were no differences in types of adverse reactions seen during maintenance treatment up to 12 months compared to short-term treatment.

Two placebo-controlled studies were conducted in 710 adult patients for the treatment of symptomatic GERD. The most common adverse reactions that were reported were: diarrhea (4%), headache (4%), and abdominal pain (4%).

Combination Treatment with NEXIUM, Amoxicillin and Clarithromycin

In clinical trials of H. pylori eradication of to reduce duodenal ulcer recurrence, no additional adverse reactions specific to the combination of NEXIUM delayed-release capsules, amoxicillin and clarithromycin were observed and were similar to those observed with NEXIUM, amoxicillin, or clarithromycin alone. The most frequently reported adverse reactions for patients who received NEXIUM, amoxicillin and clarithromycin for 10 days were diarrhea (9%), taste perversion (4%), and abdominal pain (4%). No adverse reactions were observed at higher rates with NEXIUM, amoxicillin and clarithromycin than were observed with NEXIUM alone.

Pediatrics (section moved to this place in labeling; same information) …

6.2 Postmarketing Experience

Newly added information following Body Systems:

Adverse reactions associated with omeprazole may also be expected to occur with esomeprazole. See the full prescribing information for omeprazole for complete safety information.

7 Drug Interactions

Reformatted; as below:

Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with esomeprazole and instructions for preventing or managing them.

Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.

Newly created tables; please refer to labeling for complete information:

Table 3: Clinically Relevant Interactions Affecting Drugs Co-Administered with Esomeprazole and Interaction with Diagnostics

Table 4: Clinically Relevant Interactions Affecting Esomeprazole When Co-Administered with Other Drugs

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

Healing of EE

Pediatric Patients 1 Year to 17 Years of Age

The safety and effectiveness of NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension have been established in pediatric patients 12 years to 17 years for short-term treatment (4 to 8 weeks) for healing of EE. The safety and effectiveness of NEXIUM for delayed-release oral suspension have been established in pediatric patients 1 year to 11 years for short-term treatment (up to 8 weeks) for healing of EE. Use of NEXIUM for this indication is supported by evidence from adequate and well-controlled studies in adults with additional safety and pharmacokinetic data in pediatric patients 1 year to 17 years of age. The safety profile in pediatric patients 1 year to 17 years of age was similar to adults [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.4)].

Pediatric Patients 1 Month to Less Than 1 Year of Age

The safety and effectiveness of NEXIUM for delayed-release oral suspension have been established in pediatric patients 1 month to less than 1 year of age for short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD. Use of NEXIUM for this indication is supported by evidence from adequate and well-controlled studies in adults with additional safety, pharmacokinetic, and pharmacodynamic data in pediatric patients 1 month to less than 1 year of age. The safety profile in pediatric patients 1 month to less than 1 year of age was similar to adults [see Adverse Reactions (6.1), Clinical Pharmacology (12.2, 12.3)].

The safety and effectiveness of NEXIUM for the treatment of EE due to acid-mediated GERD in pediatric patients less than 1 month of age have not been established.

Symptomatic GERD

Pediatric Patients 1 Year to 17 Years of Age

The safety and effectiveness of NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension have been established in pediatric patients 12 years to 17 years of age for the short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD. The safety and effectiveness of NEXIUM for delayed-release oral suspension have been established in pediatric patients 1 year to 11 years of age for the short-term treatment (up to 8 weeks) of heartburn and other symptoms associated with GERD. Use of NEXIUM for this indication is supported by evidence from adequate and well-controlled studies in adults with additional safety and pharmacokinetic data in pediatric patients 1 year to 17 years of age. The safety profile in pediatric patients 1 year to 17 years of age was similar to adults [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.4)].

The safety and effectiveness of NEXIUM for the treatment of symptomatic GERD in pediatric patients less than 1 year of age have not been established.

Infants 1 Month to Less Than 1 Year of Age

NEXIUM was not found to be effective in a multicenter, randomized, double-blind, controlled, treatment-withdrawal study of 98 infants aged 1 month to 11 months for the treatment of symptomatic GERD. Patients were enrolled if they had either a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD. Twenty of 98 enrolled patients underwent endoscopy, and 6 patients were found to have EE on endoscopy at baseline. All patients received NEXIUM for delayed-release oral suspension once daily during a two-week, open-label phase of the study.

There were 80 patients who attained a pre-specified level of symptom improvement and who entered the double-blind phase, in which they were randomized in equal proportions to receive NEXIUM or placebo for the next four weeks.

Efficacy was assessed by observing the time from randomization to study discontinuation due to symptom worsening during the four-week, treatment-withdrawal phase. There was no statistically significant difference between NEXIUM and placebo in the rate of discontinuation due to symptom worsening; therefore, these results do not support the use of NEXIUM for the treatment of symptomatic GERD in infants 1 month to less than 1 year of age.

Other Conditions

The safety and effectiveness of NEXIUM for the risk reduction of NSAID-associated gastric ulcer, H. pylori eradication to reduce the risk of duodenal ulcer recurrence and treatment of pathological hypersecretory conditions have not been established in pediatric patients.

Juvenile Animal Toxicity Studies …

8.6 Hepatic Impairment

Additions and/or revisions underlined:

In patients with severe hepatic impairment (Child-Pugh Class C) exposure to esomeprazole substantially increased compared to healthy subjects. Dosage modification of NEXIUM is recommended for patients with severe hepatic impairment for the healing of EE, risk reduction of NSAID-associated gastric ulcer, H. pylori eradication to reduce the risk of duodenal ulcer recurrence, and pathological hypersecretory conditions including Zollinger-Ellison Syndrome [see Dosage and Administration (2.1), Clinical Pharmacology (12.3)].

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Acute Tubulointerstitial Nephritis

Advise the patient or caregiver to call the patient’s healthcare provider immediately if they experience signs and/or symptoms associated with suspected acute TIN [see Warnings and Precautions (5.2)].

Clostridium difficile-Associated Diarrhea

Advise the patient or caregiver to immediately call the patient’s healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions (5.3)].

Bone Fracture

Advise the patient or caregiver to report any fractures, especially of the hip, wrist or spine, to the patient’s healthcare provider[see Warnings and Precautions (5.4)].

Cutaneous and Systemic Lupus Erythematosus

Advise the patient or caregiver to immediately call the patient’s healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions (5.5)].

Cyanocobalamin (Vitamin B-12) Deficiency

Advise the patient or caregiver to report any clinical symptoms that may be associated with cyanocobalamin deficiency to the patient’s healthcare provider if they have been receiving NEXIUM for longer than 3 years [see Warnings and Precautions (5.7)].

Hypomagnesemia

Advise the patient or caregiver to report any clinical symptoms that may be associated with hypomagnesemia to the patient’s healthcare provider, if they have been receiving NEXIUM for at least 3 months [see Warnings and Precautions (5.8)].

Drug Interactions

Advise the patient or caregiver to report to their healthcare provider if starting treatment with rilpivirine-containing products, clopidogrel, St. John’s Wort or rifampin; or, if they take high-dose methotrexate [see Contraindications (4), Warnings and Precautions (5.6, 5.9, 5.11)].

Administration

• Take NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension at least one hour before meals.

• Antacids may be used concomitantly with NEXIUM.

• Swallow NEXIUM delayed-release capsules whole; do not chew or crush the capsules.

• For patients who have difficulty swallowing capsules, NEXIUM delayed-release capsules can be opened, and the contents sprinkled on applesauce. Use with other foods is not recommended.

1. Add one tablespoon of applesauce to an empty bowl. The applesauce used should not be hot and should be soft enough to be swallowed without chewing.

2. Open the NEXIUM delayed-release capsule and carefully empty the granules inside the capsule onto the applesauce.

3. Mix the granules with the applesauce.

4. Administer the mixture immediately. Do not chew or crush the granules

5. Discard any remaining mixture. Do not store the mixture for future use.

• NEXIUM delayed-release capsules can also be administered via a nasogastric tube, as described in the Instructions for Use.

• Administer NEXIUM for delayed-release oral suspension orally or via a nasogastric or gastric tube, as described in the Instructions for Use.

11/27/2020 (SUPPL-57)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined

NEXIUM is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. 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 NEXIUM and evaluate patients with suspected acute TIN [see Contraindications (4)].

6 Adverse Reactions

Additions and/or revisions underlined

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

• 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

…

NEXIUM can cause serious side effects, including:

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

…

PATIENT COUNSELING INFORMATION

Addition and/or revisions underlined

…

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-53)

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:

Addition of: fundic gland polyps

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

MEDICATION GUIDE

Additions and/or revisions underlined:

What are the possible side effects of NEXIUM?

NEXIUM can cause serious side effects, including:

• Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year.

12/20/2016 (SUPPL-51)

Approved Drug Label (PDF)

5 Warnings and Precautions

(Additions and/or revisions are underlined in subsection title)

5.9 Interaction with St. John’s Wort or Rifampin

5.11 Interaction with Methotrexate

8 Use in Specific Populations

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR )Conversion; Additions and/or revisions are underlined)

Risk Summary

…Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person)…

…Changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg. When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age.

The estimated background risks of major birth defects and miscarriage for the indicated population are 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.

Data

Human Data

…A small prospective observational cohort study followed 113 women exposed to omeprazole during pregnancy (89% with first trimester exposures)…

Animal Data

Omeprazole

Reproductive studies conducted with omeprazole in rats at oral doses up to 138 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis) and in rabbits at doses up to 69.1 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis) during organogenesis did not disclose any evidence for a teratogenic potential of omeprazole. In rabbits, omeprazole in a dose range of 6.9 to 69.1 mg/kg/day (about 3.4 to 34 times an oral human dose of 40 mg on a body surface area basis) administered during organogenesis produced dose-related increases in embryo- lethality, fetal resorptions, and pregnancy disruptions. In rats, dose-related embryo/fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from parents treated with omeprazole at 13.8 to 138.0 mg/kg/day (about 3.4 to 34 times an oral human dose of 40 mg on a body surface area basis), administered prior to mating through the lactation period.

Esomeprazole

No effects on embryo-fetal development were observed in reproduction studies with esomeprazole magnesium in rats at oral doses up to 280 mg/kg/day (about 68 times an oral human dose of 40 mg on a body surface area basis) or in rabbits at oral doses up to 86 mg/kg/day (about 41 times an oral human dose of 40 mg on a body surface area basis) administered during organogenesis…

…A follow up developmental toxicity study in rats with further time points to evaluate pup bone development from postnatal day 2 to adulthood was performed with esomeprazole magnesium at oral doses of 280 mg/kg/day (about 68 times an oral human dose of 40 mg on a body surface area basis) where esomeprazole administration was from either gestational day 7 or gestational day 16 until parturition. When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age.

8.2 Lactation

(Pregnancy and Lactation Labeling Rule Conversion; Additions and/or revisions are underlined)

Risk Summary

Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk. There are no clinical data on the effects of esomeprazole on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NEXIUM and any potential adverse effects on the breastfed infant from NEXIUM or from the underlying maternal condition.

10/24/2016 (SUPPL-52)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Presence of Gastric Malignancy

In adults, symptomatic response to therapy with NEXIUM 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)

5.2 Acute Interstitial Nephritis

Acute interstitial nephritis has been observed in patients taking PPIs including NEXIUM. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue NEXIUM if acute interstitial nephritis develops.

5.5 Cutaneous and Systemic Lupus Erythematosus

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including esomeprazole. 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, histologicalfindings 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 NEXIUM, 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 NEXIUM:

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 NEXIUM?

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

NEXIUM 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 NEXIUM, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with NEXIUM. 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 NEXIUM, 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.

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 symptoms 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

  Advise patients to let you know if they are taking, or begin taking, other medications, because NEXIUM can interfere with antiretroviral drugs and drugs that are affected by gastric pH changes.

  Administration

  Let patients know that antacids …