Drug Safety-related Labeling Changes (SrLC)

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PREVACID (NDA-020406)

(LANSOPRAZOLE)

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

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03/04/2022 (SUPPL-94)

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

5.8 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.

…

Consider monitoring magnesium and calcium levels prior to initiation of PREVACID or PREVACID SoluTab 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 (5.8)]

 6.2 Postmarketing Experience

…

Metabolism and Nutritional Disorders – hypomagnesemia, hypocalcemia, hypokalemia, hyponatremia;

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

MEDICATION GUIDE

Additions underlined

…

Before you take PREVACID or PREVACID SoluTab, tell your doctor about all of your medical conditions, including if you:

• have low magnesium, calcium, potassium or sodium levels in your blood or you are taking a diuretic.

  …

   

  What are the possible side effects of PREVACID and PREVACID SoluTab?

  PREVACID and PREVACID SoluTab can cause serious side effects, including:

  …

• Low magnesium levels in the body can happen in people who have taken PREVACID for at least 3 months. Tell your doctor right away if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.

• Severe skin reactions. PREVACID 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 PREVACID 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

To discontinue PREVACID or PREVACID SoluTab and immediately call their healthcare provider for further evaluation [see Warnings and Precautions (5.5)].

…

Hypomagnesemia and Mineral Metabolism

To report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, and/or hypokalemia to their healthcare provider, if they have been receiving PREVACID or PREVACID SoluTab for at least three months [see Warnings and Precautions (5.8)].

11/27/2020 (SUPPL-92)

Approved Drug Label (PDF)

4 Contraindications

Addition and/or revision underlined

• PREVACID and PREVACID SoluTab are contraindicated in patients with known hypersensitivity 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

Addition and/or revisions underlined

Acute tubulointerstial 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 PREVACID or PREVACID SoluTab and evaluate patients with suspected acute TIN

[see Contraindications (4)].

6 Adverse Reactions

Addition and/or revision 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

…

PREVACID and PREVACID SoluTab can cause serious side effects, including:

• A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including PREVACID and PREVACID SoluTab, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with PPI medicines including PREVACID and PREVACID SoluTab. Call your doctor right away 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

…

Advise patients to:

Acute Tubulointerstitial Nephritis

To call their healthcare provider if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis [see Warnings and Precautions (5.2)].

…

09/11/2020 (SUPPL-90)

Approved Drug Label (PDF)

5 Warnings and Precautions

Newly added subsection:

5.12 Risk of Heart Valve Thickening in Pediatric Patients Less Thank One Year of Age

PREVACID and PREVACID SoluTab are not approved in pediatric patients less than one year of age. Nonclinical studies in juvenile rats with lansoprazole have demonstrated an adverse effect of heart valve thickening. The risk of heart valve injury does not appear to be relevant to patients one year of age and older [see Use in Specific Populations (8.4)].

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of PREVACID and PREVACID SoluTab have been established in pediatric patients one year to 17 years of age for short-term treatment of symptomatic GERD and erosive esophagitis. In clinical studies of symptomatic GERD and erosive esophagitis, PREVACID was not administered beyond 12 weeks in patients one year to 11 years of age. It is not known if PREVACID and PREVACID SoluTab are safe and effective if used longer than the recommended duration. Do not exceed the recommended dose and duration of use in pediatric patients (see Juvenile Animal Toxicity Data).

PREVACID was not effective in pediatric patients with symptomatic GERD one month to less than one year of age in a multicenter, double-blind, placebo-controlled study. Therefore, safety and effectiveness have not been established in patients less than one year of age. Nonclinical studies …

… Treatment-related dizziness, reported in this prescribing information as occurring in less than 1% of adult patients, was reported in this study by three adolescent patients with non-erosive GERD, who had dizziness concurrently with other reactions (such as migraine, dyspnea, and vomiting).

Juvenile Animal Toxicity Data

Heart Valve Thickening

In two oral toxicity studies, thickening of the mitral heart valve occurred in juvenile rats treated with lansoprazole. Heart valve thickening was observed primarily with oral dosing initiated on postnatal Day 7 (age equivalent to neonatal humans) and postnatal Day 14 (human age equivalent of approximately one year) at doses of 250 mg/kg/day and higher (at postnatal Day 7 and postnatal Day 14, respectively 6.2 times and 4.2 times the daily pediatric dose of 15 mg in pediatric patients age one to 11 years weighing 30 kg or less, based on AUC). The treatment durations associated with heart valve thickening ranged from 5 days to 8 weeks. The findings reversed or trended towards reversibility after a 4-week drug-free recovery period. The incidence of heart valve thickening after initiation of dosing on postnatal Day 21 (human age equivalent of approximately two years) was limited to a single rat (1/24) in groups given 500 mg/kg/day for 4 or 8 weeks (approximately 5.2 times the daily pediatric dose of 15 mg in pediatric patients age one to 11 years weighing 30 kg or less, based on AUC). Based on exposure margins, the risk of heart valve injury does not appear to be relevant to patients one year of age and older.

Bone Changes

In an eight-week oral toxicity study in juvenile rats with dosing initiated on postnatal Day 7, doses equal to or greater than 100 mg/kg/day (2.5 times the daily pediatric dose of 15 mg in children age one to 11 years weighing 30 kg or less, based on AUC) …

06/07/2018 (SUPPL-87)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

Newly added information:

In animal reproduction studies, oral administration of lansoprazole to rats during organogenesis

through lactation at 6.4 times the recommended human dose produced reductions in the offspring

in femur weight, femur length, crown-rump length and growth plate thickness (males only) on

postnatal day 21. Advise pregnant women of the potential risk of fetal harm.

Animal Data

A pre- and postnatal developmental toxicity study in rats with additional endpoints to evaluate

bone development was performed with lansoprazole at oral doses of 10 to 100 mg/kg/day (0.7 to

6.4 times the recommended human lansoprazole dose of 30 mg based on AUC [area under the

plasma concentration-time curve]) administered during organogenesis through lactation.

Maternal effects observed at 100 mg/kg/day (6.4 times the recommended human lansoprazole

dose of 30 mg based on AUC) included increased gestation period, decreased body weight gain

during gestation, and decreased food consumption. The number of stillbirths was increased at

this dose, which may have been secondary to maternal toxicity. Body weight of pups was

reduced at 100 mg/kg/day starting on postnatal day 11. Femur weight, femur length, and crown-rump length were reduced at 100 mg/kg/day on postnatal day 21. Femur weight was still

decreased in the 100 mg/kg/day group at age 17 to 18 weeks. Growth plate thickness was

decreased in the 100 mg/kg/day males on postnatal day 21, and was increased in the 30 and 100

mg/kg/day males at age 17 to 18 weeks.

Motor activity in offspring was decreased at the maternal dose of 30 mg/kg/day and higher (1.7

times the recommended human lansoprazole dose of 30 mg based on AUC). Impaired

performance in a learning and memory test occurred in the 100 mg/kg/day group. No effects on

mating and fertility in the offspring were observed.

8.4 Pediatric Use

Newly added information:

PREVACID was not effective in pediatric patients with symptomatic GERD one month to less

than one year of age in a multicenter, double- blind, placebo controlled study. Therefore, safety

and effectiveness have not been established in patients less than 1 year. Nonclinical studies in juvenile rats have demonstrated an adverse effect of heart valve thickening and bone changes at lansoprazole doses higher than the maximum recommended equivalent human dose.

In clinical studies of symptomatic GERD and erosive esophagitis, PREVACID was not

administered beyond 12 weeks in 1 to 11 year olds. It is not known if PREVACID is safe and

effective if used longer than the recommended duration. Do not exceed the recommended dose

and duration of use in pediatric patients.

Juvenile Animal Toxicity Data

In a juvenile rat study, adverse effects on bone growth and development and heart valves were observed at

lansoprazole doses higher than the maximum recommended equivalent human dose.

An eight-week oral toxicity study with a four-week recovery phase was conducted in juvenile rats, with lansoprazole administered from postnatal Day 7 (age equivalent to neonatal humans) through 62 (age equivalent to approximately 14 years in humans) at doses of 40 to 500 mg/kg/day (about 1.2 to 12 times the daily pediatric dose of 15 mg in children age one to 11 years weighing 30 kg or less, based on AUC).

Heart valve thickening occurred at a dose of 500 mg/kg/day (approximately 12 times the daily dose of 15 mg in pediatric patients age one to 11 years weighing 30 kg or less, based on AUC). Heart valve thickening was not observed at the next lower dose (250 mg/kg/day) and below. The findings trended towards reversibility after a four-week drug-free recovery period. The relevance of heart valve thickening in this study to pediatric patients less than approximately 12 years of age is unknown. These findings are not relevant for patients 12 years of age and older. No effects on heart valves were observed in a 13-week intravenous toxicity study of lansoprazole in adolescent rats (approximately 12 years human age equivalence) at systemic exposures similar to those achieved in the eight-week oral toxicity study in juvenile (neonatal) rats.

In the eight-week oral toxicity study, doses equal to or greater than 100 mg/kg/day (about 2.5 times the daily pediatric dose of 15 mg in children age one to 11 years weighing 30 kg or less, based on AUC) produced delayed growth, with impairment of weight gain observed as early as postnatal Day 10 (age equivalent to neonatal humans). At the end of treatment, the signs of impaired growth at 100 mg/kg/day and higher included reductions in body weight (14% to 44% compared to controls), absolute weight of multiple organs, femur weight, femur length, and crown-rump length. Femoral growth plate thickness was reduced only in males and only at the 500 mg/kg/day dose. The effects related to delayed growth persisted through the end of the 4-week recovery period. Longer term data were not collected.

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

PATIENT COUNSELING INFORMATION

Addition of the following:

Pregnancy

Advise a pregnant women of the potential risk to a fetus. Advise females of reproductive

potential to inform their healthcare provider of a known or suspected pregnancy.

06/07/2018 (SUPPL-88)

Approved Drug Label (PDF)

5 Warnings and Precautions

Newly created subsection:

5.11 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

04/13/2018 (SUPPL-84)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion, as below:

Risk Summary

Available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment.

The estimated background risk of major birth defects and miscarriage for the indicated populations 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.

If PREVACID or PREVACID SoluTab is administered with clarithromycin, the pregnancy information for clarithromycin also applies to the combination regimen. Refer to the prescribing information for clarithromycin for more information on use in pregnancy.

Data

Human Data

Available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and lansoprazole use. Methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. In a prospective study by the European Network of Teratology Information Services, outcomes from a group of 62 pregnant women administered median daily doses of 30 mg of lansoprazole were compared to a control group of 868 pregnant women who did not take any PPIs. There was no difference in the rate of major malformations between women exposed to PPIs and the control group, corresponding to a Relative Risk (RR)=1.04, [95% Confidence Interval (CI) 0.25-4.21]. In a population-based retrospective cohort study covering all live births in Denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to lansoprazole in 794 live births. A meta-analysis that compared 1,530 pregnant women exposed to PPIs in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to PPIs (for major malformations Odds Ratio (OR)=1.12, [95% CI 0.86-1.45] and for spontaneous abortions OR=1.29, [95% CI 0.84-1.97]).

Animal Data

No adverse effects on embryo-fetal development occurred in studies performed in pregnant rats at oral lansoprazole doses up to 150 mg/kg/day (40 times the recommended human dose [30 mg/day] based on body surface area) administered during organogenesis and pregnant rabbits at oral lansoprazole doses up to

0 mg/kg/day (16 times the recommended human dose based on body surface area) administered during organogenesis.

8.2 Lactation

PLLR conversion; as below:

Risk Summary

There is no information regarding the presence of lansoprazole in human milk, the effects on the breastfed infant, or the effects on milk production. However, lansoprazole and its metabolites are present in rat milk. The

Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PREVACID or PREVACID SoluTab and any potential adverse effects on the breastfed child from PREVACID or PREVACID SoluTab or from the underlying maternal condition.

10/18/2017 (SUPPL-83)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions are underlined)

• PREVACID and PREVACID SoluTab are contraindicated in patients with known severe hypersensitivity to any component of the formulation…

• Proton Pump Inhibitors (PPIs), including PREVACID and PREVACID SoluTab, are contraindicated with rilpivirine-containing products.

• For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with PREVACID or PREVACID SoluTab, refer to the Contraindications section of their prescribing information.

 

5 Warnings and Precautions

5.1 Presence of Gastric Malignancy

(Additions and/or revisions are underlined)

In adults, symptomatic response to therapy with PREVACID or PREVACID SoluTab does not preclude the presence of gastric malignancy…

5.10 Patients with Phenylketonuria

(Newly added subsection)

Phenylalanine can be harmful to patients with phenylketonuria (PKU). PREVACID SoluTab contains phenylalanine, a component of aspartame. Each 15 mg tablet contains 2.5 mg and each 30 mg tablet contains 5.1 mg of phenylalanine. Before prescribing PREVACID SoluTab to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including PREVACID SoluTab.

5.2 Acute Interstitial Nephritis

(Additions and/or revisions are underlined)

Acute interstitial nephritis has been observed in patients taking PPIs including PREVACID and PREVACID SoluTab… Discontinue PREVACID or PREVACID SoluTab if acute interstitial nephritis develops.

5.3 Clostridium difficile-Associated Diarrhea

(Additions and/or revisions are underlined)

Published observational studies suggest that PPI therapy like PREVACID and PREVACID SoluTab may be associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD), especially in hospitalized patients…

…For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with PREVACID or PREVACID SoluTab, refer to Warnings and Precautions section of their prescribing information.

5.5 Cutaneous and Systemic Lupus Erythematosus

(Additions and/or revisions are underlined)

…If signs or symptoms consistent with CLE or SLE are noted in patients receiving PREVACID or PREVACID SoluTab, discontinue the drug and refer the patient to the appropriate specialist for evaluation…

5.6 Cyanocobalamin (Vitamin B-12B12) Deficiency

(Additions and/or revisions are underlined)

This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed in patients treated with PREVACID or PREVACID SoluTab.

5.8 Interactions with Investigations for Neuroendocrine Tumors

(Newly added subsection)

Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Healthcare providers should temporarily stop lansoprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.

5.9 Interaction with Methotrexate

(Subsection title has been revised)

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions and/or revisions are underlined)

Additional adverse experiences have been reported since PREVACID and PREVACID SoluTab have been marketed. The majority of these cases are foreign-sourced and a relationship to PREVACID or PREVACID SoluTab has not been established…

6.3 Combination Therapy with Amoxicillin and Clarithromycin

(Additions and/or revisions are underlined)

For information about adverse reactions with antibacterial agents (amoxicillin and clarithromycin) indicated in combination with PREVACID or PREVACID SoluTab, refer to the Adverse Reactions section of their prescribing information.

6.4 Laboratory Values

(Additions and/or revisions are underlined)

For information about laboratory value changes with antibacterial agents (amoxicillin and clarithromycin) indicated in combination with PREVACID or PREVACID SoluTab, refer to the Adverse Reactions section of their prescribing information.

7 Drug Interactions

(Additions and/or revisions are underlined)

Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with PREVACID or PREVACID SoluTab and instructions for preventing or managing them.

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

Table 2. Clinically Relevant Interactions Affecting Drugs Co-Administered with PREVACID or PREVACID SoluTab and Interactions with Diagnostics

(Table has been added; please refer to label)

Table 3. Clinically Relevant Interactions Affecting PREVACID or PREVACID SoluTab When Co- Administered with Other Drugs

(Table has been added; please refer to label)

8 Use in Specific Populations

8.4 Pediatric Use

(Additions and/or revisions are underlined)

The safety and effectiveness of PREVACID and PREVACID SoluTab have been established in pediatric patients one to 17 years of age for short-term treatment of symptomatic GERD and erosive esophagitis, however, lansoprazole was not effective in patients with symptomatic GERD one month to less than one year of age in a multi-center, double-blind, placebo controlled study.

8.5 Geriatric Use

(Additions and/or revisions are underlined)

Of the total number of patients (n=21,486) in clinical studies of PREVACID, 16% of patients were aged

65 years and over, while 4% were 75 years and over. No overall differences in safety or effectiveness were observed between these patients and younger patients and other reported clinical experience has not identified significant differences in responses between geriatric and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

8.6 Hepatic Impairment

(Additions and/or revisions are underlined)

In patients with various degrees of chronic hepatic impairment the exposure to lansoprazole was increased compared to healthy subjects with normal hepatic function. No dosage adjustment for PREVACID or PREVACID SoluTab is necessary for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. The recommended dosage is 15 mg orally daily in patients with severe hepatic impairment (Child-Pugh Class C).

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

…Advise patients to:

Acute Interstitial Nephritis

To call their healthcare provider if they experience signs and/or symptoms associated with acute interstitial nephritis.

Clostridium difficile-Associated Diarrhea

To immediately call their healthcare provider if they experience diarrhea that does not improve.

Bone Fracture

To report any fractures, especially of the hip, wrist or spine, to their healthcare provider.

Cutaneous and Systemic Lupus Erythematosus

To immediately call their healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus.

Cyanocobalamin (Vitamin B12) Deficiency

To report any clinical symptoms that may be associated with cyanocobalamin deficiency to their healthcare provider, if they have been receiving PREVACID or PREVACID SoluTab for longer than three years.

Hypomagnesemia

To report any clinical symptoms that may be associated with hypomagnesemia to their healthcare provider, if they have been receiving PREVACID or PREVACID SoluTab for at least three months.

Drug Interactions

Advise patients to report to their healthcare provider if they are taking rilpivirine-containing products.

 

Administration

• Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.

• PREVACID or PREVACID SoluTab should be taken before eating.

• Do not crush or chew PREVACID capsule or PREVACID SoluTab

• Take PREVACID or PREVACID SoluTab at least 30 minutes prior to sucralfate.

• Phenylketonurics: Contains Phenylalanine 2.5 mg per 15 mg PREVACID SoluTab Tablet and 5.1 mg per 30 mg PREVACID SoluTab Tablet.

  PREVACID Capsules

• Swallow whole; do not chew.

• For patients who have difficulty swallowing capsules:

  • Alternatively, PREVACID capsules can be administered with apple juice via nasogastric tube

  • See the Instructions for Use for a description of all preparation and administration instructions

PREVACID SoluTab

• Do not break or cut.

• Place the tablet on the tongue; allow it to disintegrate, with or without water, until the particles can be swallowed. Do not chew the particles.

• Alternatively, for children or other patients who have difficulty swallowing tablets, PREVACID SoluTab can be administered with water via oral syringe or NG tube, as described in the Instructions for Use.

MEDICATION GUIDE

(Additions and/or revisions are underlined)

You should take PREVACID and PREVACID SoluTab exactly as prescribed, at the lowest dose possible and for the shortest time needed.

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

PREVACID and PREVACID SoluTab can cause serious side effects, including:

• A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including PREVACID and PREVACID SoluTab, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with PPI medicines including PREVACID and PREVACID SoluTab…

• Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever.

• Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine.

• 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 PREVACID and PREVACID SoluTab, may develop certain types of lupus erythematosus or have worsening of the lupus they already have…

Talk to your doctor about your risk of these serious side effects.

PREVACID and PREVACID SoluTab can have other serious side effects. See “What are the possible side effects of PREVACID and PREVACID SoluTab?”

What are PREVACID and PREVACID SoluTab?

In adults, PREVACID and PREVACID SoluTab are used for:

• 10 to 14 days with certain antibiotics to treat an infection caused by bacteria called H. pylori.

• maintaining healing of duodenal ulcers. PREVACID has not been studied beyond 12 months for this purpose.

• up to 8 weeks for the healing and symptom relief of stomach ulcers.

• up to 8 weeks for the healing of stomach ulcers in people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs). PREVACID has not been studied beyond 8 weeks for this purpose.

• reducing the risk of stomach ulcers in people who are at risk of developing stomach ulcers with NSAIDs. PREVACID has not been studied beyond 12 weeks for this purpose.

• up to 8 weeks for the healing and symptom relief of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). Your doctor may prescribe another 8 to 16 weeks of PREVACID or PREVACID SoluTab for patients whose EE does not improve or whose symptoms return.

• maintaining healing of EE. PREVACID has not been studied beyond 12 months for this purpose.

• the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison syndrome.

In children 1 to 11 years of age, PREVACID and PREVACID SoluTab are used for:

• up to 12 weeks to treat heartburn and other symptoms that can happen with GERD.

• up to 12 weeks for the healing and symptom relief of EE.

In children 12 to 17 years of age, PREVACID and PREVACID SoluTab are used for:

• up to eight weeks to treat heartburn and other symptoms that can happen with GERD.

• up to eight weeks for the healing and symptom relief of EE.

PREVACID and PREVACID SoluTab are not effective for treating the symptoms of GERD in children less than 1 year of age.

Do not take PREVACID or PREVACID SoluTab if you are:

• allergic to lansoprazole, any other PPI medicine, or any of the ingredients in PREVACID or PREVACID SoluTab…

• taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus)

Before you take PREVACID or PREVACID SoluTab, tell your doctor about all of your medical conditions,

including if you:

• are pregnant or plan to become pregnant. It is not known if PREVACID or PREVACID SoluTab will harm your unborn baby.

• are breastfeeding or plan to breastfeed. It is not known if PREVACID or PREVACID SoluTab passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take PREVACID or PREVACID SoluTab.

Especially tell your doctor if you take methotrexate (OTREXUP, RASUVO, TREXALL).

How should I take PREVACID and PREVACID SoluTab?

• Take PREVACID or PREVACID SoluTab exactly as prescribed by your doctor.

• Do not change your dose or stop taking PREVACID or PREVACID SoluTab without talking to your doctor.

• Take PREVACID or PREVACID SoluTab before meals.

• If you miss a dose of PREVACID or PREVACID SoluTab, take it as soon as you remember…

• If you take too much PREVACID or PREVACID SoluTab, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest hospital emergency room.

What are the possible side effects of PREVACID and PREVACID SoluTab?

PREVACID and PREVACID SoluTab can cause serious side effects, including:

• See “What is the most important information that I should know about PREVACID and PREVACID SoluTab?”

• Low vitamin B12 levels in the body can happen in people who have taken PREVACID or PREVACID SoluTab for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.

• Low magnesium levels in the body can happen in people who have taken PREVACID for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.

The most common side effects of PREVACID and PREVACID SoluTab include:…

These are not all the possible side effects of PREVACID and PREVACID SoluTab.

How should I store PREVACID and PREVACID SoluTab?

Keep PREVACID and PREVACID SoluTab and all medicines out of the reach of children.

General information about the safe and effective use of PREVACID and PREVACID SoluTab.

…Do not use PREVACID or PREVACID SoluTab for conditions for which it was not prescribed. Do not give PREVACID or PREVACID SoluTab to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about PREVACID and PREVACID SoluTab that is written for health professionals.

What are the ingredients in PREVACID and PREVACID SoluTab? …

10/24/2016 (SUPPL-82)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Presence of Gastric Malignancy

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

5.5 Cutaneous and Systemic Lupus Erythematosus (added subsection)

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

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.

7 Drug Interactions

7.7 Combination Therapy with Clarithromycin

For information about drug interactions of antibacterial agents (amoxicillin and clarithromycin) indicated in combination with PREVACID, refer to the DRUG INTERACTIONS section of their prescribing information.

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

MEDICATION GUIDE

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

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

PREVACID can cause serious side effects, including:

• A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including PREVACID, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with PREVACID. 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 PREVACID, 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.

What are the possible side effects of PREVACID? PREVACID can cause serious side effects, including:

•           See “What is the most important information that I should know about PREVACID?”

•           Vitamin B-12 deficiency. PREVACID and PREVACID SoluTab reduce the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor about the possibility of vitamin B-12 deficiency if you have been on PREVACID for a long time (more than 3 years).

•           Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a PPI medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

PATIENT COUNSELING INFORMATION

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

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

  Administration

  PREVACID is available as a capsule and as an orally disintegrating tablet (SoluTab). Both are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below.

• PREVACID should be taken before eating.

PREVACID capsule and SoluTab.  SHOULD NOT BE CRUSHED OR CHEWED.