Approved Drug Label (PDF)
4
Contraindications
Additions and/or revisions underlined
ACIPHEX
Sprinkle is contraindicated in patients with known hypersensitivity to
rabeprazole, 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 (5.3), Adverse Reactions (6)].
…
5
Warnings and Precautions
5.3 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 ACIPHEX Sprinkle 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:
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or
revisions underlined
…
ACIPHEX Sprinkle
can cause serious side effects, including:
A type of kidney problem (acute
tubulointerstitial nephritis). Some people who take proton pump inhibitor
(PPI) medicines, including ACIPHEX Sprinkle, may develop a kidney problem
called acute tubulointerstitial nephritis that can happen at any time during
treatment with ACIPHEX Sprinkle. Call your child’s doctor right away if your
child has a decrease in the amount that they urinate or if they have blood in
their urine.
…
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined
Advise
the patient or caregiver to read the FDA-approved patient labeling (Medication
Guide).
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 acute tubulointerstitial
nephritis [see Contraindications (4),
Warnings and Precautions (5.3)].
…
Approved Drug Label (PDF)
5
Warnings and Precautions
Newly
created subsection:
5.10 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:
6.2
Postmarketing Experience
Gastrointestinal:
Addition of:
fundic gland polyps
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Presence of Gastric Malignancy
(subsection revised; additions
underlined)
In adults,
symptomatic response to therapy with ACIPHEX 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.
5.6 Cutaneous and Systemic Lupus Erythematosus
(new
subsection added)
Cutaneous
lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been
reported in patients taking PPIs, including rabeprazole. 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 ACIPHEX
Sprinkle, 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
(additions underlined)
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
(additions underlined)
The following adverse reactions have been identified
during post approval use of rabeprazole sodium.
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.
Blood and
Lymphatic System Disorders: agranulocytosis,
hemolytic anemia, leukopenia, pancytopenia, and thrombocytopenia
Ear and
Labyrinth Disorders: vertigo
Eye Disorders:
blurred vision
General
Disorders and Administration Site Conditions: sudden death
Hepatobiliary
Disorders: jaundice
Immune System
Disorders: anaphylaxis,
angioedema, systemic lupus erythematosus, Stevens- Johnson syndrome, toxic
epidermal necrolysis (some fatal)
Infections and
Infestations: Clostridium difficile-associated
diarrhea
Investigations: Increases in prothrombin time/INR (in patients
treated with concomitant warfarin), TSH elevations
Metabolism and
Nutrition Disorders: hyperammonemia, hypomagnesemia
Musculoskeletal
System Disorders: bone fracture,
rhabdomyolysis
Nervous System Disorders: coma
Psychiatric
Disorders: delirium, disorientation
Renal and
Urinary Disorders: interstitial
nephritis
Respiratory,
Thoracic and Mediastinal Disorders: interstitial
pneumonia
Skin and
Subcutaneous Tissue Disorders: severe
dermatologic reactions, including bullous and other drug eruptions of the skin;
cutaneous lupus erythematosus, erythema multiforme
7
Drug Interactions
(additions underlined)
Table 2 includes clinically important drug
interactions and interaction with diagnostics when administered
concomitantly with ACIPHEX Sprinkle 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
ACIPHEX Sprinkle and Interactions with Diagnostics
(please refer to label to view Table 2)
8
Use in Specific Populations
8.1 Pregnancy
(additions
underlined)
Risk
Summary
…
Changes
in bone morphology were observed in offspring of rats treated with oral doses
of a different PPI through most of pregnancy and lactation. When maternal
administration was confined to gestation only, there were no effects on bone
physeal morphology in the offspring at any age [see Data].
Data
Animal Data
…
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 a different PPI at oral doses of 280 mg/kg/day (about 68 times an oral
human dose on a body surface area basis) where drug 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.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(additions
and revisions; please refer to label)
PATIENT COUNSELING INFORMATION
(additions
and revisions; please refer to label)
5
Warnings and Precautions
5.1 Presence of Gastric Malignancy
In adults,
symptomatic response to therapy with
ACIPHEX SPRINKLE 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 ACIPHEX
SPRINKLE, 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:
(Addition of the
following)
- Cutaneous
and Systemic Lupus Erythematosus
- Cyanocobalamin
(Vitamin B-12) Deficiency
6.2 Postmarketing Experience
The following
adverse reactions have been identified during post approval use of rabeprazole:
delirium;
anaphylaxis; angioedema; systemic lupus erythematosus, bullous and other
drug eruptions of the skin; severe dermatologic reactions, including toxic
epidermal necrolysis (some fatal), Stevens-Johnson syndrome, cutaneous lupus
erythematosus and erythema multiforme…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
What
is the most important information I should know about ACIPHEX SPRINKLE?
ACIPHEX
SPRINKLE may help your acid-related symptoms, but you could still have serious
stomach problems. Talk with your doctor.
ACIPHEX
SPRIINKLE can cause serious side effects, including: (additions
underlined)
- A type of kidney problem (acute interstitial
nephritis). Some people who take proton
pump inhibitor (PPI) medicines, including ACIPHEX SPRINKLE, may develop a
kidney problem called acute interstitial nephritis that can happen at any
time during treatment with ACIPHEX SPRINKLE. 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 ACIPHEX SPRINKLE, 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.
Talk
to your doctor about your risk of these serious side effects if you take ACIPHEX
SPRINKLE.
What
are the possible side effects of ACIPHEX SPRINKLE?
ACIPHEX
SPRINKLE may cause serious side effects, including:
- See “What is the most important information I should
know about ACIPHEX SPRINKLE?”
- Interaction
with warfarin. Taking warfarin with a PPI medicine may lead to an
increased risk of bleeding… (addition
underlined)
PATIENT COUNSELING INFORMATION
Adverse
Reactions (additions
and/or revisions underlined)
Advise the
patient or caregiver to report to the patient’s healthcare provider
if they experience any signs or symptoms consistent with:
• Cutaneous and Systemic Lupus
Erythematosus
• Cyanocobalamin (Vitamin B-12)
deficiency
Drug
Interactions
Advise the
patient or caregiver to report to the patient’s healthcare provider
if they are taking warfarin or high-dose methotrexate.
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