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Indications and Usage

GRALISE is indicated for the management of postherpetic neuralgia (PHN). GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.

GRALISE (gra leez’) (gabapentin) Tablets is a prescription medicine used in adults, 18 years and older, to treat:

pain from damaged nerves (neuropathic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection).

Important Safety Information

CONTRAINDICATIONS

GRALISE is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

WARNINGS AND PRECAUTIONS

The safety and efficacy of GRALISE in patients with epilepsy has not been studied.

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs) including gabapentin, the active ingredient in GRALISE, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Withdrawal of Gabapentin

Gabapentin should be withdrawn gradually. If GRALISE is discontinued, this should be done gradually over a minimum of 1 week or longer (at the discretion of the prescriber).

Tumorigenic Potential

In standard preclinical in vivo lifetime carcinogenicity studies, an unexpectedly high incidence of pancreatic acinar adenocarcinomas was identified in male, but not female, rats. The clinical significance of this finding is unknown.

ADVERSE REACTIONS

The most common side effects were dizziness (10.9%) and somnolence (4.5%).

Across all GRALISE clinical trials the other most common adverse reactions (≥2%) are dizziness, somnolence, headache, peripheral edema, diarrhea, dry mouth, and nasopharyngitis. The types and incidence of adverse events were similar across age groups except for peripheral edema, which tended to increase in incidence with age.

DRUG INTERACTIONS

An increase in gabapentin AUC values has been reported when administered with hydrocodone or morphine.

It is recommended that GRALISE be taken at least 2 hours following antacid administration.

USE IN SPECIFIC POPULATIONS

Pregnancy Category C: GRALISE should be used during pregnancy or in women who are nursing only if the benefits clearly outweigh the risks.

Pediatric Use

The safety and effectiveness of GRALISE in the management of postherpetic neuralgia in patients less than 18 years of age has not been studied.

Geriatric Use

The total number of patients treated with GRALISE in controlled clinical trials in patients with postherpetic neuralgia was 359, of which 63% were 65 years of age or older. The types and incidence of adverse events were similar across age groups except for peripheral edema, which tended to increase in incidence with age.

Hepatic Impairment

Because gabapentin is not metabolized, studies have not been conducted in patients with hepatic impairment.

Renal Impairment

Dosage adjustment of GRALISE is necessary in patients with impaired renal function. GRALISE should not be administered in patients with creatinine clearance <30 mL/min or in patients undergoing hemodialysis. Reductions in GRALISE dose should be made in patients with age-related compromised renal function.

Please see full Prescribing Information and Medication Guide.

Do not take GRALISE if you are allergic to gabapentin or any of the ingredients in GRALISE.

Do not change your dose or stop taking GRALISE without talking with your healthcare provider. If you stop taking GRALISE suddenly, you may experience side effects. Talk with your healthcare provider about how to stop GRALISE slowly.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying
attempts to commit suicide
new or worse depression
new or worse anxiety
feeling agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worse irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking (mania)
other unusual changes in behavior or mood

Like other antiepileptic drugs, gabapentin, the active ingredient in GRALISE, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. However, it is not known if GRALISE is safe and effective in people with seizure problems (epilepsy). Therefore, GRALISE should not be used in place of other gabapentin products.

It is not known if GRALISE is safe and effective in children under 18 years of age with postherpetic pain.

Before taking GRALISE, tell your healthcare provider if you:

have or have had depression, mood problems or suicidal thoughts or behavior
have seizures
have kidney problems or get kidney dialysis
are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while taking GRALISE.
are breastfeeding or plan to breastfeed. GRALISE can pass into your breast milk.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins or herbal supplements. Taking GRALISE with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking GRALISE without first talking to your healthcare provider. Taking GRALISE with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

Do not operate heavy machines or do other dangerous activities until you know how GRALISE affects you. GRALISE can slow your thinking and motor skills.

The most common side effect of GRALISE is dizziness. Tell your healthcare provider about any side effect that bothers you or that does not go away. This is not the only possible side effect of GRALISE. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For more information about GRALISE, please see full Prescribing Information and Medication Guide.

GRALISE copay assistance:

Indications and Usage

Important Safety Information

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Suicidal Behavior and Ideation

Withdrawal of Gabapentin

Tumorigenic Potential

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

Pediatric Use

Geriatric Use

Hepatic Impairment

Renal Impairment

Indications and Usage

Important Safety Information

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Suicidal Behavior and Ideation

Withdrawal of Gabapentin

Tumorigenic Potential

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

Pediatric Use

Geriatric Use

Hepatic Impairment

Renal Impairment

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