GRALISE Adverse Events Profile

The majority of TEAEs reported with GRALISE were mild to moderate1

The most common TEAEs with GRALISE were dizziness (11%) and somnolence (5%).1

The overall discontinuation rate in clinical trials was 9.7% (n=359) for GRALISE and 6.9% (n=364) for placebo, with 2.2% (n=8) of GRALISE patients discontinuing due to dizziness and 0.3% (n=1) for somnolence, and 0.5% (n=2) of placebo patients discontinuing due to dizziness and somnolence.12

Discontinuations due to dizziness and somnolence were infrequent2:

DIZZINESS: GRALISE—2.2%, placebo—0.5%;

SOMNOLENCE: GRALISE—0.3%, placebo—0.5%

Body System
Preferred Term		GRALISE %
N=359		Placebo %
N=364
Ear and Labyrinth Disorders
Vertigo1.40.5
Gastrointestinal Disorders
Diarrhea3.32.7
Dry mouth2.81.4
Constipation1.40.3
Dyspepsia1.40.8
General Disorders
Peripheral edema3.90.3
Pain1.10.5
Infections and Infestations
Nasopharyngitis2.52.2
Urinary tract infection1.70.5
Body System
Preferred Term		GRALISE %
N=359		Placebo %
N=364
Investigations
Weight increased1.90.5
Musculoskeletal and Connective Tissue Disorders
Pain in extremity1.90.5
Back pain1.71.1
Nervous System Disorders
Dizziness10.92.2
Somnolence4.52.7
Headache4.24.1
Lethargy1.10.3
Body System
Preferred Term		GRALISE %
N=359		Placebo %
N=364
Ear and Labyrinth Disorders
Vertigo1.40.5
Gastrointestinal Disorders
Diarrhea3.32.7
Dry mouth2.81.4
Constipation1.40.3
Dyspepsia1.40.8
General Disorders
Peripheral edema3.90.3
Pain1.10.5
Infections and Infestations
Nasopharyngitis2.52.2
Urinary tract infection1.70.5
Investigations
Weight increased1.90.5
Musculoskeletal and Connective Tissue Disorders
Pain in extremity1.90.5
Back pain1.71.1
Nervous System Disorders
Dizziness10.92.2
Somnolence4.52.7
Headache4.24.1
Lethargy1.10.3

References:

  1. GRALISE. Prescribing information. Almatica Pharma LLC; 2023.
  2. Data on file. Almatica Pharma LLC; 2009.
Savings card

Most patients pay as little as $20*‡

Download savings card
Applies to commercially insured patients. Individual costs may vary. Program eligibility and restrictions apply.

GRALISE Copay Card Program Terms and Conditions: The Almatica GRALISE Copay Card Program helps commercially insured individuals, 18 years of age or older who are permanent residents of the United States (including the United States Territories) and who are prescribed/dispensed Almatica-labeled GRALISE for a use approved by the Food and Drug Administration pay for their eligible copay for Almatica-labeled GRALISE. Under the program, eligible commercially insured patients may pay as little as $20 per 30-day supply of Almatica-labeled GRALISE. A maximum savings limit per 30-day supply applies. Patients using the GRALISE Copay Card may not also utilize the eVoucher—patients may use only the GRALISE Copay Card or the eVoucher in any 12-month rolling period. Patients with drug coverage under Medicare, Medicaid or TRICARE are not eligible for the Almatica GRALISE Copay Card Program. Furthermore, patients residing in any state where such assistance is prohibited by law are not eligible for the Almatica GRALISE Copay Card Program. This offer is void if copied, transferred, purchased, altered or traded. The Almatica GRALISE Copay Card Program is not insurance. Almatica reserves the right to change, rescind, revoke or discontinue the program at any time without notice. Limit one program enrollment per individual in any 12-month rolling period. If you have any questions regarding this program, your eligibility or benefits or if you wish to discontinue your participation in the program, please call 844-889-8686, option 1.

Gabapentin is a controlled substance in several states. Contact local authorities for more information. Advise patients to take GRALISE only as prescribed.

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 have 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. Suicidal behavior and ideation have also been reported in patients after discontinuation of gabapentin. 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.

Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation

After discontinuation of short-term and long-term treatment with gabapentin, withdrawal symptoms have been observed in some patients, Suicidal behavior and ideation have also been reported in patients after discontinuation 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).

Respiratory Depression

Gabapentin has been associated with serious, life-threatening, or fatal respiratory depression when co-administered with central nervous system (CNS) depressants, including opioids, or when there is an underlying respiratory impairment. When the decision is made to co-prescribe GRALISE with another CNS depressant, particularly an opioid, or to prescribe GRALISE to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating GRALISE at a low dose.

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.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as Multiorgan Hypersensitivity, has been reported in patients taking antiepileptic drugs, including GRALISE. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. If such signs or symptoms are present, the patient should be evaluated immediately.

Adverse Reactions

In clinical trials, the most common adverse reactions were dizziness (10.9%) and somnolence (4.5%). Across all GRALISE clinical trials, the other most common adverse reactions (≥2%) were 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

Postmarketing data suggest that extended gabapentin use with opioids close to delivery may increase the risk of neonatal withdrawal versus opioids alone. It is not known whether exposure to gabapentin alone late in pregnancy may cause withdrawal signs and symptoms. Observe neonates exposed to GRALISE and opioids for signs and symptoms of neonatal withdrawal and manage accordingly.

Pediatric Use

The safety and effectiveness of GRALISE in the management of postherpetic neuralgia in patients less than 18 years of age have 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.

Drug abuse and dependence

After discontinuation of short-term and long-term treatment with gabapentin, withdrawal symptoms have been observed in some patients. Withdrawal symptoms may occur shortly after discontinuation, usually within 48 hours.

Overdosage

Acute oral overdoses of gabapentin have been reported. Symptoms include double-vision, tremor, slurred speech, drowsiness, altered mental status, dizziness, lethargy, and diarrhea. Fatal respiratory depression has been reported with gabapentin overdose, alone and in combination with other CNS depressants.

Indications and Usage

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

Please see the full Prescribing Information, including Medication Guide.