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Gliadel

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Gliadel

Side Effects
Interactions

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the label:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Newly-Diagnosed High-Grade Malignant Glioma

The safety of GLIADEL Wafers was evaluated in a multicenter, randomized (1:1), double-blind, placebo controlled trial of 240 adult patients with newly-diagnosed high-grade malignant glioma who received up to eight GLIADEL Wafers or matched placebo implanted against the resection surfaces after maximal tumor resection (Study 1).

The population in Study 1 was 67% male, 97% white, the median age was 53 years (range: 2172). Eighty-seven percent had a Karnofsky performance status ≥ 70 and 71% had a Karnofsky performance status of ≥ 80%. Seventy-eight percent had a histologic subtype of glioblastoma multiforme as determined by central pathology review. Thirty-eight percent of patients received 8 wafers and 78% received ≥ 6 wafers. Starting three weeks after surgery, 80% of patients received standard limited field radiation therapy (RT) described as 55-60 Gy delivered in 28 to 30 fractions over six weeks; an additional 11% received no radiotherapy and the remainder received non-standard radiotherapy or a combination of standard and non-standard radiotherapy. At the time of progression, 24% received systemic chemotherapy.

Deaths occurred within 30 days of wafer implantation in 5 (4%) of patients receiving GLIADEL Wafers compared to 2 (2%) of patients receiving placebo. Deaths on the GLIADEL arm resulted from cerebral hematoma/edema (n=3), pulmonary embolism (n=1) and acute coronary event (n=1). Deaths on the placebo arm resulted from sepsis (n=1) and malignant disease (n=1).

The incidence of common adverse reactions in GLIADEL Wafer-treated patients is listed in Table 1. The incidence of local adverse reactions is shown in Table 2.

Table 1: Per-Patient Incidence of Adverse Reactions Occurring in Gliadel Wafer-Treated Patients with Newly-Diagnosed High Grade Malignant Glioma (Study 1) (Between Arm Difference of ≥ 4%)

BODY SYSTEM GLIADEL Wafer
N=120
%
Placebo
N=120
%
GASTROINTESTINAL DISORDERS
  Nausea 22 17
  Vomiting 21 16
  Constipation 19 12
  Abdominal pain 8 2
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITION   
  Asthenia 22 15
  Chest pain 5 0
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
  Wound healing abnormalities* 16 12
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
  Back pain 7 3
PSYCHIATRIC DISORDERS
  Depression 16 10
*included (1) Fluid, CDS, or subdural fluid collection; (2) CSF leak; (3) Wound dehiscence, breakdown, or poor healing; and (4) Subgaleal or wound effusions (including yellow discharge at the incision)

Table 2: Incidence of Local Adverse Reactions, Study 1*

Local Adverse Reactions GLIADEL Wafer
N=120
%
Placebo
N=120
%
Intracranial hypertension 9 2
Cerebral hemorrhage 6 4
Brain abscess 6 4
Brain cyst 2 3
Cerebral edema 23 19
*Not seen at baseline or worsened if present at baseline.

Recurrent Glioblastoma Multiforme

The safety of GLIADEL Wafers was evaluated in a multicenter, randomized (1:1), double-blind, placebo controlled trial of 222 patients with recurrent high-grade malignant glioma who received up to eight GLIADEL Wafers or matched placebo implanted against the resection surfaces after maximal tumor resection (Study 2) . Patients were required to have had prior definitive external beam radiation therapy sufficient to disqualify them from additional radiation therapy. All patients were eligible to receive chemotherapy which was withheld at least four weeks (six weeks for nitrosoureas) prior to and two weeks after surgery.

The population in Study 2 was 64% male, 92% white, and had a median age of 49 years (range: 19-80). Sixty-five percent had a histologic subtype of glioblastoma multiforme, 26% had anaplastic astrocytoma or another anaplastic variant, 73% had a Karnofsky performance status ≥ 70, 53% had a Karnofsky performance status of ≥ 80%, 73% had only one prior surgery, and 46% had prior treatment with nitrosourea. Eighty-one percent of patients received 8 wafers and 96% received ≥ 6 wafers.

Sixty-four severe adverse reactions were reported in 43(39%) patients receiving GLIADEL Wafers. Adverse reactions in GLIADEL Wafer-treated patients are shown in Table 3. Meningitis occurred in four patients receiving GLIADEL Wafers and in no patients receiving placebo. Bacterial meningitis was confirmed in two patients: the first with onset four days following GLIADEL Wafer implantation; the second following resection for tumor recurrence 155 days following GLIADEL Wafer implantation. One case, attributed to chemical meningitis resolved following steroid treatment. The cause of the fourth case was undetermined but resolved following antibiotic treatment.

Table 3: Per-Patient Incidence of Adverse Reactions in Gliadel Wafer-Treated Patients with Glioblastoma Multiforme (Study 2) (Between Arm Difference of ≥ 4%)

BODY SYSTEM GLIADEL Wafer
N=110
%
Placebo
N=112
%
GENERAL
  Fever 12 8
INFECTIOUS
  Urinary tract infections 21 17
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
  Wound healing abnormalities* 14 5
*included (1) Fluid, CDS, or subdural fluid collection; (2) CSF leak; (3) Wound dehiscence, breakdown, or poor healing; and (4) Subgaleal or wound effusions (including yellow discharge at the incision)

The incidence of seizures is shown in Table 4. The incidence of hydrocephalus, cerebral edema and intracranial hypertension is shown in Table 5.

Table 4: Incidence of Seizures, Study 2

Adverse Reaction GLIADEL Wafer
N=110
%
Placebo
N=112
%
Patients with seizures
  Any seizures after wafer implantation 37 29
  New or worsening seizures 20 20
Time to new or worsening seizures (days)*
  Mean (SD) 26.09 (0.75) 62.36 (48.66)
  Median 3.5 61
*Days from implantation to onset of first new or worsening seizure.

Table 5: Hydrocephalus and Cerebral Edema, Study 2*

Adverse Reaction GLIADEL Wafer
N=110
%
Placebo
N=112
%
Hydrocephalus 5 2
Cerebral edema 4 1
*Not seen at baseline or worsened if present at baseline.

Read the Gliadel (polifeprosan 20 with carmustine) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 9/4/2013
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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