gliadel
Pharmaranks rates Gliadel 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Gliadel (Carmustine) is an alkylating drug used to treat Brain Neoplasms, Carcinoma, Colonic Neoplasms, Ependymoma.
Carmustine · by Azurity
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Carmustine
- Drug class
- Alkylating Drug
- Form
- Wafer
- Strength
- Carmustine 7.7MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- brain neoplasms, carcinoma, colonic neoplasms
- Manufacturer
- Azurity
- FDA application
- NDA020637
What is Gliadel?
From the FDA label:GLIADEL Wafer is an implant for intracranial use, containing carmustine, a nitrosourea alkylating agent, and polifeprosan, a biodegradable copolymer used to control the release of carmustine. It is a sterile, off-white to pale yellow wafer approximately 1.45 cm in diameter and 1 mm thick. Each wafer contains 7.7 mg of carmustine [1, 3-bis (2-chloroethyl)-1-nitrosourea, or BCNU] and 192.3 mg of a biodegradable polyanhydride copolymer. The copolymer, polifeprosan 20, consists of poly [bis (p-carboxyphenoxy)] propane and sebacic acid in a 20:80 molar ratio. Carmustine is homogeneously distributed in the copolymer matrix. The structural formula for polifeprosan 20 is: The structural formula for carmustine is: Chemical Structure Chemical Structure
How to use
Recommended dose: Eight 7.7 mg wafers (61.6 mg total dose) implanted intracranially ( 2.1 , 2.2 ) Follow preparation and handling recommendations ( 2.3 ). 2.1 Recommended Dose The recommended dose of GLIADEL Wafer is eight 7.7 mg wafers for a total of 61.6 mg implanted intracranially. The safety and effectiveness of repeat administration have not been studied. 2.2 Insertion Instructions Following maximal tumor resection, confirmation of tumor pathology and establishment of hemostasis, place up to a maximum of eight GLIADEL Wafers to cover as much of the resection cavity as possible. Should the size and shape of the resected cavity not accommodate eight wafers, place the maximum number of wafers feasible within the cavity. Slight overlapping of the wafers is acceptable. Wafers broken in half may be used, but discard wafers broken in more than two pieces. Oxidized regenerated cellulose (Surgicel ® ) may be placed over the wafers to secure them against the cavity surface. After placement of the wafers, irrigate the resection cavity and close the dura in a water-tight fashion. 2.3 Preparation and Safe Handling GLIADEL Wafers contain a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Each wafer is packaged within two nested aluminum foil laminate pouches. The inner pouch is sterile and is designed to maintain product sterility and protect the product…
Side effects
The following serious adverse reactions are discussed elsewhere in the labeling: Seizures [ see Warnings and Precautions (5.1) ] Intracranial Hypertension [ see Warnings and Precautions (5.2) ] Impaired Neurosurgical Wound Healing [ see Warnings and Precautions (5.3) ] Meningitis [ see Warnings and Precautions (5.4) ] Newly-Diagnosed High-Grade Glioma: Most common adverse reactions (incidence >10% and between arm difference ≥4%) are cerebral edema, asthenia, nausea, vomiting, constipation, wound healing abnormalities and depression ( 6.1 ). Recurrent High-Grade Glioma: Most common adverse reactions (incidence >10% and between arm difference ≥4%) are urinary tract infection, wound healing abnormalities and fever ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 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 glioma who received up…
Warnings
Important safety information
Seizures: Monitor patients for seizures following implantation ( 5.1 ). Intracranial hypertension: Monitor patients for signs of increased intracranial pressure ( 5.2 ). Impaired neurosurgical wound healing: Monitor patients for complications of craniotomy ( 5.3 ). Meningitis: Monitor patients for signs of bacterial or chemical meningitis ( 5.4 ). Wafer migration: Monitor patients for signs of obstructive hydrocephalus ( 5.5 ). Embryo-fetal toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus. Advise males and females of reproductive potential to use an effective method of contraception. ( 5.6 , 8.1 , 8.3 ). 5.1 Seizures Seizures occurred in 37% of patients treated with GLIADEL Wafers for recurrent glioma in Study 2. New or worsening (treatment emergent) seizures occurred in 20% of patients; 54% of treatment emergent seizures occurred within the first 5 post-operative days [see Adverse Reactions (6.1) ]. The median time to onset of the first new or worsened post-operative seizure was four days. Institute optimal anti-seizure therapy prior to surgery. Monitor patients for seizures postoperatively. 5.2 Intracranial Hypertension Brain edema occurred in 23% of patients with newly diagnosed glioma treated with GLIADEL Wafers in Study 1. Additionally, one GLIADEL-treated patient experienced intracerebral mass effect unresponsive to corticosteroids which led to brain herniation [see Adverse Reactions (6.1) ] . Monitor patients closely for intracranial hypertension related to brain edema, inflammation, or necrosis of the brain tissue surrounding the resection. In refractory cases, consider re-operation and removal of GLIADEL Wafers or Wafer remnants. 5.3 Impaired Neurosurgical Wound Healing Impaired neurosurgical wound healing including wound dehiscence, delayed wound healing, and subdural, subgaleal, or wound effusions occur with GLIADEL Wafer treatment. In Study 1, 16% of GLIADEL Wafer-treated patients with newly diagnosed glioma experienced impaired intracranial wound healing and 5% had cerebrospinal fluid leaks. In Study 2, 14% of GLIADEL Wafer-treated patients with recurrent high-grade glioma experienced wound healing abnormalities [see Adverse Reactions (6.1) ]. Monitor patients post-operatively for impaired neurosurgical wound healing. 5.4 Meningitis Meningitis occurred in 4% of patients with recurrent glioma receiving GLIADEL Wafers in Study 2. Two cases of meningitis were bacterial; one patient required removal of the Wafers four days after implantation; the other developed meningitis following reoperation for recurrent tumor. One case was diagnosed as chemical meningitis and resolved following steroid treatment. In one case the cause was unspecified, but meningitis resolved following antibiotic treatment. Monitor postoperatively for signs of meningitis and central nervous system infection. 5.5 Wafer Migration GLIADEL Wafer migration can occur. To reduce the risk of obstructive hydrocephalus due to wafer migration into the ventricular system, close any communication larger than the diameter of a Wafer between the surgical resection cavity and the ventricular system prior to Wafer implantation. Monitor patients for signs of obstructive hydrocephalus. 5.6 Embryo-Fetal Toxicity GLIADEL Wafers can cause fetal harm when administered to a pregnant woman. Carmustine, the active component of GLIADEL Wafer, is embryotoxic and teratogenic in rats at exposures less than the exposure at the recommended human dose based on body surface area (BSA) and embryotoxic in rabbits at exposures similar to the exposure at the recommended human dose based on BSA. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception for 6 months after implantation of GLIADEL Wafer. Advise males with female partners of reproductive potential to use effective contraception for 3 months following implantation of GLIADEL Wafers [see Use in Specific Populations (8.1 , 8.3) , Nonclinical Toxicology (13.1) ].
Who should not take Gliadel
None. None ( 4 )
Drug class
How this class works, per Cyclophosphamide — StatPearls, NCBI Bookshelf (NIH).
May treat (source: NIH RxClass)
See how Gliadel ranks — best-rated alkylating drug for:
Dosage forms
Wafer
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Gliadel treat?
- Gliadel (Carmustine) may be used to treat brain neoplasms, carcinoma, colonic neoplasms, ependymoma, glioblastoma, hodgkin disease, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Gliadel work?
- Gliadel is a alkylating drug. Alkylating chemotherapy drugs attach chemical groups to a cell's DNA, forming cross-links that lock the two DNA strands together. This damage stops the cell from copying its DNA and dividing, which triggers it to die; because they are not limited to one phase of the cell cycle, they can act on cells whether or not they are actively dividing.
- How is Gliadel rated?
- pharmaranks gives Gliadel a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Gliadel?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Gliadel. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Gliadel?
- Gliadel is marketed by Azurity. You can see Azurity's full profile, rating, and other products on pharmaranks.
- Is Gliadel a brand-name or generic drug?
- Gliadel is a brand-name product with the active ingredient Carmustine.
- Is Gliadel available over the counter?
- No. Gliadel is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Gliadel come in?
- Gliadel is currently marketed as wafer, per the FDA's National Drug Code Directory.
- What class of drug is Gliadel?
- Gliadel is classified as alkylating drug, per the FDA's Established Pharmacologic Class.
- Is Gliadel FDA-registered?
- Gliadel is on record with the U.S. FDA under application number NDA020637. You can verify this on its official FDA label.
- Has Gliadel been recalled by the FDA?
- Gliadel has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Gliadel safe?
- There's no single safe-or-not verdict. pharmaranks gives Gliadel a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Gliadel?
- Gliadel's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions are discussed elsewhere in the labeling: Seizures [ see Warnings and Precautions (5.1) ] Intracranial Hypertension [ see Warnings and Precautions (5.2) ] Impaired Neurosurgical Wound Healing [ see Warnings and Precautions (5.3) ] Meningitis [ see Warnings and… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
bendeka
Bendamustine Hydrochloride
gleostine
Lomustine
vivimusta
Bendamustine Hydrochloride
evdi
Trabectedin
ivra
Melphalan Hydrochloride
bicnu
Carmustine
Compare Gliadel head-to-head
More alkylating drug drugs
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
gliadel
70/100