Gliadel


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carmustine

(kar-mus-teen) ,

BCNU

(trade name),

BiCNU

(trade name),

Gliadel

(trade name)

Classification

Therapeutic: antineoplastics
Pharmacologic: alkylating agents
Pregnancy Category: D

Indications

Alone or with other treatments (surgery, radiation) in the management of:
  • Brain tumors,
  • Multiple myeloma,
  • Hodgkin’s disease,
  • Other lymphomas.

Action

Inhibits DNA and RNA synthesis (cell-cycle phase–nonspecific).

Therapeutic effects

Death of rapidly replicating cells, especially malignant ones.

Pharmacokinetics

Absorption: Following IV administration, absorption is complete. Following implantation, action is primarily local.
Distribution: Highly lipid soluble; readily penetrates CSF. Enters breast milk.
Metabolism and Excretion: Rapidly metabolized. Some metabolites have antineoplastic activity.
Half-life: Biologic—15–30 min; chemical—5 min.

Time/action profile (effect on platelet counts)

ROUTEONSETPEAKDURATION
IVdays 4–5 wk6 wk

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: Infections;Depressed bone marrow reserve; Geriatric: Consider age related ↓ in body mass, renal/hepatic/cardiovascular function, concurrent medications and chronic illnesses;Impaired pulmonary, hepatic, or renal function;Other chronic debilitating illnesses; Obstetric: Patients with childbearing potential.

Adverse Reactions/Side Effects

Respiratory

  • pulmonary fibrosis (life-threatening)
  • pulmonary infiltrates

Gastrointestinal

  • hepatotoxicity (most frequent)
  • nausea (most frequent)
  • vomiting (most frequent)
  • anorexia
  • diarrhea
  • esophagitis

Genitourinary

  • renal failure

Dermatologic

  • alopecia

Hematologic

  • leukopenia (life-threatening)
  • thrombocytopenia (life-threatening)
  • anemia

Local

  • pain at IV site

Interactions

Drug-Drug interaction

↑ bone marrow depression with other antineoplastics or radiation therapy.Smoking ↑ risk of pulmonary toxicity.May ↓ antibody response to live-virus vaccines and ↑ risk of adverse reactions.Myelosuppression may be ↑ by cimetidine.

Route/Dosage

Intravenous (Adults and Children) 150–200 mg/m2 single dose q 6–8 wk or 75–100 mg/m2/day for 2 days q 6 wk or 40 mg/m2/day for 5 days q 6 wk.
Intracavitary: (Adults) Up to 61.6 mg (8 implants) placed in cavity created during surgical resection of brain tumor.

Availability

Injection: 100 mg/vial
Intracavitary wafer: 7.7 mg in packages of 8

Nursing implications

Nursing assessment

  • Monitor vital signs before and frequently during therapy.
  • Monitor for bone marrow depression. Assess for bleeding (bleeding gums, bruising, petechiae, guaiac stools, urine, and emesis) and avoid IM injections and taking rectal temperatures if platelet count is low. Apply pressure to venipuncture sites for 10 min. Assess for signs of infection during neutropenia. Anemia may occur; monitor for increased fatigue, dyspnea, and orthostatic hypotension.
  • Assess respiratory status for dyspnea or cough. Obtain pulmonary function tests at baseline and frequently during therapy. Pulmonary toxicity usually occurs after high cumulative doses or several courses of therapy but may also occur following 1–2 courses of low doses. Symptoms may be rapid or gradual in onset; damage may be reversible or irreversible. Delayed pulmonary fibrosis may occur years after therapy. Notify health care professional promptly if symptoms occur.
  • Monitor IV site closely. Carmustine is an irritant. Instruct patient to notify nurse immediately if discomfort occurs at IV site. Discontinue IV immediately if infiltration occurs. Ice may be applied to site. May cause hyperpigmentation of skin along vein.
  • Monitor intake and output, appetite, and nutritional intake. Assess for nausea and vomiting, which occur within 2 hr of administration and persist for 4–6 hr. Administration of an antiemetic before and during therapy and adjusting diet as tolerated may help maintain fluid and electrolyte balance and nutritional status.
  • Lab Test Considerations: Monitor CBC with differential and platelet count before and weekly for at least 6 wk following each dose. The nadir of thrombocytopenia occurs in 4–5 wk; the nadir of leukopenia in 5–6 wk. Recovery usually occurs in 6–7 wk but may take 10–12 wk after prolonged therapy. Withhold dose and notify physician if platelet count is <100,000/mm3 or leukocyte count is <4000/mm3. Anemia is usually mild.
    • Monitor serum bilirubin, AST, ALT, and LDH before and periodically during therapy. May cause mild, reversible ↑ in AST, alkaline phosphatase, and bilirubin.
    • Monitor BUN, serum creatinine, and uric acid before and periodically during therapy. Notify health care professional if BUN is elevated.

Potential Nursing Diagnoses

Risk for injury (Side Effects)
Disturbed body image (Side Effects)

Implementation

  • high alert: Fatalities have occurred with chemotherapeutic agents. Before administering, clarify all ambiguous orders; double-check single, daily, and course-of-therapy dose limits; have second practitioner independently double-check original order, calculations, and infusion pump settings.
  • Intravenous Administration
  • pH: 5.6–6.0.
  • Solution should be prepared in a biologic cabinet. Wear gloves, gown, and mask while handling medication. Discard equipment in designated containers. Contact with skin may cause transient hyperpigmentation.
  • Intermittent Infusion: Dilute contents of each 100-mg vial with 3 mL of absolute ethyl alcohol provided as a diluent. Dilute this solution with 27 mL of sterile water for injection. Concentration: 3.3 mg/mL. Diluent: May be further diluted with 500 mL of D5W or 0.9% NaCl in a glass container.
    • Solution is clear and colorless. Do not use vials that contain an oily film, which indicates decomposition. Reconstituted solution is stable for 24 hr when refrigerated and protected from light. Solution contains no preservatives; do not use as a multidose vial.
    • IV lines may be flushed with 5–10 mL of 0.9% NaCl before and after carmustine infusion to minimize irritation at the injection site.
  • Rate: Infuse dose over at least 2 hr. Rapid infusion rate may cause local pain, burning at site, and flushing. Facial flushing occurs within 2 hr and may persist for 4 hr.
  • Y-Site Compatibility: acyclovir, alfentanil, amifostine, amikacin, aminocaproic acid, aminophylline, amiodarone, amphotericin B colloidal, amphotericin B lipid complex, amphotericin B liposome, ampicillin, ampicillin/sulbactam, anidulafungin, argatroban, atracurium, azithromycin, aztreonam, bivalirudin, bleomycin, bumetanide, buprenorphine, butorphanol, calcium acetate, calcium chloride, calcium gluconate, caspofungin, cefazolin, cefepime, cefoperazone, cefotaxime, cefotetan, cefoxitin, ceftazidime, ceftriaxone, cefuroxime, chloramphenicol, chlorpromazine, ciprofloxacin, cisatracurium, cisplatin, clindamycin, cyclophosphamide, cyclosporine, cytarabine, daptomycin, dexamethasone, dexmedetomidine, dexrazoxane, digoxin, diltiazem, diphenhydramine, docetaxel, dopamine, doxacurium, doxorubicin, doxyxycline, droperidol, enalaprilat, ephedrine, ertapenem, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, filgrastim, fluconazole, fludarabine, fluorouraciol, foscarnet, fosphenytoin, furosemide, ganciclovir, gemcitabine, gentamicin, glycopyrrolate, granisetron, haloperidol, heparin, hetastarch, hydralazine, hydrocortisone, hydromorphone, imipenem/cilastatin, insulin, isoproterenol, ketorolac, labetalol, leucovorin, levofloxacin, lidocaine, linezolid, lorazepam, magnesium sulfate, mannitol, melphalan, meperidine, peropenem, mesna, metaraminol, methotrexate, methyldopate, methylprednisolone, metoprolol, metronidazole, midazolam, milrinone, mitoxantrone, morphine, nafcillin, nalbuphine, naloxone, nesiritide, nicardipine, nitriglycerine, nitroprusside, norepinephrine, octreotide, ondansetron, paclitaxel, palonosetron, pamidronate, panduronium, pantoprazole, pentamidine, pentazocine, pentobarbital, phenylephrine, piperacillin/tazobactam, potassium acetate, potassium chloride, potassium phosphates, prochlorperazine, propranolol, quinupristin/dalfopristin, ranitidine, remifentanil, dituximab, rocuronium, sargramostim, sodium acetate, sodium bicarbonate, sodium phosphates, succinylcholine, sufentanil, tacrolimus, teniposide, theophylline, thiotepa, ticarcillin/clavulanate, tigecycline, tirofiban, tobramycin, trastuzumab, trimpethoprim/sulfamethoxazole, vancomycin, vasopressin, vecuronium, verapamil, vincristine, vinorelbine, voriconazole, zidovudine, zoledronic acid
  • Y-Site Incompatibility: allopurinol, dantrolene, diazapam, epinephrine, metoclopramide, phenobarbital, phentolamine, phenytoin, procainamide, promethazine, thiopental
  • Additive Incompatibility: allopurinol, sodium bicarbonate

Patient/Family Teaching

  • Instruct patient to notify health care professional if fever; chills; sore throat; signs of infection; lower back or side pain; difficult or painful urination; bleeding gums; bruising; petechiae; or blood in urine, stool, or emesis occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor. Patients should be cautioned not to drink alcoholic beverages or to take products containing aspirin or NSAIDs.
  • Instruct patient to notify health care professional if shortness of breath or increased cough occurs. Encourage patient not to smoke, because smokers are at greater risk for pulmonary toxicity.
  • Instruct patient to inspect oral mucosa for redness and ulceration. If mouth sores occur, advise patient to use sponge brush and rinse mouth with water after eating and drinking. Stomatitis may require treatment with opioid analgesics.
  • Discuss with patient the possibility of hair loss. Explore coping strategies.
  • Advise patient of the need for contraception and to avoid breast feeding during therapy.
  • Instruct patient not to receive any vaccinations without advice of health care professional.
  • Emphasize need for periodic lab tests to monitor for side effects.

Evaluation/Desired Outcomes

  • Decrease in size and spread of tumor.
    • Improvement in hematologic parameters in nonsolid cancers.

Gliadel®

Neurosurgery A chemotherapy–polifeprosan + carmustine–
saturated wafer implanted during surgery to ↓ local recurrence of glioblastoma Side effects Seizures, pain, brain edema. See Glioblastoma multiforme.
References in periodicals archive ?
In Japan, marketing authorization for Gliadel was first received in September 2012 by Nobelpharma after it conducted clinical trials of the agent.
In addition, the companies have entered into a long-term supply agreement under which Eisai shall serve as Arbor's exclusive supplier of Gliadel for the U.
When used as an adjunct to surgery and radiation, Gliadel Implant has been approved by several European Agencies as part of the Mutual Recognition Process to treat newly-diagnosed high-grade malignant gliomas and recurrent glioblastoma multiforme (GBM).
Aggressive brain cancer has a low survival rate but trials have found Gliadel can stop tumours regrowing.
A recent clinical study of the Gliadel wafer treatment has been conducted at 38 hospitals in 14 countries.
Additional information on the newly approved uses for and ongoing studies of Gliadel may be found at http://www.
Patients with what is known as a recurrent glioblastoma multiforme (GBM) may receive GLIADEL Wafer in addition to surgery.
Gliadel is the only sustained-release formulation approved for intracranial implantation in Japan.
implant) Astrocytoma with Surgery, Gliadel Wafers and Limited Field Radiation Plus Concomitant Temozolomide Followed by Adjuvant Temozolomide
A preliminary announcement that Gliadel Implants and temozolomide, the first proven effective treatments for over 20 years, will not be provided free on the NHS for newly-diagnosed patients in the UK has left medical and patient communities stunned.
Eisai expects that the development of GLIADEL Wafer by Nobelpharma, which is actively committed to the development of drugs for highly unmet medical needs that are strongly desired by patient advocacy groups or academic society, will bring a new treatment option to patients with malignant glioma in Japan as early as possible.
6 months when Gliadel Wafer and temozolomide are used in combination with surgery and radiotherapy.