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temozolomide
(redirected from Temodar)

   Also found in: Wikipedia 0.01 sec.
temozolomide /tem·o·zo·lo·mide/ (tem″ah-zo´lah-mīd) a cytotoxic alkylating agent used as an antineoplastic in the treatment of refractory anaplastic astrocytoma.
temozolomide,
a miscellaneous antineoplastic agent.
indication It is used to treat anaplastic astrocytoma with relapse.
contraindications Pregnancy, lactation, and known hypersensitivity to this drug or to carbazine prohibit its use.
adverse effects Life-threatening effects are thrombocytopenia, leukopenia, and seizures. Other adverse effects include anemia, urinary incontinence, urinary tract infection, urinary frequency, upper respiratory infection, pharyngitis, sinusitis, cough, headache, fatigue, asthenia, fever, edema, back pain, weight increase, and diplopia. Common side effects include nausea, anorexia, vomiting, hemiparesis, dizziness, poor coordination, amnesia, insomnia, paresthesia, somnolence, paresis, ataxia, anxiety, dysphagia, depression, confusion, rash, and pruritus.

temozolomide [tem″ah-zo´lah-mīd]
a cytotoxic alkylating agent used as an antineoplastic in the treatment of refractory anaplastic astrocytoma, administered orally.

temozolomide Warning - Hazardous drug!

Temodal (CA) (UK), Temodar

Pharmacologic class: Alkylating agent

Therapeutic class: Antineoplastic

Pregnancy risk category D

Action

Rapidly converts to monomethyl triazeno imidazole carboxamide, an active compound that prevents DNA transcription

Availability

Capsules: 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg

Indications and dosages

Refractory anaplastic astrocytoma

Adults: 150 mg/m2 P.O. daily for 5 consecutive days of each 28-day treatment cycle. Adjust dosage as appropriate based on absolute neutrophil count.

Contraindications

• Hypersensitivity to drug, its components, or dacarbazine
• Pregnancy or breastfeeding

Precautions

Use cautiously in:
• severe hepatic or renal impairment, active infection, decreased bone marrow reserve, other chronic debilitating illness
• elderly patients
• patients with childbearing potential
• children (safety not established).

Administration

• Follow facility policy for handling and disposing of chemotherapeutic drugs.
• Give daily with a full glass of water, consistently either with or without food.
• Be aware that dosages in 28-day cycle depend on nadir neutrophil and platelet counts.

RouteOnsetPeakDuration
P.O.Rapid1 hrUnknown

Adverse reactions

CNS: fatigue, headache, dysphasia, poor coordination, ataxia, anxiety, depression, dizziness, drowsiness, confusion, amnesia, insomnia, mental status changes, weakness, paresis, hemiparesis, paresthesias, seizures

CV: peripheral edema

EENT: abnormal vision, diplopia, pharyngitis, sinusitis

GI: nausea, vomiting, constipation, diarrhea, abdominal pain, anorexia

GU: urinary incontinence or frequency, urinary tract infection, breast pain (in women)

Hematologic: anemia, leukopenia, thrombocytopenia

Metabolic: adrenal hypercorticism

Musculoskeletal: abnormal gait, back pain, myalgia

Respiratory: cough, upper respiratory infection

Skin: pruritus, rash

Other: fever, viral infection, weight gain

Interactions

Drug-drug. Antineoplastics: additive bone marrow depression

Live-virus vaccines: decreased antibody response to vaccine, greater risk of adverse reactions

Valproic acid: decreased oral clearance of temozolomide

Drug-diagnostic tests. Neutrophils, platelets: decreased counts

Patient monitoring

Monitor CBC with white cell differential. Stay alert for evidence of bone marrow depression.
• Assess neurologic status carefully.
• Monitor fluid intake and output, and weigh patient regularly.

Patient teaching

• Tell patient to take consistently with or without food, and with a full glass of water.
• If drug causes nausea or vomiting, advise patient to take it 1 hour before or 2 hours after a meal.
• Inform patient that drug may cause abnormal gait and dizziness.
Instruct patient to immediately report unusual bleeding or bruising.
• Advise patient to avoid live-virus vaccines.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, alertness, and vision.
• Instruct patient to report suspected pregnancy. Caution her not to breastfeed.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.


temozolomide
Temodal® Oncology An alkylating agent used for recurrent gliomas–eg, anaplastic astrocytoma, and possibly melanoma and other solid tumors. See Astrocytoma, Glioblastoma multiforme.


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The drug will probably be approved as a second-line treatment (if radiation and the drug Temodar fail).
This first issue includes post-marketing reviews of Rituxan (rituximab) and the risk of Progressive Multifocal Leukoencephalopathy (PML); Provigil (modafinil) and its potential for serious skin reactions; Temodar (temozolomide) in regard to risk of aplastic anemia.
Table I: Key settlements following non-compliant management of external players in the commercial area Company Date Products Rationale Astrazeneca 2003 Zoladex Illegal sales and marketing Baye yer 2003 Cipro, Adalat Inflated prices Pfizer (Warner 2004 Neurontin Off-label Lambert) promotion GSK 2005 Zofran, Kytril inflated prices Serono 2005 Serostim Illegal marketing Schering-Plough 2006 Temodar Illegal sales marketing Company Settlement ($ millions) Astrazeneca 354.
 
 
 
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