Drug Interaction:
Valproic acid - decreases the oral clearance of temozolamide about 5%
Drug/food interaction- food decreases the rate and extent of temozolamide absorption.
Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
92. Temozolamide capsule 140mme g/180mg 31-03-08 (Addl.stgth)
Same as approved
Anaplastic astrocytoma
TEMODAR® (temozolomide) Capsules TEMODAR® (temozolomide) for Injection
administered via intravenous infusion
Initial U.S. Approval: 1999
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Temozolamide Anti-cancer 17-01-2000
2.Temozolamide Capsules 31-03-2008
140mg/180mg
Addl.Stgth
Same as approved
3.Temozolamide Lyophilised powder 24-05-2010
100mg/ml
For the Treatment of -Adult Patients with Newly diagonised Glioblastoma
Mutiforme Concomittantly with Radiotherapy (RT) and subsequently as
monotherapy treatment-
Children from the age of Three years , Adolescents and Adult patients with
Malignant Giloma, such as Glioblastoma Multiforme or Anaplastic Astrocytoma,
showing recurrence or progression after standard therapy
Adverse Reaction:
Adverse reactions-
CNS - Abnormal coordination 10% abnormal gait 5% amnesia 8 %
Anxiety 5% Asthenia 10% Ataxia 6%
confusion 4% depression 5% dizziness 10%
fatigue 30% headache 35% hemiparesis 15%
insomnia 8% local convulsion 5% paresthesia 8%
somnolence 8%
Dermatologic - Pruritus 6% rash 7%
GI abdominal pain 8% anorexia 8% constipation 30%
diarrhea 15% dyspepsia 6% nausea 50%
vomiting 40%
GU - breast pain, female 5% micturition increased 5% urinary continence 7%
urinary tract infection 7%
Metabolic/nutrional - weight increase 4%
Ophthalmic - abnormal vision 4% diplopia 4%
Respiratory - coughing 4% pharyngitis 7% sinustis 5%
upper respiratory tract infection 7%
Miscellaneous - adrenal hypercorticism 7%
Contra-Indications:
History of hypersensitivity reaction to temozolamide
Special precations/warnings
Myelosuppression- patients treated with temozolamide may experience myelosupression.
elderly patients and women have been shown to have a higher risk of developing
myelosuppression
Renal /hepatic function impairment - excercise caution when tmozolamide is administered to patients with severe hepatic or renal function impairment
Pregnancy - if this drug is used during pregnancy or if the patient becomes pregnant
while taking the drug advice the patient of the potential hazard to the fetus.
Advice women of child bearing potential to avoid becoming pregnant during therapy
Lactation- because of the potential risk to infants , patients should discontinue
breast feeding
Children- efficacy and safety in children has not been studied
Elderly - patients over 70 years of age and older had a higher incidence of
neutropenia and thrombocytopenia
Monitoring- For concomittant treatment with radiotherapy, obtain a CBC weekly.
Dosages/ Overdosage Etc:
Indication-
Anaplastic astrocytoma
Dosage-
Recommended dose for termozolamide as Intravenous IV infusion, over 90 minutes
is the same as for oral capsule formulation
Iintial dose - adults - 150mg/m2 orally daily for 5 consecutive days per 28 day treatment cycle
Patient Information:
1. Advice patients to take temozolamide on empty stomach to ease nausea, .
2.Instruct patients to swallow capsules whole with a glass of water.
3. Advice patients not to open or chew capsules . If capsules are accidentally opened
or damaged advice patients to take rigorous precautions with the capsule contents
,to avoid inhalation or contact with the skin or mucous membrane.
4.. Advice patients to keep this medication away from children or pets.
5. Advice women women of child bearing potential to avoid becoming pregnant during
the course of therapy
Interaction with Food:
Food decreases the rate and extent of temozolamide absorption
Pregnancy and lactation:
Pregnancy -
If this drug is used during pregnancy or if the patient becomes pregnant
while taking the drug advice the patient of the potential hazard to the fetus.
Advice women of child bearing potential to avoid becoming pregnant during therapy
Lactation-
Because of the potential risk to infants , patients should discontinue
breast feeding
Children-
Efficacy and safety in children has not been studied
Elderly -
Patients over 70 years of age and older had a higher incidence of
neutropenia and thrombocytopenia