Te mozolomide 20 mg, 100 mg, 250 mg hard capsules SMPC, Taj Pharmaceuticals

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RX - children from the age of three years,

adolescents and adult patients with malignant
TEMOZOLOMIDE HARD glioma, such as glioblastoma multiforme or
anaplastic astrocytoma, showing recurrence or
CAPSULES progression after standard therapy.
20 MG, 100 MG, 250 MG 4.2 Posology and method of
administration
1.NAME OF THE MEDICINAL
PRODUCT Temozolomide capsules should only be
prescribed by physicians experienced in the
Temozolomide 20 mg, 100 mg, 250 mg hard oncological treatment of brain tumours.
capsules
Anti-emetic therapy may be administered (see
2. QUALITATIVE AND section 4.4).
QUANTITATIVE COMPOSITION
Posology
Each hard capsule contains 20 mg, 100 mg, 250
mg temozolomide. Adult patients with newly-diagnosed
glioblastoma multiforme
Excipient with known effect:
Temozolomide capsules is administered in
Each 20 mg hard capsule contains 182.2 mg of combination with focal radiotherapy
anhydrous lactose. (concomitant phase) followed by up to 6 cycles
Each 100 mg hard capsule contains 175.7 mg of of temozolomide (TMZ) monotherapy
anhydrous lactose (monotherapy phase).

Each 250 mg hard capsule contains 154.3 mg of Concomitant phase

anhydrous lactose. TMZ is administered orally at a dose of 75
For the full list of excipients, see section 6.1. mg/m2 daily for 42 days concomitant with focal
radiotherapy (60 Gy administered in 30
3. PHARMACEUTICAL FORM fractions). No dose reductions are
recommended, but delay or discontinuation of
Hard capsule (capsule).
TMZ administration should be decided weekly
The 20 mg hard capsules have an opaque white according to haematological and non-
body, an opaque yellow cap, and are imprinted haematological toxicity criteria. TMZ
with black ink. administration can be continued throughout the
42 day concomitant period (up to 49 days) if all
The 100 mg hard capsules have an opaque white of the following conditions are met:
body, an opaque pink cap, and are imprinted
with black ink. - absolute neutrophil count (ANC) ≥ 1.5 x 109/l
The 250 mg hard capsules have an opaque white - thrombocyte count ≥ 100 x 109/l
body and cap, and are imprinted with black ink.
- common toxicity criteria (CTC) non-
4. CLINICAL PARTICULARS haematological toxicity ≤ Grade 1 (except for
alopecia, nausea and vomiting).
4.1 Therapeutic indications
Temozolomide capsules is indicated for the During treatment a complete blood count should
treatment of: be obtained weekly. TMZ administration should
be temporarily interrupted or permanently
- adult patients with newly-diagnosed discontinued during the concomitant phase
glioblastoma multiforme concomitantly with according to the haematological and non-
radiotherapy (RT) and subsequently as haematological toxicity criteria as noted in Table
monotherapy treatment. 1.
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Table 1. TMZ dosing interruption or discontinuation during 1 200 Dose during Cycles 2-6 in absence
concomitant radiotherapy and TMZ of toxicity
Toxicity TMZ TMZ Table 3. TMZ dose reduction or discontinuation during
interruptiona discontinuation monotherapy treatment
Toxicity Reduce TMZ by 1 Discontinue
Absolute neutrophil ≥ 0.5 and < 1.5 < 0.5 x 109/l dose levela TMZ
count x 109/l
Absolute neutrophil count < 1.0 x 109/l See footnote b
9
Thrombocyte count ≥ 10 and < 100 < 10 x 10 /l
x 109/l Thrombocyte count < 50 x 109/l See footnote b
CTC non-haematological
CTC non- Toxicity
haematological toxicity CTC Grade 3 or (except for alopecia,
(except for alopecia, CTC Grade 2
4 nausea, vomiting) CTC Grade 3 CTC Grade 4b
nausea, vomiting)
a: TMZ dose levels are listed in Table 2.
a: Treatment with concomitant TMZ can be continued b: TMZ is to be discontinued if:
when all of the following conditions are met: absolute • dose level -1 (100 mg/m2) still results in unacceptable toxicity
neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x • the same Grade 3 non-haematological toxicity (except for
109/l; CTC non-haematological toxicity ≤ Grade 1 (except alopecia, nausea, vomiting) recurs after dose reduction.
for alopecia, nausea, vomiting). Adult and paediatric patients 3 years of age or
Monotherapy phase older with recurrent or progressive malignant
glioma:
Four weeks after completing the TMZ + RT
concomitant phase, TMZ is administered for up A treatment cycle comprises 28 days. In patients
to 6 cycles of monotherapy treatment. Dose in previously untreated with chemotherapy, TMZ
Cycle 1 (monotherapy) is 150 mg/m2 once daily is administered orally at a dose of 200
for 5 days followed by 23 days without mg/m2 once daily for the first 5 days followed
treatment. At the start of Cycle 2, the dose is by a 23 day treatment interruption (total of 28
escalated to 200 mg/m2 if the CTC non- days). In patients previously treated with
haematological toxicity for Cycle 1 is Grade ≤ 2 chemotherapy, the initial dose is 150
(except for alopecia, nausea and vomiting), mg/m2 once daily, to be increased in the second
absolute neutrophil count (ANC) is ≥ 1.5 x 109/l, cycle to 200 mg/m2 once daily, for 5 days if
and the thrombocyte count is ≥ 100 x 109/l. If there is no haematological toxicity (see section
the dose was not escalated at Cycle 2, escalation 4.4)
should not be done in subsequent cycles. Once
Special populations
escalated, the dose remains at 200 mg/m2 per
day for the first 5 days of each subsequent cycle Paediatric population
except if toxicity occurs. Dose reductions and
discontinuations during the monotherapy phase In patients 3 years of age or older, TMZ is only
should be applied according to Tables 2 and 3. to be used in recurrent or progressive malignant
glioma. Experience in these children is very
During treatment a complete blood count should limited (see sections 4.4 and 5.1). The safety and
be obtained on Day 22 (21 days after the first efficacy of TMZ in children under the age of 3
dose of TMZ). The dose should be reduced or years have not been established. No data are
administration discontinued according to Table available.
3. Patients with hepatic or renal impairment
Table 2. TMZ dose levels for monotherapy treatment The pharmacokinetics of TMZ were comparable
Dose level TMZ dose Remarks
in patients with normal hepatic function and in
(mg/m2/day) those with mild or moderate hepatic impairment.
–1 100 Reduction for prior toxicity No data are available on the administration of
TMZ in patients with severe hepatic impairment
0 150 Dose during Cycle 1 (Child's Class C) or with renal impairment.
Based on the pharmacokinetic properties of
Te mozolomide 20 mg, 100 mg, 250 mg hard capsules SMPC, Taj Pharmaceuticals
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TMZ, it is unlikely that dose reductions are Pneumocystis jirovecii pneumonia

required in patients with severe hepatic
impairment or any degree of renal impairment. Patients who received concomitant TMZ and RT
However, caution should be exercised when in a pilot trial for the prolonged 42-day schedule
TMZ is administered in these patients. were shown to be at particular risk for
developing Pneumocystis jirovecii pneumonia
Elderly patients (PCP). Thus, prophylaxis against PCP is
required for all patients receiving concomitant
Based on a population pharmacokinetic analysis TMZ and RT for the 42-day regimen (with a
in patients 19-78 years of age, clearance of TMZ
maximum of 49 days) regardless of lymphocyte
is not affected by age. However, elderly patients
count. If lymphopenia occurs, they are to
(> 70 years of age) appear to be at increased risk continue the prophylaxis until recovery of
of neutropenia and thrombocytopenia (see lymphopenia to grade ≤ 1.
section 4.4).
There may be a higher occurrence of PCP when
Method of administration TMZ is administered during a longer dosing
Temozolomide capsules hard capsules should be regimen. However, all patients receiving TMZ,
administered in the fasting state. particularly patients receiving steroids, should
be observed closely for the development of PCP,
The capsules must be swallowed whole with a regardless of the regimen. Cases of fatal
glass of water and must not be opened or respiratory failure have been reported in patients
chewed. using TMZ, in particular in combination with
If vomiting occurs after the dose is administered, dexamethasone or other steroids.
a second dose should not be administered that HBV
day.
Hepatitis due to hepatitis B virus (HBV)
reactivation, in some cases resulting in death,
4.3 Contraindications has been reported. Experts in liver disease
Hypersensitivity to the active substance or to should be consulted before treatment is initiated
any of the excipients listed in section 6.1. in patients with positive hepatitis B serology
Hypersensitivity to dacarbazine (DTIC). (including those with active disease). During
treatment patients should be monitored and
Severe myelosuppression (see section 4.4). managed appropriately.
4.4 Special Warnings and precautions for Hepatotoxicity
use Hepatic injury, including fatal hepatic failure,
Opportunistic infections and reactivation of has been reported in patients treated with TMZ
infections (see section 4.8). Baseline liver function tests
should be performed prior to treatment initiation.
Opportunistic infections (such as Pneumocystis If abnormal, physicians should assess the
jirovecii pneumonia) and reactivation of benefit/risk prior to initiating temozolomide
infections (such as HBV, CMV) have been including the potential for fatal hepatic failure.
observed during the treatment with TMZ (see For patients on a 42 day treatment cycle liver
section 4.8). function tests should be repeated midway during
Meningoencephalitis herpetic this cycle. For all patients, liver function tests
should be checked after each treatment cycle.
In post marketing cases, meningoencephalitis For patients with significant liver function
herpetic (including fatal cases) has been abnormalities, physicians should assess the
observed in patients receiving TMZ in benefit/risk of continuing treatment. Liver
combination with radiotherapy, including cases toxicity may occur several weeks or more after
of concomitant steroids administration. the last treatment with temozolomide.
Te mozolomide 20 mg, 100 mg, 250 mg hard capsules SMPC, Taj Pharmaceuticals
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Malignancies There is no clinical experience with use of TMZ

in children under the age of 3 years. Experience
Cases of myelodysplastic syndrome and in older children and adolescents is very limited
secondary malignancies, including myeloid (see sections 4.2 and 5.1).
leukaemia, have also been reported very rarely
(see section 4.8). Elderly patients (> 70 years of age)
Anti-emetic therapy Elderly patients appear to be at increased risk of
neutropenia and thrombocytopenia, compared
Nausea and vomiting are very commonly with younger patients. Therefore, special care
associated with TMZ. should be taken when TMZ is administered in
Anti-emetic therapy may be administered prior elderly patients.
to or following administration of TMZ. Male patients
Adult patients with newly-diagnosed
Men being treated with TMZ should be advised
glioblastoma multiforme
not to father a child up to 6 months after
Anti-emetic prophylaxis is recommended prior receiving the last dose and to seek advice on
to the initial dose of concomitant phase and it is cryoconservation of sperm prior to treatment
strongly recommended during the monotherapy (see section 4.6).
phase. Lactose
Patients with recurrent or progressive This medicinal product contains lactose. Patients
malignant glioma
with rare hereditary problems of galactose
Patients who have experienced severe (Grade 3 intolerance, the Lapp lactase deficiency or
or 4) vomiting in previous treatment cycles may glucose-galactose malabsorption should not take
require anti-emetic therapy. this medicine.
Laboratory parameters 4.5 Interaction with other medicinal
products and other forms of interaction
Patients treated with TMZ may experience
myelosuppression, including prolonged In a separate phase I study, administration of
pancytopenia, which may result in aplastic TMZ with ranitidine did not result in alterations
anaemia, which in some cases has resulted in a in the extent of absorption of temozolomide or
fatal outcome. In some cases, exposure to the exposure to its active metabolite
concomitant medicinal products associated with monomethyl triazenoimidazole carboxamide
aplastic anaemia, including carbamazepine, (MTIC).
phenytoin, and sulfamethoxazole/trimethoprim,
complicates assessment. Prior to dosing, the Administration of TMZ with food resulted in a
following laboratory parameters must be met: 33 % decrease in Cmax and a 9 % decrease in area
ANC ≥ 1.5 x 109/l and platelet count ≥ 100 x under the curve (AUC).
109/l. A complete blood count should be As it cannot be excluded that the change in
obtained on Day 22 (21 days after the first dose) Cmax is clinically significant, Temozolomide
or within 48 hours of that day, and weekly until capsules should be administered without food.
ANC > 1.5 x 109/l and platelet count > 100 x
109/l. If ANC falls to < 1.0 x 109/l or the platelet Based on an analysis of population
count is < 50 x 109/l during any cycle, the next pharmacokinetics in phase II trials, co-
cycle should be reduced one dose level (see administration of dexamethasone,
section 4.2). Dose levels include 100 mg/m2, prochlorperazine, phenytoin, carbamazepine,
150 mg/m2, and 200 mg/m2. The lowest ondansetron, H2 receptor antagonists, or
recommended dose is 100 mg/m2. phenobarbital did not alter the clearance of
TMZ. Co-administration with valproic acid was
Paediatric population
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associated with a small but statistically 4.7 Effects on ability to drive and use
significant decrease in clearance of TMZ. machines
No studies have been conducted to determine the
effect of TMZ on the metabolism or elimination TMZ has minor influence on the ability to drive
of other medicinal products. However, since and use machines due to fatigue and somnolence
TMZ does not undergo hepatic metabolism and (see section 4.8).
exhibits low protein binding, it is unlikely that it 4.8 Undesirable Effects
would affect the pharmacokinetics of other
medicinal products (see section 5.2).
Clinical trial experience
Use of TMZ in combination with other
In patients treated with TMZ, whether used in
myelosuppressive agents may increase the
combination with RT or as monotherapy
likelihood of myelosuppression.
following RT for newly-diagnosed glioblastoma
Paediatric population multiforme, or as monotherapy in patients with
recurrent or progressive glioma, the reported
Interaction studies have only been performed in very common adverse reactions were similar:
adults. nausea, vomiting, constipation, anorexia,
4.6 Fertility, pregnancy and lactation headache and fatigue. Convulsions were
reported very commonly in the newly-diagnosed
Pregnancy glioblastoma multiforme patients receiving
monotherapy, and rash was reported very
There are no data in pregnant women. In
commonly in newly-diagnosed glioblastoma
preclinical studies in rats and rabbits receiving
multiforme patients receiving TMZ concurrent
150 mg/m2 TMZ, teratogenicity and/or foetal
with RT and also as monotherapy, and
toxicity were demonstrated (see section 5.3).
commonly in recurrent glioma. Most
Temozolomide capsules should not be
haematologic adverse reactions were reported
administered to pregnant women. If use during
commonly or very commonly in both indications
pregnancy must be considered, the patient
(Tables 4 and 5); the frequency of grade 3-4
should be apprised of the potential risk to the
laboratory findings is presented after each table.
foetus.
In the tables undesirable effects are classified
Breast-feeding
according to System Organ Class and frequency.
It is not known whether TMZ is excreted in Frequency groupings are defined according to
human milk; thus, breast-feeding should be the following convention: Very common (≥
discontinued while receiving treatment with 1/10); Common (≥ 1/100 to < 1/10); Uncommon
TMZ. (≥ 1/1,000 to < 1/100); Rare (≥1/10,000 to
<1/1,000); Very rare (<1/10,000). Within each
Women of childbearing potential frequency grouping, undesirable effects are
Women of childbearing potential should be presented in order of decreasing seriousness.
advised to use effective contraception to avoid Newly-diagnosed glioblastoma multiforme
pregnancy while they are receiving TMZ.
Table 4 provides treatment-emergent adverse
Male fertility events in patients with newly-diagnosed
TMZ can have genotoxic effects. Therefore, glioblastoma multiforme during the concomitant
men being treated with it should be advised not and monotherapy phases of treatment.
to father a child up to 6 months after receiving
the last dose and to seek advice on
cryoconservation of sperm prior to treatment, Table 4. Treatment-emergent events during concomitant and monotherapy
treatment phases in patients with newly-diagnosed glioblastoma
because of the possibility of irreversible multiforme
infertility due to therapy with TMZ.
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System organ TMZ + concomitant RT TMZ monotherapy visual field defect, eye pain
class n=288* n=224
Infections and infestations
Ear and labyrinth disorders

Common: Infection, Herpes simplex, Infection, candidiasis oral Common: Hearing impairment Hearing impairment,
wound infection, pharyngitis, tinnitus
candidiasis oral
Uncommon: Otitis media, tinnitus, Deafness, vertigo,
Uncommon: Herpes simplex, herpes hyperacusis, earache earache
zoster, influenza–like
symptoms Cardiac disorders
Blood and lymphatic system disorders
Uncommon: Palpitation
Common: Neutropenia, Febrile neutropenia,
thrombocytopenia, thrombocytopenia,
Vascular disorders
lymphopenia, leukopenia anaemia, leukopenia
Uncommon: Febrile neutropenia, anaemia Lymphopenia, petechiae Common: Haemorrhage, oedema, Haemorrhage, deep
oedema leg venous thrombosis,
oedema leg
Endocrine disorders Uncommon: Cerebral haemorrhage, Embolism pulmonary,
hypertension oedema, oedema
Uncommon: Cushingoid Cushingoid peripheral

Respiratory, thoracic and mediastinal disorders

Metabolism and nutrition disorders
Common: Dyspnoea, coughing Dyspnoea, coughing
Very common: Anorexia Anorexia
Uncommon: Pneumonia, upper respiratory Pneumonia, sinusitis,
Hyperglycaemia, weight infection, nasal congestion upper respiratory infection,
Common: Weight decreased
decreased bronchitis
Uncommon: Hypokalemia, alkaline Hyperglycaemia, weight
Gastrointestinal disorders
phosphatase increased, increased
weight increased
Very common: Constipation, nausea, Constipation, nausea,
Psychiatric disorders vomiting vomiting
Common: Stomatitis, diarrhoea, Stomatitis, diarrhoea,
Common: Anxiety, emotional lability, Anxiety, depression, abdominal pain, dyspepsia, dyspepsia, dysphagia,
insomnia emotional lability, dysphagia mouth dry
insomnia
Uncommon: Abdominal distension,
Uncommon: Agitation, apathy, behaviour Hallucination, amnesia fecal incontinence,
disorder, depression, gastrointestinal disorder
hallucination (NOS), gastroenteritis,
haemorrhoids
Nervous system disorders

Very common: Headache Convulsions, headache

Common: Convulsions, consciousness Hemiparesis, aphasia, Skin and subcutaneous tissue disorders
decreased, somnolence, balance impaired,
aphasia, balance impaired, somnolence, confusion, Very common: Rash, alopecia Rash, alopecia
dizziness, confusion, memory dizziness, memory
impairment, concentration impairment, concentration
impaired, neuropathy, impaired, dysphasia,
Common: Dermatitis, dry skin, Dry skin, pruritus
paresthesia, speech disorder, neurological disorder
erythema, pruritus
tremor (NOS), neuropathy,
peripheral neuropathy,
paresthesia, speech Uncommon: Skin exfoliation, Erythema, pigmentation
disorder, tremor photosensitivity reaction, abnormal, sweating
pigmentation abnormal increased
Uncommon: Status epilepticus, Hemiplegia, ataxia,
extrapyramidal disorder, coordination abnormal,
hemiparesis, ataxia, cognition gait abnormal,
impaired, dysphasia, gait hyperesthesia, sensory
abnormal, hyperesthesia, disturbance Musculoskeletal and connective tissue disorders
hypoesthesia, neurological
disorder (NOS), peripheral
Common: Muscle weakness, arthralgia Muscle weakness,
neuropathy
arthralgia, musculoskeletal
pain, myalgia
Eye disorders

Common: Vision blurred Visual field defect, vision

blurred, diplopia Uncommon: Myopathy, back pain, Myopathy, back pain
Uncommon: Hemianopia, visual acuity Visual acuity reduced, eye musculoskeletal pain, myalgia
reduced, vision disorder, pain, eyes dry
Te mozolomide 20 mg, 100 mg, 250 mg hard capsules SMPC, Taj Pharmaceuticals
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In clinical trials, the most frequently occurring

Renal and urinary disorders
treatment-related undesirable effects were
Common: Micturition frequency, urinary Urinary incontinence gastrointestinal disorders, specifically nausea
incontinence
(43 %) and vomiting (36 %). These reactions
Uncommon: Dysuria were usually Grade 1 or 2 (0 – 5 episodes of
vomiting in 24 hours) and were either self-
limiting or readily controlled with standard anti-
Reproductive system and breast disorders
emetic therapy. The incidence of severe nausea
Uncommon: Impotence Vaginal haemorrhage, and vomiting was 4 %.
menorrhagia, amenorrhea,
vaginitis, breast pain Table 5 includes adverse reactions reported
during clinical trials for recurrent or progressive
malignant glioma and following the marketing
General disorders and administration site conditions of Temozolomide capsules.
Very common: Fatigue Fatigue Table 5. Adverse reactions in patients with recurrent or
progressive malignant glioma

Common: Allergic reaction, fever,
radiation injury, face oedema, radiation injury, pain, taste
pain, taste perversion
Uncommon: Asthenia, flushing, hot
flushes, condition aggravated,
rigors, tongue discolouration,
parosmia, thirst
Allergic reaction, fever, Infections and infestations
perversion Rare: Opportunistic infections, including
PCP
Blood and lymphatic system disorders
Asthenia, face oedema,
pain, condition
Very common: Neutropenia or lymphopenia (grade
aggravated, rigors, tooth 3-4), thrombocytopenia (grade 3-4)
disorder Uncommon: Pancytopenia, anaemia (grade 3-4),
leukopenia

Investigations Metabolism and nutrition disorders

Very common: Anorexia
Common: ALT increased ALT increased
Common: Weight decrease
Uncommon: Hepatic enzymes increased,
Gamma GT increased, AST Nervous system disorders
increased
Very common: Headache

Common: Somnolence, dizziness, paresthesia

Respiratory, thoracic and mediastinal disorders

*A patient who was randomised to the RT arm
only, received TMZ + RT. Common: Dyspnoea

Gastrointestinal disorders
Laboratory results
Very common: Vomiting, nausea, constipation
Myelosuppression (neutropenia and
thrombocytopenia), which is known dose- Common: Diarrhoea, abdominal pain,
dyspepsia
limiting toxicity for most cytotoxic agents,
Skin and subcutaneous tissue disorders
including TMZ, was observed. When laboratory
abnormalities and adverse events were combined Common: Rash, pruritus, alopecia
across concomitant and monotherapy treatment Very rare: Erythema multiforme, erythroderma,
phases, Grade 3 or Grade 4 neutrophil urticaria, exanthema
abnormalities including neutropenic events were General disorders and administration site conditions
observed in 8 % of the patients. Grade 3 or Very common: Fatigue
Grade 4 thrombocyte abnormalities, including
Common: Fever, asthenia, rigors, malaise,
thrombocytopenic events were observed in 14 % pain, taste perversion
of the patients who received TMZ. Very rare: Allergic reactions, including
anaphylaxis, angioedema
Recurrent or progressive malignant glioma
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Laboratory results The following additional serious adverse

reactions have been identified during post-
Grade 3 or 4 thrombocytopenia and neutropenia marketing exposure:
occurred in 19 % and 17 % respectively, of
patients treated for malignant glioma. This led to Table 6. Summary of events reported with temozolomide in the
hospitalisation and/or discontinuation of TMZ in post-marketing setting

8 % and 4 %, respectively. Myelosuppression Infections and infestations*

was predictable (usually within the first few Uncommon: cytomegalovirus infection,
cycles, with the nadir between Day 21 and Day infection reactivation such as
cytomegalovirus, hepatitis B
28), and recovery was rapid, usually within 1-2 virus†, meningoencephalitis
weeks. No evidence of cumulative herpetic†, sepsis†
myelosuppression was observed. The presence Blood and lymphatic system disorders
of thrombocytopenia may increase the risk of
Very rare: prolonged pancytopenia, aplastic
bleeding, and the presence of neutropenia or anaemia†
leukopenia may increase the risk of infection. Neoplasm benign, malignant and unspecified

Gender Very rare: myelodysplastic syndrome

(MDS), secondary malignancies,
In a population pharmacokinetics analysis of including myeloid leukaemia
clinical trial experience there were 101 female Endocrine disorders*
and 169 male subjects for whom nadir Uncommon: diabetes insipidus
neutrophil counts were available and 110 female
and 174 male subjects for whom nadir platelet Respiratory, thoracic and mediastinal disorders
counts were available. There were higher rates Very rare: interstitial
of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12 pneumonitis/pneumonitis,
% vs 5 %, and thrombocytopenia (< 20 x 109/l), pulmonary fibrosis, respiratory
failure†
9 % vs 3 %, in women vs men in the first cycle Hepatobiliary disorders*
of therapy. In a 400 subject recurrent glioma
data set, Grade 4 neutropenia occurred in 8 % of Common: liver enzymes elevations
female vs 4 % of male subjects and Grade 4 Uncommon: hyperbilirubinemia, cholestasis,
thrombocytopenia in 8 % of female vs 3 % of hepatitis, hepatic injury, hepatic
male subjects in the first cycle of therapy. In a failure†
study of 288 subjects with newly-diagnosed Skin and subcutaneous tissue disorders
glioblastoma multiforme, Grade 4 neutropenia Very rare: toxic epidermal necrolysis,
occurred in 3 % of female vs 0 % of male Stevens-Johnson syndrome
†
subjects and Grade 4 thrombocytopenia in 1 % Including cases with fatal outcome
of female vs 0 % of male subjects in the first
cycle of therapy. * Frequencies estimated based on relevant
clinical trials.
Paediatric population
Oral TMZ has been studied in paediatric patients
(age 3-18 years) with recurrent brainstem glioma Reporting of suspected adverse reactions
or recurrent high grade astrocytoma, in a Reporting suspected adverse reactions after
regimen administered daily for 5 days every 28 authorisation of the medicinal product is
days. Although the data is limited, tolerance in important. It allows continued monitoring of the
children is expected to be the same as in adults. benefit/risk balance of the medicinal product.
The safety of TMZ in children under the age of
3 years has not been established. 4.9 Overdose
Doses of 500, 750, 1,000, and 1,250
Post-Marketing Experience mg/m2 (total dose per cycle over 5 days) have
been evaluated clinically in patients. Dose-
limiting toxicity was haematological and was
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reported with any dose but is expected to be TMZ was administered as salvage therapy in the
more severe at higher doses. An overdose of follow-up phase in 161 patients of the 282 (57
10,000 mg (total dose in a single cycle, over 5 %) in the RT alone arm, and 62 patients of the
days) was taken by one patient and the adverse 277 (22 %) in the TMZ + RT arm.
reactions reported were pancytopenia, pyrexia,
multi-organ failure and death. There are reports The hazard ratio (HR) for overall survival was
of patients who have taken the recommended 1.59 (95 % CI for HR=1.33 -1.91) with a log-
rank p < 0.0001 in favour of the TMZ arm. The
dose for more than 5 days of treatment (up to 64
estimated probability of surviving 2 years or
days) with adverse events reported including
bone marrow suppression, with or without more (26 % vs 10 %) is higher for the RT +
infection, in some cases severe and prolonged TMZ arm. The addition of concomitant TMZ to
and resulting in death. In the event of an RT, followed by TMZ monotherapy in the
overdose, haematological evaluation is needed. treatment of patients with newly-diagnosed
Supportive measures should be provided as glioblastoma multiforme demonstrated a
necessary. statistically significant improvement in overall
survival (OS) compared with RT alone (Figure
5. PHARMACOLOGICAL 1).
PROPERTIES
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic

agents - Other alkylating agents
Mechanism of action
Temozolomide is a triazene, which undergoes
rapid chemical conversion at physiologic pH to
the active monomethyl triazenoimidazole
carboxamide (MTIC). The cytotoxicity of MTIC
is thought to be due primarily to alkylation at the
O6 position of guanine with additional alkylation
also occurring at the N7 position. Cytotoxic
lesions that develop subsequently are thought to
involve aberrant repair of the methyl adduct.
Clinical efficacy and safety
Figure 1 Kaplan-Meier curves for overall
Newly-diagnosed glioblastoma multiforme survival (intent-to-treat population)
A total of 573 patients were randomised to The results from the trial were not consistent in
receive either TMZ + RT (n=287) or RT alone the subgroup of patients with a poor
(n=286). Patients in the TMZ + RT arm received performance status (WHO PS=2, n=70), where
concomitant TMZ (75 mg/m2) once daily, overall survival and time to progression were
starting the first day of RT until the last day of similar in both arms. However, no unacceptable
RT, for 42 days (with a maximum of 49 days). risks appear to be present in this patient group.
This was followed by monotherapy TMZ (150 -
200 mg/m2) on Days 1 - 5 of every 28-day cycle Recurrent or progressive malignant glioma
for up to 6 cycles, starting 4 weeks after the end Data on clinical efficacy in patients with
of RT. Patients in the control arm received RT glioblastoma multiforme (Karnofsky
only. Pneumocystis jirovecii pneumonia (PCP) performance status [KPS] ≥ 70), progressive or
prophylaxis was required during RT and recurrent after surgery and RT, were based on
combined TMZ therapy. two clinical trials with oral TMZ. One was a
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non-comparative trial in 138 patients (29 % was 44 % with a median event-free survival of
received prior chemotherapy), and the other was 4.6 months, which was similar to the results for
a randomised active-controlled trial of the progression-free survival. For the eligible
TMZ vs procarbazine in a total of 225 patients histology population, the efficacy results were
(67 % received prior treatment with nitrosourea similar. Achieving a radiological objective
based chemotherapy). In both trials, the primary response or maintaining progression-free status
endpoint was progression-free survival (PFS) was strongly associated with maintained or
defined by MRI scans or neurological improved quality of life.
worsening. In the non-comparative trial, the PFS
Paediatric population
at 6 months was 19 %, the median progression-
free survival was 2.1 months, and the median Oral TMZ has been studied in paediatric patients
overall survival 5.4 months. The objective (age 3-18 years) with recurrent brainstem glioma
response rate (ORR) based on MRI scans was 8 or recurrent high grade astrocytoma, in a
%. regimen administered daily for 5 days every 28
days. Tolerance to TMZ is similar to adults.
In the randomised active-controlled trial, the
PFS at 6 months was significantly greater for
TMZ than for procarbazine (21 % vs 8 %, 5.2 Pharmacokinetic properties
respectively – chi-square p = 0.008) with median TMZ is spontaneously hydrolyzed at physiologic
PFS of 2.89 and 1.88 months respectively (log pH primarily to the active species, 3-methyl-
rank p = 0.0063). The median survival was 7.34 (triazen-1-yl)imidazole-4-carboxamide (MTIC).
and 5.66 months for TMZ and procarbazine, MTIC is spontaneously hydrolyzed to 5-amino-
respectively (log rank p = 0.33). At 6 months, imidazole-4-carboxamide (AIC), a known
the fraction of surviving patients was intermediate in purine and nucleic acid
significantly higher in the TMZ arm (60 %) biosynthesis, and to methylhydrazine, which is
compared with the procarbazine arm (44 %) believed to be the active alkylating species. The
(chi-square p = 0.019). In patients with prior cytotoxicity of MTIC is thought to be primarily
chemotherapy a benefit was indicated in those due to alkylation of DNA mainly at the O6 and
with a KPS ≥ 80. N7 positions of guanine. Relative to the AUC of
Data on time to worsening of neurological status TMZ, the exposure to MTIC and AIC is ~ 2.4 %
favoured TMZ over procarbazine as did data on and 23 %, respectively. In vivo, the t1/2 of MTIC
time to worsening of performance status was similar to that of TMZ, 1.8 hr.
(decrease to a KPS of < 70 or a decrease by at
least 30 points). The median times to
progression in these endpoints ranged from 0.7 Absorption
to 2.1 months longer for TMZ than for
After oral administration to adult patients, TMZ
procarbazine (log rank p = < 0.01 to 0.03).
is absorbed rapidly, with peak concentrations
Recurrent anaplastic astrocytoma reached as early as 20 minutes post-
administration (mean time between 0.5 and 1.5
In a multicentre, prospective phase II trial hours). After oral administration of 14C-labelled
evaluating the safety and efficacy of oral TMZ TMZ, mean faecal excretion of 14C over 7 days
in the treatment of patients with anaplastic post-dose was 0.8 % indicating complete
astrocytoma at first relapse, the 6 month PFS absorption.
was 46 %. The median PFS was 5.4 months.
Median overall survival was 14.6 months. Distribution
Response rate, based on the central reviewer
TMZ demonstrates low protein binding (10 % to
assessment, was 35 % (13 CR and 43 PR) for
20 %), and thus it is not expected to interact with
the intent-to-treat population (ITT) n=162. In 43 highly protein-bound substances.
patients stable disease was reported. The 6-
month event-free survival for the ITT population
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PET studies in humans and preclinical data degeneration were in the lethal dose range, and
suggest that TMZ crosses the blood-brain barrier no comparable effect has been observed in
rapidly and is present in the CSF. CSF clinical studies, this finding was not considered
penetration was confirmed in one patient; CSF to have clinical relevance.
exposure based on AUC of TMZ was
approximately 30 % of that in plasma, which is TMZ is an embryotoxic, teratogenic and
consistent with animal data. genotoxic alkylating agent. TMZ is more toxic
to the rat and dog than to humans, and the
Elimination clinical dose approximates the minimum lethal
dose in rats and dogs. Dose-related reductions in
The half-life (t1/2) in plasma is approximately 1.8
leukocytes and platelets appear to be sensitive
hours. The major route of 14C elimination is indicators of toxicity. A variety of neoplasms,
renal. Following oral administration, including mammary carcinomas,
approximately 5 % to 10 % of the dose is keratocanthoma of the skin and basal cell
recovered unchanged in the urine over 24 hours,
adenoma were observed in the 6-cycle rat study
and the remainder excreted as temozolomide while no tumours or pre-neoplastic changes
acid, 5-aminoimidazole-4-carboxamide (AIC) or were evident in dog studies. Rats appear to be
unidentified polar metabolites.
particularly sensitive to oncogenic effects of
Plasma concentrations increase in a dose-related TMZ, with the occurrence of first tumours
manner. Plasma clearance, volume of within 3 months of initiating dosing. This
distribution and half-life are independent of latency period is very short even for an
dose. alkylating agent.
Special populations Results of the Ames/salmonella and Human
Peripheral Blood Lymphocyte (HPBL)
Analysis of population-based pharmacokinetics chromosome aberration tests showed a positive
of TMZ revealed that plasma TMZ clearance mutagenicity response.
was independent of age, renal function or
tobacco use. In a separate pharmacokinetic 6. PHARMACEUTICAL
study, plasma pharmacokinetic profiles in PARTICULARS
patients with mild to moderate hepatic
impairment were similar to those observed in 6.1 List of excipients
patients with normal hepatic function.
Paediatric patients had a higher AUC than adult Capsule content:
patients; however, the maximum tolerated dose anhydrous lactose,
(MTD) was 1,000 mg/m2 per cycle both in colloidal anhydrous silica,
children and in adults. sodium starch glycolate type A,
5.3 Preclinical safety data tartaric acid,
stearic acid.
Single-cycle (5-day dosing, 23 days non-
treatment), 3- and 6-cycle toxicity studies were Capsule shell:
conducted in rats and dogs. The primary targets 20 mg:
of toxicity included the bone marrow,
lymphoreticular system, testes, the gelatin,
gastrointestinal tract and, at higher doses, which titanium dioxide (E 171),
were lethal to 60 % to 100 % of rats and dogs sodium lauril sulfate,
tested, degeneration of the retina occurred. Most yellow iron oxide (E 172)
of the toxicity showed evidence of reversibility, 100 mg:
except for adverse events on the male
reproductive system and retinal degeneration.
However, because the doses implicated in retinal
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gelatin, Sachets are composed of linear low density

titanium dioxide (E 171), polyethylene (innermost layer), aluminium and
sodium lauril sulfate, polyethylene terephthalate.
red iron oxide (E172). Each sachet contains 1 hard capsule and is
dispensed in a cardboard carton.
250 mg:
The carton contains 5 or 20 hard capsules,
gelatin, individually sealed in sachets.
titanium dioxide (E 171),
sodium lauril sulfate Not all pack sizes may be marketed.
Printing ink: 6.6 Special precautions for disposal and
shellac, other handling
propylene glycol,
purified water, Capsules should not be opened. If a capsule
ammonium hydroxide, becomes damaged, contact of the powder
potassium hydroxide, contents with skin or mucous membrane must be
black iron oxide (E 172). avoided. If Temozolomide capsules comes into
contact with skin or mucosa, it should be washed
6.2 Incompatibilities immediately and thoroughly with soap and
water.
Not applicable.
Patients should be advised to keep capsules out
6.3 Shelf life of the sight and reach of children, preferably in a
locked cupboard. Accidental ingestion can be
3 years lethal for children.
6.4 Special precautions for storage Any unused medicinal product or waste material
should be disposed of in accordance with local
Bottle presentation requirements.

Do not store above 30 °C.

Store in the original bottle in order to protect 7. MANUFACTURER:
from moisture.
Keep the bottle tightly closed.
Sachet presentation
Manufactured in India by:
Do not store above 30 °C. TAJ PHARMACEUTICALS LTD.
Mumbai, India
6.5 Nature and contents of container Survey No.188/1 to 189/1,190/1 to 4,
Athiyawad, Dabhel,
Bottle presentation Daman- 396210 (INDIA)

Type I amber glass bottles with polypropylene

child-resistant closures containing 5 or 20 hard
capsules.
The carton contains one bottle.
Sachet presentation
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