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Temodar Patient, Information, Instructions - Temozolomide
Temodar Patient, Information, Instructions - Temozolomide
PATIENT INFORMATION
In clinical trials,
the most frequently occurring adverse effects were nausea and vomiting.
These were usually either self-limiting or readily controlled with
standard anti-emetic
therapy. Capsules should not be opened. If capsules are accidentally
opened or damaged, rigorous precautions should be taken with the
capsule contents to
avoid inhalation
or contact with the
skin or mucous
membranes. The medication
should be kept away from children and pets.
What is TEMODAR?
TEMODAR is used to treat certain cancerous
tumors in the brain of
adult patients for whom this tumor
has recurred. Your doctor
has prescribed TEMODAR (temozolomide) as proof
of your cancer treatment.
TEMODAR is a drug you take
by mouth that interferes
with cell growth,
especially in cells that are growing rapidly, such
as cancerous cells.
TEMODAR has been shown to help slow
the growth of certain
cancerous tumors.
When given to patients with brain
cancer, TEMODAR has been
shown to reduce the size
of the tumor in some patients.
Who should not take
TEMODAR?
You should not take TEMODAR
if you have had an allergic
reaction to DTIC-Dome
(dacarbazine), a different treatment
for cancer. If you have had an allergic
reaction before to
drugs such as DTIC-Dome,
be sure to tell your doctor
before taking TEMODAR. If you are allergic
to drugs similar to TEMODAR you may also have an allergic
reaction to TEMODAR.
How should I take TEMODAR?
Take each day's dose of
capsules at one time, with a full glass
of water. DO NOT open or
split the capsules. If
the capsules are accidentally opened or damaged, you should be extremely
careful to avoid inhaling the powder in the capsules or getting
it on your skin or mucous
membranes (in nose or mouth). The medication
should be kept away from children and pets. They should be swallowed
whole and NEVER CHEWED. The medicine
is used best by your body
if you take it at the same
time every day in relation
to a meal. To reduce
nausea, try to take
TEMODAR on an empty stomach
or at bedtime. Your doctor
may also have prescribed anti-nausea or other medications to relieve
the side effects associated
with TEMODAR. Anti-nausea medications should be taken as directed
by your doctor. It is important that you continue to see your doctor
regularly to check your
progress. Your doctor
can uncover side effects of treatment
that you might not notice.
Your pharmacist
has carefully packaged the TEMODAR capsules for each day of treatment
in five separate packets or vials, labeled "Day 1", "Day
2", "Day 3", "Day 4", and "Day 5".
On the first day of treatment,
you should take all the
capsules in the package labeled "Day 1" (as a single dose),
on the second day, take
all the capsules in the package labeled Day 2 as a single dose,
and so on. Don't worry that the capsules that you take
on a given day are different sizes or colors. Your doctor
and pharmacist have
made sure that you will
be taking the correct dose
on each of the five days of the treatment cycle. If you think your
medication has been
packaged incorrectly, contact your physician
or pharmacist immediately.
Because TEMODAR is a drug
you take by mouth,
you can take it at home.
TEMODAR is usually taken for five days in a row over a 28-day period.
This period is called a treatment
cycle. That means you will
take TEMODAR for five days,
have a break from therapy
for 23 days, and then take
the drug for another five days. The number
of treatment cycles
will depend on how you
respond to and tolerate this treatment.
Your doctor may have
prescribed a treatment
regimen that is different
from the one discussed in this information sheet. If so, make sure
you follow the specific
instructions given to you by your doctor. You should talk to your
doctor about what to
do if you miss a day. If you take
more than the prescribed amount of medicine, contact
your doctor right
away.
What should I avoid while taking TEMODAR?
There are no limitations
on what you may eat or drink
while taking TEMODAR. However, to ease nausea,
try to take TEMODAR on
an empty stomach. There are no
known interactions with other medications.
TEMODAR may cause birth
defects. Therefore, male
or female patients who
take TEMODAR should use
effective birth control.
Female patients should avoid becoming pregnant
while receiving this drug. You should not breast feed an infant
while taking TEMODAR. It is not known whether TEMODAR passes into
breast milk. Because
many drugs do pass into breast
milk, there is the possibility of serious harm to nursing
infants.
What are the possible or reasonably likely side
effects of TEMODAR?
Nausea and vomiting
are the most common side
effects associated with TEMODAR. Your doctor
can prescribe medicines
that may help reduce
some of these. Other common side
effects include headache,
feeling tired, and constipation.
TEMODAR also can reduce
the number of certain
types of blood cells,
which can have serious effects. Therefore, it is important that
your doctor check your blood
periodically while you are taking TEMODAR to see if these side effects
are occurring. Patients, age
70 or older, women, and patients who have had chemotherapy
or radiation therapy
may be more likely to have their blood
cells affected.
There are other side effects
associated with TEMODAR. They are included in a longer, more technical
information leaflet written for health
care providers that you can get from your doctor
or pharmacist.
General information about the use of prescription
drug products.
Medicines are sometimes prescribed for purposes other than those
listed in a Patient Package Insert. You should contact
your health care professional
regarding any concerns you may have about using TEMODAR. TEMODAR
should not be used for a condition
for which it was not prescribed, and it should not be given to other
persons.
Pharmacist Information Sheet
IMPORTANT DISPENSING INFORMATION
For every patient,
each day’s dose of TEMODAR
must be packaged separately so that, patients take
the correct daily dose. Please see the dispensing instructions below
for more information.
What is TEMODAR?
TEMODAR (temozolomide) is an oral
alkylating agent for the treatment
of refractory-anaplastic astrocytoma.
How is TEMODAR dosed?
The daily dose
of TEMODAR for a given patient is calculated by the physician,
based on the patient’s body
surface area (BSA).
The initial daily dose
of TEMODAR in milligrams is the BSA multiplied by 150 (150 mg/m2/day).
The resulting dose is then
rounded off to the nearest 5 mg. For example, the daily dose
for a patient with a BSA of 1.84 is 1.84 x 150 = 276, or 275 mg/day.
The dose for subsequent cycles may be adjusted according to nadir
neutrophil and platelet
counts in the previous cycle
and at the time of initiating
the next cycle.
How might the dose
of TEMODAR be modified?
Dosage of TEMODAR must be adjusted according
to nadir neutrophil
and platelet counts
in the previous cycle
and neutrophil and platelet
counts at the time of initiating
the next cycle. The initial dose is 150 mg/m2
orally once daily for 5 consecutive days per
28 day treatment cycle.
If both the nadir and day of dosing (Day 29, Day 1 of next cycle)
absolute neutrophil
counts (ANC) are ³ 1.5
x 109 /L (1,500/mcL)
and both the nadir and day 29, Day 1 of next cycle
platelet counts are
³ 100
x 109 /L (100,000/mcL),
the TEMODAR dose may be
increased to 200 mg/m2/day for 5
consecutive days per 28
day treatment cycle.
During treatment,
a complete blood count
should be obtained on Day 22 (21 days after the first dose) or within
48 hours of that day, and weekly until the ANC
is above 1.5 x 109 /L (1,500/mcL)
and the platelet count
exceeds 100 x 109 /L (100,000/mcL).
The next cycle of TEMODAR
should not be started until the ANC
and platelet count, exceed these levels. If the ANC
falls to <1.0 x 109 /L (1,000/mcL)
or the platelet count
is <50 x 109 /L (50,000/mcL)
during any cycle, the next cycle
should be reduced by 50 mg/m2 ,
but not below 100 mg/m2 , the lowest
recommended dose (see DOSAGE
AND ADMINISTRATION: Table 3 - Dosing Modification).
What is the TEMODAR treatment
regimen?
TEMODAR is given for five
consecutive days on a 28-day cycle. Patients should continue taking
TEMODAR until their physician determines that their disease
has progressed, up to 2 years, or until unacceptable side
effects or toxicities occur. Physicians may alter the treatment
regimen for a given
patient.
How is TEMODAR taken?
Patients should take
each day’s dose with a full glass
of water at the same time
each day. Taking the medication on an empty stomach
or at bedtime may help ease nausea. If patients are also taking
anti-nausea or other medications to relieve
the side effects associated
with TEMODAR, they should be advised to take
these medications 30 minutes before they take
TEMODAR. Temozolomide causes the rapid appearance of malignant
tumors in rats. Patients SHOULD
NOT open or split
the capsules. If capsules are accidentally opened or damaged, rigorous
precautions should be taken with the capsule
contents to avoid inhalation
or contact with the skin
or mucous membranes.
The medication should
be kept away from children and pets. The TEMODAR capsules should
be swallowed whole and NEVER
CHEWED.
What should the patient
avoid during treatment with TEMODAR?
There are no
dietary restrictions
for patients taking TEMODAR. There are no
known interactions with other medications.
TEMODAR may affect
testicular function so male
patients should exercise
adequate birth control
measures. TEMODAR may cause
birth defects. Female
patients should avoid becoming pregnant while receiving this drug.
Women who are nursing
prior to receiving TEMODAR should discontinue nursing. It is not
known whether TEMODAR is excreted into breast
milk.
What are the side
effects of TEMODAR?
Nausea and vomiting
are the most common side
effects associated with TEMODAR. Non-cumulative myelosuppression
is the dose-limiting toxicity. Patients should be evaluated periodically
by their physician
to monitor blood
counts.
Other commonly reported side
effects reported by patients taking TEMODAR are fatigue,constipation
and headache.
How is TEMODAR supplied?
TEMODAR capsules are available
in 250mg, 100mg, 20mg, and 5mg strengths. The capsules are color
coded according to strength.
TEMODAR Capsule
|
Strength
|
Color
|
|
<5 mg
|
Green
|
|
<20 mg
|
Brown
|
|
<100 mg
|
Blue
|
|
<250 mg
|
Black
|
All capsule strengths
are available in 5-count and 20-count packages.
How is TEMODAR dispensed?
For a given prescription,
each day’s dose of TEMODAR must be packaged separately so that,
patients take the correct
dose each day. Follow the
instructions below:
Determine the number
of capsules of each strength
needed to add up to the
daily dose prescribed by
the physician (eg, 275 mg/day = 1 x 250mg capsule,
1 x 20mg capsule and
1 x 5mg capsule).
Place one day’s supply of TEMODAR
in each of five separate packets or vials. In
the above prescription
for 275 mg/day, each of the five packets or vials should contain
1 x 250mg capsule, 1 x 20mg capsule
and 1 x 5mg capsule.
Label the five packages as Day
1, Day 2, Day 3, Day 4, and Day 5, using the labels enclosed.
Dispense to the patient,
making sure that he or she understands that each day’s dose
of TEMODAR is packaged separately.
How can TEMODAR be ordered?
TEMODAR can be ordered from your
wholesaler. Remember to order
enough TEMODAR for a full five-day cycle. For example, a five-day
course of 275 mg/day would require the following to be ordered:
1 5-count package of 250mg capsules
1 5-count package of 20mg capsules
1 5-count package of 5mg capsules
-
- TEMODAR Product
|
- NDC Number
|
- 250mg capsules (5-count)
|
- 0085-1252-01
|
- 250mg capsules (20-count)
|
- 0085-1252-02
|
- 100mg capsules (5-count)
|
- 0085-1259-01
|
- 100mg capsules (20-count)
|
- 0085-1259-02
|
- 20mg capsules (5-count)
|
- 0085-1244-01
|
- 20mg capsules (20-count)
|
- 0085-1244-02
|
- 5mg capsules (5-count)
|
- 0085-1248-01
|
- 5mg capsules (20-count)
|
- 0085-1248-02
|
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