Temcad interferes with the development of cancer cells, slowing their growth and spread in the body.
Temcad is used together with radiation therapy to treat certain types of brain tumor in adults.
Temcad is usually given after other cancer medicines have been tried without success.
Temcad may also be used for purposes not listed in this medication guide.
Temcad indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Newly Diagnosed Glioblastoma Multiforme
Temcad Capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.
Refractory Anaplastic Astrocytoma
Temcad Capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
How should I use Temcad?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Temcad is given in a 28-day treatment cycle and only on certain days of this cycle.
Your doctor may occasionally change your dose. The size, color, and number of Temcad capsules you take may sometimes be different from earlier treatment cycles. Be sure you know the correct number of capsules to take and on which days to take them. Ask your doctor or pharmacist if you have any questions.
Doses are based on body surface area (height and weight). Your dose may change if you gain or lose weight or if you are still growing.
Temcad injection is given by a healthcare provider. The medicine is injected slowly into a vein, over 90 minutes.
Take your entire daily dose of the capsules at the same time on each dosing day of a treatment cycle. Swallow the capsules whole with a full glass of water.
You may take Temcad capsules with or without food, but take it the same way each time.
You may need to take Temcad Temcad capsule at bedtime or on an empty stomach if the medicine upsets your stomach.
If you vomit shortly after taking the medicine, do not take another capsule until your next regularly scheduled dose.
Do not use an open capsule. If the medicine from a broken pill gets in your mouth, eyes, or nose, or on your skin, wash with soap and water (or rinse eyes with water). Ask your pharmacist how to safely dispose of a broken pill.
You may be given medication to prevent nausea or other side effects while you are receiving Temcad.
Your blood will need to be tested often and your dose or medication schedule may be changed based on the results.
Your liver function may also need to be checked during treatment and for 2 to 4 weeks after you stop using this medicine.
Store Temcad capsule at room temperature away from moisture and heat.
Detailed Temcad dosage information
Uses of Temcad in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Anaplastic astrocytoma (refractory): Treatment of refractory anaplastic astrocytoma in adults who have experienced disease progression on a regimen containing a nitrosourea and procarbazine.
Glioblastoma (newly diagnosed): Treatment of newly diagnosed glioblastoma in adults (initially in combination with radiotherapy, then as maintenance treatment).
Off Label Uses
Anaplastic gliomas
Data from a randomized phase 3 study support the use of Temcad in the management of newly diagnosed anaplastic gliomas.
Temcad description
Temcad (Temodar and Temcad) is an oral alkylating agent used for the treatment of refractory anaplastic astrocytoma -- a type of cancerous brain tumor. Temcad is not active until it is converted at physiologic pH to the active form, 5-(3-methyltriazen-1-yl)imidazole-4-carboxamide (MTIC).
Temcad dosage
Recommended Dosing and Dose Modification Guidelines
The recommended dose for Temcad as an intravenous infusion over 90 minutes is the same as the dose for the oral capsule formulation. Bioequivalence has been established only when Temcad for injection was given over 90 minutes. Dosage of Temcad must be adjusted according to nadir neutrophil and platelet counts in the previous cycle and the neutrophil and platelet counts at the time of initiating the next cycle. For Temcad dosage calculations based on body surface area (BSA) see Table 5. For suggested capsule combinations on a daily dose see Table 6.
Patients with Newly Diagnosed High Grade Glioma:
Concomitant Phase:
Temcad is administered at 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions) followed by maintenance Temcad for 6 cycles. Focal RT includes the tumor bed or resection site with a 2- to 3-cm margin. No dose reductions are recommended during the concomitant phase; however, dose interruptions or discontinuation may occur based on toxicity. The Temcad dose should be continued throughout the 42-day concomitant period up to 49 days if all of the following conditions are met: absolute neutrophil count greater than or equal to 1.5 × 109 /L, platelet count greater than or equal to 100 × 109/L, common toxicity criteria (CTC) nonhematological toxicity less than or equal to Grade 1 (except for alopecia, nausea, and vomiting). During treatment a complete blood count should be obtained weekly. Temcad dosing should be interrupted or discontinued during concomitant phase according to the hematological and nonhematological toxicity criteria as noted in Table 1. Pneumocystis pneumonia (PCP) prophylaxis is required during the concomitant administration of Temcad and radiotherapy, and should be continued in patients who develop lymphocytopenia until recovery from lymphocytopenia (CTC Grade less than or equal to 1).
Table 1: Temcad Dosing Interruption or Discontinuation During Concomitant Radiotherapy and Temcad
TMZ=Temcad; CTC=Common Toxicity Criteria.
*
Treatment with concomitant TMZ could be continued when all of the following conditions were met: absolute neutrophil count greater than or equal to 1.5 x 109/L; platelet count greater than or equal to 100 x 109/L; CTC nonhematological toxicity less than or equal to Grade 1 (except for alopecia, nausea, vomiting).
Toxicity
TMZ Interruption*
TMZ Discontinuation
Absolute Neutrophil Count
greater than or equal to
0.5 and <1.5 × 109/L
less than 0.5 × 109/L
Platelet Count
greater than or equal to
10 and <100 × 109/L
less than 10 × 109/L
CTC Nonhematological Toxicity
(except for alopecia, nausea, vomiting)
CTC Grade 2
CTC Grade 3 or 4
Maintenance Phase:
Cycle 1:
Four weeks after completing the Temcad+RT phase, Temcad is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.
Cycles 2–6:
At the start of Cycle 2, the dose can be escalated to 200 mg/m2, if the CTC nonhematologic toxicity for Cycle 1 is Grade less than or equal to 2 (except for alopecia, nausea, and vomiting), absolute neutrophil count (ANC) is greater than or equal to 1.5 × 109/L, and the platelet count is greater than or equal to 100 × 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.
Dose Reduction or Discontinuation During
Maintenance:
Dose reductions during the maintenance phase should be applied according to Tables 2 and 3.
During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose of Temcad) or within 48 hours of that day, and weekly until the ANC is above 1.5 × 109/L (1500/mcL) and the platelet count exceeds 100 × 109/L (100,000/mcL). The next cycle of Temcad should not be started until the ANC and platelet count exceed these levels. Dose reductions during the next cycle should be based on the lowest blood counts and worst nonhematologic toxicity during the previous cycle. Dose reductions or discontinuations during the maintenance phase should be applied according to Tables 2 and 3.
Table 2: Temcad Dose Levels for Maintenance Treatment
Dose Level
Dose (mg/m2/day)
Remarks
-1
100
Reduction for prior toxicity
0
150
Dose during Cycle 1
1
200
Dose during Cycles 2–6 in absence of toxicity
Table 3: Temcad Dose Reduction of Discontinuation During Maintenance Treatment
TMZ=Temcad; CTC=Common Toxicity Criteria
*
TMZ dose levels are listed in Table 2.
†
TMZ is to be discontinued if dose reduction to less than 100 mg/m2 is required or if the same Grade 3 nonhematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Toxicity
Reduce TMZ by 1 Dose Level*
Discontinue TMZ
Absolute Neutrophil Count
less than 1 × 109/L
See footnote†
Platelet Count
less than 50 × 109/L
See footnote†
CTC Nonhematological Toxicity
(except for alopecia, nausea, vomiting)
CTC Grade 3
CTC Grade 4†
Patients with Refractory Anaplastic Astrocytoma:
For adults the initial dose is 150 mg/m2 once daily for 5 consecutive days per 28-day treatment cycle. For adult patients, if both the nadir and day of dosing (Day 29, Day 1 of next cycle) ANC are greater than or equal to 1.5 × 109/L (1500/mcL) and both the nadir and Day 29, Day 1 of next cycle platelet counts are greater than or equal to 100 × 109/L (100,000/mcL), the Temcad 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 × 109/L (1500/mcL) and the platelet count exceeds 100 × 109/L (100,000/mcL). The next cycle of Temcad should not be started until the ANC and platelet count exceed these levels. If the ANC falls to less than 1 × 109/L (1000/mcL) or the platelet count is less than 50 × 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. Temcad therapy can be continued until disease progression. In the clinical trial, treatment could be continued for a maximum of 2 years, but the optimum duration of therapy is not known.
Table 4: Dosing Modification Table
Table 5: Daily Dose Calculations by Body Surface Area (BSA)
Total BSA
(m2)
75 mg/m2
(mg daily)
150 mg/m2
(mg daily)
200 mg/m2
(mg daily)
1
75
150
200
1.1
82.5
165
220
1.2
90
180
240
1.3
97.5
195
260
1.4
105
210
280
1.5
112.5
225
300
1.6
120
240
320
1.7
127.5
255
340
1.8
135
270
360
1.9
142.5
285
380
2
150
300
400
2.1
157.5
315
420
2.2
165
330
440
2.3
172.5
345
460
2.4
180
360
480
2.5
187.5
375
500
Table 6: Suggested Capsule Combinations Based on Daily Dose in Adults
Number of Daily Capsules by Strength (mg)
Total Daily Dose (mg)
250 mg
180 mg
140 mg
100 mg
20 mg
5 mg
75
0
0
0
0
3
3
82.5
0
0
0
0
4
0
90
0
0
0
0
4
2
97.5
0
0
0
1
0
0
105
0
0
0
1
0
1
112.5
0
0
0
1
0
2
120
0
0
0
1
1
0
127.5
0
0
0
1
1
1
135
0
0
0
1
1
3
142.5
0
0
1
0
0
0
150
0
0
1
0
0
2
157.5
0
0
1
0
1
0
165
0
0
1
0
1
1
172.5
0
0
1
0
1
2
180
0
1
0
0
0
0
187.5
0
1
0
0
0
1
195
0
1
0
0
0
3
200
0
1
0
0
1
0
210
0
0
0
2
0
2
220
0
0
0
2
1
0
225
0
0
0
2
1
1
240
0
0
1
1
0
0
255
1
0
0
0
0
1
260
1
0
0
0
0
2
270
1
0
0
0
1
0
280
0
0
2
0
0
0
285
0
0
2
0
0
1
300
0
0
0
3
0
0
315
0
0
0
3
0
3
320
0
1
1
0
0
0
330
0
1
1
0
0
2
340
0
1
1
0
1
0
345
0
1
1
0
1
1
360
0
2
0
0
0
0
375
0
2
0
0
0
3
380
0
1
0
2
0
0
400
0
0
0
4
0
0
420
0
0
3
0
0
0
440
0
0
3
0
1
0
460
0
2
0
1
0
0
480
0
1
0
3
0
0
500
2
0
0
0
0
0
Preparation and Administration
Temcad Capsules:
In clinical trials, Temcad was administered under both fasting and nonfasting conditions; however, absorption is affected by food, and consistency of administration with respect to food is recommended. There are no dietary restrictions with Temcad. To reduce nausea and vomiting, Temcad should be taken on an empty stomach. Bedtime administration may be advised. Antiemetic therapy may be administered prior to and/or following administration of Temcad.
Temcad Capsules should not be opened or chewed. They should be swallowed whole with a glass of water.
If capsules are accidentally opened or damaged, precautions should be taken to avoid inhalation or contact with the skin or mucous membranes.
Administration of Temcad with ranitidine did not result in alterations in the extent of absorption of Temcad. Administration with food resulted in a 33% decrease in Cmax and a 9% decrease in AUC. As the change in Cmax is clinically significant, Temcad should be administered before food. Co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2-receptor antagonists or phenobarbital did not alter clearance of Temcad. Co-administration with valproic acid was associated with small but statistically significant decrease in clearance of Temcad.
Use of Temcad in combination with other myelosuppressive agents may increase the likelihood of myelosuppression.
As well as its needed effects, Temcad may cause unwanted side effects that require medical attention.
Major Side Effects
If any of the following side effects occur while taking Temcad, check with your doctor immediately:
Less common or rare:
Amnesia
black, tarry stools
blood in the urine or stools
convulsions
cough or hoarseness
fever or chills
lower back or side pain
muscle weakness or paralysis on one or both sides of the body
painful or difficult urination
pinpoint red spots on the skin
swelling of the feet or lower legs
unusual bleeding or bruising
Incidence not known:
Abdominal or stomach pain or tenderness
blistering, peeling, or loosening of the skin
chest pain
clay colored stools
cough
decreased appetite
diarrhea
difficulty swallowing
dizziness
fast heartbeat
headache
hives, itching, or skin rash
joint or muscle pain
nausea or vomiting
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red skin lesions, often with a purple center
red, irritated eyes
sneezing
sore throat
sores, ulcers, or white spots in the mouth or on the lips
tightness in the chest
troubled breathing
unusual tiredness or weakness
yellow skin or eyes
Minor Side Effects
Some Temcad side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
Patients who have a history of hypersensitivity reaction to the components of Temcad or to dacarbazine (DTIC). Patients with severe myelosuppression.
Use in pregnancy & lactation: There are no studies in pregnant women. In preclinical studies in rats and rabbits administered 150 mg/m2, teratogenicity and/or foetal toxicity were demonstrated. Temcad, therefore, should not normally be administered to pregnant women. If use during pregnancy must be considered, the patient should be apprised of the potential risks to the foetus.
Women of childbearing potential should be advised to avoid pregnancy while they are receiving Temcad and for the 6 months after discontinuation of Temcad therapy. It is not known whether Temcad is excreted in human milk; thus, it should not be used by a nursing woman.
Male Patients: Effective contraception should also be used by male patients taking Temcad. Temcad can have genotoxic effects. Therefore, men being treated with Temcad are advised not to father a child during and up to 6 months after treatment and to seek advice on cryoconservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Temcad.
DailyMed. "TEMOZOLOMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Temcad are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Temcad. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
User reports
Consumer reported useful
No survey data has been collected yet
Consumer reported price estimates
No survey data has been collected yet
Consumer reported time for results
No survey data has been collected yet
3 consumers reported age
Users
%
> 60
1
33.3%
46-60
1
33.3%
30-45
1
33.3%
Consumer reviews
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