Temodal - Consumer Medicine Information
|Manufacture:||Merck and Co., Inc.|
|Condition:||Anaplastic Astrocytoma, Glioblastoma Multiforme|
|Ingredients:||temozolomide, colloidal silicon dioxide, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid; capsule shells contain gelatin, sodium lauryl sulphate and titanium dioxide and are branded with black printing ink consisting of shellac, propylene glycol, ammonium hydroxide, black iron oxide and sometimes potassium hydroxide.|
About this Medication
What the Medication is Used For
- TEMODAL in combination with radiotherapy is used in the treatment of adult patients with newly diagnosed glioblastoma multiforme (GBM) (a form of brain tumor) and then as maintenance therapy.
- TEMODAL alone is used in the treatment of adult patients with recurrent or progressive GBM or anaplastic astrocytoma (AA) after standard therapy.
What it Does
TEMODAL is an antitumor agent. TEMODAL acts on cancer cells. Normal cells may also be affected which may lead to side effects (see Warnings and Precautions section).
When it Should not be Used
This medicine should not be used:
- If you are allergic to TEMODAL (temozolomide) or to any of its ingredients.
- If you have had an allergic reaction to dacarbazine (DTIC), another drug used to treat cancer.
- If you have low blood cell counts (severe myelosuppression).
What the Medicinal Ingredient Is
TEMODAL medicinal ingredient is temozolomide.
What the Nonmedicinal Ingredients Are
The TEMODAL Capsule’s non-medicinal ingredients: colloidal silicon dioxide, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid; capsule shells contain gelatin, sodium lauryl sulphate and titanium dioxide and are branded with black printing ink consisting of shellac, propylene glycol, ammonium hydroxide, black iron oxide and sometimes potassium hydroxide. 5 mg capsule shells also contain FD & C blue no. 2 and yellow iron oxide. 20 mg capsule shells also contain yellow iron oxide. 100 mg also contains red iron oxide. 140 mg capsule shells also contain FD & C blue no. 2.
The TEMODAL Powder for Solution for Injection’s non-medicinal ingredients are: mannitol, L-threonine, polysorbate-80, sodium citrate dihydrate, and hydrochloric acid.
What Dosage Form it Comes In
Each TEMODAL capsule contains 5 mg (opaque white body with opaque green cap), 20 mg (opaque white body with yellow cap), 100 mg (opaque white body with opaque pink cap), 140 mg (opaque white body with blue cap) or 250 mg (opaque white body with opaque white cap) temozolomide. TEMODAL capsules are supplied in boxes of 5 or 20 sachets containing 1 capsule each.
TEMODAL Powder for Solution for Injection is available as 100 mg powder in single use glass vial, which once reconstituted one mL of TEMODAL, contains 2.5 mg of temozolomide.
Warnings and Precautions
Serious Warnings and Precautions
TEMODAL should be prescribed by doctor experienced with the use of cancer drugs.
TEMODAL may cause a severe decrease in the production of blood cells which may be life threatening.
TEMODAL may cause liver problems which may be life threatening.
Nausea and vomiting are very common with the use of TEMODAL.
TEMODAL combination with radiotherapy may cause severe pneumonia (Pneumocystis carinii).
BEFORE you use TEMODAL talk to your doctor or pharmacist if you:
- have liver problems,
- have kidney problems,
- have a history of hepatitis B or current hepatitis B infection,
- are pregnant or planning to become pregnant,
- are breast feeding, or
- plan to father a child (or seek advice on cryoconservation, a laboratory technique which involves freezing of sperm).
In some cases, patients who have had hepatitis B might have a repeat attack of hepatitis. Tell the doctor if you think you have had hepatitis B in the past.
Infection with hepatitis B virus causes inflammation of the liver which may show as mild fever, feeling of sickness, fatigue, loss of appetite, joint and/or abdominal pain and yellowing of whites of the eyes, skin and tongue. If you experience any of these symptoms immediately contact your doctor.
TEMODAL may cause harm to your unborn child, both male and female patients should use effective method of birth control while taking TEMODAL and for 6 months after the last dose of TEMODAL.
Male patients should also be advised that TEMODAL may cause irreversible infertility.
Do not drive or use machines until you know how you react to TEMODAL.
Interactions With This Medication
To avoid the possibility of one drug affecting another drug, be sure to advise your doctor or pharmacist of any other medications you are taking. Valproic Acid is an example of such drug interaction.
Proper Use of This Medication
Your doctor will determine the dose of TEMODAL based on your height and weight (m2). Take TEMODAL as instructed by your doctor.
Newly diagnosed Glioblastoma Multiforme (GBM)
Concomitant with Radiotherapy: 75 mg/m2 daily for 42 days (up to 49 days).
Maintenance phases: 150 mg/m2 daily for 5 days for the first cycle, then 200 mg/m2 daily for cycle 2 to 6 if tolerated (a cycle equals 28 days).
GBM or anaplastic astrocytoma (AA) Recurrence or
Progression after Standard Therapy
Previously untreated with chemotherapy: 200 mg/m2 daily for 5 days every 4 weeks per 28 day cycle.
Previously treated with chemotherapy: 150 mg/m2 daily for 5 days for the first cycle to be increased in the second cycle to 200 mg/m2 once daily for 5 days, if no hematologic toxicity.
How TEMODAL is taken
TEMODAL Capsules are taken by mouth, on an empty stomach, at least one hour before a meal.
Swallow the capsule whole with a glass of water. Do not open or chew the capsule.
Avoid contact with your skin, eyes, and nose.
TEMODAL for injection is given through a vein over 90 minutes (intravenous infusion).
You may be given other medicines to prevent nausea and vomiting.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
TEMODAL Capsules: If you miss a dose, or vomit after taking a dose, contact your doctor for instructions.
Side Effects and What to do About Them
Like all medicines, TEMODAL can have unintended or undesirable, so called side effects.
Contact your doctor immediately if you have a severe allergic reaction (which may include hives, wheezing or other breathing difficulty).
Common side effects of TEMODAL during concomitant and maintenance treatment, in descending order of frequency, include: hair loss, fatigue, nausea (feeling sick), vomiting, loss of appetite or weight, constipation, headache, rash, diarrhoea, blurred vision, anemia (reduction in blood cells), fever, muscle weakness, and sleepiness.
In case of vomiting, ask your doctor about controlling the vomiting, and the best time to take TEMODAL until the vomiting is under control.
TEMODAL treatment can cause a reduction in certain kinds of blood cells. This may cause you to have increased bruising or bleeding, anemia, fever, and/or a reduced resistance to infections. The reduction of blood cells is usually transient, but in some cases may be prolonged, and may lead to a very severe form of anemia (aplastic anemia) which may be life threatening. Your doctor will monitor your blood regularly for any changes, and will decide if any specific treatment is needed. In some cases, your TEMODAL dose will be reduced or discontinued.
If you are receiving TEMODAL for the 42 day regimen, in combination with radiation treatment, your doctor will also prescribe medicine to help prevent a serious form of pneumonia called Pneumocystis carinii pneumonia (PCP).
Less common adverse events, in descending order of frequency, include: convulsions, inflammation of the mouth, cough, radiation injury, dizziness, change in taste, abnormal blood values, shortness of breath, confusion/memory impairment, itching, allergic reaction, insomnia, pain, joint pain, skin dryness, skin redness, abdominal pain, bleeding, chills, hearing impairment, speech disorder, tremor, infection, blood sugar elevation, anxiety, depression, emotional lability, and tingling sensation.
Cases of rash with skin swelling, including on the palms of the hands and soles of the feet, have been observed. Tell your doctor if this occurs.
Cases of lung side effects have been observed with TEMODAL. Patients usually present with shortness of breath and cough. Tell your doctor if you notice any of these symptoms.
Cases of painful reddening of the skin and/or blister on the body or the mouth, have been observed. Tell your doctor if you notice any of these symptoms.
The following may also occur with the use of TEMODAL Powder for Solution for Injection: pain, irritation, itching, warmth, swelling or redness at the injection site; also bruising has been observed.
ADVISE YOUR DOCTOR OR PHARMACIST OF ANY UNDESIRABLE OR TROUBLESOME EFFECT NOT LISTED.
Serious Side Effects, how Often They Happen and What to do About Them
|Symptom/effect||Talk with your doctor or pharmacist||Stop taking|
|Very Common||Blurred vision||✓|
|Loss of appetite||✓|
|Fever, other signs of infection (such as fever, chills, cough)||✓|
|Increased bruising or bleeding||✓|
|Loss of weight||✓|
|Pneumocystis carinii pneumonia (symptoms such as cough that does not go away, trouble breathing, and fever)||✓|
|Uncommon||Severe allergic reactions including: hives, wheezing or other breathing difficulty||✓|
|Rash with skin swelling, including on the palms of the hands and soles of the feet (erythema multiforme)||✓|
|Fatigue, pale skin, shortness of breath, rapid heart beat, fever, and bleeding (aplastic anemia)||✓|
|Painful reddening of the skin and/or blister on the body or the mouth [toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS)]||✓|
|Shortness of breath and cough (interstitial pneumonitis)||✓|
|Jaundice and hepatitis. Liver injury, including liver failure which may be life threatening.||✓|
This is not a complete list of side effects. For any unexpected effects while taking TEMODAL, contact your doctor or pharmacist.
How to Store It
Do not use this product after the expiration date on the package.
Store at room temperature between 15°C and 30°C. Protect from moisture.
Store out of the reach of children.
Tell your pharmacist if you notice any change in the appearance of the capsules.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffec Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
Also, you can report any suspected adverse reactions associated with the use of health products to Merck Canada Inc. by one of the following 2 ways:
- Call toll-free at 1-800-567-2594
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-877-428-8675, or
- Mail to: Merck Canada Inc.
Medical Information Center
16750 route Transcanadienne
Kirkland, QC H9H 4M7
This document plus the full product monograph, prepared for health professionals can be found at; www.merck.ca or by contacting the sponsor, Merck Canada Inc., at: 1-800-567-2594.