Details for: TARO-TEMOZOLOMIDE
Company: TARO PHARMACEUTICALS INC
|DIN||DIN name||Active Ingredient(s)||Strength||Dosage Form||Route of Administration|
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
- Taro-Temozolomide 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.
- Taro-Temozolomide alone is used in the treatment of adult patients with recurrent or progressive GBM or anaplastic astrocytoma (AA) after standard therapy.
What it does
Taro-Temozolomide is an antitumor agent. TaroTemozolomide 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 Taro-Temozolomide (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
Taro-Temozolomide medicinal ingredient is temozolomide.
What the non-medicinal ingredients are
The Taro-Temozolomide Capsule’s non-medicinal ingredients:, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid; capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide.
5 mg capsule shells are imprinted with green printing ink consisting of shellac, propylene glycol, strong ammonia
Taro-Temozolomide (Temozolomide capsules)
solution, yellow iron oxide, FD&C blue #1 aluminium lake-E133.
20 mg capsule shells are imprinted with yellow printing ink consisting of shellac, propylene glycol, strong ammonia solution, yellow iron oxide.
100 mg capsule shells are imprinted with pink printing ink consisting of shellac, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, red iron oxide-E172, yellow iron oxideE172, FD&C blue #1 aluminium lake-E133, titanium dioxide-E171.
140 mg capsule shells are imprinted with blue printing ink consisting of shellac, propylene glycol, strong ammonia solution, titanium dioxide-E171, FD&C blue #1 aluminium lake-E133.
180 mg capsule shells are imprinted with red printing ink consisting of shellac, propylene glycol, strong ammonia solution, red iron oxide-E172.
250 mg capsule shells are imprinted with black printing ink consisting of shellac, propylene glycol, strong ammonia solution, black iron oxide-E172, potassium hydroxide, purified water.
What dosage form it comes in
Each Taro-Temozolomide capsule contains 5 mg (white opaque cap and body, imprinted in green ink), 20 mg (white opaque cap and body, imprinted in yellow ink), 100 mg (white opaque cap and body, imprinted in pink ink), 140 mg (white opaque cap and body, imprinted in blue ink), 180mg (white opaque cap and body, imprinted in red ink) or 250 mg (white opaque cap and body, imprinted in black ink) temozolomide. Taro-Temozolomide capsules are supplied in boxes of 1 bottle containing 5 or 20 capsules or in boxes of 1 or 4 blisters containing 5 capsules each.
Warnings and precautions
Serious Warnings and Precautions
Taro-Temozolomide should be prescribed by doctor experienced with the use of cancer drugs.
Taro-Temozolomide may cause a severe decrease in the production of blood cells which may be life threatening.
Taro-Temozolomide may cause liver problems which may be life threatening.
Nausea and vomiting are very common with the use of temozolomide.
Taro-Temozolomide combination with radiotherapy may cause severe pneumonia (Pneumocystis carinii).
BEFORE you use Taro-Temozolomide 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.
Taro-Temozolomide may cause harm to your unborn child, both male and female patients should use effective method of birth control while taking Taro-Temozolomide and for 6 months after the last dose of Taro-Temozolomide.
Male patients should also be advised that TaroTemozolomide may cause irreversible infertility.
Do not drive or use machines until you know how you react to Taro-Temozolomide.
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 Taro-Temozolomide based on your height and weight (m2 ). Take TaroTemozolomide as instructed by your doctor.
Taro-Temozolomide (Temozolomide capsules)
Newly diagnosed Glioblastoma Multiforme (GBM):
Concomitant with Radiotherapy: 75 mg/m2
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 Taro-Temozolomide is taken:
Taro-Temozolomide 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.
You may be given other medicines to prevent nausea and vomiting.
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, Taro-Temozolomide 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 Taro-Temozolomide 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
Taro-Temozolomide until the vomiting is under control.
Taro-Temozolomide 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 TaroTemozolomide dose will be reduced or discontinued.
If you are receiving Taro-Temozolomide 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 temozolomide. 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.
ADVISE YOUR DOCTOR OR PHARMACIST OF ANY UNDESIRABLE OR TROUBLESOME EFFECT NOT LISTED
|Symptom / effect||Talk with your doctor or pharmacist Only if severe||Talk with your doctor or pharmacist In all cases||Stop taking drug and call your doctor or pharmacist|
|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)||✔|
|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), StevensJohnson syndrome (SJS)]||✔|
|Shortness of breath and cough (interstitial pneumonitis)||✔|
|Jaundice and hepatitis. Liver injury, including liver failure which may be life threatening.||✔|
|Herpes simplex encephalitis (symptoms such as fever, headache, personality change, seizures, and / or vomiting) which may be life threatening.||✔|
This is not a complete list of side effects. For any unexpected effects while taking Taro-Temozolomide contact your doctor or pharmacist.
How to store
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 and sight of children
Tell your pharmacist if you notice any change in the appearance of the capsules.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-healthproducts/medeffect-canada/adverse-reactionreporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Taro Pharmaceutical Inc. This document plus the full product monograph, prepared for health professionals can be found at: http://www.taro.ca or by contacting the sponsor,
Taro Pharmaceuticals Inc.
130 East Drive, Brampton
Ontario L6T 1C1
Toll-free telephone: 1-800-268-1975
Imported and Distributed By:
Taro Pharmaceuticals Inc.
130 East Drive
Last revised: October 17, 2018