Patient Medication Information: uses, side effects, how to take - Apo-Temozolomide
ABOUT THIS MEDICATION
What the medication is used for:
APO-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.
APO-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:
APO-TEMOZOLOMIDE is an antitumor agent. APO-TEMOZOLOMIDE 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 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:
APO-TEMOZOLOMIDE medicinal ingredient is temozolomide.
What the non-medicinal ingredients are:
APO-TEMOZOLOMIDE Capsule’s non-medicinal ingredients: colloidal silicon dioxide, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid.
The empty capsule shells contain the non-medicinal ingredients FD&C Blue No. 2 (5 mg, 140 mg), gelatin, iron oxide red (100 mg, 180 mg), iron oxide yellow (5 mg, 20 mg, 180 mg), talc and titanium dioxide.
The capsule shells are imprinted with black edible ink containing ammonium hydroxide, iron oxide black, isopropyl alcohol, N-Butyl alcohol, propylene glycol and shellac glaze.
What dosage forms it comes in:
APO-TEMOZOLOMIDE 5 mg Capsules: Each white opaque body, green opaque cap, hard gelatin capsule, imprinted “APO TEM 5” in black ink, white to light pink powder fill, contains 5 mg of temozolomide. Available in bottles of 5 and 20, and unit dose sachets of 1 capsule (5 or 20 sachets per box).
APO-TEMOZOLOMIDE 20 mg Capsules: Each white opaque body, gold opaque cap, hard gelatin capsule, imprinted “APO TEM 20” in black ink, white to light pink powder fill, contains 20 mg of temozolomide. Available in bottles of 5 and 20, and unit dose sachets of 1 capsule (5 or 20 sachets per box).
APO-TEMOZOLOMIDE 100 mg Capsules: Each white opaque body, flesh opaque cap, hard gelatin capsule, imprinted “APO TEM 100” in black ink, white to light pink powder fill, contains 100 mg of temozolomide. Available in bottles of 5 and 20, and unit dose sachets of 1 capsule (5 or 20 sachets per box).
APO-TEMOZOLOMIDE 140 mg Capsules: Each white opaque body, blue transparent cap, hard gelatin capsule, imprinted “APO TEM 140” in black ink, white to light pink powder fill, contains 140 mg of temozolomide. Available in bottles of 5 and 20, and unit dose sachets of 1 capsule (5 or 20 sachets per box).
APO-TEMOZOLOMIDE 180 mg Capsules: Each white opaque body, swedish orange opaque cap, hard gelatin capsule, imprinted “APO TEM 180” in black ink, white to light pink powder fill, contains 180 mg of temozolomide. Available in bottles of 5 and 20, and unit dose sachets of 1 capsule (5 or 20 sachets per box).
APO-TEMOZOLOMIDE 250 mg Capsules: Each white opaque body, white opaque cap, hard gelatin capsule, imprinted “APO TEM 250” in black ink, white to light
pink powder fill, contains 250 mg of temozolomide. Available in bottles of 5 and unit dose sachets of 1 capsule (5 or 20 sachets per box).
WARNINGS AND PRECAUTIONS
Nausea and vomiting are very common with the use of APO-TEMOZOLOMIDE.
APO-TEMOZOLOMIDE combination with radiotherapy may cause severe pneumonia (Pneumocystis carinii).
BEFORE you use APO-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.
APO-TEMOZOLOMIDE may cause harm to your unborn child, both male and female patients should use effective method of birth control while taking APO-
TEMOZOLOMIDE and for 6 months after the last dose of
APO-TEMOZOLOMIDE.
Male patients should also be advised that APO-TEMOZOLOMIDE may cause irreversible infertility.
Do not drive or use machines until you know how you react to APO-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 APO-TEMOZOLOMIDE based on your height and weight (m2). Take APO-TEMOZOLOMIDE as instructed by your doctor.
Usual dose:
Adult Dose:
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 APO-TEMOZOLOMIDE is taken:
APO-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, divide, crush or chew the capsule.
Avoid contact with your skin, eyes, and nose.
You may be given other medicines to prevent nausea and vomiting.
Serious Warnings and Precautions
APO-TEMOZOLOMIDE should be prescribed by doctor experienced with the use of cancer drugs.
APO-TEMOZOLOMIDE may cause a severe decrease in the production of blood cells which may be life threatening.
APO-TEMOZOLOMIDE may cause liver problems which may be life threatening.
Overdose:
If you think you have taken too much APO-TEMOZOLOMIDE contact your health care professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
APO-TEMOZOLOMIDE 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, APO-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 APO-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 APO-TEMOZOLOMIDE until the vomiting is under control.
APO-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 APO-TEMOZOLOMIDE dose will be reduced or discontinued.
If you are receiving APO-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 APO-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.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and get immediate medical help | ||
| Only if severe | In all cases | |||
Very Common | Blurred vision Loss of appetite Rash Vomiting | √ √ √ √ | ||
| Common | Confusion Convulsion Diarrhea Fever, other signs of infection (such as fever, chills, cough) Increased bruising or bleeding Loss of weight Memory impairment Pneumocystis carinii pneumonia (symptoms such as cough that does not go away, trouble breathing, and fever) | √ √ √ √ √ √ √ √ | ||
Un- common | Severe allergic reactions including: hives, wheezing or other breathing difficulty | √ |
| Unknown | 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. 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 APO-TEMOZOLOMIDE, contact your doctor or pharmacist.
HOW TO STORE IT
APO-TEMOZOLOMIDE Capsules:
Do not use this product after the expiration date on the package.
Store at room temperature 15°C to 30°C. Protect from moisture.
Keep out of 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/health-canada/services/drugs-health-
products/medeffect-canada/adverse-reaction-reporting.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.
MORE INFORMATION
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at:
1-800-667-4708
This leaflet can also be found at:
http://www.apotex.ca/products.