Patient Medication Information: uses, side effects, how to take - ACH-Temozolomide (Accord Healthcare, 20 mg, ..., 5 mg)
What is ACH-TEMOZOLOMIDE used for?
ACH-TEMOZOLOMIDE is used to treat adults with:
Gliobastoma multiforme that:
- was recently diagnosed. These patients will also be treated with radiation.
- that has come back or gotten worse after other treatment.
- Anaplastic astrocytoma that has come back or gotten worse after other treatment.
How does ACH-TEMOZOLOMIDE work?
ACH-TEMOZOLOMIDE is an antitumor agent. It acts on cancer cells. Normal cells may also be affected which may lead to side effects.
What are the ingredients in ACH-TEMOZOLOMIDE?
Medicinal ingredient: temozolomide
Non-medicinal ingredients: colloidal anhydrous silicon dioxide, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid; capsule shells contain gelatin and, titanium dioxide and branded with black printing ink consisting of shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and 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.
ACH-TEMOZOLOMIDE comes in the following dosage forms?
Capsules: 5 mg (white body with green cap), 20 mg (white body with yellow cap), 100 mg (white body with pink cap), 140 mg (white body with transparent blue cap), or 250 mg (white body with white cap).
Serious Warnings and Precautions
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Do not use ACH-TEMOZOLOMIDE if:
- you are allergic to temozolomide or to any other ingredients in this medicine.
- you have had an allergic reaction to dacarbazine (DTIC), another drug used to treat cancer.
- you have low blood cell counts (severe myelosuppression).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ACH-TEMOZOLOMIDE. Talk about any health conditions or problems you may have, including if you:
- have liver problems.
- have kidney problems.
- have or have had hepatitis B infection. This is because patients who have had hepatitis B in the past, might have a repeat attack after treatment with ACH-TEMOZOLOMIDE.
- have other diseases or conditions.
- have an infection including herpes simplex encephalitis (inflammation of the brain).
- are over 70 years of age.
- are also taking steroid medicines.
Other warnings you should know about:
Nausea and vomiting are very common with the use of ACH-TEMOZOLOMIDE. For this reason, your healthcare professional may recommend that you also take medicines to treat and prevent these side effects. Your healthcare professional will tell you the best time to take ACH-TEMOZOLOMIDE until the vomiting is under control.
Female patients – pregnancy and breastfeeding:
- If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your healthcare professional.,
- You should not use ACH-TEMOZOLOMIDE if you are pregnant. It may harm your unborn baby.
- Avoid becoming pregnant while you are taking ACH-TEMOZOLOMIDE and for 6 months after your last dose.
- Use effective birth control during your treatment for 6 months after your last dose.
- Tell your healthcare professional right away if you become pregnant or think you may be pregnant during your treatment with ACH-TEMOZOLOMIDE.
- Do not breastfeed while you are taking ACH-TEMOZOLOMIDE. It is not known if it passes into breastmilk.
Male patients – pregnancy and fertility:
- Avoid fathering a child while you are taking ACH-TEMOZOLOMIDE and for at least 6 months after your last dose. Use effective birth control during your treatment.
- Taking ACH-TEMOZOLOMIDE may affect your ability to father a child (your fertility). This may be permanent. If you want to have a child in the future, you may want to preserve some semen. Talk to your healthcare professional if you have questions about this.
Driving and using machines: Do not drive or use machines until you know how you react to ACH-TEMOZOLOMIDE.
Pneumocystis carinii: This type of severe pneumonia has been seen when ACH-TEMOZOLOMIDE is used with radiation. If you will receive ACH-TEMOZOLOMIDE for the 42 day treatment regimen, your healthcare professional will also give you medicines to prevent Pneumocystis carinii.
Blood tests: Your healthcare professional will do blood tests before and during your treatment. The results of these tests will tell them how ACH-TEMOZOLOMIDE is affecting your blood and liver.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with ACH-TEMOZOLOMIDE:
- A medicine used to treat seizures called valproic acid.
- Other chemotherapy drugs used to treat cancer such as bendamustine, carboplatin and cisplatin.
How to take ACH-TEMOZOLOMIDE:
Take ACH-TEMOZOLOMIDE:
- exactly as your healthcare professional has told you. If you are not sure, ask your doctor, nurse or pharmacist.
on an empty stomach, at least one hour before a meal.
- Swallow the capsule (s) whole with a glass of water. Do not open or chew the capsule.
- Avoid contact with your skin, eyes, and nose.
- You may also be given other medicines to prevent nausea and vomiting.
Usual dose: The dose of ACH-TEMOZOLOMIDE will be different for each adult. Your doctor will determine the dose of ACH-TEMOZOLOMIDE that is right for you. It will be based on your height and weight (m2), your disease and whether you have had previous treatment.
Your doctor will tell you how much ACH-TEMOZOLOMIDE to take. They will also tell you when to take it and for how long.
Overdose:
| If you think you, or a person you are caring for, have taken too much ACH-TEMOZOLOMIDE, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you miss a dose, or vomit after taking a dose, contact your doctor for instructions.
What are possible side effects from using ACH-TEMOZOLOMIDE?
These are not all the possible side effects you may have when taking ACH-TEMOZOLOMIDE. If you experience any side effects not listed here, tell your healthcare professional.
- Hair loss
- Fatigue
- Shortness of breath
- Chills
- Nausea (feeling sick)
- Inflamed and sore mouth
- Constipation
- Change in taste
- Headache
- Fever
- Cough
- Muscle weakness
- Sleepiness
- Trouble sleeping
- Trouble hearing
- Dizziness
- Tremor
- Tingling sensation
- Anxiety
- Depression
- Changes in emotions
- Pain, pain in the joints, abdominal pain
- Itching
- Dry skin
- Skin redness
- Difficulty speaking
- Damage to the skin or tissue under the skin from radiation
ACH-TEMOZOLOMIDE can cause abnormal blood test results. Your healthcare professional will monitor your blood regularly for any changes. They will decide if any specific treatment is needed. In some cases, your ACH-TEMOZOLOMIDE dose will be reduced or discontinued.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||||
|---|---|---|---|---|---|---|---|
| Only if severe | In all cases | ||||||
| VERY COMMON | |||||||
| Blurred vision | √ | ||||||
| Loss of appetite | √ | ||||||
Myelosuppression (low blood cell counts): Anemia (low red blood cells): shortness of breath, feeling very tired, loss of energy, weakness, irregular heartbeat, pale complexion. Neutropenia (low white blood cells): fever, fatigue, aches, pains, flu-like symptoms Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness | √ | ||||||
| Rash | √ | ||||||
| Vomiting | √ | ||||||
| COMMON | |||||||
| Allergic Reaction: difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, hives or rash, | √ | ||||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||||
|---|---|---|---|---|---|---|---|---|
| Only if severe | In all cases | |||||||
| swelling of the face, lips, tongue or throat | ||||||||
| Bleeding: seizures, loss of consciousness, severe headache, tingling, weakness, numbness or paralysis of face, arm or leg, vomiting up blood, black and tarry stool, bleeding from the rectum, abdominal pain, blood in urine | √ | |||||||
| Confusion | √ | |||||||
| Convulsion | √ | |||||||
| Diarrhea | √ | |||||||
| Hyperglycemia: (high blood sugar): increased thirst, frequent urination, dry skin, headache, blurred vision and fatigue | √ | |||||||
| Infection: fever, chills, cough | √ | |||||||
| Loss of weight | √ | |||||||
| Memory problems | √ | |||||||
| Pneumocystis carinii pneumonia (severe infection of the lungs caused by fungus): cough that does not go away, trouble breathing, and fever | √ | |||||||
| UNCOMMON | ||||||||
| Severe allergic reactions: hives, itching, flushed or pale skin, low blood pressure, swollen tongue or throat, wheezing, difficulty breathing, weak and rapid heartbeat, nausea, vomiting, diarrhea, dizziness, fainting | √ | |||||||
| UNKNOWN FREQUENCY | ||||||||
| Aplastic anemia (body stops producing enough new blood cells): fatigue, pale skin, shortness of breath, rapid heart beat, fever, bleeding | √ | |||||||
| Cytomegalovirus infection (viral infection that is new or becomes active again): fatigue, fever, sore throat, muscle aches, swollen glands | √ | |||||||
| Drug reaction with eosinophilia and systemic symptoms (DRESS; serious skin reaction that may affect one or more organs): fever, severe rash, peeling skin, swelling of the face and lymph glands, flu-like feeling, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feel thirsty, urinating less often, less urine | √ | |||||||
| Erythema multiforme (serious skin reaction): rash with skin swelling, including on the | √ | |||||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||
|---|---|---|---|---|---|---|
| Only if severe | In all cases | |||||
| palms of the hands and soles of the feet | ||||||
| Herpes simplex encephalitis (inflammation of the brain): fever, headache, personality change, seizures, and/or vomiting, which may be life threatening. | √ | |||||
| Interstitial pneumonitis (scarring of the lung): shortness of breath, cough | √ | |||||
| Liver problems including jaundice, hepatitis and liver failure: loss of appetite, abdominal pain, yellowing of the whites of they eyes, skin and tongue (jaundice), may be life threatening | √ | |||||
| Myelodysplastic syndrome or other cancers including myeloid leukemia: fatigue, pale skin, easy or unusual bruising, bleeding, shortness of breath, weight loss, fever, loss of appetite, tiny red spots on your skin | √ | |||||
| Serious skin reactions including Toxic epidermal necrolysis and Stevens-Johnson syndrome: painful reddening of the skin and/or blister on the body or the mouth | √ | |||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
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Storage:
Store between 15°C and 30°C. Protect from moisture.
Do not use this product after the expiration date on the package.
Keep out of reach and sight of children.
Tell your pharmacist if you notice any change in the appearance of the capsules.
If you want more information about ACH-TEMOZOLOMIDE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.accordhealth.ca or by calling the sponsor Accord Healthcare Inc. at 1-866-296-0354.
Accord Healthcare Inc.
3535 Boulevard St-Charles, Suite 704
Kirkland, Quebec H9H 5B9
Canada