Temodal

Temodal Medication Information:

Price Break On Temodal
Generic is available for less money: Generic Temozolomide

Temodal medication comes in several different strengths; click on the strength you need to view prices from pharmacies competing to earn your business.

Temodal 5 mg
Temodal 20 mg
Temodal 100 mg
Temodal 250 mg

About Temodal

What Temodal is used for

  • TEMODAL capsules are used to treat newly diagnosed adult patients with a specific form of brain tumor (glioblastoma multiforme (GBM)) in a combination treatment with radiation.

  • TEMODAL capsules are used to treat adult patients with recurrent brain tumours. A recurrent tumour is a tumour that has returned.

What Temodal 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:).

When Temodal 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 some components of your blood are severely reduced.

  • If you are pregnant. TEMODAL should not be used by a woman who is pregnant or breast feeding a baby. Both male and female patients should use effective contraceptive precautions while taking TEMODAL and up to six months after stopping treatment (See Warnings and Precautions:).

What the medicinal ingredient is

TEMODAL medicinal ingredient is temozolomide.

What the nonmedicinal ingredients for Temodal are

Nonmedicinal 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. 180 mg capsule shells also contain yellow and red iron oxides.

What dosage forms Temodal 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), 180 mg (opaque white body with opaque orange cap), or 250 mg (opaque white body with opaque white cap) temozolomide.


Warnings and Precautions

BEFORE you use TEMODAL talk to your doctor or pharmacist if:

  • If you have anemia (low blood count) or blood clotting problems, your doctor will decide whether any change in your treatment is needed.

  • If you vomit frequently.

  • In Male Patients: TEMODAL can have genotoxic effects which means that it may damage the genetic material contained in your sperm and cause birth defects. Effective contraception should be used by male patients taking TEMODAL. Men being treated with TEMODAL are advised not to father a child during or up to 6 months after treatment and to seek advice on cryoconservation (this is a laboratory technique which involves freezing) of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with TEMODAL.

  • Ask your doctor if it is safe for you to drive and operate machinery.


Interactions with Temodal

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 Temodal

INFORMATION NECESSARY BEFORE TAKING TEMODAL:

IN CASE YOU HAVE ANY QUESTIONS ABOUT THIS MEDICINE IT IS IMPORTANT THAT YOU ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.

EACH TIME YOU START A NEW CYCLE TREATMENT, BE SURE YOU UNDERSTAND EXACTLY HOW MANY CAPSULES OF EACH STRENGTH YOU NEED TO TAKE EACH DAY OF DOSING.

IMPORTANT: Note that before each new cycle of your treatment, your blood will be tested and your dose of medicine may change. In some cases, it may be necessary to stop treatment with TEMODAL. Sometime the dose or mix of capsules you need to take will be different from the last cycle.

TEMODAL comes in different strength capsules (shown on the outer label in mg). Each strength has a different colour band. Depending on the dose of TEMODAL that your doctor prescribes, you may have to take several capsules on each dosing day of the treatment cycle (Day 1 through Day 5, followed by 23 days with no capsules).

  • Each time you start a new treatment be sure you understand exactly how many capsules of each strength you need to take each day of dosing.

  • Once you take the medicine home, if you are confused about how to take the dose, call for re-instructions before beginning your treatment cycle.

  • Be sure you know exactly which days are your dosing day. Marking them down on a calendar will help you.

  • Be sure you review the dose with your healthcare provider each time you start a new cycle. ERRORS IN HOW YOU TAKE THE MEDICINE MAY HAVE SERIOUS HEALTH CONSEQUENCES.

Usual dose

How to take TEMODAL?

Your doctor will determine the correct dose of TEMODAL for you to take, based on your size (height and weight) and whether you have had chemotherapy treatment. You may be given other medication to take before and/or after TEMODAL to avoid or control nausea.

Take your prescribed dose of TEMODAL once a day for five days or once a day for 42 days with radiotherapy. Make sure you understand the schedule of dosing. Do not open or chew the capsules. Swallow the capsule(s) whole with a glass of water.

If a capsule is damaged, avoid contact with your skin, eyes or nose. Avoid inhaling the powder. If you accidentally get some in your eyes or nose, flush the area with water.

Although TEMODAL is not affected by food, take your dose preferably before your first food of the day or at least one hour before or after you eat. This will help you lessen nausea or vomiting.

There are 2 dosing schedules.

Patients with a New Diagnosis of GBM

One schedule with concomitant phase followed by a maintenance phase. In the first part of your treatment during the concomitant phase, TEMODAL (temozolomide) is prescribed for 42 days (up to 49 days) with radiotherapy. In this phase you will complete your radiotherapy. Your blood will be tested weekly and your treatment maybe interrupted depending on how you tolerate the medicine. After 42 days period, your treatment will be interrupted for 4 weeks to give your body a chance to recover. You will also receive a treatment to prevent a certain kind of pneumonia during this phase.

Then, you will start the next phase of treatment (“maintenance phase”) and your TEMODAL dose will change. In this phase, there are 6 treatment cycles (duration approximately 6 months). Each treatment cycle lasts 28 days. You will take your new dose of TEMODAL capsules once daily for the first five days (“dosing days”) of each cycle, followed by 23 days without TEMODAL; this adds up to a 28 day treatment cycle. After day 28, the next cycle will begin, in which you will again take this medicine once daily for five days followed by 23 days without TEMODAL. Before each new treatment cycle begins, your blood will be tested to determine if the TEMODAL dose needs to be adjusted.

Other Schedule for Patients with Recurrent Disease

In the other schedule a new treatment cycle will begin each 28 days. A treatment cycle with TEMODAL comprises 28 days. You will take the capsules once daily for the first five days (“dosing days”) followed by 23 days without TEMODAL, adding up to the 28 day treatment cycle. After day 28, the next cycle will begin, in which you will again take this medicine once daily for five days followed by 23 days without TEMODAL. The dose will depend upon your tolerance during the previous cycle and the results of your blood test.

Overdose

TEMODAL should be taken only as prescribed for you. If you take more capsules that you were told to, advise your doctor or pharmacists immediately. If you are not able to contact them, go to the nearest hospital emergency department for medical help. ERRORS IN HOW YOU TAKE THE MEDICINE MAY HAVE SERIOUS HEALTH CONSEQUENCES.

Missed dose

Take the missed dose as soon as possible during the same day. If a full day has gone by, check with your doctor. Do not double the next dose unless your doctor tells you to do so.

If vomiting occurs after the dose is taken or administered a second dose should not be taken that day.


Side Effects for Temodal and What to Do About Them

Like all medicines, TEMODAL can have side effects.

Contact your doctor immediately if you have severe allergic reaction (which may include hives, wheezing or other breathing difficulty).

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). 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 taking 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). There may be a higher occurrence of PCP when TEMODAL is administered during a longer dosing regimen. However, all patients receiving TEMODAL, particularly patients receiving steroids, should be observed closely for the development of PCP, regardless of the regimen.

The following side effects may occur and medical attention may be required: nausea (feeling sick), vomiting, tiredness, constipation, headache, loss of appetite or weight, diarrhea, sleepiness, fever, cough, rash, weakness, pain, confusion/memory impairment, convulsion, dizziness, blurred vision, dizziness, shortness of breath, upset stomach, hair loss, chills, itching, feeling unwell, change in taste, tingling sensation, and abnormal blood values.

In case of vomiting, ask your doctor about controlling the vomiting, and the best time to take TEMODAL until the vomiting is under control.

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.

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 call your doctor or pharmacist
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)    
Uncommon 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)    

This is not a complete list of side effects. For any unexpected effects while taking TEMODAL, contact your doctor or pharmacist.


 

Technical Information