Temomedac 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg Temozolomide Hard Capsules
What Is Temomedac, And What Temomedac Used For?
Temomedac contains the medicine temozolomide. Temomedac used for tumors. This medicine is used to treat specific forms of brain tumors:
- In adults with newly diagnosed glioblastoma multiforme. Temomedac is first used together with radiation (concomitant treatment phase) and then alone (the monotherapy phase of treatment).
- In children over 3 years and adult patients with malignant gliomas, such as glioblastoma multiforme or anaplastic astrocytoma. This medicine is used for these tumors if they return or continue to develop after standard treatment.
What You Need To Know Before Taking Temomedac
Do Not Take Temomedac
- If you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6)
- If you have had an allergic reaction to dacarbazine (an anti-cancer medicine, sometimes called DTIC). Signs of an allergic reaction include:
- Feeling itchy
- Shortness of breath or wheezing
- Swelling of the face, lips, tongue, or throat
- If certain types of blood cells are greatly reduced (myelosuppression), such as the white blood cells or platelets. These blood cells are important when it comes to fighting infection and for functioning blood coagulation. Your doctor will check your blood to make sure you have enough of these blood cells before you start treatment.
Warnings And Precautions
Talk to your doctor, pharmacist, or nurse before taking Temomedac.
- Because you should be closely monitored for developing a serious form of pneumonia called Pneumocystis jirovecii pneumonia (PCP), if you have recently received your diagnosis ( glioblastoma multiforme ), you may receive Temomedac for 42 days in combination with radiation. If so, your doctor will also prescribe medication to help you prevent this type of pneumonia (PCP).
- If you have ever had or possibly now have hepatitis B infection. Temomedac can cause hepatitis B to become active again, and in some cases, this can lead to death. Patients will be carefully examined by their doctor for signs of this infection before starting treatment.
- If you have low numbers of red blood cells (anemia), white blood cells and platelets ( thrombocytes ), or blood clotting problems before starting treatment, or if you develop them during treatment. Your doctor may decide to lower the dose, stop it, or change treatment. You may also need other treatments. In some cases, it may be necessary to discontinue treatment with this medicine. Your blood will be tested regularly during treatment to monitor the side effects of Temomedac on your blood cells.
- As you may have a small risk of other blood cell changes, including leukemia,
- If you experience nausea and vomiting, which are very common side effects of Temomedac (see section 4), your doctor may prescribe medicine (an antiemetic ) to prevent vomiting.
- If you frequently vomit before and during treatment, ask your doctor when it is best to take Temomedac until the vomiting is under control. If you vomit after taking your dose, do not take a second dose on the same day.
- If you develop a fever or symptoms of an infection, contact your doctor immediately.
- If you are over 70, you may be more susceptible to infection, bruise, or bleeding more easily.
- If you have liver or kidney problems, your Temomedac dose may need to be adjusted.
Children And Young People
Do not give this medicine to children younger than 3 years because there is no experience. There is limited information on patients older than 3 years who have taken this medicine.
Other Medicines And Temomedac
Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines.
Pregnancy, Breastfeeding, And Fertility
If you are pregnant, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine. You should not be treated with Temomedac if you are pregnant unless your doctor tells you so.
Effective contraceptive methods must be used by female patients who may become pregnant during treatment with this medicine and for at least 6 months after stopping treatment. You should stop breastfeeding while receiving treatment with this medicine.
Male fertility:
Temomedac can cause permanent infertility. Male patients should use an effective method of contraception and not have children for at least 3 months after the end of treatment. It is recommended to consult about sperm freezing before starting treatment.
Driving Ability And Use Of Machinery:
This medicine may make you feel tired or sleepy. If this is the case, do not drive, use machinery, or cycle until you know how this medicine affects you (see section 4).
Temomedac Contains lactose
Temomedac contains lactose (a type of sugar). If you are intolerant to certain sugars, you should consult your doctor before taking this medication.
Temomedac contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e., it is almost ‘sodium-free.’
Additional information for Temomedac 20 mg hard capsules
The additive para-orange (E 110) found in the capsule shell can cause allergic reactions.
How To Take Temomedac?
- Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
- Dosage and duration of treatment
- Your doctor will determine the Temomedac dose. It is based on your body size (height and weight) and whether you have a recurrent tumor and have previously received chemotherapy.
- You may be prescribed other medicines (antiemetics) to be taken before and after you take this medicine to prevent or control nausea and vomiting.
Patients with newly diagnosed glioblastoma multiforme
If you are a newly diagnosed patient, the treatment will take place in two phases:
- Treatment together with radiation (concurrent phase) first
- Followed by treatment with Temomedac alone (monotherapy phase).
During the concurrent phase, your doctor will start you with Temomedac at 75 mg/m 2 (usual dose ). With radiotherapy, you will take this dose daily for 42 days (up to 49 days).
Temomedac dose one can be postponed or interrupted depending on your blood values and how well you tolerate the drug during the concurrent phase. When the radiation treatment is finished, you will have a treatment break of 4 weeks. It will allow your body to recover.
You will then begin the monotherapy phase.
During the monotherapy phase, the dose and how you take Temomedac will differ. Your doctor will work out exactly what amount you should have. You can have up to 6 treatment periods (cycles). Each of these lasts for 28 days. You will take only the new dose once a day for the first 5 days (“dosing days”) of each cycle.
The first dose will be 150 mg/m 2. After that, you will have 23 days without Temomedac. In total, there will be a 28-day treatment cycle.
After day 28, the next cycle begins. You will again take Temomedac once a day for 5 days, followed by 23 days without Temomedac. The dose of this medicine can be adjusted, postponed, or discontinued depending on your blood levels and how well you tolerate the medicine during each treatment cycle.
Patients with tumors that have come back or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma ) receiving Temomedac alone
A treatment cycle with Temomedac lasts 28 days.
You will take Temomedac alone once daily for the first 5 days. The daily dose depends on whether you have previously received chemotherapy or not.
If you have not previously been treated with chemotherapy, the first dose of Temomedac will be 200 mg/m 2 once daily for the first 5 days. If you have previously been treated with chemotherapy, the first dose of this medicine will be 150 mg/m 2 once daily for the first 5 days. After that, you will have 23 days without this medicine. In total, there will be a treatment cycle of 28 days.
After day 28, the next treatment cycle begins. You will again receive Temomedac once daily for 5 days, followed by 23 days without this medicine.
Before each new treatment cycle, your blood will be tested to see if the Temomedac dose needs to be adjusted. Depending on the results of your blood tests, your doctor may adjust the dosage from one to the next cycle.
How to take Temomedac?
- Take the prescribed dose of this medicine once a day, preferably at the same time each day.
- Take the capsules on an empty stomach; for example, at least one hour before breakfast.
- Swallow the capsule(s) whole together with a glass of water. Do not open, crush or chew the capsules. If a capsule is broken, avoid the powder coming into contact with the skin, eyes, or nose. If you accidentally get something in your eyes or nose, rinse with water.
- Depending on your prescribed dose, you may need to take several capsules simultaneously, possibly in different strengths (the active substance in mg). The capsule’s lid’s color differs for the different Strengths (see the table below).
| Strength | Color/marking |
| Temomedac 5 mg | Two stripes in green ink on the upper part and “T 5 mg” in green ink on the lower part. |
| Temomedac 20 mg | Two stripes with orange ink on the upper part and “T 20 mg” with orange ink on the lower part |
| Temomedac 100 mg | Two stripes with pink ink on the upper part and “T 100 mg” with pink ink on the lower part |
| Temomedac 140 mg | Two stripes in blue ink on the upper part and “T 140 mg” in blue ink on the lower part |
| Temomedac 180 mg | Two stripes in red ink on the upper part and “T 180 mg” in red ink on the lower part |
| Temomedac 250 mg | Two stripes in black ink on the upper part and “T 250 mg” in black ink on the lower part |
Make sure you understand exactly and remember the following:
- How many capsules do you need to take each dosing day? Ask your doctor or pharmacist to write it down (including the color).
- Which days are your dosing days?
Review the dosage with your doctor each time you start a new treatment, as it may differ from the previous period.
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure. Mistakes in how you take your medication can have serious consequences on your health.
If You Have Taken Too Much Temomedac:
If you accidentally take more capsules than prescribed, contact your doctor, pharmacist or nurse immediately.
If You Forget To Take Temomedac:
Take the missed dose as soon as possible on the same day. If a day has already passed, contact your doctor. Do not take a double dose to make up for a missed dose unless your doctor has told you to do so. Contact your doctor, pharmacist, or nurse if you have further questions about this medicine.
Possible Temomedac Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them. Contact your doctor immediately if you experience any of the following:
- A severe allergic (hypersensitivity) reaction ( hives, wheezing, or other breathing difficulties)
- Uncontrolled bleeding
- Seizures (convulsions)
- Fever
- Chills
- Severe headache that does not go away
Treatment with this medicine can cause a reduction in certain types of blood cells. This may mean you bruise or bleed more easily, have anemia (lack of red blood cells ), fever, and reduced resistance to infection. The reduced number of blood cells is usually transient.
In some cases, it can be more prolonged and lead to a very severe form of anemia (aplastic anemia ). Your doctor will measure your blood levels regularly to detect changes and determine if special treatment is required. Sometimes, your dose ofthis medicine may be reduced, or treatment may be stopped.
Other side effects that have been reported are listed below:
Very common (may affect more than 1 in 10 users):
- Loss of appetite
- Difficulty speaking
- Headache
- Vomiting
- Nausea
- Diarrhea
- Constipation
- Rash
- Hair loss
- Fatigue
Common (may affect up to 1 in 10 users) :
- Infection, infection in the oral cavity
- Reduced number of blood cells ( neutropenia, lymphopenia, thrombocytopenia )
- Allergic reaction
- Elevated blood sugar
- Impaired memory
- Depression
- Anxiety
- Confusion
- Inability to fall asleep or stay asleep
- Impaired coordination and balance
- Difficulty concentrating
- Changes in mood or attention
- Forgetfulness
- Dizziness
- Impaired sensation
- Tingling
- Tremors
- Changes in taste
- Partial vision loss
- Abnormal vision
- Double vision
- Painful eyes
- dDeafness
- Ringing in the ears
- Earache
- Blood clots in the lungs or legs
- High blood pressure
- Pneumonia
- Shortness of breath
- Bronchitis
- Cough
- Sinusitis
- Stomach or abdominal pain
- Upset stomach/heartburn
- Difficulty swallowing
- Dry skin
- Itching
- Muscle damage
- Muscle weakness
- Muscle aches and pains
- Joint pain
- Back pain
- Frequent urges to urinate
- Difficulty holding tight
- Fever, flu-like symptoms
- Aches
- Malaise
- Cold or flu
- Fluid retention, leg swelling
- Elevated levels of liver enzymes
- Weight loss
- Weight gain
- Radiation damage
Uncommon (may affect up to 1 in 100 users) :
- Infection in the brain (meningoencephalitis caused by the herpes virus), which can be fatal
- New or reactivated (recurrent) infection with cytomegalovirus
- Wound infections
- Reactivated hepatitis B virus infections
- Secondary cancer, including leukemia
- Reduced number of blood cells (pancytopenia, anemia, leukopenia )
- Red dots under the skin
- Diabetes insipidus (symptoms include increased urine output and thirst), low blood potassium levels
- Mood swings
- Hallucinations
- Partial paralysis
- Changes in the sense of smell
- Dry eyes
- Impaired hearing
- Infection in the middle ear
- Palpitations (you can feel the heartbeat)
- Hot flushes
- Bloated stomach
- Difficulty controlling bowel movements
- Hemorrhoids
- Dry mouth
- Liver inflammation and liver damage (including fatal liver failure), cholestasis, increased level of bilirubin
- Blisters on the body or in the mouth, scaly skin, skin reactions
- Painful reddening of the skin
- A severe rash with skin swelling (on the palms of the hands and soles of the feet)
- Increased sensitivity to sunlight, urticaria (hives)
- Increased sweating
- Change in skin color
- Difficulty urinating
- Vaginal bleeding
- Vaginal irritation
- Missed or heavy periods
- Pain in the breasts
- Sexual impotence
- Tremors
- Swelling of the face
- Discoloration of the tongue
- Thirst
- Toothache
How To Store Temomedac?
- Keep this medicine out of sight and reach of children, preferably in a locked cabinet. Accidental ingestion can be fatal for children.
- Use before the expiry date stated on the label and carton. The expiration date is the last day of the specified month.
- Store at a maximum of 30 °C.
- Store in the original packaging. Moisture sensitive.
- Close the jar well.
- Tell the pharmacist if you notice any change in the appearance of the capsules.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents Of The Packaging And Other Information
Contents Declaration
- The active substance is temozolomide. Temomedac 5 mg hard capsules: One capsule contains 5 mg temozolomide.Temomedac 20 mg hard capsules: One capsule contains 20 mg temozolomide.Temomedac 100 mg hard capsules: One capsule contains 100 mg temozolomide.Temomedac 140 mg hard capsules: One capsule contains 140 mg temozolomide.Temomedac 180 mg hard capsules: One capsule contains 180 mg temozolomide.Temomedac 250 mg hard capsules: One capsule contains 250 mg temozolomide.
- Other ingredients are Contents of the capsule:
Anhydrous lactose, sodium starch glycolate, silicon dioxide, tartaric acid, and stearic acid (see section 2, “Temomedac contains lactose”).The capsule casing (including printing ink): Temomedac 5 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, indigo carmine (E 132), aluminum lake, yellow iron oxide (E 172).Temomedac 20 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, para-orange aluminum lake (E 110).Temomedac 100 mg hard capsules: gelatin, titanium dioxide (E 171), red iron oxide (E 172), shellac, propylene glycol, yellow iron oxide (E 172).Temomedac 140 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, indigo carmine (E 132), aluminum lake.Temomedac 180 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, red iron oxide (E 172)Temomedac 250 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, black iron oxide (E 172).
Appearance And Package Sizes Of The Medicine
- Temomedac 5 mg hard capsules have a white opaque body and body. The upper part is marked with 2 stripes in green ink, and the lower part is marked with “T 5 mg” in green ink.
- Temomedac 20 mg hard capsules have a white opaque body and body. The upper part is marked with 2 stripes in orange ink, and the lower part is marked with “T 20 mg” in orange ink.
- Temomedac 100 mg hard capsules have a white opaque body and body. The upper part is marked with 2 stripes in pink ink, and the lower part is marked with “T 100 mg” in pink ink.
- Temomedac 140 mg hard capsules have a white opaque body and body. The upper part is marked with 2 stripes in blue ink, and the lower part is marked with “T 140 mg” in blue ink.
- Temomedac 180 mg hard capsules have a white opaque body and body. The upper part is marked with 2 stripes in red ink, and the lower part is marked with “T 180 mg” in red ink.
- Temomedac 250 mg hard capsules have a white opaque body and body. The upper part is marked with 2 stripes in black ink, and the lower part is marked with “T 250 mg” in black ink.
- The hard capsules for oral use are supplied in amber glass jars containing 5 or 20 capsules.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany