Temodar (oral)

Temodar (oral)

Uses for Temodar

Temozolomide interferes with the growth of cancer cells, which are then destroyed by the body. Since the growth of normal body cells can also be impaired by temozolomide, other side effects may occur. Some of these can be serious and should be reported to your doctor. Some side effects may not appear until months or years after using the drug.

Before you start treatment with temozolomide, you and your doctor should discuss the risks and benefits of this medication.

This medicine is only available with a doctor's prescription.

Before using Temodar

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

No appropriate studies have been conducted on the relationship between age and the effects of temozolomide in children and adolescents. Safety and effectiveness have not been established. .

geriatrics

Adequate studies on the relationship between age and the effects of temozolomide have not been conducted in the geriatric population. Geriatric-specific problems are not expected to limit the usefulness of temozolomide in the elderly. However, older patients are at higher risk of kidney, liver, or heart problems, which may require caution and dose adjustment in patients receiving temozolomide.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are taking this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or to change some of the other medications you are taking.

• Masernvirus-Impfstoff, lebend
• Mumpsvirus-Impfstoff, lebend
• Rotavirus-Impfstoff, lebend
• Rötelnvirus-Impfstoff, lebend
• Varizellenvirus-Impfstoff, lebend
• Zoster-Impfstoff, lebend

Using this medicine with any of the following medicines is not usually recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Adenovirus-Impfstoff
• Bacillus of Calmette und Guerin-Impfstoff, lebend
• Cholera-Impfstoff, lebend
• Tetravalenter Dengue-Impfstoff, lebend
• Influenzavirus-Impfstoff, lebend
• Poliovirus-Impfstoff, lebend
• Pockenimpfstoff
• Typhus-Impfstoff, lebend
• Gelbfieber-Impfstoff

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. The following interactions were selected for their potential significance and are not necessarily exhaustive.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Knochenmarksprobleme (z. B. Anämie, Leukämie, myelodysplastisches Syndrom, Panzytopenie, Thrombozytopenie) oder
• Leberprobleme – Mit Vorsicht anwenden. Kann diese Bedingungen verschlimmern.

• Infektion – Kann die Fähigkeit Ihres Körpers, Infektionen zu bekämpfen, beeinträchtigen.

• Nierenerkrankung, schwere oder
• Lebererkrankung, schwer – mit Vorsicht anwenden.

Proper use of Temodar

Only take this medicine as directed by your doctor. Do not take more or less of it or take it for longer than directed. This may increase the risk of unwanted side effects.

This medicine should be accompanied by a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine at the same time every day, either with or without food.

Temozolomide often causes nausea and vomiting. However, it is very important that you continue taking the medicine even if you feel unwell. You can take the medicine on an empty stomach or at bedtime to relieve nausea. Ask your doctor about other ways to lessen these effects.

Swallow the capsules whole with a full glass of water. Do not open, chew or dissolve. If the capsule is accidentally opened, be careful not to let the powder come into contact with your skin, mouth or nose. Be careful not to inhale the contents of the capsule.

dosage

The dose of this medicine is different for different patients. Follow your doctor's instructions or the label directions. The following information includes average doses of this medicine only. If your dose is different, do not change it unless your doctor tells you to.

The amount of medicine you take depends on the strength of the medicine. In addition, the number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical problem for which you are using the medicine.

• Für orale Darreichungsform (Kapseln):
  • Bei neu diagnostiziertem Glioblastoma multiforme:
    • Erwachsene – Die Dosis richtet sich nach der Körpergröße und muss von Ihrem Arzt festgelegt werden. Die Dosis beträgt normalerweise 75 Milligramm (mg) pro Quadratmeter (m).[2]) der Körpergröße einmal täglich für 42 bis 49 Tage zusammen mit einer Strahlenbehandlung. Gefolgt von einer Erhaltungstherapie mit 150 mg/m2 an den Tagen 1 bis 5 jedes 28-Tage-Zyklus über 6 Zyklen. Ihr Arzt kann Ihre Dosis je nach Bedarf und Verträglichkeit anpassen.
    • Kinder – Anwendung und Dosis müssen von Ihrem Arzt festgelegt werden.
  • Bei neu diagnostiziertem anaplastischem Astrozytom:
    • Erwachsene – Die Dosis richtet sich nach der Körpergröße und muss von Ihrem Arzt festgelegt werden. Die Dosis beträgt normalerweise 150 Milligramm (mg) pro Quadratmeter (m).[2]) der Körpergröße einmal täglich an den Tagen 1 bis 5 jedes 28-Tage-Zyklus über 12 Zyklen, beginnend 4 Wochen nach der Strahlenbehandlung. Ihr Arzt kann Ihre Dosis je nach Bedarf und Verträglichkeit anpassen.
    • Kinder – Anwendung und Dosis müssen von Ihrem Arzt festgelegt werden.
  • Bei refraktärem anaplastischem Astrozytom:
    • Erwachsene – Die Dosis richtet sich nach der Körpergröße und muss von Ihrem Arzt festgelegt werden. Die Anfangsdosis beträgt normalerweise 150 Milligramm (mg) pro Quadratmeter (m).[2]) der Körpergröße einmal täglich an den Tagen 1 bis 5 jedes 28-Tage-Zyklus. Ihr Arzt kann Ihre Dosis je nach Bedarf und Verträglichkeit anpassen.
    • Kinder – Anwendung und Dosis müssen von Ihrem Arzt festgelegt werden.

Missed dose

Call your doctor or pharmacist for instructions.

storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Protect from freezing.

Keep away from children.

Do not keep medications that are outdated or no longer needed.

Ask your doctor how to throw away medicines you don't use.

Precautions when using Temodar

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for adverse effects.

This medicine may cause birth defects if either partner takes it during conception or pregnancy. If you are a woman who can become pregnant, your doctor may do tests to make sure you are not pregnant before starting you on this medicine. Use an effective form of contraception during treatment and for at least 6 months after your last dose. Men with partners who may become pregnant should use an effective form of contraception during treatment and for 3 months after the last dose. If you think you have become pregnant, tell your doctor immediately.

Temozolomide can temporarily lower the number of white blood cells in your blood, increasing the risk of infection. It can also reduce the number of platelets needed for proper blood clotting. If this happens, you can take certain precautions to reduce your risk of infection or bleeding, especially if your blood count is low:

• Wenn möglich, meiden Sie Menschen mit Infektionen. Wenden Sie sich sofort an Ihren Arzt, wenn Sie glauben, eine Infektion zu bekommen, oder wenn Sie Fieber oder Schüttelfrost, Husten oder Heiserkeit, Schmerzen im unteren Rücken oder in den Seiten oder schmerzhaftes oder erschwertes Wasserlassen verspüren.
• Wenden Sie sich sofort an Ihren Arzt, wenn Sie ungewöhnliche Blutungen oder Blutergüsse, schwarzen, teerigen Stuhl, Blut im Urin oder Stuhl oder punktförmige rote Flecken auf Ihrer Haut bemerken.
• Seien Sie vorsichtig, wenn Sie eine normale Zahnbürste, Zahnseide oder einen Zahnstocher verwenden. Ihr Arzt, Zahnarzt oder das medizinische Fachpersonal empfiehlt Ihnen möglicherweise andere Methoden zur Reinigung Ihrer Zähne und Ihres Zahnfleisches. Fragen Sie Ihren Arzt, bevor Sie zahnärztliche Eingriffe durchführen lassen.
• Berühren Sie nicht Ihre Augen oder die Innenseite Ihrer Nase, es sei denn, Sie haben sich gerade die Hände gewaschen und in der Zwischenzeit nichts anderes berührt.
• Achten Sie darauf, sich nicht zu schneiden, wenn Sie scharfe Gegenstände wie einen Rasierhobel oder Finger- oder Zehennagelschneider verwenden.
• Vermeiden Sie Kontaktsportarten oder andere Situationen, in denen es zu Blutergüssen oder Verletzungen kommen kann.

Contact your doctor immediately if you have pain or tenderness in your upper abdomen, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of serious liver disease.

This medicine may cause serious lung or breathing problems (e.g., pneumonia). Contact your doctor immediately if you have chest pain or tightness, cough, fever or chills, sneezing, sore throat, or difficulty breathing.

This medicine may increase the risk of blood problems and secondary cancers (e.g. myeloid leukemia). Consult your doctor immediately if you have chest pain, chills, cough or hoarseness, fever, pain in the lower back or sides, painful or difficult urination, sores, ulcers or white spots on the lips or mouth, swollen glands or problems breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

Male patients should not donate semen during treatment and for at least 3 months after the last dose of this medicine.

If you plan to have children, talk to your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Do not take any other medicines unless you have discussed this with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medications and herbal or vitamin supplements.

Temodar side effects

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Consult your doctor immediately if any of the following side effects occur:

Less common or rare

• Amnesie
• schwarzer, teeriger Stuhl
• Blut im Urin oder Stuhl
• Husten oder Heiserkeit
• Fieber oder Schüttelfrost
• Schmerzen im unteren Rücken oder an der Seite
• Muskelschwäche oder -lähmung auf einer oder beiden Körperseiten
• schmerzhaftes oder schwieriges Wasserlassen
• Punktgenaue rote Flecken auf der Haut
• Anfälle
• Schwellung der Füße oder Unterschenkel
• ungewöhnliche Blutungen oder Blutergüsse

Incident not known

• Blasenbildung, Abschälen oder Lockerung der Haut
• Brustschmerzen oder Engegefühl
• lehmfarbener Stuhlgang
• Husten
• verminderter Appetit
• Durchfall
• Schwierigkeiten beim Schlucken
• Schwindel
• schneller Herzschlag
• Kopfschmerzen
• Nesselsucht, Juckreiz oder Hautausschlag
• Gelenk- oder Muskelschmerzen
• Übelkeit oder Erbrechen
• Schwellungen oder Schwellungen der Augenlider oder um die Augen, das Gesicht, die Lippen oder die Zunge
• rote Hautläsionen, oft mit violettem Zentrum
• rote, gereizte Augen
• niesen
• Halsentzündung
• Wunden, Geschwüre oder weiße Flecken im Mund oder auf den Lippen
• Magenschmerzen oder Empfindlichkeit
• Atembeschwerden
• ungewöhnliche Müdigkeit oder Schwäche
• gelbe Haut oder Augen

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

More common

• Verstopfung

Less common or rare

• Angst
• verschwommenes oder doppeltes Sehen
• Brustschmerzen (bei Frauen)
• brennendes oder prickelndes Gefühl auf der Haut
• Verwirrung
• Durchfall
• Schwierigkeiten beim Sprechen
• Schläfrigkeit
• verstärkter Harndrang
• Appetitverlust
• Verlust der Muskelkoordination
• mentale Depression
• laufende oder verstopfte Nase
• Schlafstörungen
• ungewöhnliche Gewichtszunahme

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• Temodar

Available dosage forms:

• Kapsel

Therapeutic class: Antineoplastic agent

Pharmacological class: Alkylating agents

Chemical Class: Imidazolecarboxamide

More information