Trastuzumab-dttb (intravenous)

Trastuzumab-dttb (intravenous)

Intravenous route (powder for solution)

Cardiomyopathy

Administration of trastuzumab products may result in subclinical and clinical heart failure. Incidence and severity were highest in patients receiving trastuzumab concomitantly with anthracycline-containing chemotherapy regimens. Assess left ventricular function in all patients before and during treatment with trastuzumab-dttb. Withhold trastuzumab Dttb treatment in patients receiving adjuvant therapy and discontinue trastuzumab Dttb treatment in patients with metastatic disease due to a clinically significant decrease in left ventricular function.

Infusion reactions, pulmonary toxicity

Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Discontinue trastuzumab DTTB infusion if dyspnea or clinically significant hypotension. Monitor patients until symptoms resolve completely. Discontinue trastuzumab DTTB for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Embryo-fetal toxicity

Exposure to trastuzumab products during pregnancy may result in oligohydramnios and oligohydramnios sequence, manifested by pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Inform patients of these risks and the need for effective contraception.

Uses for Trastuzumab-DTTB

Trastuzumab dttb injection is also used alone to treat HER2-overexpressing metastatic breast cancer (cancer that has spread) in patients who have previously received one or more treatments for cancer, or as a first-line treatment together with paclitaxel to treat HER2-overexpressing metastatic breast cancer.

Trastuzumab dttb injection is also used in combination with cisplatin and capecitabine or 5-fluorouracil to treat HER2-overexpressing metastatic (cancer that has spread) gastric and gastroesophageal (stomach and esophageal cancer).

Trastuzumab-dttb prevents the growth of some tumors that produce extra amounts of a certain substance known as the HER2 protein. It should only be used in patients whose tumors have been shown to produce excess amounts of this protein (HER2 overexpression). Your doctor will test for the presence of this protein.

Trastuzumab-dttb is a monoclonal antibody. It impairs the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells can also be affected by trastuzumab-dttb, other effects also occur. Some of these can be serious and should be reported to your doctor.

This medicine should only be administered by or under your doctor's direct supervision.

Before using trastuzumab-dttb

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 association between age and the effects of trastuzumab DTTB injection in children and adolescents. Safety and effectiveness have not been established.

geriatrics

Related studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of trastuzumab DTTB injection in the elderly. However, older patients are at higher risk of age-related heart problems, so caution may be warranted in patients receiving this drug.

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 receiving 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.

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.

• Daunorubicin
• Daunorubicincitrat-Liposom
• Daunorubicin-Liposom
• Doxorubicin
• Doxorubicin-Hydrochlorid-Liposom
• Epirubicin
• Idarubicin
• Pirarubicin
• Pixantrone
• Valrubicin

Using this medicine with any of the following medicines may result in an increased risk of certain side effects, but using both medicines may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Warfarin

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. Discuss using your medicine with food, alcohol or tobacco with your doctor.

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:

• Herzerkrankungen (z. B. Kardiomyopathie, Herzinsuffizienz) oder
• Herzrhythmusstörungen (z. B. Arrhythmie) oder
• Hypertonie (Bluthochdruck) bzw
• Lungenerkrankung (z. B. interstitielle Pneumonitis, Lungenfibrose) – Mit Vorsicht anwenden. Kann diese Bedingungen verschlimmern.

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

Proper use of trastuzumab-DTTB

Cancer treatment medications are very powerful and can have many side effects. Before you receive this medicine, make sure you understand all of the risks and benefits. It is important that you work closely with your doctor during treatment.

A doctor or other trained healthcare professional will give you this medicine. It is given through a needle inserted into one of your veins. Administration must be done slowly so that the needle should remain in place for at least 30 to 90 minutes.

Avoid taking other cancer medications (e.g., anthracyclines) for up to 7 months after stopping treatment with Trastuzumab DTTB Injection. If you are receiving an anthracycline medicine, your doctor may need to check regularly for heart problems.

Precautions when using Trastuzumab-DTTB

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

Taking this medicine during pregnancy may harm your unborn baby. Use an effective form of contraception to prevent pregnancy during treatment and for 7 months after the last dose. If you think you have become pregnant while taking this medicine, tell your doctor immediately.

Your doctor may test your heart before you start trastuzumab DTTB injection and while you are being treated with this medicine. Contact your doctor immediately if you experience chest pain, increased cough, difficulty breathing, sudden difficulty breathing at night, rapid weight gain, or unusual swelling in the ankles or legs. These could be symptoms of a serious heart problem.

This medicine can cause infusion-related reactions that can be life-threatening and require immediate medical attention. Tell your doctor immediately if you experience fever, chills or tremors, dizziness, trouble breathing, itching or rash, lightheadedness, or fainting after taking this medicine.

Serious lung or breathing problems may occur after taking this medication. Call your doctor immediately if you notice changes in your breathing, chest tightness, or other breathing problems.

This medicine may temporarily reduce 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.

Side effects of trastuzumab-DTTB

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.

Contact your doctor or nurse immediately if any of the following side effects occur:

More common

• Schwarzer, teeriger Stuhl
• Zahnfleischbluten
• Blähungen oder Schwellungen im Gesicht, an Armen, Händen, Unterschenkeln oder Füßen
• blutiger Urin
• Körperschmerzen oder Schmerzen
• Brustschmerzen
• Schüttelfrost
• Husten
• verminderte Häufigkeit oder Menge des Urins
• Durchfall
• Schwierigkeiten beim Atmen
• erweiterte Halsvenen
• trockener Mund
• Trockenheit oder Schmerzen im Hals
• verstopfte Ohren
• extreme Müdigkeit oder Schwäche
• Fieber
• allgemeines Unwohlsein oder Krankheitsgefühl
• Kopfschmerzen
• Heiserkeit
• erhöhter Blutdruck
• verstärkter Husten
• Erhöhter Durst
• unregelmäßige Atmung
• Herzrhythmusstörung
• Gelenkschmerzen
• Appetitverlust
• Verlust der Stimme
• Schmerzen im unteren Rücken oder an der Seite
• Stimmungsschwankungen
• Muskelschmerzen oder Krämpfe
• Brechreiz
• Taubheitsgefühl oder Kribbeln in den Händen, Füßen oder Lippen
• Schmerzen oder Druckempfindlichkeit um die Augen und Wangenknochen
• schmerzhaftes oder schwieriges Wasserlassen
• blasse Haut
• Punktgenaue rote Flecken auf der Haut
• schnelle Gewichtszunahme
• Anfälle
• Zittern
• niesen
• Halsentzündung
• verstopfte oder laufende Nase
• Schwitzen
• empfindliche, geschwollene Drüsen im Nacken
• Engegefühl in der Brust
• Schwierigkeiten beim Schlucken
• Schlafstörungen
• Atembeschwerden bei Anstrengung
• Geschwüre, Wunden oder weiße Flecken im Mund
• ungewöhnliche Blutungen oder Blutergüsse
• ungewöhnliche Müdigkeit oder Schwäche
• ungewöhnliche Gewichtszunahme oder -abnahme
• Stimme verändert sich
• Erbrechen

Less common

• Blasenschmerzen
• Blindheit oder Sehstörungen
• verschwommene Sicht
• Brennen im Gesicht oder Mund
• Brennen, Krabbeln, Jucken, Taubheitsgefühl, Schmerzen, Kribbeln, „Ameisenlaufen“ oder Kribbeln
• trüber Urin
• Ungeschicklichkeit oder Unsicherheit
• Schwindel
• schneller, hämmernder oder unregelmäßiger Herzschlag oder Puls
• häufiger Harndrang
• Nervosität
• Nasenbluten
• schmerzhafte Fieberbläschen oder Blasen an Lippen, Nase, Augen oder Genitalien
• in den Ohren hämmern
• langsamer Herzschlag
• Schwäche in den Händen oder Füßen

Rarely

• Verminderte Fähigkeit, Sport zu treiben
• Ohnmacht
• Nesselsucht, Juckreiz, Hautausschlag
• Reizung
• Gelenksteifheit oder Schwellung
• Nackenschmerzen oder Schwellung
• Rötung der Haut

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

• Rückenschmerzen
• Knochenschmerzen
• Geschmacksveränderung oder Geschmacksverlust
• rissige Lippen
• Depression
• Schwierigkeiten beim Bewegen
• Mangel oder Verlust der Kraft
• Magenschmerzen
• Schwellung oder Entzündung des Mundes
• Schlafstörungen
• Gewicht nahm ab

Less common

• Aufstoßen
• Sodbrennen
• Verdauungsstörungen
• Muskelkrampf
• stechender Schmerz
• Magenbeschwerden oder Magenverstimmung
• Schmerzen im Oberbauch

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

• Ontruzant

Available dosage forms:

• Pulver zur Lösung

Therapeutic class: Antineoplastic agent

Pharmacological class: Trastuzumab

• Wie lange können Sie Herceptin und Perjeta einnehmen?
• Was passiert nach der Behandlung mit Herceptin?
• Wie lange kann ich Herceptin einnehmen?
• Was ist eine TDM1-Chemotherapie?
• Wie viele Biosimilars wurden in den USA zugelassen?
• Was ist Herceptin? Ist Herceptin ein Chemomedikament? Wie funktioniert es?
• Was ist ein biologisches Medikament?
• Wie lange bleibt Herceptin in Ihrem Körper?
• Wie wirken Herceptin (Trastuzumab) und Perjeta (Pertuzumab) zusammen?

View more FAQs

More information