Doxorubicin liposome (intravenous)

Doxorubicin liposome (intravenous)

Doxorubicin liposome (intravenous) Intravenous route (solution)

DOXOrubicin hydrochloride (HCl) liposome injection may result in myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 and 550 mg/m(2). Assess left ventricular cardiac function before initiating DOXOrubicin HCl liposomes and during and after treatment. Serious, life-threatening and fatal infusion-related reactions can occur with DOXOrubicin HCl Liposome. Acute infusion-related reactions occurred in 11% of patients with solid tumors. For infusion-related reactions, interrupt and restart DOXOrubicin HCl Liposome at a reduced rate. If serious or life-threatening infusion-related reactions occur, discontinue taking DOXOrubicin HCl Liposome.

Used for doxorubicin liposome

Doxorubicin liposome interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells can also be impaired by doxorubicin liposomes, other undesirable side 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 doxorubicin liposomes

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 doxorubicin liposome 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 doxorubicin liposome injection in the elderly.

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.

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.

• Atazanavir
• Boceprevir
• Cobicistat
• Lopinavir
• Nelfinavir
• Saquinavir
• Telaprevir

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.

• Abirateronacetat
• Adagrasib
• Amiodaron
• Amitriptylin
• Amobarbital
• Amprenavir
• Aprepitant
• Aprobarbital
• Azathioprin
• Azithromycin
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Capmatinib
• Captopril
• Carbamazepin
• Carvedilol
• Ceritinib
• Chlorpromazin
• Cinacalcet
• Ciprofloxacin
• Cisplatin
• Clarithromycin
• Clobazam
• Clozapin
• Conivaptan
• Crizotinib
• Cyclophosphamid
• Cyclosporin
• Darunavir
• Delavirdin
• Desipramin
• Desvenlafaxin
• Dexamethason
• Diltiazem
• Dronedaron
• Duloxetin
• Efavirenz
• Enzalutamid
• Erythromycin
• Escitalopram
• Etravirin
• Felodipin
• Fluconazol
• Fluoxetin
• Fluphenazin
• Fluvoxamin
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Imatinib
• Indinavir
• Itraconazol
• Ketoconazol
• Mephobarbital
• Mercaptopurin
• Methohexital
• Miconazol
• Mifepriston
• Modafinil
• Morphium
• Morphinsulfat-Liposom
• Nafcillin
• Nefazodon
• Nevirapin
• Oxcarbazepin
• Paclitaxel
• Paroxetin
• Pentobarbital
• Phenobarbital
• Phenytoin
• Piperaquin
• Posaconazol
• Quercetin
• Chinidin
• Ranolazin
• Regorafenib
• Rifabutin
• Rifampin
• Rifapentin
• Ritonavir
• Secobarbital
• Sertralin
• Simeprevir
• Stavudin
• Johanniskraut
• Telithromycin
• Terbinafin
• Thiopental
• Thioridazin
• Ticagrelor
• Tipranavir
• Tocophersolan
• Trastuzumab
• Valspodar
• Venetoclax
• Verapamil
• Vinflunin
• Voriconazol
• Warfarin
• Zidovudin

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.

• Rolapitant
• Sorafenib

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.

The use of this medicine for any of the following conditions is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of use of this medication, or give you special instructions about food, alcohol, or tobacco consumption.

• Grapefruitsaft

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:

• Herzinsuffizienz oder
• Herz- oder Blutgefäßerkrankungen, Vorgeschichte: Mit Vorsicht anwenden. Kann diese Bedingungen verschlimmern.

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

• Lebererkrankung – Mit Vorsicht anwenden. Die Wirkung kann durch die langsamere Entfernung des Arzneimittels aus dem Körper verstärkt werden.

Proper use of doxorubicin liposomes

A doctor or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle inserted into your vein.

Do not replace Doxil® with doxorubicin HCl injection.

This medicine often causes nausea and vomiting. Your doctor may prescribe medication to prevent this. Talk to your doctor if you continue to experience nausea and vomiting after taking the medicine.

Precautions when using doxorubicin liposomes

It is very important that your doctor checks you regularly while you are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for adverse effects.

Using this medicine during pregnancy may harm your unborn baby. Use an effective form of contraception to avoid pregnancy during treatment with this medicine and for up to 6 months after treatment. If you think you or your partner has become pregnant, tell your doctor immediately.

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

Contact your doctor immediately if you have chest pain or discomfort, a fast or irregular heartbeat, swelling of the feet and lower legs, or difficulty breathing. These could be symptoms of a serious heart problem.

This medicine can cause an infusion reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor immediately if you experience chest tightness, cough, dizziness, rapid heartbeat, difficulty breathing, difficulty swallowing, swelling of the face or hands, fever or chills, or lightheadedness or fainting while taking this medicine.

This medicine may cause hand-foot syndrome. Contact your doctor immediately if you experience tingling or burning, redness, swelling, blisters, or small sores on the palms of your hands or soles of your feet.

Doxorubicin liposome 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.

If you continue to receive this medicine for a full year, tell your doctor immediately if you have any discomfort, pain, sores, or mouth ulcers. These could be symptoms of oral cancer.

Tell your doctor right away if you notice redness, pain, or swelling at the injection site after taking this medicine. If doxorubicin liposome accidentally leaks from the vein into which it is injected, skin damage and scarring may occur.

This medicine may cause your urine to be red or orange for one to two days after you receive the injection. That's normal.

Side effects of doxorubicin liposomes

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
• Blasenbildung, Abschälen, Rötung oder Schwellung der Handflächen oder Fußsohlen
• Blut im Urin oder Stuhl
• Schüttelfrost
• Husten oder Heiserkeit
• Gesichtsschwellung
• Fieber
• Kopfschmerzen
• Verlust von Kraft und Energie
• Schmerzen im unteren Rücken oder an der Seite
• Taubheitsgefühl, Schmerzen, Kribbeln oder ungewöhnliche Empfindungen in den Handflächen oder Fußsohlen
• schmerzhaftes oder schwieriges Wasserlassen
• Punktgenaue rote Flecken auf der Haut
• Kurzatmigkeit
• Halsentzündung
• Wunden im Mund und auf den Lippen
• ungewöhnliche Blutungen oder Blutergüsse
• ungewöhnliche Müdigkeit oder Schwäche

Less common

• Schmerzen an der Injektionsstelle
• Hautausschlag oder Juckreiz

Rarely

• Brustschmerzen
• verminderte Urinausscheidung
• erweiterte Halsvenen
• extreme Müdigkeit
• unregelmäßige Atmung
• Herzrhythmusstörung
• Schwellung von Gesicht, Fingern, Füßen oder Unterschenkeln
• Engegefühl in der Brust
• Gewichtszunahme
• Gelbfärbung der Augen und 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

• Cremeweiße, quarkartige Flecken im Mund oder Rachen
• Durchfall
• Appetitverlust
• Brechreiz
• Schmerzen beim Essen oder Schlucken
• Halsentzündung
• Schluckbeschwerden
• Erbrechen

Less common

• Angst
• Rückenschmerzen
• schlechter, ungewöhnlicher oder unangenehmer Nachgeschmack
• brennende, trockene oder juckende Augen
• Veränderung der Hautfarbe
• Verstopfung
• Schwindel
• übermäßiges Reißen
• Juckreiz
• Gelenkschmerzen
• Muskelkater
• Rötung, Schmerzen oder Schwellung des Auges, des Augenlids oder der inneren Augenlidschleimhaut
• Schlafstörungen

Rarely

• Abnormales Denken
• Veränderung des Geruchssinns
• Schüttelfrost
• Ungeschicklichkeit, Unsicherheit, Zittern oder Probleme mit der Muskelkoordination
• Husten
• Fieber
• allgemeines Unwohlsein oder Krankheitsgefühl
• Zittern
• Schwitzen

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

• Doxil
• Lipodox
• Lipodox 50

Available dosage forms:

• Lösung

Therapeutic class: Antineoplastic agent

Chemical Class: Anthracycline

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