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Brand Name

Doxil

Generic Name
DOXOrubicin
View Brand Information
FDA approval date: May 01, 1996
Classification: Anthracycline Topoisomerase Inhibitor
Form: Injection, Injectable

What is Doxil (DOXOrubicin)?

Receiving a cancer diagnosis can be one of the most challenging moments in life. Treatment often involves a combination of surgery, radiation, and powerful medicines designed to target and destroy cancer cells. Adriamycin (doxorubicin) is one of the most widely used and effective chemotherapy drugs, known for its ability to treat a broad range of cancers. 

Adriamycin belongs to a class of medications called anthracycline antibiotics. Despite its name, it is not an antibiotic used for infections; instead, it’s a chemotherapy agent that interferes with cancer cell growth and reproduction. This drug has been a cornerstone in cancer treatment for decades and is often part of combination chemotherapy regimens. Doctors use it to treat cancers such as breast cancer, lymphomas, leukemias, sarcomas, and ovarian cancer, among others. 

Although Adriamycin is a strong and potent medication, it plays a vital role in improving survival rates and helping patients achieve remission when carefully managed by an oncology team. 

What does Adriamycin do? 

Adriamycin is used to treat various types of cancer by slowing or stopping the growth of malignant cells. It is often included in combination chemotherapy protocols where multiple drugs are used together to improve effectiveness and reduce the likelihood of resistance. 

Some of the most common cancers treated with Adriamycin include: 

  • Breast cancer (often part of the “AC” regimen with cyclophosphamide) 
     
  • Hodgkin and non-Hodgkin lymphoma 
     
  • Leukemias (such as acute lymphoblastic leukemia) 
     
  • Sarcomas (cancers of connective tissues like bone or muscle) 
     
  • Bladder, ovarian, and thyroid cancers 

In these settings, Adriamycin helps shrink tumors, control disease spread, and enhance the effectiveness of other cancer treatments. Clinical studies have shown that doxorubicin remains one of the most active drugs against solid and blood cancers, significantly improving long-term outcomes when used appropriately (NIH, 2024). 

How does Adriamycin work? 

Adriamycin works by interfering with the DNA inside cancer cells, preventing them from dividing and multiplying. In simple terms, it disrupts the “instructions” that cancer cells need to grow. 

Doxorubicin acts through several mechanisms: 

  1. DNA intercalation: The drug slips between DNA strands, blocking the enzymes responsible for replication. 
     
  1. Topoisomerase II inhibition: This enzyme helps unwind DNA during cell division; Adriamycin blocks it, halting the process. 
     
  1. Free radical generation: The drug produces reactive oxygen species that damage cell membranes, proteins, and DNA, leading to cancer cell death. 

This multi-targeted approach makes Adriamycin one of the most effective chemotherapy drugs in oncology. However, because it affects rapidly dividing cells, it can also impact healthy tissues like hair follicles, bone marrow, and the lining of the digestive tract leading to some of its side effects. 

Clinically, its mechanism is powerful because it helps kill cancer cells at multiple stages of their growth cycle, reducing the risk of recurrence and improving treatment success. 

Adriamycin side effects 

Like most chemotherapy medications, Adriamycin can cause side effects, some of which are temporary and manageable with supportive care. Oncologists closely monitor patients to balance treatment effectiveness with safety. 

Common side effects may include: 

  • Nausea and vomiting 
     
  • Hair loss (usually temporary) 
     
  • Fatigue and weakness 
     
  • Mouth sores 
     
  • Changes in urine color (reddish tint for a day or two after treatment) 

Serious side effects, though managed, include heart damage (monitored via echocardiograms), bone marrow suppression (reducing white/red blood cells and platelets), and liver toxicity (checked with blood tests). Infusion must be intravenous to prevent tissue damage. 

Patients should immediately contact their doctor if they experience chest pain, shortness of breath, fever, unexplained bruising, or swelling. 

Who should avoid Adriamycin: 
Individuals with severe heart disease, prior high-dose anthracycline exposure, or doxorubicin allergies should avoid this drug or seek alternatives. Pregnant patients are generally advised against Adriamycin unless benefits clearly outweigh risks.  

However, oncologists have extensive experience safely using Adriamycin with modern protocols, including dose adjustments, protective agents, and regular monitoring, to minimize risks. 

Adriamycin dosage 

Adriamycin is given intravenously in a hospital by an oncology nurse or doctor as part of a chemotherapy cycle, typically every few weeks. Dosage and frequency depend on cancer type and stage, patient’s body surface area, heart and liver function, and whether other chemotherapy drugs are used. 
 

Due to Adriamycin’s potency, close monitoring of blood counts, heart function, and liver enzyme levels is essential. Dosing may be adjusted for older adults or those with existing heart or liver disease, with alternatives like liposomal doxorubicin (Doxil) considered to reduce side effects. 

Does Adriamycin have a generic version? 

Yes. Doxorubicin, the active ingredient in Adriamycin, is available as a generic medication approved by the U.S. Food and Drug Administration (FDA). Generic versions have the same active ingredient, strength, safety, and effectiveness as the brand-name drug but are typically more affordable. 

Doxorubicin comes in conventional and liposomal (encapsulated) forms. Liposomal doxorubicin (Doxil, Caelyx) reduces heart-related side effects and may be used when the standard version isn’t tolerated. Adriamycin is another brand. Your oncologist will choose the best version based on your cancer, prior treatments, and health. 

Conclusion 

Adriamycin (doxorubicin) remains one of the most trusted and effective chemotherapy drugs in modern oncology. By targeting cancer cells at the DNA level, it helps slow tumor growth, improve remission rates, and extend survival in many types of cancer. 

Adriamycin can cause heart and bone marrow side effects, but careful monitoring and supportive care improve safety and tolerability. Most side effects are temporary. Discuss concerns with your oncology team and follow monitoring. Adriamycin, when used responsibly, remains a key cancer therapy that has helped millions. 

References 

  1. U.S. Food and Drug Administration (FDA). (2024). Doxorubicin hydrochloride: Prescribing information. Retrieved from https://www.accessdata.fda.gov 
     
  1. Mayo Clinic. (2024). Doxorubicin (injection route) drug information. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Doxorubicin injection: Uses, side effects, and precautions. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Cancer Institute (NCI). (2024). Doxorubicin and anthracycline chemotherapy agents. Retrieved from https://www.cancer.gov 

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Brand Information

DOXIL (doxorubicin hydrochloride)
WARNING: CARDIOMYOPATHY and INFUSION-RELATED REACTIONS
  • DOXIL liposomal infusion can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 mg/m
  • Serious, life-threatening, and fatal infusion-related reactions can occur with DOXIL liposomal infusion Acute infusion-related reactions occurred in 11% of patients with solid tumors. Withhold DOXIL liposomal infusion for infusion-related reactions and resume at a reduced rate. Discontinue DOXIL liposomal infusion for serious or life-threatening infusion-related reactions
1DOSAGE FORMS AND STRENGTHS
DOXIL (doxorubicin hydrochloride liposome injection): 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) translucent, red liposomal dispersion in single dose vials.
2CONTRAINDICATIONS
DOXIL liposomal infusion is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride
3ADVERSE REACTIONS
The following adverse reactions are discussed in more detail in other sections of the labeling.
  • Cardiomyopathy
  • Infusion-Related Reactions
  • Hand-Foot Syndrome
  • Secondary Oral Neoplasms
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates on other clinical trials and may not reflect the rates observed in clinical practice.
The safety data reflect exposure to DOXIL liposomal infusion in 1310 patients including: 239 patients with ovarian cancer, 753 patients with AIDS-related Kaposi’s sarcoma, and 318 patients with multiple myeloma.
The most common adverse reactions (>20%) observed with DOXIL liposomal infusion are asthenia, fatigue, fever, nausea, stomatitis, vomiting, diarrhea, constipation, anorexia, hand-foot syndrome, rash and neutropenia, thrombocytopenia and anemia.
The following tables present adverse reactions from clinical trials of single-agent DOXIL liposomal infusion in ovarian cancer and AIDS-Related Kaposi’s sarcoma.
3.2Postmarketing Experience
The following additional adverse reactions have been identified during postapproval use of DOXIL liposomal infusion. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Musculoskeletal and Connective Tissue Disorders: muscle spasms
Respiratory, Thoracic and Mediastinal Disorders: pulmonary embolism (in some cases fatal)
Hematologic Disorders: Secondary acute myelogenous leukemia
Skin and Subcutaneous Tissue Disorders: erythema multiforme, Stevens‑Johnson syndrome, toxic epidermal necrolysis, lichenoid keratosis
Secondary Oral Neoplasms: [see
4DRUG INTERACTIONS
No formal drug interaction studies have been conducted with DOXIL liposomal infusion.
5OVERDOSAGE
Acute overdosage with doxorubicin hydrochloride causes increased risk of severe mucositis, leukopenia, and thrombocytopenia.
6DESCRIPTION
The active ingredient in DOXIL liposomal infusion is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in STEALTH liposomes for intravenous use.
The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6‑trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11‑trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C27-H29 -NO11•HCl and the molecular weight is 579.99.
The structural formula is:
Structural Formula
DOXIL liposomal infusion is a sterile, translucent, red liposomal dispersion. Each single- dose vial contains 20 mg or 50 mg doxorubicin hydrochloride at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin). The STEALTH liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine, 1.55 mg as a buffer; hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (6.0 to 7.0); and sucrose, 94 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the STEALTH liposomes.
MPEG-DSPE has the following structural formula:
MPEG-DSPE Structural Formula
HSPC has the following structural formula:
HSPC Structural Formula
Representation of a STEALTH liposome:
Representation of a STEALTH liposome
7REFERENCES
  1. “Hazardous Drugs”,
8HOW SUPPLIED/STORAGE AND HANDLING
DOXIL (doxorubicin hydrochloride liposome injection) is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials.
The following individually cartoned vials are available:
9PRINCIPAL DISPLAY PANEL - 20 mg Vial Carton
NDC 0338-0063-01
DOXIL
20 mg in 10 mL
Single-Dose Vial. Discard unused portion.
LIPOSOMAL FORMULATION - DO NOT
FOR INTRAVENOUS INFUSION ONLY
Rx only
Cytotoxic
HA-65-01-805
Refrigerate, 2°-8°C
See package insert for
Baxter Healthcare
Baxter, Doxil, and
Bar Code
Bar Code
LOT
EXP
US
749703
Barcode
NDC 0338-0063-01
20 mg in 10 mL
Single-Dose Vial. Discard unused portion.
LIPOSOMAL FORMULATION -
FOR INTRAVENOUS
Refrigerate, 2°-8°C
Rx only
Baxter Logo
NDC 0338-0063-01
Use 5% Dextrose Injection, USP
Bar Code
Note: Liposomal formulation.
NDC 0338-0063-01
NDC 0338-0063-01
LIPOSOMAL FORMULATION -
Manufactured for:
Baxter, Doxil, and Stealth
GTIN 00303380063017
NDC 0338-0063-01
Each mL contains
HA-80-02-881
NDC 0338-0063-01
20 mg in 10 mL
Single-Dose Vial. Discard unused portion.
LIPOSOMAL FORMULATION -
FOR INTRAVENOUS
Refrigerate, 2°-8°C
Rx only
Baxter Logo
NDC 0338-0063-01
N
Note: Liposomal formulation.
USA
Bar Code
NDC 0338-0063-01
LIPOSOMAL FORMULATION -
Manufactured for:
Baxter, Doxil, and Stealth
NDC 0338-0063-01
GTIN 00303380063017
NDC 0338-0063-01
Each mL contains
HA-80-02-880
NDC 0338-0067-01
DOXIL
50 mg in 25 mL
Single-Dose Vial. Discard unused portion.
LIPOSOMAL FORMULATION - DO NOT
FOR INTRAVENOUS
Rx only
Cytotoxic
HA-65-01-806
Refrigerate, 2°-8°C (36°-46°F).
See package insert for dosage
Baxter Healthcare Corporation
Baxter, Doxil, and Stealth are registered trademarks of
Bar Code
Bar Code
LOT
EXP
US
Barcode
NDC 0338-0067-01
DOXIL
50 mg in 25 mL
Single-Dose Vial. Discard unused portion.
LIPOSOMAL FORMULATION -
FOR INTRAVENOUS
Refrigerate, 2°-8°C
Rx only
Baxter Logo
NDC 0338-0067-01
Use 5% Dextrose Injection, USP
Bar Code
Note: Liposomal formulation.
NDC 0338-0067-01
NDC 0338-0067-01
LIPOSOMAL FORMULATION -
Manufactured for:
Baxter, Doxil, and Stealth
GTIN 00303380067015
NDC 0338-0067-01
Each mL contains
HA-80-02-883
NDC 0338-0067-01
DOXIL
50 mg in 25 mL
Single-Dose Vial. Discard unused portion.
LIPOSOMAL FORMULATION -
FOR INTRAVENOUS
Refrigerate, 2°-8°C
Rx only
Baxter Logo
NDC 0338-0067-01
N
Note: Liposomal formulation.
USA
Bar Code
NDC 0338-0067-01
LIPOSOMAL FORMULATION -
Manufactured for:
Baxter, Doxil, and Stealth
NDC 0338-0067-01
GTIN 00303380067015
NDC 0338-0067-01
Each mL contains
HA-80-02-882