New Manufacturer of DOXIL® (doxorubicin HCl liposome injection) Now Approved by the FDA for the U.S.


We are pleased to announce the U.S. Food and Drug Administration (FDA) has approved a new manufacturer of DOXIL (doxorubicin HCl liposome injection) for the U.S. market.

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How This Site Works and What You Can Expect

We've created as an informational resource to share updates with patients, their loved ones and others about the DOXIL® supply situation. This site complements the healthcare professional updates on our DOXIL® website (

Our intent is to provide timely information about the DOXIL® supply situation and what we're doing to address it. While we won't be able to address every question or statement made, our goal is to provide clarification and context about the supply situation. The site is not intended to discuss product matters of a more general nature.

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Drug Manufacturing: A Complex Process

Manufacturing medicines can be a complex process and the production of chemotherapy products has special requirements. Producing chemotherapy drugs and sterile injectable medicines requires layers of complexity and production time. The process is made even more complex when additional steps, such as liposomal pegylation—the drug delivery system used by DOXIL®—are involved.

A typical sterile, intravenous chemotherapy formulation requires only a few process vessels and one or two manufacturing steps, with batch completion typically taking a matter of hours. Creating the formulation for DOXIL® requires 17 different process vessels, plus specialized equipment, requiring more time and adding complexity to the process. These proprietary DOXIL® formulation steps are managed by specially trained personnel. These personnel must have specialized expertise for manufacturing DOXIL® in addition to the training needed for manufacturing standard chemotherapies.

DOXIL(R) is specially coated to increase the time the drug is in the body and reaching the tissue

DOXIL® is specially coated to increase the time the drug is in the body and reaching the tissue.

DOXIL® is a specially coated form of doxorubicin that starts with the active agent, doxorubicin, and covers it with 2 layers of protective coating. This coating allows DOXIL® to evade detection and destruction by the immune system, which increases the time the drug is in the body. As a result, DOXIL® has more time to reach the tumor tissue, where the medication is slowly released. However, DOXIL® may also affect normal tissue.

Put another way, this STEALTH® Liposome technology gives the doxorubicin a shield, allowing it to better evade the body's immune system defenses.

Manufacturing is Just the Beginning...

Each batch of DOXIL® takes at least 5 days to create, and once production is complete, it's just the beginning of the process to bring this medication to physicians and patients. Next, there are multiple steps to carefully review each batch and conduct tests. Each review requires time periods between tests to ensure the medication meets all US Food and Drug Administration (FDA) quality standards and requirements. And, the process of sampling and testing must happen in a specific order. Some of these tests are specific to drugs of a liposomal formulation.

Beyond the specialized equipment and process steps required to make DOXIL®, special manufacturing expertise and facilities are needed to complete the entire process to specification. Given the unique requirements of the DOXIL® production process, most chemotherapy manufacturers are not equipped to produce DOXIL® and must build new in-house facilities and train staff to conduct each of the many steps required to make it. And, any new manufacturing facilities require further steps related to the development of new manufacturing suites. These additional requirements might include adding new equipment and tests to ensure the product being produced is exactly and precisely equivalent to DOXIL®.
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Serious and possibly permanent heart-related side effects that may lead to congestive heart failure can occur in patients treated with DOXIL®. Inform your doctor of any history of heart disease, radiation to your chest, or prior anticancer therapy. Your doctor will monitor your heart function.

Infusion-related reactions may also occur during administration. Be sure to tell your doctor if you have any symptoms during infusion, including: flushing, shortness of breath, facial swelling, headaches, chills, chest pain, back pain, tightness in your chest or throat, dizziness, or lightheadedness. In some cases, these reactions may be serious and sometimes life-threatening and may be fatal.

You should not take DOXIL® if you have a prior history of allergic reactions to doxorubicin or other ingredients found in the formulation. Please inform your doctor about your history of allergic reactions to medications or other substances.

DOXIL® may severely reduce the number of blood cells (red blood cells, white blood cells, and cells that prevent bleeding called platelets) in your body that may potentially increase risk of infections, anemia, and bleeding. Speak to your doctor if you notice any changes in your health such as a new onset fever or symptoms of infection. Your doctor will monitor your blood laboratory results.

Hand-Foot Syndrome may occur while taking DOXIL®. This may lead to tingling or burning, redness, flaking, bothersome swelling, small blisters, or small sores on palms of hands or soles of feet. In certain cases, this reaction can be more severe leading to serious infections, interfering with walking and other daily activities.

Cases of oral cancer have been reported in people who had taken DOXIL® for more than one year. The oral cancer was diagnosed during treatment and up to 6 years after the last dose. Your doctor will examine you at regular times for the signs and symptoms of oral cancer.

If you are pregnant, planning to become pregnant, or nursing, inform your doctor. DOXIL® can cause fetal harm. Nursing should be discontinued during treatment with DOXIL®. Females and males of reproductive potential should use effective contraception during and for 6 months following treatment with DOXIL®. DOXIL® may cause temporary or permanent infertility.

The most common side effects reported in at least 20% of patients treated with DOXIL® during clinical studies were: weakness, tiredness, fever, nausea, stomatitis (painful redness, swelling, or sores in the mouth), vomiting, diarrhea, constipation, loss of appetite, hand-foot syndrome, rash, low white blood cell count, low platelet count, and anemia. Tell your doctor if you experience these or other side effects.

In the treatment of multiple myeloma, nerve damage called peripheral neuropathy, which may lead to pain, numbness, burning sensation, tingling, and more serious symptoms, was reported in >40% of patients. Be sure to tell your doctor immediately if you experience any of these or other symptoms.

Following administration, DOXIL® may turn urine and other bodily fluids a reddish-orange color. This is due to the color of DOXIL® and will go away as the drug leaves the body.

Your doctor may prescribe antinausea medications before or during your DOXIL® treatment.

Talk to your doctor if you have a history of heart disease or liver disease, or have received prior radiation therapy and/or anticancer therapy.


DOXIL® is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

DOXIL® in combination with bortezomib is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.

DOXIL® is administered intravenously by your healthcare professional.

Click here to read Full Prescribing Information for DOXIL, including BOXED WARNINGS, and discuss any questions you have with your doctor.

For more information about DOXIL® therapy, please visit

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit, or
call 1-800-FDA-1088.



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Last Updated: May 15, 2015

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