MULTIPLE MYELOMA KNOWLEDGE CENTER

What are Doxil side effects?

Like many other chemotherapy drugs, Doxil® (doxorubicin HCl liposome injection, Janssen) can have a number of different side effects. Side effects vary depending on an individual’s past health history and current multiple myeloma stage. Doxil is associated with less frequent side effects than conventional doxorubicin. The most common side effects observed in the clinical trial that led to the approval of combination therapy with Velcade® (bortezomib, Takeda Oncology) and Doxil were:

  • Gastrointestinal effects (ie, nausea, vomiting, diarrhea, and constipation)
  • Peripheral neuropathy
  • Fatigue
  • Low numbers of white blood cells known as neutrophils, a condition known as neutropenia
  • Low platelet counts, also referred to as thrombocytopenia
  • Fever
  • Anemia, or low numbers of red blood cells

Doxil may cause urine and other body fluids to turn a reddish-orange color. This nontoxic reaction is due to the color of the product and will go away as the drug is eliminated from the body.

Serious side effects seen with Doxil-Velcade combination therapy

In the trial that led to Doxil’s approval, a number of patients with relapsed myeloma receiving Velcade-Doxil combination therapy experienced serious (Grade 3) or less commonly, very serious (Grade 4) side effects during the course of their treatment. These serious side effects included:

  • Neutropenia
  • Thrombocytopenia
  • Anemia
  • Fatigue
  • A marked loss of strength
  • Diarrhea
  • Peripheral neuropathy
  • Hand-foot syndrome (HFS), a severe skin reaction resulting in redness, tenderness, and possibly peeling of the palms of the hand and soles of the feet

Other possible serious side effects of Doxil therapy

Although rare, severe infusion-related reactions, such as difficulty breathing or low blood pressure, may occur, most often during the first cycle of treatment. If such a reaction occurs, the infusion of Doxil will be temporarily stopped until symptoms have resolved and the infusion will be restarted at a slower rate. Doxil will be discontinued if the reaction is severe.

A potential side effect of long-term Doxil therapy is damage to the heart muscle (myocardial damage). Myocardial damage is related to the total dosage of doxorubicin a patient has received over time, which includes both conventional doxorubicin and Doxil. For this reason, it is generally recommended that patients receive a total of no more than 550 mg/m2 of doxorubicin over time. A lower total cumulative dose may be recommended if a patient has received radiotherapy to the area of the heart, or therapy with other agents that are potentially toxic to the heart, such as cyclophosphamide.

Fortunately, Doxil is potentially less toxic to heart muscle than conventional doxorubicin. This is mainly because there are much lower circulating levels of free doxorubicin in the blood when Doxil is used.

Doxil can cause harm to a fetus, so it should not be used during pregnancy. Women must use effective contraception during and for 6 months after treatment with Doxil.

How are side effects of Velcade-Doxil managed?

Patients experiencing side effects with Velcade-Doxil may have their dose reduced or delayed until symptoms resolve.