September 2, 2015
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Doxil

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Doxil




Doxil Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Doxil (doxorubicin HCl liposome injection) is used to treat metastatic ovarian cancer and AIDS-related Kaposi's sarcoma. It is a cancer (antineoplastic) medication. Common side effects include body aches/pains, headache, nausea or vomiting (may be severe), constipation, diarrhea, stomach upset, and loss of appetite. It may also cause urine, tears, and sweat to have a reddish-orange color. Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Doxil is only administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Dose and frequency of treatment depends on the condition being treated and the patient's response. Doxil may interact with "live" vaccines. Other drugs may also interact with Doxil. Talk to your doctor before taking any other prescription or over-the-counter medicines, or supplements. Doxil is not recommended for use during pregnancy. It may harm a fetus. Men and women should use two effective forms of birth control (e.g., condoms and birth control pills) while being treated with Doxil and for some time afterward. It is not known whether this drug passes into breast milk. Breast-feeding while using this drug is not recommended.

Our Doxil (doxorubicin HCl liposome injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Doxil in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Call your doctor at once if you have:

  • pain, redness, swelling, blistering, or peeling skin on your hands or feet;
  • feeling short of breath (even with mild exertion), swelling, rapid weight gain;
  • fever, chills, body aches, flu symptoms;
  • white patches or sores inside your mouth or on your lips;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Doxorubicin liposomal may cause your urine to turn a reddish-orange color. This side effect by itself is usually not harmful. However, call your doctor if you also have upper stomach pain, clay-colored stools, or jaundice (yellowing of your skin or the whites of your eyes).

Common side effects may include:

  • tired feeling;
  • loss of appetite, nausea, vomiting;
  • constipation, diarrhea; or
  • temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Doxil (Doxorubicin Hcl Liposome Injection)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Doxil Overview - Patient Information: Side Effects

SIDE EFFECTS: Body aches/pains, headache, nausea, vomiting, constipation, diarrhea, stomach upset, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, drug therapy may be needed to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet and lifestyle, such as eating several small meals and limiting activity, may help lessen some of these effects. If any of these effects continue or worsen, notify your doctor or pharmacist.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may give a reddish-orange color to your urine, tears, and sweat. This is a normal effect of the drug and should not be mistaken for blood in your urine.

Treatment with this drug may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome (palmar-plantar erythrodysesthesia). Notify your doctor promptly if you experience swelling, pain, redness, dryness, peeling, blisters, or tingling/burning of the hands/feet. The symptoms can be made worse by heat/pressure on your hands/feet. Avoid prolonged sun exposure, tanning booths, and sunlamps, as well as unnecessary exposure to heat (e.g., hot dishwater, long hot baths). Avoid pressure on elbows, knees, and soles of feet (e.g., leaning on elbows, kneeling, long walks). Wear loose clothing. Depending on how severe your hand-foot syndrome is, your doctor may give you something to reduce the symptoms, or decrease or delay your next dose of liposomal doxorubicin.

Temporary hair loss may occur. Normal hair growth should return several months after treatment has ended.

Tell your doctor right away if you have any serious side effects, including: drowsiness, trouble sleeping, mental/mood changes (e.g., anxiety, confusion, depression), cough/hoarseness, redness/pain/swelling of arms/legs, eye redness/itching, unusual tiredness, swelling of ankles/feet, painful/difficult urination, stomach/abdominal pain, yellowing of the skin/eyes, dark urine, black/tarry stools, bloody mucus or discharge in stools, vision changes (e.g., blindness), fast/irregular heartbeat, shortness of breath.

Painful swelling or sores on the lips, mouth and throat may occur. To decrease the risk, limit hot foods and drinks, brush your teeth carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water.

Get medical help right away if this rare but very serious side effect occurs: chest pain.

Within days to weeks after doxorubicin treatment, a serious skin reaction that looks likes a severe sunburn (radiation recall) may develop on any area of skin that has been previously treated with radiation. Tell your doctor immediately if you develop skin redness, pain, tenderness, swelling, peeling, or blisters. Your doctor may prescribe medication to help your skin heal faster and reduce the swelling. Sunlight may worsen any skin reactions that may occur while you are using this drug. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

In children, radiation recall may occur in the lungs. Tell the doctor immediately if you notice wheezing or trouble breathing in the child.

Very rarely, people with cancer who are treated with this type of medication have developed other cancers (such as secondary leukemia, oral cancer). Your risk is greater if you have received this medication long-term (more than 1 year), or with certain types of chemotherapy or radiation treatment. Consult your doctor for more details.

A very serious allergic reaction to this drug is unlikely, but fatal reactions have rarely occurred. Get medical help right away if you notice symptoms of a serious allergic reaction, which may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Doxil (Doxorubicin Hcl Liposome Injection)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Doxil FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling.

The most common adverse reactions ( > 20%) observed with DOXIL are asthenia, fatigue, fever, nausea, stomatitis, vomiting, diarrhea, constipation, anorexia, hand-foot syndrome, rash and neutropenia, thrombocytopenia and anemia.

Adverse Reactions In Clinical Trials

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 in 1310 patients including: 239 patients with ovarian cancer, 753 patients with AIDS-related Kaposi's sarcoma, and 318 patients with multiple myeloma.

The following tables present adverse reactions from clinical trials of single-agent DOXIL in ovarian cancer and AIDS-Related Kaposi's sarcoma.

Patients With Ovarian Cancer

The safety data described below are from Trial 4, which included 239 patients with ovarian cancer treated with DOXIL 50 mg/m² once every 4 weeks for a minimum of four courses in a randomized, multicenter, open-label study. In this trial, patients received DOXIL for a median number of 3.2 months (range 1 day to 25.8 months). The median age of the patients is 60 years (range 27 to 87), with 91% Caucasian, 6% Black, and 3% Hispanic or Other.

Table 3 presents the hematologic adverse reactions from Trial 4.

Table 3: Hematologic Adverse Reactions in Trial 4

  DOXIL Patients
(n=239)
Topotecan Patients
(n=235)
Neutropenia
  500 - < 1000/mm³ 8% 14%
   < 500/mm³ 4.2% 62%
Anemia
  6.5 - < 8 g/dL 5% 25%
   < 6.5 g/dL  0.4% 4.3%
Thrombocytopenia
  10,000 - < 50,000/mm³ 1.3% 17%
   < 10,000/mm³ 0.0% 17%

Table 4 presents the non-hematologic adverse reactions from Trial 4.

Table 4: Non-Hematologic Adverse Reactions in Trial 4

Non-Hematologic Adverse Reaction 10% or Greater DOXIL (%) treated
(n=239)
Topotecan (%) treated
(n=235)
All grades Grades 3-4 All grades Grades 3-4
Body as a Whole
  Asthenia 40 7 52 8
  Fever 21 0.8 31 6
  Mucous Membrane Disorder 14 3.8 3.4 0
  Back Pain 12 1.7 10 0.9
  Infection 12 2.1 6 0.9
  Headache 11 0.8 15 0
Digestive
  Nausea 46 5 63 8
  Stomatitis 41 8 15 0.4
  Vomiting 33 8 44 10
  Diarrhea 21 2.5 35 4.2
  Anorexia 20 2.5 22 1.3
  Dyspepsia 12 0.8 14 0
Nervous
  Dizziness 4.2 0 10 0
Respiratory 
  Pharyngitis 16 0 18 0.4
  Dyspnea 15 4.1 23 4.3
  Cough increased 10 0 12 0
Skin and Appendages
  Hand-foot syndrome 51 24 0.9 0
  Rash 29 4.2 12 0.4
  Alopecia 19 N/A 52 N/A

The following additional adverse reactions were observed in patients with ovarian cancer with doses administered every four weeks (Trial 4).

Incidence 1% to 10%

Cardiovascular: vasodilation, tachycardia, deep vein thrombosis, hypotension, cardiac arrest.

Digestive: oral moniliasis, mouth ulceration, esophagitis, dysphagia, rectal bleeding, ileus.

Hematologic and Lymphatic: ecchymosis.

Metabolic and Nutritional: dehydration, weight loss, hyperbilirubinemia, hypokalemia, hypercalcemia, hyponatremia.

Nervous: somnolence, dizziness, depression.

Respiratory: rhinitis, pneumonia, sinusitis, epistaxis.

Skin and Appendages: pruritus, skin discoloration, vesiculobullous rash, maculopapular rash, exfoliative dermatitis, herpes zoster, dry skin, herpes simplex, fungal dermatitis, furunculosis, acne.

Special Senses: conjunctivitis, taste perversion, dry eyes.

Urinary: urinary tract infection, hematuria, vaginal moniliasis.

Patients With AIDS-Related Kaposi's Sarcoma

The safety data described is based on the experience reported in 753 patients with AIDS-related Kaposi's sarcoma (KS) enrolled in four open-label, uncontrolled trials of DOXIL administered at doses ranging from 10 to 40 mg/m² every 2 to 3 weeks. Demographics of the population were: median age 38.7 years (range 24-70); 99% male; 88% Caucasian, 6% Hispanic, 4% Black, and 2% Asian/other/unknown. The majority of patients were treated with 20 mg/m² of DOXIL every 2 to 3 weeks with a median exposure of 4.2 months (range 1 day to 26.6 months). The median cumulative dose was 120 mg/m² (range 3.3 to 798.6 mg/m²); 3% received cumulative doses of greater than 450 mg/m² .

Disease characteristics were: 61% poor risk for KS tumor burden, 91% poor risk for immune system, and 47% poor risk for systemic illness; 36% were poor risk for all three categories; median CD4 count 21 cells/mm³ (51% less than 50 cells/mm³); mean absolute neutrophil count at study entry approximately 3,000 cells/mm³.

Of the 693 patients with concomitant medication information, 59% were on one or more antiretroviral medications [35% zidovudine (AZT), 21% didanosine (ddI), 16% zalcitabine (ddC), and 10% stavudine (D4T)]; 85% received PCP prophylaxis (54% sulfamethoxazole/trimethoprim); 85% received antifungal medications (76% fluconazole); 72% received antivirals (56% acyclovir, 29% ganciclovir, and 16% foscarnet) and 48% patients received colony-stimulating factors (sargramostim/filgrastim) during their course of treatment.

Adverse reactions led to discontinuation of treatment in 5% of patients with AIDS-related Kaposi's sarcoma and included myelosuppression, cardiac adverse reactions, infusion-related reactions, toxoplasmosis, HFS, pneumonia, cough/dyspnea, fatigue, optic neuritis, progression of a non-KS tumor, allergy to penicillin, and unspecified reasons. Tables 5 and 6 summarize adverse reactions reported in patients treated with DOXIL for AIDS-related Kaposi's sarcoma in a pooled analysis of the four trials.

Table 5: Hematologic Adverse Reactions Reported in Patients With AIDS-Related Kaposi's Sarcoma

  Patients With Refractory or Intolerant AIDS-Related Kaposi’s Sarcoma
(n=74*)
Total Patients With AIDS-Related Kaposi’s Sarcoma
(n=720**)
Neutropenia
   < 1000/mm³ 46% 49%
   < 500/mm³ 11% 13%
Anemia
   < 10 g/dL 58% 55%
   < 8 g/dL 16% 18%
Thrombocytopenia
   < 150,000/mm³ 61% 61%
   < 25,000/mm³ 1.4% 4.2%
*This includes a subset of subjects who were retrospectively identified as having disease progression on prior systemic combination chemotherapy (at least 2 cycles of a regimen containing at least 2 of 3 treatments: bleomycin, vincristine or vinblastine, or doxorubicin) or as being intolerant to such therapy.
**This includes only subjects with AIDS-KS who had available data from the 4 pooled trials.

Table 6: Non-Hematologic Adverse Reactions Reported in ≥ 5% of Patients With AIDS-Related Kaposi's Sarcoma

Adverse Reactions Patients With Refractory or Intolerant AIDS-Related Kaposi’s Sarcoma
(n=77*)
Total Patients With AIDS-Related Kaposi’s Sarcoma
(n=705**)
Nausea 18% 17%
Asthenia 7% 10%
Fever 8% 9%
Alopecia 9% 9%
Alkaline Phosphatase Increase 1.3% 8%
Vomiting 8% 8%
Diarrhea 5% 8%
Stomatitis 5% 7%
Oral Moniliasis 1.3% 6%
*This includes a subset of subjects who were retrospectively identified as having disease progression on prior systemic combination chemotherapy (at least 2 cycles of a regimen containing at least 2 of 3 treatments: bleomycin, vincristine or vinblastine, or doxorubicin) or as being intolerant to such therapy.
**This includes only subjects with AIDS-KS who had available adverse event data from the 4 pooled trials.

The following additional adverse reactions were observed in 705 patients with AIDS-related Kaposi's sarcoma.

Incidence 1% to 5%

Body as a Whole: headache, back pain, infection, allergic reaction, chills.

Cardiovascular: chest pain, hypotension, tachycardia.

Cutaneous: herpes simplex, rash, itching.

Digestive: mouth ulceration, anorexia, dysphagia.

Metabolic and Nutritional: SGPT increase, weight loss, hyperbilirubinemia.

Other: dyspnea, pneumonia, dizziness, somnolence.

Incidence Less Than 1%

Body As A Whole: sepsis, moniliasis, cryptococcosis.

Cardiovascular: thrombophlebitis, cardiomyopathy, palpitation, bundle branch block, congestive heart failure, heart arrest, thrombosis, ventricular arrhythmia.

Digestive: hepatitis.

Metabolic and Nutritional Disorders: dehydration

Respiratory: cough increase, pharyngitis.

Skin and Appendages: maculopapular rash, herpes zoster.

Special Senses: taste perversion, conjunctivitis.

Patients With Multiple Myeloma

The safety data described are from 318 patients treated with DOXIL (30 mg/m²) administered on day 4 following bortezomib (1.3 mg/m² i.v. bolus on days 1, 4 , 8 and 11) every 3 weeks, in a randomized, open-label, multicenter study (Trial 6). In this trial, patients in the DOXIL + bortezomib combination group were treated for a median number of 4.5 months (range 21 days to 13.5 months). The population was 28 to 85 years of age (median age 61), 58% male, 90% Caucasian, 6% Black, and 4% Asian and Other. Table 7 lists adverse reactions reported in 10% or more of patients treated with DOXIL in combination with bortezomib for multiple myeloma.

Table 7: Frequency of Treatment-Emergent Adverse Reactions Reported in ≥ 10% Patients Treated for Multiple Myeloma With DOXIL in Combination With Bortezomib

  DOXIL + bortezomib
(n=318)
Bortezomib
(n=318)
Any (%) Grade 3-4 Any (%) Grade 3-4
Blood and lymphatic system disorders
  Neutropenia 36 32 22 16
  Thrombocytopenia 33 24 28 17
  Anemia 25 9 21 9
General disorders and administration site conditions
  Fatigue 36 7 28 3
  Pyrexia 31 1 22 1
  Asthenia 22 6 18 4
Gastrointestinal disorders
  Nausea 48 3 40 1
  Diarrhea 46 7 39 5
  Vomiting 32 4 22 1
  Constipation 31 1 31 1
  Mucositis/Stomatitis 20 2 5 < 1
  Abdominal pain 11 1 8 1
Infections and infestations
  Herpes zoster 11 2 9 2
  Herpes simplex 10 0 6 1
  Investigations Weight decreased 12 0 4 0
Metabolism and Nutritional disorders
  Anorexia 19 2 14 < 1
Nervous system disorders
  Peripheral Neuropathy1 42 7 45 11
  Neuralgia 17 3 20 4
  Paresthesia/dysesthesia 13 < 1 10 0
Respiratory, thoracic and mediastinal disorders
  Cough 18 0 12 0
Skin and subcutaneous tissue disorders
  Rash2 22 1 18 1
  Hand-foot syndrome 19 6 < 1 0
1Peripheral neuropathy includes the following adverse reactions: peripheral sensory neuropathy, neuropathy peripheral, polyneuropathy, peripheral motor neuropathy, and neuropathy NOS.
2Rash includes the following adverse reactions: rash, rash erythematous, rash macular, rash maculo-papular, rash pruritic, exfoliative rash, and rash generalized.

Postmarketing Experience

The following additional adverse reactions have been identified during post approval use of DOXIL. 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

Secondary oral neoplasms: [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Doxil (Doxorubicin Hcl Liposome Injection)

Doxil - User Reviews

Doxil User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Doxil sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

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


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