DOXIL PI PDF

For neuropathic pain or peripheral neuropathy, no dosage adjustments are required for Doxil. Administration Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if a precipitate or foreign matter is present. Do not use with in-line filters.

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For neuropathic pain or peripheral neuropathy, no dosage adjustments are required for doxorubicin hydrochloride liposome injection. Administration Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not use if a precipitate or foreign matter is present. Do not use with in-line filters. If no infusion-related adverse reactions are observed, increase the infusion rate to complete the administration of the drug over one hour [see Warnings and Precautions 5. Do not rapidly flush the infusion line.

Do not mix doxorubicin hydrochloride liposome injection with other drugs. Management of Suspected Extravasation Discontinue doxorubicin hydrochloride liposome injection for burning or stinging sensation or other evidence indicating perivenous infiltration or extravasation. Manage confirmed or suspected extravasation as follows: Do not remove the needle until attempts are made to aspirate extravasated fluid Do not flush the line Avoid applying pressure to the site Apply ice to the site intermittently for 15 min 4 times a day for 3 days If the extravasation is in an extremity, elevate the extremity Procedure for Proper Handling and Disposal Doxorubicin hydrochloride liposome injection is a cytotoxic drug.

Follow applicable special handling and disposal procedures. The drug product appears as a translucent, red liposomal dispersion. Contraindications Doxorubicin hydrochloride liposome injection is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see Warnings and Precautions 5.

Warnings and Precautions Cardiomyopathy Doxorubicin hydrochloride can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy with doxorubicin hydrochloride is generally proportional to the cumulative exposure. Include prior use of other anthracyclines or anthracenediones in calculations of cumulative dose.

The risk of cardiomyopathy may be increased at lower cumulative doses in patients with prior mediastinal irradiation. Two percent of patients developed signs and symptoms of congestive heart failure without documented evidence of cardiomyopathy. Assess left ventricular cardiac function e. MUGA or echocardiogram prior to initiation of doxorubicin hydrochloride liposome injection, during treatment to detect acute changes, and after treatment to detect delayed cardiomyopathy.

Administer doxorubicin hydrochloride liposome injection to patients with a history of cardiovascular disease only when the potential benefit of treatment outweighs the risk.

Infusion-Related Reactions Serious, life-threatening, and fatal infusion-related reactions characterized by one or more of the following symptoms can occur with doxorubicin hydrochloride liposome injection: flushing, shortness of breath, facial swelling, headache, chills, chest pain, back pain, tightness in the chest and throat, fever, tachycardia, pruritus, rash, cyanosis, syncope, bronchospasm, asthma, apnea, and hypotension.

All occurred during cycle 1 and none during subsequent cycles. The majority of infusion-related events occurred during the first infusion. Ensure that medications to treat infusion-related reactions and cardiopulmonary resuscitative equipment are available for immediate use prior to initiation of doxorubicin hydrochloride liposome injection. Withhold doxorubicin hydrochloride liposome injection for Grade 1, 2, or 3 infusion-related reactions and resume at a reduced infusion rate.

Discontinue doxorubicin hydrochloride liposome injection for serious or life-threatening infusion-related reactions. HFS or other skin toxicity required discontinuation of doxorubicin hydrochloride liposome injection in 4.

HFS was generally observed after 2 or 3 cycles of treatment but may occur earlier. Delay doxorubicin hydrochloride liposome injection for the first episode of Grade 2 or greater HFS [see Dosage and Administration 2. Discontinue doxorubicin hydrochloride liposome injection if HFS is severe and debilitating.

Secondary Oral Neoplasms Secondary oral cancers, primarily squamous cell carcinoma, have been reported from postmarketing experience in patients with long-term more than one year exposure to doxorubicin hydrochloride liposome injection. These malignancies were diagnosed both during treatment with doxorubicin hydrochloride liposome injection and up to 6 years after the last dose.

Examine patients at regular intervals for the presence of oral ulceration or with any oral discomfort that may be indicative of secondary oral cancer.

The altered pharmacokinetics and preferential tissue distribution of liposomal doxorubicin that contributes to enhanced skin toxicity and mucositis compared to free doxorubicin may play a role in the development of oral secondary malignancies with long-term use. Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, doxorubicin hydrochloride liposome injection can cause fetal harm when administered to a pregnant woman; avoid the use of doxorubicin hydrochloride liposome injection during the 1st trimester.

Available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of doxorubicin hydrochloride during the 2nd and 3rd trimesters. At doses approximately 0. Advise pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use effective contraception during and for 6 months after treatment with doxorubicin hydrochloride liposome injection [see Use in Specific Populations 8.

Adverse Reactions The following adverse reactions are discussed in more detail in other sections of the labeling. Cardiomyopathy [see Warnings and Precautions 5. In this trial, patients received doxorubicin hydrochloride liposome injection for a median number of 3.

Table 3 presents the hematologic adverse reactions from Trial 4.

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