Doxorubicin Hydrochloride

DOXORUBICIN HYDROCHLORIDE- doxorubicin hydrochloride injectable, liposomal
BluePoint Laboratories

WARNING: CARDIOMYOPATHY and INFUSION-RELATED REACTIONS

Doxorubicin hydrochloride can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 mg/m2 to 550 mg/m2. Assess left ventricular cardiac function prior to initiation of doxorubicin hydrochloride liposome injection and during treatment, and after treatment (5.1)
Serios, life-threatening, and fatal infusion-related reactions can occur with doxorubicin hydrochloride liposome injection. Acute infusion-related reactions occurred in 11% of patients with solid tumors. Withhold doxorubicin hydrochloride for infusion-related reactions and resume at a reduced rate. Discontinue doxorubicin hydrochloride liposome injection infusion for serious or life-threatening infusion-related reactions (5.2)].

1 INDICATIONS AND USAGE

1.1 Ovarian Cancer

Doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

1.2 AIDS-Related Kaposi’s Sarcoma

Doxorubicin hydrochloride liposome injection is indicated for the treatment of AIDS-related Kaposi’s sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.

1.3 Multiple Myeloma

Doxorubicin hydrochloride liposome injection, 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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Use Information

Do not substitute doxorubicin hydrochloride liposome injection for other doxorubicin hydrochloride products.

Do not administer as an undiluted suspension or as an intravenous bolus [see Warnings and Precautions (5.2)].

2.2 Ovarian Cancer

The recommended dose of doxorubicin hydrochloride liposome injection is 50 mg/m 2 intravenously over 60 minutes every 28 days until disease progression or unacceptable toxicity.

2.3 AIDS-Related Kaposi’s Sarcoma

The recommended dose of doxorubicin hydrochloride liposome injection is 20 mg/m2 intravenously over 60 minutes every 21 days until disease progression or unacceptable toxicity.

2.4 Multiple Myeloma

The recommended dose of doxorubicin hydrochloride liposome injection is 30 mg/m2 intravenously over 60 minutes on day 4 of each 21-day cycle for eight cycles or until disease progression or unacceptable toxicity. Administer doxorubicin hydrochloride liposome injection after bortezomib on day 4 of each cycle [see Clinical Studies (14.3)].

2.5 Dose Modifications for Adverse Reactions

Do not increase doxorubicin hydrochloride liposome injection after a dose reduction for toxicity.

Table 1: Recommended Dose Modifications for Hand-Foot Syndrome, Stomatitis, or Hematologic Adverse Reactions

Toxicity

Dose Adjustment

Hand-Foot Syndrome (HFS)

Grade 1: Mild erythema, swelling, or desquamation not interfering with daily activities

• If no previous Grade 3 or 4 HFS: no dose adjustment. • If previous Grade 3 or 4 HFS: delay dose up to 2 weeks, then decrease dose by 25%.

Grade 2: Erythema, desquamation, or swelling interfering with, but not precluding normal physical activities; small blisters or ulcerations less than 2 cm in diameter

Delay dosing up to 2 weeks or until resolved to Grade 0-1. Discontinue doxorubicin hydrochloride liposome injection if no resolution after 2 weeks. • If resolved to Grade 0-1 within 2 weeks: o And no previous Grade 3 or 4 HFS: continue treatment at previous dose. o And previous Grade 3 or 4 toxicity: decrease dose by 25%.

Grade 3: Blistering, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing

Delay dosing up to 2 weeks or until resolved to Grade 0-1, then decrease dose by 25%.•Discontinue doxorubicin hydrochloride liposome injection if no resolution after 2 weeks.

Grade 4: Diffuse or local process causing infectious complications, or a bed ridden state or hospitalization

Delay dosing up to 2 weeks or until resolved to Grade 0-1, then decrease dose by 25%. •Discontinue doxorubicin hydrochloride liposome injection if no resolution after 2 weeks.

Stomatitis

Grade 1: Painless ulcers, erythema, or mild soreness

• If no previous Grade 3 or 4 toxicity: no dose adjustment.

• If previous Grade 3 or 4 toxicity: delay up to 2 weeks then decrease dose by 25%.

Grade 2: Painful erythema, edema, or ulcers, but can eat

Delay dosing up to 2 weeks or until resolved to Grade 0-1. • Discontinue doxorubicin hydrochloride liposome injection if there is no resolution after 2 weeks.• If resolved to Grade 0-1 within 2 weeks: o And no previous Grade 3 or 4 stomatitis: resume treatment at previous dose. o And previous Grade 3 or 4 toxicity: decrease dose by 25%.

Grade 3: Painful erythema, edema, or ulcers, and cannot eat

Delay dosing up to 2 weeks or until resolved to Grade 0-1. Decrease dose by 25% and return to original dose interval. • If after 2 weeks there is no resolution, discontinue doxorubicin hydrochloride liposome injection.

Grade 4: Requires parenteral or enteral support

Delay dosing up to 2 weeks or until resolved to Grade 0-1. Decrease dose by 25% and return to original dose interval.

• If after 2 weeks there is no resolution, discontinue doxorubicin hydrochloride liposome injection.

Neutropenia or Thrombocytopenia

Grade 1

No dose reduction

Grade 2

Delay until ANC ≥ 1,500 and platelets ≥ 75,000; resume treatment at previous dose

Grade 3

Delay until ANC ≥ 1,500 and platelets ≥ 75,000; resume treatment at previous dose

Grade 4

Delay until ANC ≥ 1,500 and platelets ≥ 75,000; resume at 25% dose reduction or continue previous dose with prophylactic granulocyte growth factor

Table 2: Recommended Dose Modifications of Doxorubicin Hydrochloride Liposome Injection for Toxicity When Administered in Combination With Bortezomib

Toxicity

Doxorubicin Hydrochloride Liposome Injection

Fever ≥38°C and ANC <1,000/mm3

• Withhold dose for this cycle if before Day 4;

• Decrease dose by 25%, if after Day 4 of previous cycle.

On any day of drug administration after Day 1 of each cycle: • Platelet count <25,000/mm3 • Hemoglobin <8 g/dL • ANC <500/mm3

• Withhold dose for this cycle if before Day 4;

• Decrease dose by 25%, if after Day 4 of previous cycle AND if bortezomib is reduced for hematologic toxicity.

Grade 3 or 4 non-hematologic drug related toxicity

Do not dose until recovered to Grade <2, then reduce dose by 25%.

For neuropathic pain or peripheral neuropathy, no dosage adjustments are required for doxorubicin hydrochloride liposome injection. Refer to bortezomib manufacturer’s prescribing information.

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