Irinotecan Hydrochloride 40 Mg/2 ML

IRINOTECAN HYDROCHLORIDE 40 MG/2 ML- irinotecan hydrochloride injection
Armas Pharmaceuticals Inc.

WARNING

FULL PRESCRIBING INFORMATION

WARNING: DIARRHEA and MYELOSUPPRESSION

  • Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt Irinotecan hydrochloride injection and reduce subsequent doses if severe diarrhea occurs.
  • Severe myelosuppression may occur.

1 INDICATIONS AND USAGE

• Irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

2 DOSAGE AND ADMINISTRATION

2.2 Colorectal Single Agent Regimens 1 and 2

Administer irinotecan hydrochloride injection as a 90-minute intravenous infusion. The currently recommended regimens are shown in Table 3.

A reduction in the starting dose by one dose level of irinotecan hydrochloride injection may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels. Dosing for patients with bilirubin >2 mg/dL cannot be recommended because there is insufficient information to recommend a dose in these patients.

Table 3. Single-Agent Regimens of irinotecan hydrochloride injection and Dose Modifications
a Subsequent doses may be adjusted as high as 150 mg/m2  or to as low as 50 mg/m2  in 25 to 50 mg/m2  decrements depending upon individual patient tolerance.
b Subsequent doses may be adjusted as low as 200 mg/m2 in 50 mg/m2 decrements depending upon individual patient tolerance.
c Provided intolerable toxicity does not develop, treatment with additional cycles may be continued indefinitely as long as patients continue to experience clinical benefit.

Regimen 1

(weekly)a

125 mg/m2 intravenous infusion over 90 minutes, days 1,8,15,22 then 2-week rest

Starting Dose and Modified Dose Levelsc (mg/m2)

Starting Dose

Dose Level -1

Dose Level -2

125

100

75

Regimen 2

(every 3 weeks)b

350 mg/m2 intravenous infusion over 90 minutes, once every 3 weeks c

Starting Dose and Modified Dose Levels (mg/m2)

Starting Dose

Dose Level -1

Dose Level -2

350

300

250

Dose Modifications

Based on recommended dose-levels described in Table 3, Single-Agent Regimens of irinotecan hydrochloride injection and Dose Modifications, subsequent doses should be adjusted as suggested in Table 4, Recommended Dose Modifications for Single-Agent Schedules. All dose modifications should be based on the worst preceding toxicity.

Table 4: Recommended Dose Modifications For Single-Agent Schedulesa
a  All dose modifications should be based on the worst preceding toxicity
b National Cancer Institute Common Toxicity Criteria (version 1.0)
c Pretreatment
d Excludes alopecia, anorexia, asthenia

A new cycle of therapy should not begin until the granulocyte count has recovered to ≥1500/mm3 , and the platelet count

has recovered to ≥100,000/mm3 , and treatment-related diarrhea is fully resolved. Treatment should be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicities. If the patient has not recovered after a 2-week delay, consideration should be given to discontinuing irinotecan hydrochloride injection.

Worst Toxicity NCI Grade b (Value)

During a Cycle of Therapy

At the Start of the Next Cycles of Therapy (After

Adequate Recovery), Compared with the Starting Dose in the Previous Cycle a

Weekly

Weekly

Once Every 3

Weeks

No toxicity

Maintain dose level

↑ 25 mg/m2 up to a maximum dose of 150 mg/m2

Maintain dose

level

Neutropenia

1 (1500 to 1999/mm3)

Maintain dose level

Maintain dose level

Maintain dose

level

2 (1000 to 1499/mm3)

↓ 25 mg/m2

Maintain dose level

Maintain dose

level

3 (500 to 999/mm3)

Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m2

↓ 25 mg/m2

↓ 50 mg/m2

4 (<500/mm3)

Omit dose until resolved to ≤ grade 2, then ↓ 50 mg/m2

↓ 50 mg/m2

↓ 50 mg/m2

Neutropenic fever

Omit dose until resolved, then ↓ 50 mg/m2 when resolved

↓ 50 mg/m2

↓ 50 mg/m2

Other hematologic

toxicities

Dose modifications for leukopenia, thrombocytopenia, and anemia during a cycle of therapy

and at the start of subsequent cycles of therapy are also based on NCI toxicity criteria and are the same as recommended for neutropenia above.

Diarrhea

1 (2–3 stools/day > pretxc)

Maintain dose level

Maintain dose level

Maintain dose

level

2 (4–6 stools/day > pretx)

↓ 25 mg/m2

Maintain dose level

Maintain dose

level

3 (7–9 stools/day > pretx)

Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m2

↓ 25 mg/m2

↓ 50 mg/m2

4 (≥10 stools/day >

pretx)

Omit dose until resolved to ≤ grade 2 then ↓ 50 mg/m2

↓ 50 mg/m2

↓ 50 mg/m2

Other nonhematologicd toxicities

1

Maintain dose level

Maintain dose level

Maintain dose level

2 ↓ 25 mg/m2 ↓ 25 mg/m2 ↓ 50 mg/m2
3 Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m2 ↓ 25 mg/m2 ↓ 50 mg/m2

4

Omit dose until resolved to ≤ grade 2, then ↓ 50 mg/m2

↓ 50 mg/m2

↓ 50 mg/m2

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