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Camptosar spacer Pharmacia & Upjohn

WEEKLY DOSING

125 mg/m2, Weekly x4 CAMPTOSAR® Injection

weeklygraph

Omit dosage, then arrow50 mg/m2 when resolved to = or < grade 2

Recommended Dosage Modifications*

A new course of therapy should not begin until the granulocyte count has recovered to ≥1,500/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 CAMPTOSAR.

Toxicity: NCI Grade† (value)

During a Course of Therapy

At the Start of Subsequent Courses of Therapy&8225;

No Toxicity

Maintain dosage level

arrow25 mg/m2 to a maximum of 150 mg/m2

Neutropenia

1 (1,500 to 1,999/mm3)

Maintain dosage level

Maintain dosage level

2 (1,000 to 1,499/mm3)

arrow25 mg/m2

Maintain dosage level

3 (500 to 999/mm3)

Omit dosage, then arrow25 mg/m2 when resolved to = or < grade 2

25 mg/m2

4 (<500/mm3)

arrow50 mg/m2

Neutropenic Fever

Omit dosage, then arrow50 mg/m2 when resolved

arrow50 mg/m2

Other Hematologic Toxicities

Dosage modifications for leukopenia or thrombocytopenia during a course of therapy and at start of subsequent courses of therapy are also based on NCI Common Toxicity Criteria and are the same as recommended for neutropenia above.


Diarrhea

1 (2-3 stools/day > pretreatment)

Maintain dosage level

Maintain dosage level

2 (4-6 stools/day > pretreatment)

arrow25 mg/m2

Maintain dosage level

3 (7-9 stools/day > pretreatment) to = or < grade 2

Omit dose, then arrow25 mg/m2 when resolved

arrow25 mg/m2

4 (≥10 stools/day > pretreatment)

Omit dose, then arrow50 mg/2 when resolved to = or < grade 2

arrow50 mg/m2

Other Nonhematologic Toxicities

1

Maintain dosage level

Maintain dosage level

2

arrow25 mg/m2

arrow25 mg/m2

3

Omit dose, then arrow25 mg/m2 when resolved to = or < grade 2

arrow25 mg/m2

4

Omit dose, then arrow50 mg/m2 when resolved to = or < grade 2

arrow50 mg/m2

* All dosage modifications should be based on the worst preceding toxicity.
† NCI Common Toxicity Criteria version 2.0, Final 1/30/98, NCI revised 3/23/98.
&8225; Refers to initial dose used in previous course.

ONCE-EVERY-3-WEEK DOSING

350 mg/m2, Once-Every-3-Weeks CAMPTOSAR® Injection

triweeklygraph

Recommended Dosage Modifications*

A new course of therapy should not begin until the granulocyte count has recovered to greaterthan1,500/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 CAMPTOSAR.

Toxicity: NCI GradeÝ (value)

At the Start of Subsequent Courses of Therapy

No Toxicity

Maintain dosage level

1 (1,500 to 1,999/mm3)

Maintain dosage level

2 (1,000 to 1,499/mm3)

Maintain dosage level

3 (500 to 999/mm3)

arrow50 mg/m2

4 (<500/mm3)

arrow50 mg/m2

Neutropenic Fever

arrow50 mg/m2

Other Hematologic Toxicities

Dosage modifications for leukopenia or thrombocytopenia at the start of subsequent courses of therapy are also based on NCI Common Toxicity Criteria and are the same as recommended for neutropenia above.

Diarrhea

1 (2-3 stools/day > pretreatment)

Maintain dosage level

2 (4-6 stools/day > pretreatment)

Maintain dosage level

3 (7-9 stools/day > pretreatment)

arrow50 mg/m2

4 (≥10 stools/day > pretreatment)

arrow50 mg/m2

Other Nonhematologic Toxicities

1

Maintain dosage level

2

arrow 50 mg/m2

3

arrow 50 mg/m2

4

arrow 50 mg/m2

* All dosage modifications should be based on the worst preceding toxicity.
Ý NCI Common Toxicity Criteria version 2.0, Final 1/30/98, NCI revised 3/23/98.

Camptosar



Pharmacia & Upjohn Yakult Daiichi

Revised September 1998


USX 2030.00 January 1999

 

Full Prescribing Information

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