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Camptosar
Pharmacia & Upjohn

WEEKLY DOSING

125 mg/m2, Weekly x4 CAMPTOSAR® Injection

Omit dosage, then 50 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

No Toxicity

Maintain dosage level

25 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)

25 mg/m2

Maintain dosage level

3 (500 to 999/mm3)

Omit dosage, then 25 mg/m2 when resolved to = or < grade 2

25 mg/m2

4 (<500/mm3)

50 mg/m2

Neutropenic Fever

Omit dosage, then 50 mg/m2 when resolved

50 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)

25 mg/m2

Maintain dosage level

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

Omit dose, then 25 mg/m2 when resolved

25 mg/m2

4 (10 stools/day > pretreatment)

Omit dose, then 50 mg/2 when resolved to = or < grade 2

50 mg/m2

Other Nonhematologic Toxicities

1

Maintain dosage level

Maintain dosage level

2

25 mg/m2

25 mg/m2

3

Omit dose, then 25 mg/m2 when resolved to = or < grade 2

25 mg/m2

4

Omit dose, then 50 mg/m2 when resolved to = or < grade 2

50 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.
Refers to initial dose used in previous course.

ONCE-EVERY-3-WEEK DOSING

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

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)

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)

50 mg/m2

4 (<500/mm3)

50 mg/m2

Neutropenic Fever

50 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)

50 mg/m2

4 (10 stools/day > pretreatment)

50 mg/m2

Other Nonhematologic Toxicities

1

Maintain dosage level

2

50 mg/m2

3

50 mg/m2

4

50 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.

Camptosar


Pharmacia & Upjohn Yakult Daiichi

Revised September 1998


USX 2030.00 January 1999

 

Full Prescribing Information

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