Management of Side Effects

For Weekly or Once-Every-3-Week Dosage Schedules

What to expect

• Patient may experience one or more of the following symptoms:

- Early-onset diarrhea - Contraction of pupils - Lacrimation - Flushing

- Rhinitis - Increased salivation - Diaphoresis - Abdominal cramping

• Symptoms occur during or shortly after administration of Camptosar and are expected to occur more frequently at higher doses.
• Symptoms are usually transient and only infrequently severe.

How to treat

• Administer 0.25 to 1.0 mg of intravenous or subcutaneous atropine (unless clinically contraindicated) which should result in prompt resolution of symptoms.
• Consider prophylactic administration of atropine prior to subsequent doses of Camptosar at discretion of physician.

What to expect

• Generally occurs more than 24 hours after administration of Camptosar and may be severe.
• Median time to onset after Day 1 of current course of Camptosar:
  - Weekly schedule = 11 days
  - Once-Every-3-Week schedule = 5 days
• Can be prolonged, may lead to dehydration and electrolyte imbalance, and can be life-threatening.

How to treat

• Treat promptly with loperamide:
  - At the first episode of poorly formed or loose stools or the earliest onset of bowel movements more frequent than normally expected for the patient, instruct patient to take 2 caplets (4 mg) of Imodium A-D (loperamide HCl). Then take 1 caplet (2 mg) every 2 hours until the patient is diarrhea-free (no bowel movements) for 12 hours. During the night, instruct patient to take 2 caplets (4 mg) of Imodium A-D every 4 hours. Patient should also be instructed to notify the physician's office if diarrhea occurs.
• Carefully monitor patients with Grade 3 or 4 diarrhea. If patient becomes dehydrated, give fluid and electrolyte replacement. Delay administration of Camptosar until the patient recovers and modify subsequent doses. (See Treatment Options).
• Patients with concomitant occurrences of Grade 3 or 4 diarrhea and Grade 3 or 4 neutropenia should be treated aggressively (IV hydration, loperamide, oral antibiotics). Modify dose. (See Treatment Options).

What to expect

• Camptosar is emetogenic.
• When observed, nausea and vomiting usually occur during or shortly after administration of Camptosar. However, delayed-onset nausea and vomiting may also occur.

How to treat

• Premedication with antiemetic agents is recommended.
• In clinical studies of the weekly dosage schedule, the majority of patients received 10 mg dexamethasone in conjunction with another type of antiemetic agent, such as a 5-HT³ blocker.
• Antiemetic agents should be given on the day of treatment, starting at least 30 minutes before the administration of Camptosar.
• The administration of prochlorperazine on the same day as Camptosar has been associated with a higher incidence of akathisia.
• If patient experiences protracted nausea and vomiting after administration of Camptosar, patients should be instructed to take scheduled oral prophylactic antiemetic agents for 48 to 72 hours following administration of subsequent courses of Camptosar.

What to expect

• Among patients on the weekly schedule, Grade 3 or 4 neutropenia has been found to be significantly higher in patients with previous pelvic/abdominal irradiation and in patients with modestly elevated baseline serum total bilirubin levels ( 1.0 mg/dL).
• Deaths due to sepsis following severe myelosuppression have been reported.

How to treat

• Careful monitoring of the white blood cell count with differential is recommended before each dose of Camptosar.
• Therapy with Camptosar should be temporarily omitted if neutropenic fever occurs or if the absolute neutrophil count drops below 1000/mm³. After the patient recovers, subsequent doses of Camptosar should be reduced depending upon the level of myelosuppression observed. (See Treatment Options).
• Routine administration of colony-stimulating factor (CSF) is not necessary; but, in individual patients experiencing significant neutropenia, physicians may wish to consider CSF use.

© 1998 Pharmacia & Upjohn Company	USX 2288.00 December 1998	Immodium A-D is a registered trademark of Janssen/McNeil Consumer Products

Full Prescribing Information

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