17 PATIENT COUNSELING INFORMATION
- Patients and caregivers should be informed of gastrointestinal complications, such as nausea, vomiting, abdominal cramping, and diarrhea. Patients should have loperamide readily available to begin treatment for late diarrhea (generally occurring more than 24 hours after administration of CAMPTOSAR). Begin loperamide at the first episode of poorly formed or loose stools or the earliest onset of bowel movements more frequent than normal. One dosage regimen for loperamide is 4 mg at the first onset of late diarrhea and then 2 mg every 2 hours until the patient is diarrhea-free for at least 12 hours. Loperamide is not recommended to be used for more than 48 consecutive hours at these doses, because of the risk of paralytic ileus. During the night, the patient may take 4 mg of loperamide every 4 hours. Patients should contact their physician if any of the following occur: diarrhea for the first time during treatment; black or bloody stools; symptoms of dehydration such as lightheadedness, dizziness, or faintness; inability to take fluids by mouth due to nausea or vomiting; or inability to get diarrhea under control within 24 hours.
- Patients should be warned about the potential for dizziness or visual disturbances which may occur within 24 hours following the administration of CAMPTOSAR.
- Explain the significance of routine blood cell counts. Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever or infection.
- Embryo-Fetal Toxicity [see Warnings and Precautions (5.9), Use in Specific Populations (8.1, 8.3), Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1)]
- Advise pregnant women and females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy.
- Advise females of reproductive potential to use effective contraception during treatment with CAMPTOSAR and for 6 months after the final dose.
- Advise male patients with female partners of reproductive potential to use condoms during treatment and for 3 months after the final dose of CAMPTOSAR.
- Lactation
- Advise women not to breastfeed during treatment with CAMPTOSAR and for at least 7 days after the final dose [see Use in Specific Populations (8.2)].
- Infertility
- Advise females and males of reproductive potential that CAMPTOSAR may impair fertility [see Use in Specific Populations (8.3)].
- Patients should be alerted to the possibility of alopecia.
- Contains sorbitol.