"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
Advise the patient of the following:
- Inform patients of the possibility of myelosuppression, immunosuppression, and infections. Explain the need for routine blood cell counts. Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever [see WARNINGS AND PRECAUTIONS
- Advise the patient to report urinary symptoms (patients should report if their urine has turned a pink or red color) and the need for increasing fluid intake and frequent voiding [see WARNINGS AND PRECAUTIONS].
- Advise patients to contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see WARNINGS AND PRECAUTIONS].
- Warn patients of the possibility of developing non-infectious pneumonitis. Advise patients to report promptly any new or worsening respiratory symptoms [see WARNINGS AND PRECAUTIONS].
- Advise female patients of reproductive potential to use highly effective contraception during treatment and for up to 1 year after completion of therapy. There is a potential for harm to a fetus if a patient becomes pregnant during this period. Patients should immediately contact their healthcare provider if they become pregnant or if pregnancy is suspected during this period [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].
- Advise male patients who are sexually active with a female partner who is or may become pregnant to use condoms during treatment and for up to 4 months after completion of therapy. There is a potential for harm to a fetus if a patient fathers a child during this period. Patients should immediately contact their healthcare provider if their female partner becomes pregnant or if pregnancy is suspected during this period [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].
- Advise nursing mothers treated with Cytoxan (cyclophosphamide) to discontinue nursing or discontinue cyclophosphamide, taking into account the importance of the drug to the mother [see Use In Specific Populations].
- Explain to patients that side effects such as nausea, vomiting, stomatitis, impaired wound healing, amenorrhea, premature menopause, sterility and hair loss may be associated with cyclophosphamide administration. Other undesirable effects (including, e.g., dizziness, blurred vision, visual impairment) could affect the ability to drive or use machines [see ADVERSE REACTIONS].
- Instruct the patient to swallow cyclophosphamide tablets whole. Do not cut, chew, or crush tablets [see DOSAGE AND ADMINISTRATION].
- Advise caregivers to wear gloves when handling bottles containing cyclophosphamide tablets and avoid exposure to broken tablets. If contact with broken tablets occurs, wash hands immediately and thoroughly [see DOSAGE AND ADMINISTRATION].
Last reviewed on RxList: 6/13/2013
This monograph has been modified to include the generic and brand name in many instances.
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