"The U.S. Food and Drug Administration today approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.
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Discuss the following with patients prior to treatment with VELCADE:
Ability to Drive or Operate Machinery or Impairment of Mental Ability: VELCADE may cause fatigue, dizziness, syncope, orthostatic/postural hypotension. Advise patients not to drive or operate machinery if they experience any of these symptoms.
Dehydration/Hypotension: Patients receiving VELCADE therapy may experience vomiting and/or diarrhea. Advise patients how to avoid dehydration. Instruct patients to seek medical advice if they experience symptoms of dizziness, light headedness or fainting spells, or muscle cramps.
Pregnancy/Nursing: Advise patients to use effective contraceptive measures to prevent pregnancy during treatment with VELCADE. Instruct patients to report pregnancy to their physicians immediately. Advise patients that they should not receive VELCADE while pregnant or breast-feeding. If a patient wishes to restart breastfeeding after treatment, she should be advised to discuss the appropriate timing with her physician.
Concomitant Medications: Advise patients to speak with their physicians about any other medication they are currently taking.
Diabetic Patients: Advise patients to check their blood sugar frequently if using an oral antidiabetic medication and to notify their physicians of any changes in blood sugar level.
Peripheral Neuropathy and Nervous System: Advise patients to contact their physicians if they experience new or worsening symptoms of peripheral neuropathy such as tingling, numbness, pain, a burning feeling in the feet or hands, or weakness in the arms or legs. Advise patients to contact their physicians if they experience symptoms possibly indicative of PRES [see WARNINGS AND PRECAUTIONS] or PML, such as convulsion, persistent headache, reduced eyesight, blurred vision, confusion, lethargy, altered ability to think, or difficulty walking.
Cardiac: Advise patients to contact their physicians if they experience swelling of the feet, ankles, or legs or other heart-related problems [see WARNINGS AND PRECAUTIONS].
Respiratory: Advise patients to contact their physicians if they experience shortness of breath, cough, or other lung problems [see WARNINGS AND PRECAUTIONS].
Dermal: Advise patients to contact their physicians if they experience rash, severe injection site reactions [see DOSAGE AND ADMINISTRATION], or skin pain. Discuss with patients the option for antiviral prophylaxis for herpes virus infection [see Clinical Trials Safety Experience].
Other: Instruct patients to contact their physicians if they develop an increase in blood pressure, bleeding, fever, constipation, or decreased appetite.
Last reviewed on RxList: 10/16/2014
This monograph has been modified to include the generic and brand name in many instances.
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