Prezista

Prezista Patient Counseling Information

darunavir

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Full Prescribing Info
Patient Counseling Information
Information About Therapy with PREZISTA: PREZISTA is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using PREZISTA.
Patients should be advised to avoid doing things that can spread HIV-1 infection to others.
Do not share needles or other injection equipment.
Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
Do not breastfeed. It is not known if PREZISTA can be passed to the baby through breast milk and whether it could harm the baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.
Instructions for Use: Patients should be advised to take PREZISTA and ritonavir (NORVIR) with food every day as prescribed. Patients should be instructed to swallow whole tablets with a drink such as water or milk. PREZISTA must always be used with ritonavir (NORVIR) in combination with other antiretroviral drugs. Patients should not alter the dose of either PREZISTA or ritonavir (NORVIR), discontinue ritonavir (NORVIR), or discontinue therapy with PREZISTA without consulting their physician.
Patients Taking PREZISTA Once Daily: If a patient misses a dose of PREZISTA or ritonavir (NORVIR) by more than 12 hours, the patient should be told to wait and then take the next dose of PREZISTA and ritonavir (NORVIR) at the regularly scheduled time. If the patient misses a dose of PREZISTA or ritonavir (NORVIR) by less than 12 hours, the patient should be told to take PREZISTA and ritonavir (NORVIR) immediately, and then take the next dose of PREZISTA and ritonavir (NORVIR) at the regularly scheduled time. If a dose of PREZISTA or ritonavir (NORVIR) is skipped, the patient should not double the next dose. Inform the patient that he or she should not take more or less than the prescribed dose of PREZISTA or ritonavir (NORVIR).
Patients Taking PREZISTA Twice Daily: If a patient misses a dose of PREZISTA or ritonavir (NORVIR) by more than 6 hours, the patient should be told to wait and then take the next dose of PREZISTA and ritonavir (NORVIR) at the regularly scheduled time. If the patient misses a dose of PREZISTA or ritonavir (NORVIR) by less than 6 hours, the patient should be told to take PREZISTA and ritonavir (NORVIR) immediately, and then take the next dose of PREZISTA and ritonavir (NORVIR) at the regularly scheduled time. If a dose of PREZISTA or ritonavir (NORVIR) is skipped, the patient should not double the next dose. Inform the patient that he or she should not take more or less than the prescribed dose of PREZISTA or ritonavir (NORVIR).
Hepatotoxicity: Patients should be informed that Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA co-administered with 100 mg of ritonavir. Monitor liver function before and during therapy, especially in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases. Post-marketing cases of liver injury, including some fatalities, have been reported. Patients should be advised about the signs and symptoms of liver problems. These may include jaundice of the skin or eyes, dark (tea colored) urine, pale colored stools, nausea, vomiting, loss of appetite, or pain, aching or sensitivity in the right upper quadrant of the abdomen.
Severe Skin Reactions: Patients should be informed that skin reactions ranging from mild to severe, including Stevens-Johnson Syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, have been reported with PREZISTA co-administered with 100 mg of ritonavir. Patients should be advised to discontinue PREZISTA/ritonavir immediately if signs or symptoms of severe skin reactions develop. These can include but are not limited to severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
Drug Interactions: PREZISTA/ritonavir may interact with many drugs; therefore, patients should be advised to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products, including St. John's wort.
Patients receiving estrogen-based contraceptives should be instructed to use alternate contraceptive measures during therapy with PREZISTA/ritonavir because hormonal levels may decrease.
Fat Redistribution: Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy, including PREZISTA/ritonavir, and that the cause and long-term health effects of these conditions are not known at this time.
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