Indication
APTIVUS is indicated for use in HIV infected patients who are treatment-experienced and infected with HIV strains resistant to more than one protease inhibitor (PI). APTIVUS must be used in combination with at least 2 other anti-HIV medicines.
This indication is based on the results of the viral load levels in 2 controlled studies of APTIVUS during 48 weeks in treatment experienced adult patients. Both studies? patients had advanced HIV infection and had used 3 classes of anti-HIV medicines (NRTIs, NNRTIs, PIs). These patients also had ongoing HIV replication despite taking anti-HIV therapy.
Important Safety Information about APTIVUS
APTIVUS capsules are always taken with Norvir? (ritonavir). This is referred to as APTIVUS/r.
Patients taking APTIVUS may develop severe liver disease that can cause death. If you develop any of the following symptoms of liver problems, you should stop taking APTIVUS treatment and CALL your HCP right away: tiredness, general ill feeling or ?flu-like? symptoms, loss of appetite, nausea (feeling sick to your stomach), yellowing of your skin or whites of your eyes, dark (tea-colored) urine, pale stools (bowel movements), or pain, ache, or sensitivity on your right side below your ribs. If you have chronic hepatitis B or C infection, your HCP should check your blood tests more often because you have an increased chance of developing liver problems.
Patients taking APTIVUS may develop severe bleeding in the brain that can cause death. You should report any unusual or unexplained bleeding to your HCP if you are taking APTIVUS.
* Your HCP will prescribe at least 2 other anti-HIV medicines with APTIVUS. This usually will increase the likelihood of treatment response.
* Baseline HIV resistance may affect your response to APTIVUS. Therefore, your HCP should conduct resistance tests and know your treatment history before prescribing APTIVUS.
* Tell your HCP if you have liver disease, are infected with hepatitis B or C infection, or reduced liver function because you may have increased chance of liver disease problems while taking APTIVUS.
* Your HCP should perform certain liver tests before you start therapy with APTIVUS. Your HCP will monitor the function of your liver during your APTIVUS therapy.
* Taking APTIVUS with certain drugs can reduce the effectiveness of your treatment and can result in serious or life-threatening events.
* Tell your HCP if you have hemophilia or other medical conditions that increase the chances of bleeding. Tell your HCP about medicines you are taking to find out if they may increase your chance of bleeding.
* If you are taking APTIVUS oral solution, which contains vitamin E, you should not take additional vitamin E other than that contained in a standard multivitamin.
* Tell your HCP immediately if you develop or if you suspect you have a skin rash. APTIVUS should be used with caution in patients with a known sulfa allergy.
* Patients may develop new or worsening diabetes, high blood sugar (hyperglycemia), immune reconstitution syndrome, changes in body fat, and elevated lipids. Your HCP may monitor your cholesterol and triglycerides before starting APTIVUS and while on treatment.
* Women taking APTIVUS and estrogen-based hormonal contraceptives are advised to use alternative methods of contraception during therapy with APTIVUS. Women using estrogens for birth control or hormone replacement have an increased chance of developing a skin rash while taking APTIVUS. If a rash occurs, it is usually mild to moderate, but you should call your HCP.
* Tell your HCP if you are thinking about becoming pregnant, if you are pregnant, or are thinking about breast-feeding. Breastfeeding can result in passing the HIV virus to your baby.
* The most common side effects of APTIVUS include diarrhea, nausea, fever, vomiting, tiredness, headache, and stomach pain. Rash was seen more frequently in children.
* APTIVUS should not be used in children under 2 years of age.
