Possible Side Effects

APTIVUS may cause serious side effects, including

Liver problems, including liver failure and death. Your healthcare provider (HCP) should do blood tests to monitor your liver function during treatment with APTIVUS. Patients with liver diseases such as hepatitis B and hepatitis C may have worsening of their liver disease with APTIVUS and should have more frequent monitoring of blood tests.
 
Bleeding in the brain. This has occurred in patients treated with APTIVUS in clinical trials and can lead to permanent disability or death. Many of the patients experiencing bleeding in the brain had other medical conditions or were receiving other medications that may have caused or added to bleeding in the brain. Patients with hemophilia or another medical condition that increases the chance of bleeding, or patients taking medicines that may cause bleeding may have an increased chance of bleeding in the brain.

Rash. Including flat or raised rashes or sensitivity to the sun, have been reported in approximately 10% of subjects receiving APTIVUS. Some patients who developed rash also had one or more of the following symptoms: joint pain or stiffness, throat tightness, generalized itching, muscle aches, fever, redness, blisters, or peeling of the skin. Women taking birth control pills may get a skin rash. If you develop any of these symptoms, stop using APTIVUS and call your HCP right away.

Increased bleeding in patients with hemophilia. This can happen in patients taking APTIVUS or other protease inhibitors.
 
Diabetes and high blood sugar (hyperglycemia). This can happen in patients taking APTIVUS or other protease inhibitor medicines. Some patients have diabetes before starting or during treatment with APTIVUS. Some patients will need changes in their diabetes medicine. Some patients will need new diabetes medicine.

Increased blood fat (lipid) levels. Your HCP should do blood tests to monitor your blood fat (triglycerides and cholesterol) during treatment with APTIVUS. Some patients taking APTIVUS have large increases in triglycerides and cholesterol. The long-term chance of having a heart attack or stroke due to increases in blood fats caused by APTIVUS is not known at this time.

Changes in body fat. These changes have happened in patients taking APTIVUS and other anti-HIV medicines. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known.

The most common side effects of APTIVUS include diarrhea, nausea, fever, vomiting, tiredness, headache, and stomach pain.  Rash was seen more frequently in children.

It may be hard to tell the difference between side effects caused by APTIVUS, by the other medicines you are also taking, or by the complications of HIV infection. For this reason it is very important that you tell your HCP about any changes in your health. You should report any new or continuing symptoms to your HCP right away. Your HCP may be able to help you manage these side effects.

This list of side effects is not complete.  Ask your HCP or pharmacist for more information.