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.

Important Safety Information for APTIVUS

• 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. 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.
• 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.
• APTIVUS capsules and oral solution are always taken with Norvir^® (ritonavir)
• APTIVUS taken with ritonavir capsules or solution can be taken with or without meals
• APTIVUS taken with ritonavir tablets must only be taken with meals
• 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 healthcare professional about all the medications you take. 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.