How Should I Store APTIVUS?

Capsules
Store APTIVUS capsules in a refrigerator at approximately 36°F to 46°F (2°C to 8°C). Once the bottle is opened, the contents must be used within 60 days. You may take the bottle with you for use away from home as long as the bottle remains at a temperature of approximately 59°F to 86°F (15°C to 30°C). Do not use after the expiration date written on the bottle.

Oral Solution
Store APTIVUS oral solution at room temperature, approximately 77°F (25°C); a range of 59°F to 86°F (15°C to 30°C) is permitted. Do not refrigerate or freeze. The solution must be used within 60 days after first opening the bottle. Do not use after the expiration date written on the bottle.

Keep APTIVUS and all medicines out of the reach of children.

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.