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Darunavir is available as a 75 mg, 150 mg, 600 mg, and 800 mg oral tablet and a 100 mg/ml oral suspension.

• Darunavir is a protease inhibitor that is used in the treatment of HIV infection in people aged 3 years and older

Darunavir is a protease inhibitor, which means it blocks a protein called protease. Normally, protease helps to process viral proteins so that the HIV virus can infect healthy cells. By blocking protease from working, Darunavir prevents the virus from making copies of itself and spreading.

Darunavir is typically dosed as follows:

• Adults: The typical dose is 800 mg by mouth once a day taken together with 100 mg ritonavir (Norvir) and food
• Children 3 years and older: The dose will depend on your child’s weight
• 10 kg (22 lbs) to less than 15 kg (33 lbs): The dosage ranges from 350 mg to 490 mg by mouth once a day taken together with 64 mg to 96 mg ritonavir (Norvir) and food
• 15 kg (33 lbs) to less than 30 kg (66 lbs): The typical dose is 600 mg by mouth once a day taken together with 100 mg ritonavir (Norvir) and food
• 30 kg (66 lbs) to less than 40 kg (88 lbs): The typical dose is 675 mg by mouth once a day taken together with 100 mg ritonavir (Norvir) and food
• 40 kg (88 lbs) and more: The typical dose is 800 mg by mouth once a day taken together with 100 mg ritonavir (Norvir) with food
• Your dose might be different depending on the results of the drug-resistance test. Your dose might also be different if you’re pregnant

Darunavir is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. Co-administration of Darunavir/ritonavir is contraindicated with drugs that
are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index).

Common side effects of Darunavir:

• Diarrhea
• Rash
• Nausea
• Headache
• Stomach pain
• Vomiting
• Feeling weak
• Indigestion
• Swollen belly
• Weight loss

Serious side effects are rare with Darunavir. Contact your healthcare provider immediately if you experience any of the following.

• Severe allergic reactions: facial swelling, hives, rash, itchy skin, blistering or peeling of skin, body aches, trouble breathing
• Serious liver problems: nausea, vomiting, not feeling hungry, pain in the right side of the stomach, yellowing of the whites of the eyes or skin, dark-colored urine, light-colored stool

The following medications may interact with Darunavir:

• Co-administration of Darunavir/ritonavir with other drugs can alter the concentrations of other drugs and other drugs may alter the concentrations of Darunavir. The potential drug-drug interactions must be considered prior to and during therapy

Various FDA-approved generic manufacturers

The recommended dosage in pregnant patients is Darunavir 600 mg taken with ritonavir 100 mg twice daily with food.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Darunavir during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) 1-800-258-4263.

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