Product Information

Darunavir tablets

What is darunavir?

Darunavir is an antiviral medicine that is used to treat HIV (human immunodeficiency virus). HIV can cause acquired immunodeficiency syndrome (AIDS). Darunavir is not a cure for HIV or AIDS.
Darunavir must be given in combination with ritonavir and other antiviral medications and should not be used alone.
Darunavir may also be used for purposes not listed in this medication guide.

Warnings

Stop taking darunavir and call your doctor right away if you have a severe skin reaction: fever, burning or redness in your eyes, mouth sores, or a skin rash that spreads and causes blistering and peeling.
Tell your doctor about all your other medicines. Some drugs should not be used with darunavir.
Darunavir can cause serious liver problems. Call your doctor if you have upper stomach pain, loss of appetite, tiredness, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Before taking this medicine

You should not take darunavir if you have severe liver disease.
Some drugs should not be used with darunavir. Your treatment plan may change if you also use:

• alfuzosin;
• cisapride;
• colchicine (in people with liver or kidney disease);
• dronedarone;
• elbasvir and grazoprevir;
• lurasidone;
• naloxegol;
• pimozide;
• rifampin;
• sildenafil (Revatio, for pulmonary arterial hypertension);
• St. John's wort;
• triazolam or oral midazolam;
• heart medicine--ivabradine, ranolazine;
• cholesterol medication--lomitapide, lovastatin, simvastatin; or
• ergot medicines--dihydroergotamine, ergotamine, methylergonovine.

Tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C);
• diabetes;
• a bleeding disorder such as hemophilia; or
• an allergy to sulfa drugs.

To prevent HIV in a newborn baby, use all medications to control your infection during pregnancy. Your name may be listed on an antiviral pregnancy registry.
Darunavir can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using darunavir, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.
Women with HIV should not breastfeed. The virus can pass to your baby in your breast milk.
Darunavir and ritonavir should not be given to a child younger than 3 years old, or a child who weighs less than 22 pounds (10 kilograms).

How should I take darunavir?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Darunavir must be taken together with ritonavir and other antiviral medications. Use the medicine exactly as directed.
Darunavir works best if you take it with food. Take darunavir and ritonavir together at the same time every day.
Swallow the darunavir tablet whole and do not crush, chew, or break it.
Shake the oral suspension (liquid). Measure a dose with the supplied syringe or a dose-measuring device (not a kitchen spoon).
You will need frequent medical tests.
Use all HIV medications as directed. Do not change your dose or stop using a medicine without your doctor's advice. Remain under the care of a doctor.
Store at room temperature away from moisture and heat.

What should I avoid while taking darunavir?

Using darunavir may not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Darunavir side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Call your doctor at once if you have:

• a skin rash, no matter how mild;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
• signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes).

Darunavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

• nausea, vomiting, diarrhea, stomach pain;
• headache;
• rash; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur.

What other drugs will affect darunavir?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
If you also take didanosine (Videx), take your darunavir dose 2 hours before or 1 hour after you take didanosine.
Many drugs can affect darunavir, and some drugs should not be used at the same time. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.