Descovy (Emtricitabine/Tenofovir)

Take Descovy exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Descovy one time per day with or without food. Do not miss a dose,

Use this medicine regularly to get the most benefit.

While using Descovy, you may need frequent blood tests. Your kidney and liver function, or bone mineral density may also need to be checked.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using Descovy.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

When your Descovy supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to Descovy and become harder to treat.

Store in the original container at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.

Get emergency medical help if you have signs of an allergic reaction to Descovy: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have:

• sudden or unusual bone pain;

• kidney problems - little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or

• liver problems - nausea, swelling around your midsection, upper stomach pain, itching, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Descovy may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Descovy. Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

• cold sores, sores on your genital or anal area;

• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

• trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common Descovy side effects may include:

• headache, dizziness, feeling depressed or tired;

• sleep problems (insomnia), strange dreams;

• stomach pain;

• weight loss; or

• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You should not take Descovy if you are allergic to emtricitabine or tenofovir. Do not take if you also use other medicines that contain emtricitabine, tenofovir, lamivudine, or adefovir (such as Atripla, Combivir, Complera, Emtriva, Epivir, Epzicom, Genvoya, Hepsera, Odefsey, Stribild, Triumeq, Trizivir, Truvada, or Viread).

Do not take Descovy to reduce infection risk if you are HIV-positive, if have been exposed to HIV within the past month, or if you had any symptoms (such as fever, sore throat, night sweats, swollen glands, diarrhea, body aches).

To make sure Descovy is safe for you, tell your doctor if you have:

• liver or kidney disease;

• osteopenia (low bone mineral density); or

• if you also have hepatitis B infection.

Some people taking Descovy develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

You should not breast-feed while you are using Descovy to treat or prevent HIV. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Descovy is not approved for anyone younger than 12 years old. The child receiving this medicine must weigh at least 37 pounds.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• chemotherapy, injected antibiotics, injectable osteoporosis medications, medicine for bowel disorders, medicine to prevent organ transplant rejection;

• antiviral medicine to treat hepatitis C - ledipasvir, sofosbuvir, velpatasvir;

• other HIV medications - atazanavir, darunavir, didanosine, lopinavir, ritonavir; or

• some pain or arthritis medicines - aspirin, Tylenol, Advil, and Aleve.

This list is not complete. Other drugs may interact with emtricitabine and tenofovir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.