Triumeq PD

Triumeq PD is a combination medicine used to treat human immunodeficiency virus (HIV), which can lead to acquired immunodeficiency syndrome (AIDS). Triumeq PD is not a cure for HIV or AIDS.

Triumeq PD is for use in adults and children who weigh at least 22 pounds (10 kilograms).

Triumeq PD should not be used alone in people who are resistant to certain types of medicine.

Triumeq PD may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Triumeq tablets are different from Triumeq PD tablets for oral suspension and should not be used interchangeably. Ensure you receive the correct dosage form each time your prescription is filled to avoid using the wrong medicine.

Doses are based on weight in children and teenagers. Your child's dose may change if they gain or lose weight.

Do not swallow, cut, crush, or chew a dispersible tablet. Dissolve the tablet in a small amount of water. Stir and drink this mixture right away.

You may take Triumeq PD with or without food.

Triumeq PD comes with a Medication Guide and a Warning Card that lists symptoms of an allergic reaction. Read this information and learn what symptoms to watch for. Keep the Wallet Card with you at all times.

You may need to take an extra daily dose of dolutegravir (Tivicay) if you take Triumeq PD with certain other medicines.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or stop using a medicine without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

If you've had hepatitis B, it may return or worsen after you stop using Triumeq PD. You may need frequent liver function tests for several months.

You should not take Triumeq PD if you have ever had an allergic reaction to any medicine that contains abacavir, or if you have a gene variation called HLA-B*5701 allele. Also, you should not use this medicine if you have moderate or severe liver disease, or if you are also taking dofetilide (Tikosyn).

Stop using this medicine and call your doctor immediately if you have any of these signs of an allergic reaction: fever; rash; nausea, vomiting, diarrhea, stomach pain; general ill feeling, extreme tiredness, body aches; shortness of breath, cough, sore throat.

If you've had hepatitis B, it may return or worsen after you stop using Triumeq PD. You may need frequent liver function tests for several months.

You should not use Triumeq PD if you are allergic to abacavir, dolutegravir, or lamivudine, or if:

• you also take dofetilide (Tikosyn);
• you have moderate or severe liver disease;
• you have a gene variation called HLA-B*5701 allele (your doctor will test you for this); or
• you have a history of allergic reaction to Combivir, Dutrebis, Epivir, Epzicom, Tivicay, Trizivir, or Ziagen.

Tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C);
• heart problems or risk factors such as diabetes, smoking, high blood pressure, high cholesterol; or
• kidney disease.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you are overweight, or if you are a woman. Ask your doctor about your risk.

You may need to have a negative pregnancy test before starting this treatment.

Triumeq PD may harm an unborn baby if you take the medicine at the time of conception or during the first 12 weeks of pregnancy. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

If you are pregnant, use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

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.

Call your doctor right away if you have signs of an allergic reaction from two or more of these specific side effect groups:

• Group 1 - fever;
• Group 2 - rash;
• Group 3 - nausea, vomiting, diarrhea, stomach pain;
• Group 4 - general ill feeling, extreme tiredness, body aches;
• Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to a medicine that contains abacavir or dolutegravir, you must never use it again. If you stop taking Triumeq PD for any reason, talk to your doctor before you start taking it again.

Triumeq PD may cause serious side effects. Call your doctor right away if you have:

• other signs of allergic reaction--skin blisters or peeling, eye redness, swelling in your face or throat, trouble breathing;
• lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired; or
• liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Triumeq PD 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 of Triumeq PD may include:

• headache;
• tiredness; or
• trouble sleeping.

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.

Take the medicine as soon as you can, but if it is almost time for your next dose, skip the missed dose. Do not take two doses at once.

Get your prescription refilled before you completely run out of medicine. If you miss several doses, you may have a serious or even fatal allergic reaction when you start taking this medication again.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Using Triumeq PD will not stop your disease from spreading. Ask your doctor how to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe.

Sometimes it is not safe to use certain medications together. Some drugs can change how much of other drugs is in your blood, which might increase side effects or make the medications less effective.

Some medicines can make Triumeq PD much less effective when taken at the same time. If you take any of the following medicines, take your Triumeq PD dose 2 hours before or 6 hours after you take the other medicine.

• antacids or laxatives that contain aluminum or magnesium (Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, and others);
• the ulcer medicine sucralfate (Carafate);
• buffered medicine; or
• vitamin or mineral supplements that contain calcium or iron (can be taken at the same time with Triumeq PD if you take with food).

Many drugs can affect Triumeq PD. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.