Dolutegravir

Dolutegravir is a prescription medication used to treat human immunodeficiency virus (HIV) infection in adults and children who are at least 12 years of age and weigh at least 66 lb (30 kg). Dolutegravir does not cure HIV. Dolutegravir belongs to a group of drugs called HIV integrase inhibitors. These work by decreasing the amount of HIV in your blood and increasing the number of immune cells that help fight infections in your body.

This medication comes as a tablet to take by mouth once or twice a day with or without food.

Common side effects include trouble sleeping, tiredness (fatigue), and headache.

Dolutegravir is a prescription medication used to treat human immunodeficiency virus (HIV) infection in adults and children who are at least 12 years of age and weigh at least 66 lb (30 kg). Dolutegravir does not cure HIV infection or AIDS. You must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.

It is not known if dolutegravir is safe and effective in children under 12 years of age or who weigh less than 66 pounds.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Dolutegravir may be found in some form under the following brand names:

• Tivicay

Common side effects include trouble sleeping and headache.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of dolutegravir. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medications for HIV including efavirenz (Sustiva, in Atripla), etravirine (Intelence), fosamprenavir (Lexiva) taken with ritonavir (Norvir), nevirapine (Viramune), and tipranavir (Aptivus) taken with ritonavir (Norvir)
• certain medications for seizures including carbamazepine (Carbatrol, Equetro, Tegretol), oxcarbazepine (Oxtellar XR, Trileptal), phenobarbital (Luminal), and phenytoin (Dilantin, Phenytek)
• metformin (Fortomet, Glumetza, Glucophage, Riomet)
• rifampin (Rifadin, Rimactane, in Rifamate, in Rifater)
• antacids or laxatives that contain aluminum, magnesium or calcium, sucralfate (Carafate), iron or calcium supplements, including multivitamins containing calcium or iron, or buffered medicines. Dolutegravir should be taken at least 2 hours before or 6 hours after you take these medicines.
• dofetilide (Tikosyn)

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

Dolutegravir may cause serious side effects, including:

• Allergic reactions. Call your healthcare provider right away if you develop a rash with dolutegravir. Stop taking dolutegravir and get medical help right away if you:
  • ​develop a rash with any of the following signs or symptoms
    • fever
    • generally ill feeling
    • extreme tiredness
    • muscle or joint aches
    • blisters or sores in mouth
    • blisters or peeling of the skin
    • redness or swelling of the eyes
    • swelling of the mouth, face, lips, or tongue
    • problems breathing
  • develop any of the following signs or symptoms of liver problems:
    • ​yellowing of the skin or whites of the eyes
    • dark or tea-colored urine
    • pale-colored stools or bowel movements
    • nausea or vomiting
    • loss of appetite
    • pain, aching, or tenderness on the right side below the ribs
• ​Changes in liver tests. People with a history of hepatitis B or C virus may have an increased risk of developing new or worsening changes in certain liver tests during treatment with dolutegravir. Your healthcare provider may do tests to check your liver function before and during treatment with dolutegravir.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after starting your HIV medicine.

​Do not take dolutegravir if

• you take dofetilide (Tikosyn). Taking dolutegravir and dofetilide (Tikosyn) can cause side effects that may be life-threatening.
• you are allergic to it or to any of the inactive ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you

• have ever had an allergic reaction to dolutegravir
• have or had liver problems, including hepatitis B or C infection
• have any other medical condition
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. There are no well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

• Tell your doctor if you are breastfeeding or plan to breastfeed.
• Do not breastfeed if you take dolutegravir.
• You should not breastfeed if you have HIV because of the risk of passing HIV to your baby.
• It is not known if dolutegravir passes into your breast milk.
• Talk to your healthcare provider about the best way to feed your baby.

• Take dolutegravir exactly as your healthcare provider tells you.
• Do not change your dose or stop taking dolutegravir without talking with your healthcare provider.
• Stay under the care of a healthcare provider while taking dolutegravir.
• You can take dolutegravir with or without food.
• If you miss a dose of dolutegravir, take it as soon as you remember. If it is within 4 hours of your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time. If you are not sure about your dosing, call your healthcare provider.
• Do not run out of dolutegravir. The virus in your blood may become resistant to other HIV medicines if dolutegravir is stopped for even a short time. When your supply starts to run low, get more from your healthcare provider or pharmacy.
• Dolutegravir should be taken at least 2 hours before or 6 hours after you take antacids or laxatives that contain aluminum, magnesium or calcium, sucralfate (Carafate), iron or calcium supplements, or buffered medicines.

Avoid doing things that can spread HIV infection to others.

• Do not share or re-use needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

For children (treatment-naïve or treatment-experienced, *INSTI-naïve, aged 12 years and older, and weighing at least 40 kg)

• The recommended dose is 50 mg once daily. If you are also taking efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin, then the recommended dose is 50 mg twice daily.

For children (treatment-naïve or treatment-experienced, *INSTI-naïve, aged 12 years and older, and weighing at least 30 kg to less than 40 kg)

• The recommended dose is 35 mg once daily. If you are also taking efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin, then the recommended dose is 35 mg twice daily.

*INSTI = integrase strand transfer inhibitor

If you take too much dolutegravir, call your healthcare provider or go to the nearest hospital emergency room right away.

• Store dolutegravir at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep dolutegravir and all medicines out of the reach of children.