Dolutegravir

💊 What is Dolutegravir used for?

• •The label says Tivicay is used with other antiretroviral (HIV) medicines to treat HIV-1 infection in adults, whether they are new to HIV treatment or have taken HIV medicines before. It is also used with children aged at least 4 weeks and weighing at least 3 kg (about 6.6 pounds) who have not taken certain HIV medicines before, or who need to change their current HIV medicines. The label also says Tivicay is used with rilpivirine as a complete treatment regimen in certain adults whose HIV is suppressed (virologically suppressed) and who meet other conditions. The label says it is not known if Tivicay is safe and effective in children under 4 weeks old.

How it works

The label describes dolutegravir as an HIV-1 integrase strand transfer inhibitor (INSTI). It is always used in combination with other HIV medicines.

How it is usually taken

• •The label says Tivicay tablets may be taken with or without food. Calcium or iron supplements can be taken at the same time as Tivicay when taken with food. Tivicay should be taken 2 hours before or 6 hours after cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medicines. For Tivicay PD, the label says the tablets may be swallowed whole or dispersed in drinking water. They should not be chewed, cut, or crushed. The amount of water needed depends on how many tablets are prescribed. Follow the instructions from your prescriber or pharmacist about how many tablets to take and when.

Comes as

• •Tivicay tablets, 10 mg (white, round, film-coated, marked SV 572 and 10)
• •Tivicay tablets, 25 mg (pale yellow, round, film-coated, marked SV 572 and 25)
• •Tivicay tablets, 50 mg (yellow, round, film-coated, marked SV 572 and 50)
• •Tivicay PD tablets for oral suspension, 5 mg (white, round, strawberry cream flavored)

⚠️ Dolutegravir side effects

🛑 Who should not take Dolutegravir, and who should be careful

The label says not to take it if

• 🚨You have had a previous hypersensitivity (allergic-type) reaction to dolutegravir. The label lists this as a contraindication.
• 🚨You are taking dofetilide. The label says this combination is contraindicated because of the potential for increased dofetilide levels and the risk of serious or life-threatening events.

Tell your doctor before taking it if

• •Tell your healthcare provider about all other prescription and non-prescription medicines and herbal products, including St. John's wort.
• •Tell your provider if you have liver disease, such as hepatitis B or C. The label says liver tests are recommended during therapy, especially for people with liver disease.
• •Tell your provider right away if you develop a rash.
• •Tivicay tablets and Tivicay PD tablets are not bioequivalent and are not substitutable on a milligram-per-milligram basis. The label says patients who switch from one form to the other must have their dose adjusted for the new form.
• •The label strongly advises checking the tablets each time the prescription is filled to confirm the correct formulation.
• •The label says there is an antiretroviral pregnancy registry that monitors outcomes for people who take Tivicay during pregnancy.

🔀 Dolutegravir with other medicines, food and alcohol

The label says to discuss these with your doctor or pharmacist

• •St. John's wort. The label says to report its use to your healthcare provider.
• •Cation-containing antacids or laxatives, sucralfate, iron or calcium supplements, and buffered medicines. Tivicay should be taken 2 hours before or 6 hours after these.
• •Certain drugs that increase the breakdown of dolutegravir (metabolic inducers) may lower its levels. The label says alternative combinations that do not include these should be considered where possible.
• •Dofetilide (contraindicated). Dolutegravir may raise levels of drugs such as dofetilide, dalfampridine, and metformin.
• •The label says Tivicay may interact with other drugs, so ask your pharmacist or prescriber to review all your medicines.

Alcohol and food

The label says Tivicay may be taken without regard to food. It does not give specific alcohol instructions in the provided text. Calcium or iron supplements may be taken at the same time as Tivicay when taken with food.

🤰 Dolutegravir in pregnancy and breastfeeding

Pregnancy

The label says a pregnancy exposure registry monitors outcomes in people who take Tivicay during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry at 1-800-258-4263. The label reports that studies in Botswana and Eswatini, including more than 14,000 people, showed a similar rate of neural tube defects in babies whose mothers took dolutegravir at conception compared with other groups. The label also says there are not enough human data to definitively assess the risk of birth defects or miscarriage with dolutegravir. Talk with your healthcare provider about your situation.

Breastfeeding

The label says people with HIV-1 are told that the potential risks of breastfeeding include HIV-1 transmission to HIV-negative infants, development of viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant similar to those seen in adults.

🗓️ Storage, missed doses and taking too much

Storage

The label says to store Tivicay 50 mg tablets at 25°C (77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). For the 10 mg Tivicay tablets and the 5 mg Tivicay PD tablets, the label says to keep them in the original package, keep the bottle tightly closed, protect them from moisture, and do not remove the desiccant.

If a dose is missed

The label says that if a dose is missed, take it as soon as you remember. Do not double the next dose or take more than the prescribed dose. Follow the instructions from your prescriber or pharmacist.

If too much is taken

The label says there is no known specific treatment for an overdose with Tivicay. If an overdose occurs, the person should be monitored and standard supportive treatment given as needed. The label notes that dolutegravir is highly bound to plasma proteins, so it is unlikely to be significantly removed by dialysis. Contact a poison control center or emergency services right away if an overdose is suspected.

🗒️ Questions to ask about Dolutegravir

• Which other HIV medicines will I take with Tivicay, and how should they be timed?
• Do any of my current medicines, vitamins, or herbal products interact with Tivicay, including St. John's wort?
• Do I need to take Tivicay with food, and how should I time it with antacids, iron, or calcium supplements?
• How often will my liver be checked while I take Tivicay, given my health history?
• Which form of Tivicay (tablets or PD tablets for oral suspension) is right for me, and how do I make sure I get the correct one at each refill?
• What should I do if I miss a dose?
• Is Tivicay recommended if I am pregnant or planning a pregnancy, or if I am breastfeeding?

❓ Dolutegravir: frequently asked questions