Tivicay

The recommended dose of dolutegravir for adults and adolescents 12 to 18 years old, who weigh at least 40 kg is 50 mg (1 tablet) taken once a day. Depending on other medications you may be using or may have used in the past to treat HIV infection, you may be advised to take 50 mg (1 tablet) twice a day.

The recommended dose of dolutegravir for children who weigh 15 kg to 40 kg is based on body weight and will be determined by your child’s doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Dolutegravir may be taken with food or on an empty stomach. It should be swallowed with some liquid.

It is important that Tivicay be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 4 hours before your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Tivicay at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause diarrhea; it may cause stomach ache; it may cause sleep disturbances or insomnia; it may cause nausea or, rarely, vomiting. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

10 mg
Each white, round, film-coated, biconvex tablet, debossed with "SV 572" on one side and "10" on the other side, contains 10 mg of dolutegravir (as dolutegravir sodium). Nonmedicinal ingredients: D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate. The tablet film-coating contains the inactive ingredients macrogol/PEG, polyvinyl alcohol – part hydrolyzed, talc, and titanium dioxide.

25 mg
Each pale yellow, round, film-coated, biconvex tablet, debossed with "SV 572" on one side and "25" on the other side. Each tablet contains 25 mg of dolutegravir (as dolutegravir sodium). Nonmedicinal ingredients: D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate. The tablet film-coating contains the inactive ingredients iron oxide yellow, macrogol/PEG, polyvinyl alcohol – part hydrolyzed, talc, and titanium dioxide.

50 mg
Each yellow, round, film-coated, biconvex tablet, debossed with "SV 572" on one side and "50" on the other, contains 50 mg of dolutegravir as dolutegravir sodium. Nonmedicinal ingredients: D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate. The tablet film-coating contains the inactive ingredients iron oxide yellow, macrogol/PEG, polyvinyl alcohol – part hydrolyzed, talc, and titanium dioxide.

Do not take dolutegravir if you:

• are allergic to dolutegravir or any ingredients of the medication
• are taking the medication dofetilide

There may be an interaction between dolutegravir and any of the following:

• aluminum hydroxide
• calcium supplements (e.g., calcium carbonate, calcium citrate)
• Carbamazepine
• dofetilide
• efavirenz
• etravirine
• fosamprenavir
• fosphenytoin
• iron (e.g., ferrous fumarate, ferrous gluconate, ferrous sulfate)
• isoniazid
• magnesium (e.g., magnesium hydroxide, magnesium oxide)
• Metformin
• multiple vitamins and minerals with vitamins A, E
• nevirapine
• Orlistat
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• primidone
• rifampin
• selenium
• St. John's wort
• Sucralfate
• tipranavir
• zinc

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Tivicay. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Tivicay.

HEALTH CANADA ADVISORY

June 7, 2018

Health Canada has issued new restrictions concerning the use of dolutegravir. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Hepatitis: Dolutegravir may cause decreased liver function or liver failure. This may be more likely for people who also have hepatitis B or Hepatitis C. If you have hepatitis, discuss with your doctor how Tivicay may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tivicay, and whether any special monitoring is needed.

If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.

Hypersensitivity reactions: A Anaphylaxis (severe allergic reaction) called hypersensitivity syndrome has occurred for some people taking dolutegravir. This reaction involves a number of organs in the body and may be fatal if not treated quickly. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Immune reconstitution inflammatory syndrome: Tivicay may cause immune reconstitution inflammatory syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medication and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms (such as pneumonia, herpes, or Tuberculosis). Report any new symptoms to your doctor as soon as possible.

Kidney function: If you have kidney problems, discuss with your doctor how Tivicay may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tivicay, and whether any special monitoring is needed.

Liver function: Dolutegravir can cause liver problems, including liver failure. If you have liver disease or decreased liver function, discuss with your doctor how Tivicay may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tivicay, and whether any special monitoring is needed.

If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.

Stopping the medication: If you stop taking Tivicay, your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.

Pregnancy: Dolutegravir may cause birth defects in the baby if the mother takes Tivicay while she is pregnant. Women who are of childbearing age should use effective birth control while taking Tivicay. If you are planning to become pregnant, discuss other options for medications with your doctor. If you become pregnant while taking Tivicay, contact your doctor immediately. Tivicay should not be used during pregnancy.

Breast-feeding: It is not known if dolutegravir passes into breast milk. Women who have HIV infection are cautioned against breast-feeding because this increases the risk of passing HIV to a baby who does not have the infection.

Children: The safety and effectiveness of using Tivicay have not been established for children less than 6 years old who weigh less than 15 kg.

This medication is typically used once or twice a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. If you forget a dose and there is more than 4 hours left before the next dose, take immediately the missed dose. Do not double the next dose to catch up. This medication may be taken with or without food. To ensure effectiveness, avoid taking an antacid for at least 6 hours before and 2 hours after this medication. Also avoid mineral supplements (calcium, iron, magnesium or zinc).