Tivicay (Dolutegravir Sodium)

TIVICAY will not stop you from passing HIV to others through sexual contact or blood contamination. You should use appropriate precautions, such as using condoms when you have oral or penetrative sex, and not reusing or sharing needles.

BEFORE you use TIVICAY talk to your doctor or pharmacist if you:

• have liver problems, including hepatitis B or C
• are pregnant or planning to become pregnant; do not take TIVICAY without speaking with your doctor. Your doctor will consider the benefit to you and the risk to your baby when taking TIVICAY while pregnant. If you take TIVICAY while you are pregnant, talk to your doctor about enrolling in the Antiretroviral Pregnancy Registry.
• are breastfeeding or plan to breastfeed. Where possible, women who are HIV positive should not breast feed, because HIV infection can pass into breast milk and harm your baby.
• It is not known if TIVICAY can pass into breast milk and harm your baby. Talk to your doctor immediately, if you are breastfeeding, or thinking about breastfeeding. Do not breastfeed while taking TIVICAY.
• have any other medical condition
• are taking any other medications

The most common side effects of TIVICAY include:

• diarrhea
• headache
• trouble sleeping (insomnia)
• feeling sick (nausea)
• lack of energy (fatigue)

Other side effects include, rash, itching (pruritus), being sick (vomiting), stomach pain (abdominal pain), stomach (abdominal) discomfort, intestinal gas (flatulence), dizziness, abnormal dreams, depression (feelings of deep sadness and unworthiness), and suicidal thoughts and behaviours (mainly in patients who have had depression or mental health problems before). If you have such feelings, talk to your doctor.

Side effects that may show up in blood tests include an increase in bilirubin (a substance produced by the liver), and/or an increase in the level of enzymes produced in the muscles (creatine phosphokinase, creatinine).

Changes in your immune system (Immune Reconstitution Inflammatory 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, or you could develop an autoimmune disease in which your immune system reacts against your own body (e.g. Graves' disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system) or polymyositis (which affects the muscles) and it may develop at any time, sometimes months later after the start of HIV therapy). Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling, or fatigue or any new symptoms contact your doctor immediately.

Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amounts of fat on the upper back and neck (“buffalo hump”), breasts, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known at this time.

Tell your healthcare provider about all prescription and non-prescription medications you are taking; including any vitamins, herbal supplements, and dietary supplements. Some drugs may interact with TIVICAY and can affect how TIVICAY works, or make it more likely that you will have side effects. These include:

• metformin, to treat diabetes
• medicines called antacids, to treat indigestion and heartburn. Do not take an antacid during the 6 hours before you take TIVICAY, or for at least 2 hours after you take it.
• calcium and iron supplements. Do not take a calcium or iron supplement during the 6 hours before you take TIVICAY, or for at least 2 hours after you take it. If you take food with your medicine, you can take a calcium or iron supplement at the same time asTIVICAY.
• etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine or tipranavir/ritonavir, to treat HIV infection
• rifampin, to treat tuberculosis (TB) and other bacterial infections
• phenytoin and phenobarbital, to treat epilepsy
• oxcarbazepine and carbamazepine, to treat epilepsy and bipolar disorder
• St. John’s wort, (Hypericum perforatum), a herbal remedy to treat depression

Always take TIVICAY exactly as your doctor has told you to. Check with your doctor or pharmacist if you're not sure. Do not change your dose or stop taking TIVICAY without talking with your doctor.

Usual dose:

For adults and adolescents 12-18 years weighing at least 40 kg, the usual dose of TIVICAY is one 50 mg tablet, once a day.

For adults with HIV infection that is resistant to other HIV medicines similar to TIVICAY, the usual dose of TIVICAY is one 50 mg tablet, twice a day.

Your doctor will decide on the correct dose of TIVICAY for you.

Swallow the tablet with some liquid. TIVICAY can be taken with or without food.

Antacid medicines:

Antacids, to treat indigestion and heartburn, can stop TIVICAY from being absorbed into your body and make it less effective.

Do not take an antacid during the 6 hours before you take TIVICAY, or for at least 2 hours after you take it. Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as TIVICAY. Talk to your doctor for further advice on taking acid-lowering medicines with TIVICAY.

Calcium or iron supplements:

Calcium or iron supplements can stop TIVICAY from being absorbed into your body and make it less effective.

Do not take a calcium or iron supplement during the 6 hours before you take TIVICAY, or for at least 2 hours after you take it. If you take food with TIVICAY, then you can take calcium and iron supplements at the same time as TIVICAY.

Be sure to keep a supply of your anti-HIV medicines:

• When your TIVICAY supply starts to run low, get more from your physician or pharmacy.
• Do not wait until your medicine runs out to get more.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you take too many tablets of TIVICAY, contact your doctor or pharmacist for advice. If possible, show them the TIVICAY pack.

Missed dose:

If you miss a dose, take it as soon as you remember, but if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before. DO NOT take a double dose of your medicine to make up for a missed dose.