Triumeq (Abacavir Sulfate/Dolutegravir Sodium/Lamivudine)

Serious Warnings and Precautions

Hypersensitivity Reactions: You should be screened for the HLA-B*5701 gene variation prior to starting or re-starting treatment with TRIUMEQ. Patients who have the HLA-B*5701 gene variation have a high risk of developing a hypersensitivity reaction (serious allergic reaction) to abacavir, which is in the drug TRIUMEQ. This hypersensitivity reaction can be life threatening if you continue to take TRIUMEQ.

Build-up of acid in your blood (lactic acidosis) and swollen and fatty liver: Lactic acidosis (too much acid in the blood) and swollen and fatty liver (hepatomegaly with steatosis), including fatal cases, have been reported using nucleoside analogues alone or in combination. If you suffer symptoms (see Table Serious Side Effects, How Often They Happen and What to Do About Them), contact your doctor.

Worsening of hepatitis B virus in people who have HIV-1 infection: If you have a hepatitis B infection, you should not stop taking TRIUMEQ without instructions from your doctor as your hepatitis may worsen or reoccur. Your doctor will monitor your conditions for several months after stopping treatment with TRIUMEQ.

If you stop TRIUMEQ because of a serious allergic reaction, never take TRIUMEQ or any other medicine containing abacavir or dolutegravir (such as ZIAGEN, KIVEXA, TRIZIVIR, or TIVICAY) again, regardless of whether you have the HLA-B*5701 gene variation or not. Within hours you may experience a life threatening lowering of your blood pressure or death. If you stop TRIUMEQ for any other reason, even for a few days, and you are not allergic to TRIUMEQ, talk with your doctor before taking it again. Taking TRIUMEQ again may cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before.

If your healthcare provider tells you that you can take TRIUMEQ again, start taking it when you are around medical help or people who can call a doctor if you need one.

BEFORE you use TRIUMEQ talk to your doctor or pharmacist:

• If you have had previous use of any NRTI class medicine.
• If you have been tested and know whether or not you have a gene variation called HLA-B*5701
• If you have kidney or liver problems, including hepatitis B or C
• If you are taking interferon or ribavirin
• If you are pregnant or plan to become pregnant; do not take TRIUMEQ without speaking with your doctor first. Babies and infants exposed to medicines containing Nucleoside Reverse Transcriptase Inhibitors (NRTIs) during pregnancy or labour show minor temporary increases in blood levels of lactate. There have also been very rare reports of disease that affect babies’ nervous systems such as delayed development and seizures. These finding do not affect current recommendations to use antiretroviral therapy in pregnant women to prevent transmission of HIV to their babies. Your doctor will consider the benefit to you and the risk to your baby when taking TRIUMEQ while pregnant. If you take TRIUMEQ while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.
• If you are breastfeeding or plan to breastfeed. Where possible, women who are HIV positive should not breastfeed, because HIV infection can pass into breast milk and harm your baby. Abacavir and lamivudine, components of TRIUMEQ, can pass into breast milk. Talk to your doctor about how to feed your infant.
• If you have any other medical condition
• About all your medicines you are taking including vitamins, herbal supplements and non-prescription drugs

Other special warnings:

Two components of TRIUMEQ (abacavir sulfate and lamivudine) belong to a class of medicines (NRTIs) that can cause a condition called lactic acidosis (excess of lactic acid in your blood), together with an enlarged liver. Symptoms of lactic acidosis include feeling of weakness, loss of appetite, sudden unexplained weight loss, upset stomach and difficulty breathing or rapid breathing. This rare but serious side effect occurs more often in women. If you have liver disease you may also be more at risk of getting this condition. While you are being treated with TRIUMEQ your doctor will monitor you closely for any signs that you may be developing lactic acidosis.

If you have hepatitis B infection, you should not stop TRIUMEQ without instructions from your doctor, as you may have recurrence of your hepatitis. This may occur due to you suddenly stopping the active ingredient lamivudine in TRIUMEQ.

Some HIV medicines including abacavir may increase your risk of heart attack. If you have heart problems, smoke or suffer from diseases that increase your risk of heart disease such as high blood pressure and diabetes, tell your doctor. Do not stop taking your medication unless you are advised to do so by your doctor.

You may continue to develop other infections and other illnesses associated with HIV disease. You should therefore keep in regular contact with your doctor while taking TRIUMEQ.

Remember: This medicine is for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.

Like all medicines, TRIUMEQ can have side effects. When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by TRIUMEQ, by other medicines you are taking at the same time or by the HIV infection. For this reason it is very important that you inform your doctor about any changes in your health.

A hypersensitivity reaction (serious allergic reaction) has been reported in patients who have been treated with abacavir containing products.

TRIUMEQ contains dolutegravir, abacavir and lamivudine. The most common side effects for this combination are nausea, vomiting, diarrhea, abdominal pain and bloating (abdominal distension), headache, high temperature (fever), lethargy (unusual lack of energy), fatigue, trouble sleeping, depression/depressed mood (feelings of deep sadness and unworthiness), loss of appetite, hair loss, joint and muscle pain, abacavir hypersensitivity (serious allergic reaction) and skin rash (without any other illness). If these symptoms persist or become bothersome, contact your doctor.

Other side effects include, stomach discomfort, dizziness, abnormal dreams, suicidal thoughts and behaviours (mainly in patients who have had depression or mental health problems before) and intestinal gas (flatulence). Very rare side effects include serious skin reactions and severe anemia.

Changes in body fat have been seen in patients taking antiretroviral therapy. These changes may include increased amount 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 effect of these conditions is not known at this time.

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.

Inflammation of the pancreas (pancreatitis) has been observed in patients treated with abacavir and lamivudine, although it was not clear whether this was due to the medicine or the HIV infection itself (see Table Serious Side Effects, How Often They Happen and What to Do About Them). If your doctor detects clinical signs, symptoms or lab tests suggestive of pancreatitis, they will stop treatment with TRIUMEQ immediately.

No drug interaction studies have been done with the fixed dose combination, TRIUMEQ. Tell your healthcare provider about all prescription and non-prescription medications listed below or any that you are taking; including any vitamins, herbal supplements, and dietary supplements. Some drugs may interact with TRIUMEQ and can affect how TRIUMEQ 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 TRIUMEQ, or for at least 2 hours after you take it.
• calcium or iron supplements. Do not take these supplements during the 6 hours before you take TRIUMEQ, or for at least 2 hours after you take it. If you take food with TRIUMEQ, then you can take calcium and iron supplements at the same time as TRIUMEQ.
• etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine or tipranavir/ritonavir, zalcitabine (HIVID, ddc) 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
• retinoids
• trimethoprim sulphamethoxazole (co-trimoxazole, an antibiotic used to treat PCP—Pneumocystis carinii pneumonia or toxoplasmosis)
• interferon and/or ribavirin
• medicines that already contain abacavir, lamivudine or emtricitabine such as 3TC, HEPTOVIR, COMBIVIR, ZIAGEN, TRIZIVIR, KIVEXA, TRUVADA, COMPLERA, ATRIPLA, EMTRIVA and STRIBILD

If you are taking methadone, your doctor may need to adjust your methadone dose, as abacavir increases the rate at which methadone leaves your body. This is unlikely to affect most methadone users.

Usual dose:

The usual dose in adults (18 years and older) is one tablet once a day. Swallow the tablet whole with water or some liquid. TRIUMEQ can be taken with or without food.

TRIUMEQ is a set (fixed) dose combination of dolutegravir, abacavir and lamivudine, and therefore cannot be dose reduced. Therefore, TRIUMEQ cannot be used if you have certain kidney or liver problems because you cannot change the dose. If you are unsure about how to take it, ask your doctor or pharmacist.

Overdose:

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

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.

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.

If you stopped taking TRIUMEQ:

If you stop taking TRIUMEQ because of side effects or illness, you must contact your doctor before restarting to make sure that symptoms of a hypersensitivity reaction have not been missed. In some cases your doctor will ask you to restart TRIUMEQ under direct medical supervision or in a place where you will be able to get ready access to medical care if needed.