Patient Medication Information: uses, side effects, how to take - Ziagen
Serious Warnings and Precautions
Hypersensitivity Reaction Serious and sometimes fatal hypersensitivity reactions (serious allergic reactions) have happened in people taking ZIAGEN and other medicines containing abacavir. You should be screened for the HLA-B*5701 gene variation prior to starting or re-starting treatment with ZIAGEN, unless you have been screened previously and this is documented. Patients who have the HLA-B*5701 gene variation have a high risk of developing a hypersensitivity reaction to abacavir, which is the medicinal ingredient in ZIAGEN. This hypersensitivity reaction can be life threatening if you continue to take ZIAGEN. Do not take ZIAGEN if you have the HLA-B*5701 gene variation or have had a reaction in the past to ZIAGEN or any other medicine containing abacavir (such as TRIZIVIR (no longer marketed in Canada), KIVEXA or TRIUMEQ). If you stop ZIAGEN because of a hypersensitivity reaction, never take ZIAGEN or any other medicine containing abacavir again, regardless of whether you have the HLA-B*5701 gene variation or not. If you restart ZIAGEN or any other medicine containing abacavir, within hours you may experience a life threatening lowering of your blood pressure or death. If you stop ZIAGEN for any other reason, even for a few days, and you are not allergic to ZIAGEN, talk with your healthcare professional before taking it again. Taking ZIAGEN again may cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before. |
A list of these symptoms is on the Warning Card provided by your healthcare professional. You should carry this Warning Card with you at all times. If you notice these symptoms while taking ZIAGEN, call your healthcare professional immediately. Your healthcare professional may advise you to stop taking ZIAGEN.
If your healthcare professional tells you that you can take ZIAGEN, again, start taking it when you are around medical help or people who can call a healthcare professional if you need one.
Occasionally, reactions have developed in people who start taking abacavir again, and had only one symptom on the Warning Card before they stopped taking it.
If you are hypersensitive (allergic) to ZIAGEN, return all your unused ZIAGEN tablets or oral solution for safe disposal. Ask your healthcare professional for advice.
What is ZIAGEN used for?
ZIAGEN is a medicine used with other antiretrovirals to treat Human Immunodeficiency Virus (HIV) infection.
How does ZIAGEN work?
ZIAGEN contains the medicinal ingredient abacavir sulfate. This belongs to a group of antiretroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs), which are used to treat HIV infection.
HIV is a retrovirus (a type of virus). Infection with HIV damages the immune system and can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses.
ZIAGEN does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection.
What are the ingredients in ZIAGEN?
Tablets
Medicinal ingredients: abacavir (as abacavir sulfate).
Non-medicinal ingredients: colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polysorbate 80, sodium starch glycolate, titanium dioxide, triacetin, and yellow iron oxide.
Oral Solution
Medicinal ingredients: abacavir (as abacavir sulfate).
Non-medicinal ingredients: artificial strawberry and banana flavours, citric acid (anhydrous), hydrochloric acid, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate (dihydrate), sodium hydroxide, and sorbitol solution.
ZIAGEN comes in the following dosage forms:
300 mg tablets
20 mg/mL oral solution
Do not use ZIAGEN if you:
- previously had an allergic reaction (hypersensitivity) to the medicinal ingredient abacavir, which is also included in medicines called KIVEXA, TRIUMEQ and TRIZIVIR (no longer marketed in Canada), or to any of the other ingredients found in ZIAGEN.
- have the HLA-B* 5701 gene variation.
- have moderate or severe liver disease.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ZIAGEN. Talk about any health conditions or problems you may have, including if you:
- have liver problems
- have been tested and know whether or not you have a gene variation called HLA-B*5701
- are already taking a medicine that contains abacavir, including KIVEXA or TRIUMEQ.
- or the person your are caring for is less than 3 months of age or 65 years of age or older
Other warnings you should know about:
ZIAGEN can cause serious side effects, including:
- Lactic Acidosis and Severe Liver Problems: The class of medicines to which ZIAGEN belongs (NRTIs) 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 problems you may also be more at risk of getting this condition.
- Heart Attack: Some HIV medicines including ZIAGEN 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 healthcare professional.
- Risk of Infections: You may continue to develop other infections and other illnesses associated with HIV while you are taking ZIAGEN. You should therefore keep in regular contact with your healthcare professional.
Immune Reconstitution Inflammatory Syndrome: Changes to your immune system can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.
Autoimmune disorders happen when the immune system attacks healthy body tissue. This may happen after you start taking medicines for HIV infection. Examples of this include: Grave's disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system), polymyositis (which affects the muscles), or autoimmune hepatitis (which affects the liver). Autoimmune disorders may occur many months after the start of treatment.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Blood Tests: Your blood sugar levels (glucose) or level of fats (lipids) in your blood may increase with HIV treatment. Your healthcare professional will decide when to do blood tests, to check for these and other side effects, and will interpret the results.
Intolerance to Fructose: ZIAGEN oral solution contains sorbitol which may cause stomach (abdominal) pain and diarrhea. Sorbitol changes to fructose in the body and is not recommended for patients who cannot tolerate fructose (hereditary fructose intolerance).
Pregnancy and Newborns: If you are pregnant, or planning to become pregnant, talk to your healthcare professional before taking ZIAGEN. It is not known if ZIAGEN is safe to use during pregnancy. Your healthcare professional will decide whether you should continue to take ZIAGEN if you are pregnant. If you are pregnant and taking ZIAGEN to prevent passing HIV to your unborn baby continue to follow your healthcare professionals recommendations. If you have questions about the risks to your baby talk to your healthcare professional. If you take ZIAGEN while you are pregnant, talk to your healthcare professional about how you can be included in the Antiretroviral Pregnancy Registry.
Babies born to mothers who have taken Nucleoside Reverse Transcriptase Inhibitors (NRTIs) like ZIAGEN during pregnancy or labour have had increased levels of lactate in their blood. The increases are usually temporary. There have also been very rare reports of problems that affect the babies nervous system such as delayed development and seizures. The longterm effects of ZIAGEN are not known.
Breastfeeding: Do not breastfeed while taking ZIAGEN. There is a risk of passing HIV-1 to your baby if you breastfeed. ZIAGEN can also be passed through breast milk and could harm your baby. If you are breastfeeding or planning to breastfeed, talk with your healthcare professional about the best way to feed your baby.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with ZIAGEN:
- Methadone, to treat pain and drug addiction
- Retinoids, to treat skin conditions
- Riociguat, to treat high blood pressure
- Alcohol
Talk to your healthcare professional for further advice if you are taking any of these medicines. For some of these medicines, your healthcare professional may need to adjust the dose of one of your medicines in order for it to work properly.
How to take ZIAGEN:
- Take ZIAGEN exactly as directed by your healthcare professional. If you are unsure about how to take it, ask your healthcare professional.
You can take ZIAGEN with or without food.
- ZIAGEN is always prescribed with other antiretroviral agents.
- If you have liver problems your healthcare professional may have to adjust your dose.
- ZIAGEN tablets can be given to children and adults able to swallow tablets.
- ZIAGEN oral solution can be used in children and adults who are not able to swallow tablets.
Usual dose:
Adults, Adolescents and Children (weighing at least 25 kg): 600 mg daily.
- Tablets: 1 tablet (300 mg) twice daily or 2 tablets (600 mg) once daily
- Oral Solution: 15 mL twice daily or 30 ml once daily
Adolescents and Children (> 3 months of age and weighing less than 25 kg): The dose of ZIAGEN tablets or oral solution will be decided by your healthcare professional based on your child’s weight.
Overdose:
| If you think you have taken too much ZIAGEN, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
It is important to take this medicine as prescribed to ensure you get maximum benefit. If you forget to take a dose, take it as soon as you remember, and then continue as before. Do not take a double dose to make up for forgotten individual doses.
If you stopped taking ZIAGEN:
If you stop taking ZIAGEN because of side effects or illness, you must contact your healthcare professional before restarting to make sure that symptoms of a hypersensitivity reaction have not been missed. In some cases your healthcare professional will ask you to restart ZIAGEN under direct medical supervision or in a place where you will be able to get ready access to medical care if needed.
What are possible side effects from using ZIAGEN?
These are not all the possible side effects you may feel when taking ZIAGEN. If you experience any side effects not listed here, contact your healthcare professional.
Like all medicines, ZIAGEN can have side effects. When treating HIV infection, it is not always possible to tell whether some of the side effects that occur are caused by ZIAGEN, 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 healthcare professional about any changes in your health.
Side effects may include:
- nausea (feeling sick), vomiting
- diarrhea
- loss of appetite
- lack of energy, fatigue
- fever
- headache
- rash
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
|---|---|---|---|---|
| Only if severe | In all cases | |||
| COMMON | ||||
Hypersensitivity Reaction/Serious Allergic Reaction, which can present as skin rash and/or symptoms from at least 2 of the following groups: -fever -shortness of breath, sore throat or cough -nausea or vomiting, diarrhea, or stomach pain -severe tiredness or achiness, or generally feeling ill. | √ | |||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||
|---|---|---|---|---|---|
| Only if severe | In all cases | ||||
| RARE | |||||
| Lactic Acidosis (high level of acid in the blood) and Liver Problems: weight loss, fatigue, malaise, abdominal pain, shortness of breath, swollen and enlarged liver with symptoms of liver problems such as nausea, vomiting, abdominal pain, weakness and diarrhea | √ | ||||
| Pancreatitis (inflammation of the pancreas): abdominal pain that lasts and gets worse when you lie down, nausea, vomiting | √ | ||||
| VERY RARE | |||||
| Serious Skin Reactions [erythema multiforme, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)]: severe rash, itching, fever, swollen lymph nodes, flu-like feeling, blisters and peeling of skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body | √ | ||||
| FREQUENCY NOT KNOWN | |||||
| Immune Reconstitution Inflammatory Syndrome and Autoimmune Disorders: fever, redness, rash or swelling, fatigue, joint or muscle pain , numbness or weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, chest pain or rapid heart rate, yellowing of the eyes and skin | √ | ||||
| Heart Attack: chest pain or discomfort, pain in the jaw, neck or back or pain radiating down the left arm, shortness of breath, nausea, dizziness | √ | ||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Tablets
Store ZIAGEN tablets between 15 and 30°C.
Oral Solution
Store ZIAGEN oral solution between 15 and 25°C.
Keep out of reach and sight of children.
Do not take your medicine after the expiry date shown on the bottle and/or the carton.
If you want more information about ZIAGEN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website ( https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.viivhealthcare.com, or by calling 1-877-393-8448.
Last Revised JUL 05, 2023
©2023 ViiV Healthcare group of companies or its licensor
Trademarks are owned by or licensed to the ViiV Healthcare group of companies
ADEMPAS is a registered trademark of Bayer Inc.
INFORMATION FOR PRESCRIBERS:
A copy of the warning card included with the ZIAGEN carton is shown below.
WARNING CARD
ZIAGEN abacavir tablets and oral solution
Patients taking ZIAGEN may develop a hypersensitivity reaction (a serious allergic reaction) which can be life-threatening if you continue to take ZIAGEN. If you notice two or more of the following sets of symptoms while taking ZIAGEN, contact your healthcare professional immediately to find out if you should stop taking ZIAGEN.
| SYMPTOM(S) | |
|---|---|
| Group 1 | Fever |
| Group 2 | Rash |
| Group 3 | Nausea, vomiting, diarrhea, or abdominal (stomach area) pain |
| Group 4 | Generally ill feeling, extreme tiredness or achiness |
| Group 5 | Shortness of breath, cough or sore throat |
If you have already had this reaction to ZIAGEN, never take any medicine containing abacavir, such as KIVEXA (abacavir/lamivudine) or TRIUMEQ (dolutegravir/ abacavir/lamivudine) again. If you take any medicine containing abacavir, such as ZIAGEN, KIVEXA or TRIUMEQ again, within hours you may experience a life-threatening lowering of your blood pressure or death.
Carry this card with you at all times.
You should return all of your unused ZIAGEN to your healthcare professional for proper disposal.
Questions or concerns?
ViiV Healthcare ULC Montreal, Quebec H3C 2N6
www.viivhealthcare.ca