Details for: APO-ABACAVIR-LAMIVUDINE
Company: APOTEX INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02399539 | APO-ABACAVIR-LAMIVUDINE | ABACAVIR (ABACAVIR SULFATE); LAMIVUDINE | 600 MG; 300 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
The Human Immunodeficiency Virus (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.
APO-ABACAVIR-LAMIVUDINE belongs to a group of antiretroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs), and is used in combination with other antiretrovirals to treat Human Immunodeficiency Virus (HIV) infection.
What it does
APO-ABACAVIR-LAMIVUDINE does not cure HIV, but helps to prevent further damage to the immune system by slowing down production of new viruses. You must be sure to be seen regularly by your health care provider.
APO-ABACAVIR-LAMIVUDINE 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 fight infection.
When it should not be used
APO-ABACAVIR-LAMIVUDINE should not be taken if:
- you previously had an allergic reaction (hypersensitivity) to the active ingredient abacavir, which is also included in medicines called abacavir sulfate, abacavir sulfate/ lamivudine, abacavir sulfate/ lamivudine/ zidovudine and dolutegravir/ abacavir/ lamivudine (see What the nonmedicinal ingredients are).
- you previously had an allergic reaction to the active ingredient lamivudine which is included in medicines called lamivudine, lamivudine/ zidovudine or abacavir sulfate/ lamivudine/ zidovudine or any of the other ingredients found in APO-ABACAVIR-LAMIVUDINE. (see What the nonmedicinal ingredients are).
- you have the HLA-B* 5701 gene variation
- you have liver disease.
What the medicinal ingredient is
APO-ABACAVIR-LAMIVUDINE is a treatment that contains a fixed dose combination of two active ingredients that are currently available as separate medicines: abacavir sulfate and lamivudine. Each APO-ABACAVIR-LAMIVUDINE tablet contains 600 mg of abacavir (as abacavir sulfate) and 300 mg lamivudine.
What the non-medicinal ingredients are
Each APO-ABACAVIR-LAMIVUDINE tablet contains the following nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6 aluminium lake 17% to 19%, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000 and titanium dioxide.
What dosage form it comes in
APO-ABACAVIR-LAMIVUDINE tablets are orange colored, modified capsule-shaped biconvex, film-coated tablets with engraved "APO" on one side and "600/300" on the other side.
Warnings and precautions
Hypersensitivity Reaction
You should be screened for the HLA-B*5701 gene variation prior to starting or re-starting treatment with APO-ABACAVIR-LAMIVUDINE. Patients who have the HLAB*5701 gene variation have a high risk of developing a hypersensitivity reaction (serious allergic reaction) to abacavir, which is in the drug APO-ABACAVIR-LAMIVUDINE. This hypersensitivity reaction can be life threatening if you continue to take APO-ABACAVIR-LAMIVUDINE (see Important Information on Hypersensitivity Reactions).
If you have a hepatitis B infection, you should not stop taking APO-ABACAVIR-LAMIVUDINE 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 APO-ABACAVIR-LAMIVUDINE.
Important Information on Hypersensitivity Reactions
If you get two or more of the following groups of symptoms while taking APO-ABACAVIR-LAMIVUDINE contact your doctor immediately to find out if you should stop taking APO-ABACAVIR-LAMIVUDINE:
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 |
A list of these symptoms is on the Warning Card provided by your pharmacist. You should carry this Warning Card with you at all times. If you notice these symptoms while taking APO-ABACAVIR-LAMIVUDINE, call your doctor immediately. Your doctor may advise you to stop taking APO-ABACAVIR-LAMIVUDINE.
If you stop APO-ABACAVIR-LAMIVUDINE because of a serious allergic reaction, never take APO-ABACAVIR-LAMIVUDINE or any other medicine containing abacavir (such as abacavir sulfate, abacavir sulfate/ lamivudine/ zidovudine or dolutegravir/ abacavir/ lamivudine) 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 APO-ABACAVIR-LAMIVUDINE for any other reason, even for a few days, and you are not allergic to APO-ABACAVIR-LAMIVUDINE, talk with your doctor before taking it again. Taking APO-ABACAVIR-LAMIVUDINE 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 APO-ABACAVIR-LAMIVUDINE, again, start taking it when you are around medical help or people who can call a doctor 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 to APO-ABACAVIR-LAMIVUDINE, return all your unused APO-ABACAVIR-LAMIVUDINE tablets for safe disposal. Ask your doctor or pharmacist for advice.
Before you use APO-ABACAVIR-LAMIVUDINE, talk to your doctor or pharmacist:
- About all your medicines and medical conditions
- If you have kidney or liver disease (including hepatitis B or C)
- 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 are pregnant, or planning to become pregnant, breastfeeding or planning to breastfeed
- About all the medicines you are taking including vitamins, herbal supplements and nonprescription drugs
Other special warnings
Your blood sugar levels (glucose) or levels of fats (lipids) in your blood may increase with HIV treatment. Your doctor may order blood tests for you.
The class of medicines to which APO-ABACAVIR-LAMIVUDINE 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 disease you may also be more at risk of getting this condition. While you are being treated with APO-ABACAVIR-LAMIVUDINE 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 APO-ABACAVIR-LAMIVUDINE 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 APO-ABACAVIR-LAMIVUDIN
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 APO-ABACAVIR-LAMIVUDINE.
APO-ABACAVIR-LAMIVUDINE helps to control your condition but is not a cure for HIV infection. You will need to take it every day. Unless you suspect you are having an allergic reaction with APO-ABACAVIR-LAMIVUDINE, do not stop taking your medicine without first talking to your doctor.
Treatment with APO-ABACAVIR-LAMIVUDINE has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer. You should continue to use appropriate precautions to prevent this.
Use of this medicine during pregnancy and breastfeeding:
If you are pregnant, or planning to become pregnant soon, you must inform your doctor before taking any medicine.
The safe use of abacavir sulfate/ lamivudine in pregnancy has not been established. Your doctor will decide whether you should continue to be treated with APO-ABACAVIR-LAMIVUDINE if you are pregnant. If you take APO-ABACAVIR-LAMIVUDINE while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.
Babies and infants exposed to Nucleoside Reverse Transcriptase Inhibitors (NRTIs) during pregnancy or labour show minor temporary increases in blood levels of lactate. The clinical importance of these temporary increases is unknow.
These findings do not affect current recommendations to use antiretroviral therapy in pregnant women to prevent transmission of HIV to their babies. There have been very rare reports of disease that affect the neonatal (babies) nervous system such as delayed development and seizures. The long term effects of abacavir sulfate/ lamivudine are not known.
It is recommended that HIV infected women do not breastfeed their infants under any circumstances in order to avoid transmission of HIV from mother to child. Both of the active substances in APO-ABACAVIR-LAMIVUDINE are likely to be found in breast milk.
You are recommended not to breastfeed your baby while taking APO-ABACAVIR-LAMIVUDINE.
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.
Interactions with this medication
APO-ABACAVIR-LAMIVUDINE should not be taken with:
- lamivudine
- lamivudine and zidovudine
- abacavir sulfate
- abacavir sulfate/lamivudine / zidovudine
- Emtricitabine / Tenofovir Disoproxil Fumarate Tablets
- Emtricitabine / Rilpivirine / Tenofovir Disoproxil Fumarate
- Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate
- Emtricitabine
- Elvitegravir / Cobicistat / Emtricitabine/ Tenofovir Disoproxil Fumarate
- abacavir sulfate / lamivudine
- dolutegravir, abacavir, and lamivudine
Some of these medicines are already in APO-ABACAVIR-LAMIVUDINE.
It is important that you tell your doctor or pharmacist about all the medicines listed below or any that you are taking or have recently taken, including those you have bought yourself:
- Sorbitol-containing medicines (usually liquids) used regularly
- Methadone
- Retinoids
- Trimethoprim sulphamethoxazole (co-trimoxazole) an antibiotic used to treat Pneumocystis jiroveci pneumonia (often referred to as PCP) or toxoplasmosis
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.
In men, alcohol does increase the amount of abacavir in your blood. However, the meaning of this is unknown. This interaction has not been studied in women.
Proper use of this medication
Usual Dose
Take APO-ABACAVIR-LAMIVUDINE exactly as your doctor has advised you, and try not to miss any doses. The usual dose in adults and children who weigh at least 25 kg is one tablet once a day. Your doctor will determine if the child is able to swallow the tablet. Swallow the tablet whole with water. APO-ABACAVIR-LAMIVUDINE can be taken with or without food. APO-ABACAVIR-LAMIVUDINE is a set (fixed) dose combination of abacavir sulfate and lamivudine, and therefore cannot be dose reduced. Therefore, APO-ABACAVIR-LAMIVUDINE cannot be used if you have kidney or liver problems or if you weigh less than 25 kg because you cannot change the dose. If you are unsure about how to take it, ask your doctor or pharmacist.
Overdose
If you have taken too much APO-ABACAVIR-LAMIVUDINE, contact your health care 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 APO-ABACAVIR-LAMIVUDINE
If you stop taking APO-ABACAVIR-LAMIVUDINE 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 APO-ABACAVIR-LAMIVUDINE under direct medical supervision or in a place where you will be able to get ready access to medical care if needed.
Side effects and what to do about them
Like all medicines, APO-ABACAVIR-LAMIVUDINE 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 APO-ABACAVIR-LAMIVUDINE, 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. This is described in the Warnings and Precautions section on Hypersensitivity Reaction in the beginning of this leaflet. It is important that you read and understand the information about this serious reaction.
APO-ABACAVIR-LAMIVUDINE contains both abacavir sulfate and lamivudine. The most common side effects for this combination are nausea, vomiting, diarrhea, upper abdominal pain, headache, high temperature (fever), lethargy (unusual lack of energy), fatigue, trouble sleeping, depression/depressed mood, 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 (very rare) include serious skin reactions and severe anemia.
Changes to your immune system (Immune Reconstitution
Inflammatory Syndrome) 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 (when the immune system attacks
healthy body tissue), may also occur 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. Look for
any other symptoms such as:
- High temperature (fever), redness, rash or swelling
- Joint or muscle pain
- Fatigue
- 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 skin or eyes
If you notice these or any symptoms of inflammation or infection, tell 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 Side Serious Side Effects table). If your doctor detects clinical signs, symptoms or lab tests suggestive of pancreatitis, they will stop treatment with APO-ABACAVIR-LAMIVUDINE immediately.
Always tell your doctor or pharmacist if any of the side effects mentioned becomes severe or troublesome, or if you notice any other side effects not listed in this leaflet.
Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
---|---|---|---|
Common | |||
Hypersensitivity to abacavir: Serious allergic reaction and 2 or more of the following symptoms: fever, skin rash, nausea, vomiting, diarrhea, abdominal pain, severe tiredness, achiness, general ill-feeling, sore throat, shortness of breath. | ✔ | ||
Uncommon | |||
Blood problems and symptoms such as anemia (lowered red blood cell count –resulting in fatigue, breathlessness), low white blood cell count (neutropeniaincreasing chance of infection), reduced platelets (blood cells important for blood clotting –could increase chance of bruising) and increases in enzymes produced by the liver. | ✔ | ||
Rare | |||
Pancreatitis (inflammation of the pancreas) and symptoms such as nausea, vomiting and abdominal pain. | ✔ | ||
Lactic acidosis (high level of acid in the blood): Weight loss, fatigue, malaise, abdominal pain, shortness of breath, severe hepatomegaly (swollen and enlarged liver) with symptoms of liver problems such as nausea, vomiting, abdominal pain, weakness and diarrhea. | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking APO-ABACAVIR-LAMIVUDINE, contact your doctor or pharmacist.
How to store
Store APO-ABACAVIR-LAMIVUDINE tablets between 15°C to 30°C.
As with all medicines, keep APO-ABACAVIR-LAMIVUDINE out of the reach and sight of children.
Do not take your medicine after the expiry date shown on the bottle, blister and/or the carton.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
More information
If you want more information about APO-ABACAVIR-LAMIVUDINE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/indexeng.jsp). Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800- 667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: November 2, 2020