Patient Medication Information: uses, side effects, how to take - Symtuza
What is SYMTUZA® used for?
- SYMTUZA® is used to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
SYMTUZA® is for adults and children 12 years of age and older and who weigh at least 40 kg (88 lbs).
How does SYMTUZA® work?
SYMTUZA® works by reducing the amount of HIV in your blood (called “viral load”). HIV infection affects the immune system. The immune system helps fight infection. Reducing the amount of HIV may improve your immune system (your body’s natural defences).
SYMTUZA® does not cure HIV infection or AIDS. At present, there is no cure for HIV infection. People taking SYMTUZA® may still develop infections or other conditions associated with HIV infection. Because of this, it is very important for you to remain under the care of a healthcare professional.
What are the ingredients in SYMTUZA®?
Each SYMTUZA® tablet contains:
Medicinal ingredients:
Darunavir (800 mg) as ethanolate, Cobicistat (150 mg), Emtricitabine (200 mg) and Tenofovir alafenamide (10 mg) as hemifumarate.
Non-medicinal ingredients:
Tablet core: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate,
Serious Warnings and Precautions
“Flare-ups” of Hepatitis B Virus infection can occur if you also have hepatitis B and stop taking SYMTUZA®. In these cases, your infection may return and become worse than it was before. Do not stop taking SYMTUZA® without your healthcare professional’s advice. If you stop taking SYMTUZA®, tell your healthcare professional right away. Tell your healthcare professional about any new, unusual or worsening symptoms that you notice after stopping treatment. After you stop taking SYMTUZA®, your healthcare professional will still need to check your health and take blood tests to check your liver. SYMTUZA® is not approved for the treatment of hepatitis B virus infection.
microcrystalline cellulose.
Film-coating: polyethylene glycol (macrogol), polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, yellow ferric oxide.
SYMTUZA® tablets are yellow to yellowish brown, capsule-shaped, debossed on one side with the number “8121” and “JG” on the other side.
SYMTUZA® comes in the following dosage forms:
Film-coated tablet: 800 mg darunavir ethanolate / 150 mg cobicistat/ 200 mg emtricitabine/ 10 mg tenofovir alafenamide hemifumarate (see “What are the ingredients in SYMTUZA®?”).
Do not use SYMTUZA® if:
- you are taking any medication that is listed in this leaflet under “Drugs that should not be taken with SYMTUZA®”.
- you are allergic to SYMTUZA® or any of its ingredients, including non-medicinal ingredients or components of the container (see “What are the ingredients in SYMTUZA®?”).
- Have severe liver problems.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SYMTUZA®. Talk about any health conditions or problems you may have, including if you:
- Have lactic acidosis (high levels of acid in the blood). See “Serious side effects and what to do about them” table for symptoms. Contact your healthcare professional right away if you get these side effects.
- Have hepatitis B and/or C or severe liver problems (hepatotoxicity) including enlarged or fatty liver. See “Serious side effects and what to do about them” table for symptoms. Cases leading to death have been reported.
- If you have hepatitis B virus (HBV) infection at the same time and take SYMTUZA®. Do not stop taking SYMTUZA®. Your HBV infection may get worse (flare-up) and symptoms worsen if you stop taking SYMTUZA® (see “Serious Warnings and Precautions” box and "Serious side effects and what to do about them” table). Worsening of hepatitis may be life-threatening for patients with advanced liver disease or cirrhosis.
- Have a history of pancreatitis (swelling of the pancreas). See the "Serious side effects and what to do about them” table for symptoms.
- Have kidney problems. Kidney problems, including kidney failure, have occurred. Your kidney problems could get worse if you take SYMTUZA® with some medicines such as non-steroidal anti-inflammatory drugs. Darunavir crystals may form in the kidney. These can cause kidney disease.
- Have a history of bone fracture, bone loss or osteoporosis.
- Have diabetes. In general, anti-HIV medicines, such as SYMTUZA®, might increase sugar levels in the blood. Some patients have diabetes before starting treatment with SYMTUZA®, which gets worse. Some patients get diabetes during treatment with SYMTUZA®. Some patients will need changes in their diabetes medicine. Some patients may need new diabetes medicine. See “Serious side effects and what to do about them” table.
- Have hemophilia. SYMTUZA®, might increase the risk of bleeding.
- Are allergic to sulfa medicines.
- Notice any symptoms of infection. Tell your healthcare professional right away if you have high fever, joint or muscle pain, redness, rash, swelling, or fatigue.
Other warnings you should know about:
If you are pregnant or plan to become pregnant:
It is not known if SYMTUZA® can harm your unborn child. Talk to your healthcare professional. You should not take SYMTUZA® during pregnancy.
Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. This registry collects information about your health and your baby’s health. If you become pregnant while taking SYMTUZA®, talk with your healthcare professional about taking part in this registry.
If you are breast-feeding or plan to breast-feed:
Do not breast-feed if you have HIV because of the chance of passing the HIV virus to your baby. Do not breast-feed if you take SYMTUZA®. One of the ingredients of SYMTUZA®, emtricitabine, can be passed to your baby in your breast milk and may cause harm to your baby. It is not known if the other components can be passed to your baby in breast milk. If you are a woman who has or will have a baby, 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 SYMTUZA®:
Drugs that must not be taken with SYMTUZA® (contraindicated)
| Type of Drug | Examples of Generic Names (Brand Names) |
|---|---|
| Alpha1-Adrenoreceptor Antagonists (to treat enlarged prostate | alfuzosin |
| Antiarrhythmics/Antianginals (to treat abnormal heart rhythms) | amiodarone (CORDARONE), dronedarone (MULTAQ), ivabradine (LANCORA), lidocaine (when given by injection) |
| Anticoagulants (to prevent the clotting of red blood cells) | apixaban (ELIQUIS), dabigatran (PRADAXA), rivaroxaban (XARELTO) |
| Anti-convulsants (to prevent seizures) | carbamazepine (TEGRETOL), phenobarbital phenytoin (DILANTIN) |
| Anti-gout (to treat gout and familial Mediterranean fever) | colchicine |
| Antimycobacterial (to treat tuberculosis) | rifampin (RIFADIN, RIFATER, RIFAMATE, ROFACT) |
| Ergot Derivatives (to treat migraine and headaches) | dihydroergotamine (MIGRANAL), ergonovine, ergotamine (CAFERGOT) |
| Hepatitis C Virus Direct-Acting Antivirals (to treat hepatitis C infection) | elbasvir/grazoprevir |
| Herbal products (to improve mood) | St. John’s Wort (HYPERICUM PERFORATUM) |
| Drugs used to lower cholesterol | lovastatin (MEVACOR), simvastatin (ZOCOR), lomitapide (JUXTAPID) |
| Type of Drug | Examples of Generic Names (Brand Names) |
|---|---|
| Inhaled Beta-Agonists (to treat asthma and/or chronic obstructive pulmonary disease) | salmeterol (ADVAIR) |
| Neuroleptics (to treat psychiatric conditions) | lurasidone, pimozide (ORAP) |
| PDE-5 Inhibitor (to treat pulmonary arterial hypertension) | sildenafil (REVATIO) |
| Platelet Aggregation Inhibitor (to prevent blood clots) | ticagrelor (BRILINTA) |
| Sedatives/Hypnotics (to treat trouble with sleeping and/or anxiety) | triazolam (HALCION) |
| Opioid antagonist (to treat opioid-induced constipation) | naloxegol (MOVANTIK) |
Drugs that should not be taken with SYMTUZA®:
- Any other medicines to treat HIV-1 infection.
- Any other medicines that contain protease inhibitors (PREZISTA®, PREZCOBIX®, REYATAZ, CRIXIVAN, INVIRASE, KALETRA).
- Any other medicines that contain tenofovir (GENVOYA, ATRIPLA, COMPLERA, ODEFSY, STRIBILD, TRUVADA, VEMLIDY, VIREAD).
- Any other medicines that contain emtricitabine or lamivudine (ATRIPLA, COMPLERA, EMTRIVA, GENVOYA, ODEFSY, STRIBILD, TRUVADA; 3TC, COMBIVIR, HEPTOVIR, KIVEXA, TRIUMEQ, TRIZIVIR).
- Any other medicines containing ritonavir or cobicistat (NORVIR, KALETRA, HOLKIRA PAK, PREZCOBIX®, TYBOST, STRIBILD).
- adefovir (HEPSERA).
- medications that may affect your kidneys and have not been discussed with your healthcare professional
Drugs that interact with SYMTUZA® and where the dose of SYMTUZA® or the dose of the other drug should be changed or more instruction from your healthcare professional is needed:
- Tell your healthcare professional if you are taking hormonal contraceptives. SYMTUZA® might reduce the effectiveness of this type of birth control and/or increase their side effects. Additional or other methods of non-hormonal birth control, such as a condom, are recommended.
- Tell your healthcare professional if you are taking any of the following medicines. Your healthcare professional might do some additional blood tests.
| Type of Drug | Examples of Generic Names (Brand Names) |
| Antiarrhythmics/Antianginals (for the heart) | digoxin, disopyramide, flecainide, mexiletine, propafenone |
| Anticancer Agents (to treat cancer) | dasatinib (SPRYCEL), nilotinib (TASIGNA), vinblastine, vincristine, everolimus (AFINITOR), irinotecan |
| Anticoagulants (to prevent the clotting of red blood cells) | dabigatran (PRADAXA), edoxaban (LIXIANA), warfarin (COUMADIN) |
| Anticonvulsants (to treat epilepsy and prevent seizures) | clonazepam (CLONAPAM), ethosuximide (ZARONTIN), oxcarbazepine (TRILEPTAL) |
| Antidepressants (to treat depression, anxiety, or panic disorder) | amitriptyline, desipramine, imipramine, nortriptyline, paroxetine (PAXIL), sertraline (ZOLOFT), trazodone (OLEPTRO) |
| Type of Drug | Examples of Generic Names (Brand Names) |
| Anti-infectives (to treat bacterial infections) | clarithromycin (BIAXIN), erythromycin (ERYC) |
| Antifungals (to treat fungal infections) | fluconazole (DIFLUCAN), ketoconazole (NIZORAL®), itraconazole (SPORANOX®), isavuconazole, posaconazole (POSANOL), voriconazole (VFEND) |
| Anti-gout (to treat gout and familial Mediterranean fever) | colchicine |
| Antimycobacterials (to treat bacterial infections) | rifabutin (MYCOBUTIN) |
| Antiplatelets (to prevent the clotting of red blood cells) | clopidogrel (PLAVIX) |
| Βeta-Blockers (to treat heart disease) | carvedilol, metoprolol (BETALOC, LOPRESOR), timolol |
| Calcium Channel Blockers (to treat heart disease) | amlodipine (CADUET. TWYNSTA), diltiazem (CARDIZEM, TIAZAC) felodipine, nifedipine (ADALAT), verapamil (ISOPTIN, VERELAN) |
| Corticosteroids (to treat inflammation or asthma) | bethamethasone, budesonide (PULMICORT, RHINOCORT, SYMBICORT), dexamethasone, fluticasone propionate (ADVAIR DISKUS, CUTIVATE, FLONASE, FLOVENT DISKUS), mometasone, prednisone (WINPRED), triamcinolone |
Endothelin Receptor Antagonists (to treat pulmonary arterial hypertension) | bosentan (TRACLEER®) |
| Hormonal Contraceptives | ethinyl estradiol, norethindrone, norgestimate, drospirenone |
| Eugeroics | modafinil |
| Hepatitis C Virus direct-acting antivirals (to treat Hepatitis C Virus [HCV]) | glecaprevir/pibrentasvir (MAVIRET) |
| HMG-CoA Reductase Inhibitors (to lower cholesterol levels) | atorvastatin (LIPITOR), pravastatin (PRAVACHOL), rosuvastatin (CRESTOR) |
| Immunosuppressants (to prevent organ transplant rejection) | cyclosporine (SANDIMMUNE, NEORAL), tacrolimus (PROGRAF), sirolimus (RAPAMUNE), everolimus (AFINITOR) |
| Narcotic Analgesics (to treat opioid dependence) | buprenorphine/naloxone (SUBOXONE), fentanyl (ABSTRAL, DURAGESIC®), methadone, meperidine, oxycodone tramadol (DURELA, RALIVIA, TRAMACET®, TRIDURAL, ULTRAM®, ZYTRAM XL) |
| Neuroleptics (to treat psychotic disorders) | perphenazine, risperidone (RISPERDAL®, RISPERDAL CONSTA®), quetiapine (SEROQUEL) |
| PDE-5 Inhibitors (to treat erectile dysfunction) | sildenafil (VIAGRA), vardenafil (LEVITRA), tadalafil (CIALIS) |
| Sedatives/Hypnotics (to treat trouble with sleeping and/or anxiety) | buspirone, clorazepate, diazepam (DIAZEMULS, VALIUM), midazolam (taken by injection), flurazepam (DALMANE, SOM-PAM), zolpidem |
| Antiemetics (to manage symtoms of upper gastrointestinal motility disorders) | domperidone |
| Urinary antispasmodics (to treat overactive bladder) | fesoterodine solifenacin |
This is not a complete list of medicines that you should tell your healthcare professional that you are taking. You can ask your healthcare professional for a list of medicines that can interact with SYMTUZA®. Do not start any new medicines while you are taking SYMTUZA® without first talking with your healthcare professional.
How to take SYMTUZA®:
Always use SYMTUZA® exactly as your healthcare professional has told you. You must check with your healthcare professional if you are not sure.
You should always take SYMTUZA® with food. The type of food is not important. SYMTUZA® cannot work properly without food. Take SYMTUZA® within 30 minutes of eating.
Swallow SYMTUZA® tablets whole without breaking or crushing. Swallow the tablet with a drink such as water, milk, or a nutritional drink. If you have trouble swallowing SYMTUZA®, tell your healthcare professional. Your healthcare professional will determine whether SYMTUZA® or its individual components are right for you.
Take SYMTUZA® at about the same time each day, every day. Talk to your healthcare professional if you need help with making a schedule that works for you.
Do not stop using SYMTUZA® without talking to your healthcare professional first.
Even when you feel better.
If you have both HIV infection and hepatitis B, it is very important not to stop taking SYMTUZA® without talking to your healthcare professional first (see “Serious Warnings and Precautions”).
Do not run out of SYMTUZA®. Refill your prescription or talk to your healthcare professional before your SYMTUZA® is all gone. This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time.
Usual dose:
The dose of SYMTUZA® is 1 tablet once a day for adults and adolescents 12 years of age and older, who weigh at least 40 kg.
Removing the child resistant cap
The plastic bottle comes with a child resistant cap and should be opened as follows:
|
Overdose:
| If you think you, or a person you are caring for, have taken too much SYMTUZA®, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
It is important that you do not miss any doses. If you forget to take SYMTUZA®.
 |
- If you notice within 12 hours of the time you usually take SYMTUZA®, take the tablet immediately, with food. Then take the next dose at your usual time.
- If you notice after 12 hours, do NOT take the missed dose. Wait to take the next dose with food at your usual time.
- Do NOT take a double dose (two doses together).
- Call your healthcare professional if you are not sure what to do.
Do not take more or less than your prescribed dose of SYMTUZA® at any one time
What are possible side effects from using SYMTUZA®?
These are not all the possible side effects you may have when taking SYMTUZA®. If you experience any side effects not listed here, tell your healthcare professional.
The most common side effects with SYMTUZA® include:
- Diarrhea
- Rash
- Tiredness (fatigue)
- Swelling of the belly (abdominal distension)
- Feeling sick (nausea)
- Muscle aches (myalgia)
Some side effects are typical for anti-HIV medicines in the same family as SYMTUZA®. These are:
- High blood sugar (hyperglycemia) and diabetes.
- Increases in triglycerides and cholesterol (forms of fat that are found in your blood).
- Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV medicines. Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling, abdominal pain, yellowing of the skin and eyes, or fatigue or any new symptoms contact your healthcare professional straight away.
- Bone problems including bone pain, softening or thinning (which may lead to fractures).
- Kidney problems.
Tell your healthcare professional promptly about these or any other unusual symptoms. If the condition persists or worsens, seek medical attention.
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 | |
UNCOMMON Severe and sometimes life-threatening rash (blisters, peeling skin) which may be accompanied by
| ||
| ✓ | ||
| |||
|---|---|---|---|
Liver problems with symptoms such as
| ✓ | ||
Diabetes with symptoms such as
| ✓ | ||
Inflammation of the pancreas with symptoms such as
| ✓ | ||
RARE Lactic acidosis with symptoms such as
| ✓ | ||
VERY RARE Hepatotoxicity (severe liver problems) with hepatomegaly (liver enlargement) and steatosis (fat in the liver) with symptoms such as
| ✓ | ||
VERY RARE Flare-ups of hepatitis B virus infection following drug discontinuation with symptoms such as
| ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell 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:
Store SYMTUZA® in the original package with desiccant inside the bottle in order to protect the tablets from moisture. Keep the bottle tightly closed. Store between 15 to 30°C.
Keep out of reach and sight of children.
If you want more information about SYMTUZA®:
- Talk to your healthcare professional
- For questions or concerns, contact the manufacturer, Janssen Inc. (www.janssen.com/canada)
- 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.janssen.com/canada, or by contacting the manufacturer at: 1-800-567-3331 or 1-800-387-8781.
This information is also available on the Health Canada Drug and Health Product Register at: https://hpr-rps.hres.ca
Last Revised: March 3, 2023
© 2023 JANSSEN Inc.
All trademarks used under license.
All listed brand names are registered trademarks of their respective manufacturers.