Patient Medication Information: uses, side effects, how to take - Auro-Ritonavir
Serious Warnings and Precautions
Auro-Ritonavir can cause pancreatitis (inflammation of the pancreas).
Tell your doctor if you develop symptoms, such as:
- abdominal pain
- nausea
- vomiting
These may be signs of pancreatitis. Your doctor must decide if these are related to pancreatitis and what to do about them.
Auro-Ritonavir may react with certain drugs and cause serious and life-threatening side effects. Read the “Do not use Auro-Ritonavir if:” and “The following may interact with Auro-Ritonavir ” sections below very carefully.
What is Auro-Ritonavir used for?
- the treatment of HIV (Human Immunodeficiency Virus) Infection
- HIV is the virus that causes Acquired Human Immunodeficiency Syndrome (AIDS)
it is used in adults and children 2 – 16 years of age
- it is used along other medicines to treat HIV infection
How does Auro-Ritonavir work?
Auro-Ritonavir works by stopping the HIV virus from multiplying. This will help lower the amount of
- HIV in your body and keep it at a low level.
- Auro-Ritonavir is not a cure for HIV infection or AIDS. You can still get infections or other serious illnesses associated with HIV infection or AIDS.
- Auro-Ritonavir does not reduce the risk of passing HIV to others with sexual contact or blood contamination. You should use appropriate precautions, such as practicing safe sex and not reusing or sharing needles.
What are the ingredients in Auro-Ritonavir?
Medicinal ingredient: ritonavir
Non-medicinal ingredients: Calcium hydrogen phosphate anhydrous, calcium hydrogen phosphate dihydrate, copovidone, maize starch, mannitol, microcrystalline cellulose, silicified microcrystalline cellulose (prosolv SMCC 50), silicified microcrystalline cellulose (prosolv SMCC 90), powdered cellulose, sodium stearyl fumarate and sorbitan laurate.
The film coat, Aquarius Prime BAP 118010 white contains: Hypromellose 2910, titanium dioxide, talc, polyethylene glycol and polysorbate.
Auro-Ritonavir comes in the following dosage forms:
Auro-Ritonavir is available as film-coated tablets containing 100 mg ritonavir.
Do not use Auro-Ritonavir if:
- you are allergic to ritonavir or to any of the ingredients in Auro-Ritonavir.
Do not use Auro-Ritonavir if you are currently taking any of the following medicines. Taking Auro-Ritonavir with these can cause serious problems and death:
- alfuzosin, used to treat high blood pressure
- amiodarone, bepridil, dronedarone, flecainide, propafenone, quinidine, used to treat irregular heartbeats
- apalutamide, used for prostate cancer
- astemizole or terfenadine, used to relieve allergy symptoms
- cisapride, used to relieve certain stomach problems
- colchicine, when used in patients with kidney and/or liver problems, used to treat gout
- ergotamine, dihydroergotamine (used to treat headaches), ergonovine, methylergonovine (used after labour and delivery)
- fusidic acid, used as an antibiotic
- lovastatin, lomitapide or simvastatin, used to lower cholesterol
- lurasidone, pimozide, used to treat mental health problems
- neratinib, used to treat breast cancer
- ranolazine, used to treat chronic angina (chest pain)
- rifampin and saquinavir, used to treat tuberculosis, should not be used together with ritonavir
- rivaroxaban, used as an anticoagulant
- salmeterol, used for asthma and chronic obstructive pulmonary disease
- St. John’s Wort (Hypericum perforatum), an herbal product used to treat depression
- triazolam and midazolam (oral or injected), used to relieve anxiety and/or trouble sleeping
- PDE5 inhibitors vardenafil, used to treat erectile dysfunction, or sildenafil, used for the treatment of pulmonary arterial hypertension (PAH)
- voriconazole, used as an antifungal
- venetoclax during the dose initiation and during the ramp-up phase, used to treat chronic lymphocytic leukemia
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Auro-Ritonavir. Talk about any health conditions or problems you may have, including if you:
- have liver problems.
- are infected with hepatitis B or hepatitis C. If you have liver disease, such as hepatitis B and hepatitis C, taking Auro-Ritonavir may worsen your liver disease.
- have diabetes or symptoms, such as frequent urination and/or increase in thirst.
- have hemophilia, since taking Auro-Ritonavir can increase bleeding in these patients.
- have heart disease or heart condition, including conditions of Congenital Long QT Syndrome.
- have been told you have high triglyceride levels in your blood.
- have had a condition called pancreatitis in the past.
Other warnings you should know about:
Pregnancy
Tell your doctor if you are pregnant or planning to become pregnant. It is not known if Auro-Ritonavir can harm your unborn baby. Tell your doctor if you become pregnant while you are taking Auro-Ritonavir.
Pregnancy Registry
There is a pregnancy registry for women who take antiretroviral medicines while they are pregnant. The purpose of this registry is to collect information about the health of you and your baby. If you do become pregnant while taking Auro-Ritonavir, talk to your doctor about taking part in this registry.
Breastfeeding
You should not breastfeed if you are taking Auro-Ritonavir. You should also not breastfeed a baby if you are infected with HIV. This is because you can pass HIV to your baby.
Severe Liver Problems
Severe liver problems, including deaths, have been reported in those using Auro-Ritonavir. This has often occurred in those with advanced HIV disease, other liver disease or those taking many medications. Symptoms of serious liver problems include yellow skin and whites of eyes, nausea, tiredness, loss of appetite, fever, skin rash, pain in the upper abdomen, pale stools, and dark-coloured urine. Talk to your doctor if you get any of these symptoms.
Contraception
If you are taking oral contraceptives (“the pill”) or the contraceptive patch (i.e., ethinyl estradiol) to prevent pregnancy, you should use a different type of contraception since Auro-Ritonavir may reduce the effectiveness of oral or patch contraceptives.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.
The following medicines should only be used together with Auro-Ritonavir if advised by your physician.
The following may interact with Auro-Ritonavir:
- medicines used to treat erectile dysfunction, such as tadalafil
- medicines used to treat pulmonary arterial hypertension, such as bosentan or tadalafil
- medicines used to lower blood cholesterol, such as atorvastatin and rosuvastatin
- some medicines affecting the immune system, such as cyclosporin, sirolimus and tacrolimus
- some medicines used to treat seasonal allergies and ear and eye infections, such as budesonide, dexamethasone, fluticasone propionate, prednisone, and triamcinolone
- medicines used to treat AIDS and related infections, such as amprenavir, indinavir, nelfinavir, saquinavir, didanosine, rifabutin, tipranavir, delavirdine, atazanavir, maraviroc, fosamprenavir, raltegravir, tenofovir and darunavir
- medicines used to treat depression, such as trazodone, desipramine and bupropion
- certain heart medicines, such as calcium channel antagonists including diltiazem, nifedipine and verapamil
- medicines used to correct heart rhythm, such as systemic lidocaine and digoxin
- antifungals, such as ketoconazole and itraconazole
- morphine-like medicines used to treat severe pain, such as methadone and meperidine
- anticonvulsants, such as carbamazepine, phenytoin, and phenobarbital
- anticoagulants, such as warfarin
- certain antibiotics, such as rifabutin and clarithromycin
- antibiotics used in the treatment of tuberculosis, such as rifampin
- bronchodilators used to treat asthma, such as theophylline
- medicines used to treat cancer, such as abemaciclib, dasatinib, encorafenib, ibrutinib, ivosidenib, nilotinib, vincristine and vinblastine
- medicines used for low blood platelet count, such as fostamatinib
- some heart rhythm drugs, such as mexiletine and disopyramide
- some anticonvulsants, such as clonazepam, divalproex, lamotrigine and ethosuximide
- some narcotic analgesics, such as fentanyl in all forms, tramadol and propoxyphene
- quetiapine used to treat schizophrenia, bipolar disorder and major depressive disorder
- medicines used to treat hepatitis C, such as simeprevir, glecaprevir/pibrentasvir or ombitasvir, paritaprevir and ritonavir with or without dasabuvir
- some sedatives or medicines to treat anxiety, such as buspirone, clorazepate, diazepam, flurazepam and zolpidem
- stimulants, such as methamphetamine
- medicines used to treat pain associated with endometriosis, such as elagolix
How to take Auro-Ritonavir:
- Take Auro-Ritonavir exactly as your doctor tells you to.
- Do not change your dose or stop taking Auro-Ritonavir without talking to your doctor.
- You must stay under your doctor's care when taking Auro-Ritonavir.
- Swallow the Auro-Ritonavir tablets whole. Do not chew, break, or crush tablets.
You should take Auro-Ritonavir tablets with food.
Usual dose:
- Your doctor will tell you how much Auro-Ritonavir you should take and when you should take it.
- The usual dose for adults is six 100 mg tablets twice a day.
Overdose:
If you think you, or a person you are caring for, have taken too much Auro-Ritonavir, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll- free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you missed a dose of this medication, take it as soon as you remember. But if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Go back to the regular dosing schedule. Do not take 2 doses at the same time.
What are possible side effects from using Auro-Ritonavir?
These are not all the possible side effects you may feel when taking Auro-Ritonavir. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Changes in taste
- Diarrhea
- Dizziness
- Feeling weak or tired
- Headache
- Loss of appetite
- Tingling feeling or numbness in hands, feet or around the lips
- Some patients have large increases in triglycerides and cholesterol (forms of fat that are found in your blood)
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
- 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 skin or eyes
If you notice these or any symptoms of inflammation or infection, tell your doctor immediately.
Your doctor may monitor blood levels of fats (lipids), cholesterol and glucose before and during Auro-Ritonavir treatment.
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 | |||
| Chest Pain | ✓ | ||
Diabetes or hyperglycemia (high blood sugar): increased thirst, frequent urination, dry skin, headache, blurred vision, and fatigue | ✓ | ||
Pancreatitis (inflammation of the pancreas): abdominal pain, nausea, and vomiting | ✓ | ||
Severe liver problems: yellow skin and whites of eyes, nausea, tiredness, loss of appetite, fever, skin rash, pain in the upper abdomen, pale stools, and dark- coloured urine | ✓ | ||
Stevens-Johnson syndrome (SJS) (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swelling | ✓ | ||
Toxic Epidermal Necrolysis (TEN) (severe skin reaction): redness, blistering and/or peeling of large areas of the skin | ✓ | ||
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:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) 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.
Storage:
Store between 15 and 30°C. It is recommended that the product be stored and dispensed in the original container.
Exposure of the product to high humidity outside the original container for longer than 2 weeks is not recommended.
Do not use after the expiry date on the package.
Keep out of reach and sight of children.
If you want more information about Auro-Ritonavir:
- 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 (http:// www.auropharma.ca), or by calling 1-855-648-6681.