Patient Medication Information: uses, side effects, how to take - M-Darunavir
What is M-DARUNAVIR used for?
- for the treatment of HIV (Human Immunodeficiency Virus) infection
- in adults
- in children that weigh at least 40 kg who have taken anti-HIV medicines in the past
- always with a low dose (100 mg) of ritonavir (NORVIR) and
- in combination with other anti-HIV medicines.
How does M-DARUNAVIR work?
HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). M-DARUNAVIR is a type of anti-HIV medicine called a protease (PRO-tee-ase) inhibitor. M-DARUNAVIR blocks HIV protease, an enzyme which is needed for HIV to multiply. When used with other anti-HIV medicines, M-DARUNAVIR can help to reduce the amount of HIV in your blood (called “viral load”) and increase your CD4+ (T) cell count. HIV infection destroys CD4+ (T) cells, which are important to the immune system. The immune system helps fight infection. Reducing the amount of HIV and increasing the CD4+ (T) cell count may improve your immune system.
M-DARUNAVIR does not cure HIV infection or AIDS. At present, there is no cure for HIV infection.
What are the ingredients in M-DARUNAVIR?
Medicinal ingredient: darunavir
Non-medicinal ingredients (alphabetical):
Tablets: Crospovidone, colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, polacrilin potassium, silicified microcrystalline cellulose and sodium chloride
The tablet film coatings contain:
- 400 mg and 600 mg film coated tablets contain Opadry II Beige 85F570070 (Iron oxide yellow, Iron oxide red, polyethylene glycol, polyvinyl alcohol, purified water, talc and titanium dioxide).
- 800 mg film coated tablets contain Opadry II Brown 85F565137 (Iron oxide red, polyethylene glycol, polyvinyl alcohol, purified water, talc and titanium dioxide).
M-DARUNAVIR comes in the following dosage forms:
Tablets: 400 mg, 600 mg and 800 mg
Do not use M-DARUNAVIR if:
- you are allergic to darunavir or any of the other ingredients in M-DARUNAVIR or components of the container
- you are allergic to ritonavir (NORVIR)
- you have severe liver disease
- you take any of the following types of medicines because you could experience serious side effects:
| Type of Drug | Examples of Generic Names (Brand Names) | Type of Drug | Examples of Generic Names (Brand Names) |
|---|---|---|---|
Alpha1- Adrenoreceptor Antagonists (to treat enlarged prostate) | alfuzosin | Ergot Derivatives (to treat migraine and headaches) | dihydroergotamine (MIGRANAL) ergonovine ergotamine (CAFERGOT) |
Anti-coagulant (to prevent the clotting of red blood cells) | apixaban (ELIQUIS) rivaroxaban (XARELTO) | Herbal products (to improve mood) | St. John’s Wort |
Antiarrhythmics/ Antianginals (to treat abnormal heart rhythms) | dronedarone (MULTAQ) ivabradine (LANCORA) lidocaine (when taken by injection) amiodarone (CORDARONE) | HMG-CoA Reductase Inhibitors also known as statins (to lower cholesterol) Other Lipid Modifying Agents cholesterol lowering drug | lovastatin (MEVACOR) simvastatin (ZOCOR) lomitapide |
Anti-gout (to treat gout and familial Mediterranean fever) if you have kidney or liver problems | colchicine | Neuroleptics (to treat psychiatric conditions) | lurasidone (LATUDA) pimozide (ORAP) |
PDE-5 Inhibitor (to treat pulmonary arterial hypertension) | sildenafil (REVATIO) | ||
Antimycobacterials (to treat tuberculosis) | rifampin (RIFADIN, RIFATER) | Sedatives/Hypnotics (to treat trouble with sleeping and/or anxiety) | triazolam (HALCION®) |
| Antivirals (to treat hepatitis C infection) | elbasvir/grazoprevir (ZEPATIER) | ||
| Opioid Antagonist (to treat opioid-induced constipation) | naloxegol (MOVANTIK) | ||
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take M-DARUNAVIR. Talk about any health conditions or problems you may have, including if you:
- have diabetes. Anti-HIV medicines, such as M-DARUNAVIR, might increase your blood sugar levels.
- have liver problems, including hepatitis B and/or C.
- have hemophilia. Anti-HIV medicines, such as M-DARUNAVIR, might increase your risk of bleeding.
- are allergic to sulpha medications.
- have had pancreatitis in the past.
- have advanced HIV infection.
- are 65 years of age or older.
Other warnings you should know about:
M-DARUNAVIR does not reduce the risk of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with any body fluids. Never use or share dirty needles.
People taking M-DARUNAVIR may still develop infections or other illnesses associated with HIV infection. Because of this, it is very important for you to remain under the care of a healthcare professional.
Pregnancy: Tell your healthcare professional immediately if you are pregnant or planning to get pregnant. It is not known if M-DARUNAVIR can harm your unborn baby. You must not take M-DARUNAVIR during pregnancy, unless your healthcare professional believes the benefit is greater than the risk to your unborn baby. If you take M-DARUNAVIR while you are pregnant, talk to your healthcare professional about how you can be included in the Antiretroviral Pregnancy Registry.
Breast-feeding: Do not breast-feed if you are taking M-DARUNAVIR because of the possibility of your baby becoming infected with HIV through your breast milk and because of the unknown effects of the medicine on your baby. Talk with your healthcare professional about the best way to feed your baby.
M-DARUNAVIR should not be used in children under 3 years of age and who weigh under 40 kg. Talk to your healthcare professional if your child has never taken an HIV medicine before.
M-DARUNAVIR must always be used with low-dose ritonavir (NORVIR). Your healthcare professional will tell you how to take M-DARUNAVIR and which medicines you can take with M-DARUNAVIR. Tell your healthcare professional if you take other anti-HIV medicines (e.g., rilpivirine). M-DARUNAVIR can be combined with some other anti-HIV medicines while other combinations are not recommended.
M-DARUNAVIR can interact with many other medicines. Sometimes serious side effects will happen if you take M-DARUNAVIR with some other medicines (see Do not use M-DARUNAVIR if:).
M-DARUNAVIR should not be used with phenobarbital, phenytoin, rifampin or St. John’s wort because M-DARUNAVIR may not work as well if you take these medicines with it.
M-DARUNAVIR should not be used with vardenafil, because you may be at increased risk of side effects of vardenafil such as low blood pressure, visual changes and penile erection lasting more than 4 hours.
Tell your healthcare professional if you are taking estrogen-based contraceptives. M-DARUNAVIR might reduce the effectiveness of estrogen-based contraceptives (birth control). Therefore, additional or alternative(non-hormonal) methods of contraception, such as a condom, are recommended.
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 M-DARUNAVIR. Your healthcare professional might want to do some additional blood tests.
| Type of Drug | Examples of Generic Names (Brand Names) | Type of Drug | Examples of Generic Names (Brand Names) |
|---|---|---|---|
| Antiarrhythmics/ Antianginals (for the heart) | Digoxin disopyramide flecainide mexiletine propafenone | Endothelin receptor Antagonists (to treat pulmonary arterial hypertension) | bosentan (TRACLEER®) |
| Anticancer Agents | dasatinib (SPRYCEL) nilotinib (TASIGNA) vinblastine vincristine everolimus (AFINITOR) irinotecan | HIV-CCR5 Antagonist (to treat HIV infection) | Maraviroc (CELSENTRI) |
| Anticoagulants (to prevent the clotting of red blood cells) | apixaban (ELIQUIS) dabigatran (PRADAXA) rivaroxaban (XARELTO) warfarin (COUMADIN) edoxaban (LIXIANA) | HIV- Integrase strand transfer Inhibitors (to treat HIV infection) | dolutegravir (TIVICAY) elvitegravir (STRIBILD) |
| Anticonvulsants (to treat epilepsy and prevent seizures) | carbamazepine (TEGRETOL) clonazepam phenobarbital phenytoin (DILANTIN) | HIV- Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) (to treat HIV infection) | delavirdine (RESCRIPTOR) |
| Antigout (to treat gout and familial Mediterranean fever) | colchicine | HIV- Protesase Inhibitors (to treat HIV infection) | lopinavir/ritonavir (KALETRA) saquinavir (INVIRASE) indinavir (CRIXIVAN) |
| Anti-bacterials (to treat bacterial infections) | clarithromycin (BIAXIN) | HMG-CoA Reductase Inhibitors (to lower cholesterol levels) | atorvastatin (LIPITOR) pravastatin (PRAVACHOL) rosuvastatin (CRESTOR) |
| Antidepressants (to treat depression, anxiety, or panic disorder) | amitriptyline desipramine imipramine nortriptyline paroxetine (PAXIL) sertraline (ZOLOFT) trazodone (OLEPTRO) | Immunosuppressants (to prevent organ transplant rejection) | cyclosporine (SANDIMMUNE, NEORAL) tacrolimus (PROGRAF) sirolimus (RAPAMUNE) everolimus (AFINITOR) |
| Antifungals (to treat fungal infections) | ketoconazole (NIZORAL) itraconazole (SPORANOX®) isavuconazole | Inhaled beta agonist (to treat asthma) | salmeterol (ADVAIR) |
| Type of Drug | Examples of Generic Names (Brand Names) | Type of Drug | Examples of Generic Names (Brand Names) |
|---|---|---|---|
| voriconazole (VFEND) posaconazole (POSANOL) clotrimazole fluconazole | Narcotic Analgesics (to treat opioid dependence) | methadone meperidine buprenorphine/naloxone (SUBOXONE) fentanyl oxycodone (OXYCONTIN) tramadol | |
| Contraceptives (to prevent pregnancy) | Norethindrone and drospirenone-containing estrogen-based contraceptives | ||
| Antimycobacterials (to treat bacterial infections) | rifabutin (MYCOBUTIN) rifampin (RIFADIN, RIFATER) | Neuroleptics (to treat psychotic disorders) | risperidone (RISPERDAL®, RISPERDAL CONSTA®) quetiapine (SEROQUEL) perphenazine |
| Antiplatelets (to prevent the clotting of red blood cells) | clopidogrel (PLAVIX) | ||
| Antivirals (to treat Hepatitis C infection) | glecaprevir/pibrentasvir (MAVIRET) | PDE-5 Inhibitors (to treat erectile dysfunction) | sildenafil (VIAGRA) vardenafil (LEVITRA) tadalafil (CIALIS) |
| Βeta-Blockers (to treat heart disease) | carvedilol metoprolol (BETALOC, LOPRESOR) timolol | Sedatives/Hypnotics (to treat trouble with sleeping and/or anxiety) | buspirone (BUSTAB) clorazepate diazepam (DIAZEMULS, VALIUM) flurazepam (DALMANE, SOM-PAM) zolpidem midazolam (taken by injection) |
| Type of Drug | Examples of Generic Names (Brand Names) | Type of Drug | Examples of Generic Names (Brand Names) |
|---|---|---|---|
| Calcium Channel Blockers (to treat heart disease) | amlodipine (CADUET, TWYNSTA) diltiazem (CARDIZEM, TIAZAC) felodipine nifedipine (ADALAT) verapamil (ISOPTIN, VERELAN) | Platelet Aggregation Inhibitors (to prevent the clotting of platelets) | ticagrelor (BRILINTA) |
| Corticosteroids (to treat inflammation or asthma) | Betamethasone Budesonide (PULMICORT, RHINOCORT, SYMBICORT) dexamethasone fluticasone (ADVAIR DISKUS, CUTIVATE, FLONASE, FLOVENT DISKUS) mometasone prednisone (WINPRED) triamcinolone | Antiemetics (to manage symtoms of upper gastrointestinal motility disorders) | domperidone |
| Urinary antispasmodics (to treat overactive bladder) | fesoterodine solifenacin | ||
If you have also been prescribed enteric-coated didanosine as well as M-DARUNAVIR and ritonavir, take didanosine 2 hours before or after the M-DARUNAVIR /rtv combination.
This is not a complete list of medicines that you should tell your healthcare professional that you are taking. Know and keep track of all the medicines you take and have a list of them with you. Show this list to all of your healthcare professionals and pharmacists any time you get a new medicine. Do not start any new medicines while you are taking M-DARUNAVIR without first talking with your healthcare professional or pharmacist.
How to take M-DARUNAVIR:
- Your healthcare professional will tell you how much M-DARUNAVIR to take and when to take it.
- Always take M-DARUNAVIR exactly as your healthcare professional has told you for the medicine to work properly.
- Do not stop taking it, skip doses or interrupt the use of M-DARUNAVIR unless your healthcare professional tells you to.
- You must check with your healthcare professional if you are not sure how to take it.
- You must take ritonavir (NORVIR) at the same time as M-DARUNAVIR.
Always take M-DARUNAVIR with food.
- Swallow M-DARUNAVIR tablets whole with water.
- If you have trouble swallowing M-DARUNAVIR tablets your healthcare professional might prescribe a different treatment to you, such as an oral suspension.
Usual dose
Adults:
For adults who have never taken anti-HIV medicines the usual dose is 800 mg of M-DARUNAVIR, together with 100 mg of ritonavir (NORVIR), once every day.
For adults who have taken anti-HIV medicines in the past, the usual dose is either 800 mg of M-DARUNAVIR together with 100 mg of ritonavir (NORVIR), once every day OR 600 mg of M-DARUNAVIR together with 100 mg ritonavir (NORVIR), twice every day. Your healthcare professional will tell you which dose is right for you.
Children:
- M-DARUNAVIR is used in children who weigh at least 40 kg (88 lbs) and have taken anti-HIV medicines in the past.
- The usual dose for children is 600 mg M-DARUNAVIR together with 100 mg ritonavir (NORVIR), twice every day.
- If your child does not tolerate ritonavir (NORVIR), talk to your healthcare professional for advice.
- Your child should always take M-DARUNAVIR as told by their healthcare professional.
Overdose:
| If you think you, or a person you are caring for, have taken too much M-DARUNAVIR, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
Patients taking 800 mg of M-DARUNAVIR once a day:
If you miss a dose by less than 12 hours, take it as soon as you remember. Then, take your next dose of M-DARUNAVIR and ritonavir (NORVIR) at the regularly scheduled time.
If you miss a dose by more than 12 hours, wait until your next scheduled dose of M-DARUNAVIR and ritonavir (NORVIR) and take it then.
Never take a double dose to make up for a missed dose.
Patients taking 600 mg of M-DARUNAVIR twice a day:
If you miss a dose by less than 6 hours, take it as soon as you remember. Then, take your next dose of M-DARUNAVIR and ritonavir (NORVIR) at the regularly scheduled time.
If you miss a dose by more than 6 hours, wait until your next scheduled dose of M-DARUNAVIR and ritonavir (NORVIR) and take it then.
Never take a double dose to make up for a missed dose.
What are possible side effects from using M-DARUNAVIR?
These are not all the possible side effects you may have when taking M-DARUNAVIR. If you experience any side effects not listed here, tell your healthcare professional.
Rash has been reported in 10.3% of patients receiving M-DARUNAVIR. Occasionally a rash can be severe or potentially life threatening. In patients taking M-DARUNAVIR and raltegravir, rashes (generally mild or moderate) may occur more frequently than in patients taking either drug separately. If you develop a severe rash (e.g. blisters, peeling skin) which may be accompanied with symptoms such as fever, fatigue, muscle aches and pain, and liver problems, stop use of M-DARUNAVIR and contact your healthcare professional right away.
Liver problems that may occasionally be severe have been reported. Your healthcare professional should do blood tests before you take M-DARUNAVIR and while you are taking it. If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems.
Common side effects may include:
- diarrhea
- nausea and vomiting
- headache
- abdominal pain
Some side effects are typical for anti-HIV medicines in the same family as M-DARUNAVIR. These are:
- high blood sugar (hyperglycemia) and diabetes or worsening of diabetes. You may need to start or change your diabetes medicine.
- increased bleeding in patients with hemophilia.
- changes in body fat which may include an increased amount of fat in the upper back and neck, breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
- increases in triglycerides and cholesterol (forms of fat that are found in your blood). Your healthcare professional may order blood testing for you.
- development of pancreatitis (inflammation of the pancreas) with symptoms such as abdominal pain, nausea and vomiting.
- changes in your immune system (Immune Reconstitution Inflammatory Syndrome). 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. Grave’s disease (which affects the thyroid gland), autoimmune hepatitis, Guillain-Barre syndrome (which affects the nervous system) or polymyositis (which affects the muscles). This may develop at any time, sometimes months 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, abdominal pain, yellowing of the skin and eyes, or fatigue or any new symptoms contact your healthcare professional right away.
| 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 potentially life- threatening rash (blisters, peeling skin) which may be accompanied by fever, fatigue, swelling of the face or lymph nodes, muscle aches and pain, and liver problems. | ✓ | ||
| Liver problems: yellowing of the skin or whites of the eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or sensitivity on right side below ribs. | ✓ | ||
| Diabetes or worsening of diabetes or high blood sugar: excessive thirst, excessive urination, excessive eating, unexplained weight loss, poor wound healing, infections. | ✓ | ||
| Inflammation of the pancreas: abdominal pain, nausea and vomiting. | ✓ | ||
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. |
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Storage:
Keep out of sight and reach of children.
Store M-DARUNAVIR tablets at room temperature between 15-30°C.
If you want more information about M-DARUNAVIR:
- 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); or by contacting Mantra Pharma Inc. at medinfo@mantrapharma.ca or at 1-833-248-7326.
Mantra Pharma Inc.
9150 Leduc Blvd., Suite 201
Brossard, Quebec
J4Y 0E3