Patient Medication Information: uses, side effects, how to take - Mylan-Darunavir
What is Mylan-Darunavir used for?
Mylan-Darunavir is used:
- for the treatment of HIV (Human Immunodeficiency Virus) infection
- in adults
- in children 6 years of age and older 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 Mylan-Darunavir work?
HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). Mylan-Darunavir is a type of anti-HIV medicine called a protease (PRO-tee-ase) inhibitor. Mylan-Darunavir blocks HIV protease, an enzyme which is needed for HIV to multiply. When used with other anti- HIV medicines, Mylan-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.
Mylan-Darunavir does not cure HIV infection or AIDS. At present, there is no cure for HIV infection.
What are the ingredients in Mylan-Darunavir?
Medicinal ingredients: darunavir
Non-medicinal ingredients:
Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.
Coating:
75 mg and 150 mg: polyvinyl alcohol - partially hydrolyzed, macrogol 4000/PEG 3350,
talc, and titanium dioxide.
300 mg, 400 mg, 600 mg: polyvinyl alcohol - partially hydrolyzed, macrogol 4000/PEG
3350, titanium dioxide, talc, and FD&C yellow number 6/ sunset yellow FCF aluminum lake.
800 mg: polyvinyl alcohol - partially hydrolyzed, macrogol 4000/PEG 3350, talc, iron
oxide red and titanium dioxide.
Mylan-Darunavir comes in the following dosage forms:
Tablets: 75 mg, 150 mg, 300 mg, 400 mg, 600 mg, 800 mg
Do not use Mylan-Darunavir if:
- you are allergic to darunavir or any of the other ingredients in Mylan-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) |
|---|---|
Alpha1-Adrenoreceptor Antagonists (to treat enlarged prostate) | alfuzosin |
| Anti-coagulant (to prevent the clotting of red blood cells) | apixaban (Eliquis®) rivaroxaban (Xarelto®) |
Antiarrhythmics /antianginals (to treat abnormal heart rhythms) | dronedarone (Multaq®)lidocaine (when taken by injection) ivabradine(Lancora®)amiodarone (Cordarone®) |
Anti-gout (to treat gout and familial Mediteraranean fever) if you have renal hepatic impairment | colchicine |
| Antimycobacterials (to treat tuberculosis) | rifampin (Rifadin®, Rifater®) |
| Antivirals (to treat hepatitis C infection) | elbasvir/grazoprevir (Zepatier®) |
Ergot Derivatives (to treat migraine and headaches) | dihydroergotamine (Migranal®) ergonovine ergotamine (Cafergot®) |
| Herbal products (to improve mood) | St. John’s Wort |
HMG-CoA Reductase Inhibitors also known as statins (to lower cholesterol) Other Lipid Modifying Agents cholesterol lowering drug | lovastatin (Mevacor®) simvastatin (Zocor®) lomitapide |
Neuroleptics (to treat psychiatric conditions) | lurasidone (Latuda®) pimozide (Orap®) |
PDE-5 Inhibitor (to treat pulmonary arterial hypertension) | sildenafil (Revatio®) |
Sedatives/Hypnotics (to treat trouble with sleeping and/or anxiety) | triazolam (Halcion®) |
| 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 Mylan-Darunavir. Talk about any health conditions or problems you may have, including
if you:
- have diabetes. Anti-HIV medicines, such as Mylan-Darunavir, might increase your blood sugar levels.
- have liver problems, including hepatitis B and/or C.
- have hemophilia. Anti-HIV medicines, such as Mylan-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:
Mylan-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 Mylan-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 doctor.
Pregnancy: Tell your doctor immediately if you are pregnant or planning to get pregnant. It is not known if Mylan-Darunavir can harm your unborn baby. You must not take Mylan-Darunavir during pregnancy, unless your doctor believes the benefit is greater than the risk to your unborn baby. If you take Mylan-Darunavir while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.
Breast-feeding: Do not breast-feed if you are taking Mylan-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 doctor about the best way to feed your baby.
Mylan-Darunavir should not be used in children under 3 years of age. Talk to your doctor if your child has never taken an HIV medicine before.
Mylan-Darunavir must always be used with low-dose ritonavir (NORVIR®). Your doctor will tell you how to take Mylan-Darunavir and which medicines you can take with Mylan-Darunavir. Tell your doctor if you take other anti-HIV medicines (e.g., rilpivirine). Mylan-Darunavir can be combined with some other anti-HIV medicines while other combinations are not recommended.
Mylan-Darunavir can interact with many other medicines. Sometimes serious side effects will happen if you take Mylan-Darunavir with some other medicines (see Do not use Mylan-Darunavir if:).
Mylan-Darunavir should not be used with phenobarbital, phenytoin, rifapentine, rifampin or St. John’s wort because Mylan-Darunavir may not work as well if you take these medicines with it.
Mylan-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 doctor if you are taking estrogen-based contraceptives. Mylan-Darunavir might reduce the effectiveness of estrogen-based contraceptives (birth control). Therefore, 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 Mylan-Darunavir:
| Type of Drug | Examples of Generic Names (Brand Names) |
|---|---|
Antiarrhythmics/ Antianginals (for the heart) | Digoxin disopyramide flecainide mexiletine propafenone |
| Anticancer Agents | dasatinib (Sprycel®) nilotinib (Tasigna®) vinblastine vincristine everolimus (Afinitor®) irinotecan |
Anticoagulants (to prevent the clotting of red blood cells) | apixaban (Eliquis®) dabigatran (Pradaxa®) edoxaban(Lixiana®) rivaroxaban (Xarelto®) warfarin (Coumadin®) |
Anticonvulsants (to treat epilepsy and prevent seizures) | carbamazepine (Tegretol®) clonazepam phenobarbital phenytoin (Dilantin®) |
Antigout (to treat gout and familial Mediterranean fever | colchicine |
| Anti-bacterials (to treat bacterial infections) | clarithromycin (Biaxin®) |
Antidepressants (to treat depression, anxiety, or panic disorder) | amitriptyline desipramine imipramine nortriptyline paroxetine (Paxil®) sertraline (Zoloft®) trazodone (Oleptro®) |
Antifungals (to treat fungal infections) | ketoconazole (Nizoral®) itraconazole (Sporanox®) isavuconazole |
| Type of Drug | Examples of Generic Names (Brand Names) |
|---|---|
voriconazole (Vfend®) posaconazole (Posanol®) clotrimazole fluconazole | |
Contraceptives (to prevent pregnancy) | Norethindrone and drospirenone-containing estrogen-based contraceptives |
| Antimycobacterials (to treat bacterial infections) | rifabutin (Mycobutin®) rifampin (Rifadin®, Rifater®) |
| Antivirals (to treat Hepatitis C infection) | Glecaprevir/pibrentasvir(Maviret®) |
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) | Betamethasone Budesonide (Pulmicort®, Rhinocort®, Symbicort®) dexamethasone fluticasone (Advair Diskus®, Cutivate®, Flonase®, Flovent Diskus®) mometasone prednisone (Winpred®) triamcinolone |
Urinary Antispamodics (to treat overactive bladder) | fesoterodine solifenacin |
Endothelin receptor Antagonists (to treat pulmonary arterial hypertension) | bosentan (Tracleer®) |
HIV- CCR5 Antagonist (to treat HIV infection) | maraviroc (Celsentri®) |
| HIV- Integrase strand transfer inhibitors (to treat HIV infection) | dolutegravir (Tivicay®) elvitegravir (Stribild®) |
HIV- Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) (to treat HIV infection) | delavirdine (Rescriptor®) |
HIV- Protesase Inhibitors (to treat HIV infection) | lopinavir/ritonavir (Kaletra®) saquinavir (Invirase®) indinavir (Crixivan®) |
HMG-CoA Reductase Inhibitors (to lower cholesterol levels) | atorvastatin (Lipitor®) pravastatin (Pravachol®) rosuvastatin (Crestor®) |
| Immunosuppressants | cyclosporine (Sandimmune®, Neoral®) |
| Type of Drug | Examples of Generic Names (Brand Names) |
|---|---|
(to prevent organ transplant rejection) | tacrolimus (Prograf®) sirolimus (Rapamune®) everolimus (Afinitor®) |
| Inhaled beta agonist (to treat asthma) | salmeterol (Advair®) |
Narcotic Analgesics (to treat opioid dependence) | methadone meperidine buprenorphine/naloxone (Suboxone®) fentanyl oxycodone (Oxycontin®) tramadol |
Neuroleptics (to treat psychotic disorders) | risperidone (Risperdal®, Risperdal® Consta®) quetiapine (Seroquel®) perphenazine |
| PDE-5 Inhibitors (to treat erectile dysfunction) | sildenafil (Viagra®) vardenafil (Levitra®) tadalafil (Cialis®) |
Sedatives/Hypnotics (to treat trouble with sleeping and/or anxiety) | buspirone (Bustab®) clorazepate diazepam (Diazemuls®, Valium®) flurazepam (Dalmane®, Som-Pam®) zoldipem midazolam (taken by injection) |
| Platelet Aggregation Inhibitors (to prevent the clotting of platelets) | Ticagrelor (Brilinta®) |
| Antiemetics (to manage symptoms of upper gastrointestinal motility disorders) | domperidone |
If you have also been prescribed enteric-coated didanosine as well as Mylan-Darunavir and ritonavir, take didanosine 2 hours before or after the Mylan-Darunavir/ritonavir combination.
This is not a complete list of medicines that you should tell your doctor 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 doctors and pharmacists any time you get a new medicine. Do not start any new medicines while you are taking Mylan-Darunavir without first talking with your doctor or pharmacist.
How to take Mylan-Darunavir:
- Your doctor will tell you how much Mylan-Darunavir to take and when to take it.
Always take Mylan-Darunavir exactly as your doctor has told you for the medicine to work
properly.
- Do not stop taking it, skip doses or interrupt the use of Mylan-Darunavir unless your doctor tells you to.
- You must check with your doctor if you are not sure how to take it.
- You must take ritonavir (NORVIR®) at the same time as Mylan-Darunavir.
Always take Mylan-Darunavir with food.
- Swallow Mylan-Darunavir tablets whole with water.
If you have trouble swallowing Mylan-Darunavir tablets your doctor might prescribe an oral
- darunavir suspension to you.
- Your doctor will decide whether you should take Mylan-Darunavir tablets or an oral darunavir suspension.
Mylan-Darunavir is NOT available as an oral suspension.
Usual dose:
Adults:
For adults who have never taken anti-HIV medicines the usual dose is 800 mg (two 400 mg tablets or one 800 mg tablet) of Mylan-Darunavir, together with 100 mg (one 100 mg capsule) of ritonavir (NORVIR®), once every day.
For adults who have taken anti-HIV medicines in the past, the usual dose is either 800 mg (two 400 mg tablets or one 800 mg tablet) of Mylan-Darunavir together with 100 mg (one 100 mg capsule) of ritonavir (NORVIR®), once every day OR 600 mg (one 600 mg tablet) of Mylan-Darunavir together with 100 mg (one 100 mg capsule) ritonavir (NORVIR®), twice every day. Your doctor will tell you which dose is right for you.
Children:
- Your child’s doctor will tell you how much Mylan-Darunavir your child should take.
- The dose that they are given will be based on their weight.
- Mylan-Darunavir is used in children who are 6 years of age and older and who weigh at least 33 lbs (15 kg).
- It is used in children who have taken anti-HIV medicines in the past.
- Your child’s doctor will also tell you how much ritonavir (NORVIR®) your child should take along with Mylan-Darunavir.
- If your child does not tolerate ritonavir (NORVIR®), talk to your doctor for advice
Overdose:
| If you think you have taken too much Mylan-Darunavir, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose:
Patients taking 800 mg of Mylan-Darunavir once daily:
If you miss a dose by less than 12 hours, take it as soon as you remember. Then, take your next dose of Mylan-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 Mylan-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 Mylan-Darunavir twice daily:
If you miss a dose of by less than 6 hours, take it as soon as you remember. Then, take your next dose of Mylan-Darunavir and ritonavir (NORVIR®) at the regular scheduled time.
If you miss a dose by more than 6 hours, wait until your next scheduled dose of Mylan-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 Mylan-Darunavir?
These are not all the possible side effects you may feel when taking Mylan-Darunavir. If you experience any side effects not listed here, contact your healthcare professional.
Rash has been reported in 10.3% of patients receiving darunavir. Occasionally, a rash can be severe or potentially life threatening. In patients taking Mylan-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 Mylan-Darunavir and contact your doctor right away.
Liver problems that may occasionally be severe have been reported. Your doctor should do blood tests before you take Mylan-Darunavir and while you are taking it. If you have chronic hepatitis B or C infection, your doctor 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 Mylan-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 doctor 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-Barré 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 doctor 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, 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:
Keep out of reach and sight of children.
Mylan-Darunavir should be stored at controlled room temperature, between 15°C and 30°C.
If you want more information about Mylan-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.html); the manufacturer’s website www.mylan.ca or by calling 1-800-575-1379
Etobicoke, Ontario M8Z 2S6
Last Prepared: June 21, 2019
Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca