75 mg film-coated tablets
darunavir
What Darunavir Mylan is
Darunavir Mylan contains the active substance darunavir. Darunavir is an antiretroviral drug used in the treatment of infection with the human immunodeficiency virus ( HIV ). It belongs to a group of medicines called protease inhibitors. Darunavir works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses associated with HIV – infection.
What is it used for
Darunavir is used to treat adults and children over 3 years of age who weigh at least 15 kg who are infected with HIV and who have already used other antiretroviral medicines.
Darunavir must be taken in combination with a low dose of ritonavir and other HIV medicines. Your doctor will discuss with you which drug combination is best for you.
- if you are allergic to darunavir or any of the other ingredients of this medicine (listed in section 6) or to ritonavir.
- if you have severe liver disease. Talk to your doctor if you are unsure about the severity of your liver disease. Additional tests may be necessary.
Do not combine Darunavir Mylan with any of the following medicines
If you take any of these, ask your doctor if you can switch to another medicine.
| Drug | Area of the use of the drug |
| Avanafil | to treat erection problems |
| Astemizole or terfenadine | to treat allergy symptoms |
| Triazolam and midazolam took by mouth | to help you sleep and/or to relieve anxiety |
| Cisapride | to treat certain stomach problems |
| Colchicine (if you have kidney and/or liver problems) | to treat gout or familial Mediterranean fever |
| Lurasidone, pimozide, quetiapine, or sertindole | to treat psychiatric conditions |
| Ergotamine alkaloids such as ergotamine, dihydroergotamine, ergonovine, and methylergometry (methylergonovine) | to treat migraine headaches |
| Amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine | to treat certain heart diseases, e.g. irregular heartbeat |
| Lovastatin, simvastatin, and lomitapide | to lower cholesterol levels |
| Rifampicin | to treat certain infections like tuberculosis |
| The combination drug lopinavir/ritonavir | this anti- HIV drug belongs to the same class as darunavir |
| Elbasvir / grazoprevir | To treat hepatitis C infection |
| Alfuzosin | for the treatment of enlarged prostate |
| Sildenafil | for the treatment of high blood pressure in the blood vessels of the lungs. |
| Dabigatran, ticagrelor | to prevent platelets from clotting in the treatment of patients who have had a heart attack |
| Naloxegol | to treat constipation caused by opioid you |
| Dapoxetine | to treat premature ejaculation |
| Domperidone | to treat nausea and vomiting |
Do not take Darunavir with products containing St. John’s wort (Hypericum perforatum).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Darunavir Mylan.
Darunavir does not cure HIV – infection. You can still transmit HIV infection while taking this medicine, even though the risk of effective antiviral therapy is reduced. Discuss with your doctor the necessary steps to avoid infecting others.
People taking darunavir may still develop infections you or other illnesses associated with HIV – infection. You must continue to have regular contact with your doctor.
People taking darunavir may develop skin rashes. In rare cases, a rash can be serious or potentially life-threatening. Always consult your doctor if you develop a rash.
Rashes (generally mild or moderate) may occur more frequently in patients taking both darunavir and raltegravir (at HIV – infection ) than in patients taking either of these drugs.
Inform your doctor about your situation BEFORE and DURING your treatment
Check the following points and tell your doctor if any of these apply to you.
- Tell your doctor if you have a history of liver problems, including hepatitis B or C infection. Your doctor can assess the severity of your liver disease before deciding if you can take darunavir.
- Tell your doctor if you have diabetes. Darunavir may increase blood sugar levels.
- Tell your doctor immediately if you notice any symptoms of infection (such as enlarged lymph nodes or fever). In some patients with advanced HIV – infection and a history of opportunistic infection, signs, and symptoms of inflammation from previous infections may occur soon after treatment with HIV -läkemedel began. It is believed that these symptoms are due to an improvement in the body’s immune response, which enables the body to fight infections that may have been present without giving clear symptoms.
- In addition to opportunistic infection, you can autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines to treat your HIV – infection. Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, inform your doctor immediately for the necessary treatment.
- Tell your doctor if you have hemophilia. Darunavir may increase the risk of bleeding.
- Tell your doctor if you are allergic to sulfonamides (for example, used to treat certain infections ).
- Tell your doctor if you notice problems with muscles and bones. Some patients taking combination antiviral therapy may develop a skeletal disease called osteonecrosis (dead bone tissue due to loss of blood supply to the skeleton). The duration of combination antiviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression (severely weakened immune system), and high BMI ( body mass index ) can be some of the many risk factors for developing the disease. Signs of osteonecrosis are stiff and aching joints (especially in the hip, knee, and shoulder) and difficulty moving. If you notice any of these symptoms, talk to your doctor.
Older
Darunavir has only been used in a limited number of patients aged 65 years or older. If you belong to this age group, discuss with your doctor if you can use Darunavir Mylan.
Children
Darunavir should not be used in children under 3 years of age or weighing less than 15 kg.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
There are certain medicines that you must not combine with darunavir. These are listed above under the heading “Do not combine Darunavir Mylan with any of the following medicines”.
In most cases, darunavir can be combined with anti- HIV medicines belonging to other classes (eg NRTIs ( nucleoside analogs), NNRTIs (non-nucleoside analogs), CCR5 antagonists, and FIs (fusion inhibitors). darunavir with ritonavir has not been tested with all PIs ( protease inhibitors ) and must not be used with other HIV -PI preparations. In some cases, the dosage of the other drugs may have to be changed. therefore, always tell your doctor if you take other medicines for HIV and carefully follow your doctor’s instructions on which medicines can be combined.
The effect of darunavir may be reduced if you take any of the following medicines. Tell your doctor if you are taking:
- phenobarbital, phenytoin (to prevent seizures)
- dexamethasone ( corticosteroid )
- efavirenz (against HIV – infection )
- rifapentine, rifabutin (medicines to treat certain infections, such as tuberculosis )
- saquinavir (against HIV – infection ).
The effects of other medicines may be affected if you take darunavir. Tell your doctor if you are taking:
- amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil(for heart disease) as the treatment effect or side effects of these medicines may be increased.
- apixaban, edoxaban, rivaroxaban, warfarin (to reduce blood clotting) as their treatment effect or side effects may change; Your doctor may need to check your blood.
- estrogen-based hormonal contraceptives or hormonal replacement therapy. Darunavir may reduce their effect. If these are used as a method of contraception, alternative non-hormonal methods of contraception are recommended.
- ethinyl estradiol / drospirenone. Darunavir may increase the risk of increased potassium levels caused by drospirenone.
- atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels). The risk of muscle damage may be increased. Your doctor will evaluate which cholesterol-lowering treatment best suits your specific situation.
- clarithromycin ( antibiotic )
- ciclosporin, everolimus, tacrolimus, sirolimus (to suppress the immune system) as the treatment effect or side effects of these medicines may be increased. Your doctor may want to do additional tests.
- Corticosteroids include betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These drugs are used to treat allergies, asthma, inflammatory bowel disease, diseases of the eyes, joints, and muscles, and other inflammatory diseases. If no alternatives can be used, they should only be used after medical evaluation and under close medical supervision concerning side effects of corticosteroids.
- buprenorphine / naloxone (opioid treatment drug)
- salmeterol (medicine to treat asthma )
- artemether / l lumefantrine (a combination drug against malaria )
- dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (to treat cancer)
- sildenafil, tadalafil, vardenafil (for erection problems or to treat a lung disease called pulmonary arterial hypertension )
- telaprevir / pibrentasvir, (to treat hepatitis C infection )
- fentanyl, oxycodone, tramadol (to treat pain).
- fesoterodine, solifenacin (to treat urinary tract problems ).
The dosage of one of the other medicines may need to be changed as either their own or darunavir’s treatment effect or side effects can be affected if they are combined.
Tell your doctor if you are taking:
- alfentanil (powerful and short-acting painkiller for injection used in surgery)
- digoxin (to treat certain heart diseases)
- clarithromycin ( antibiotic )
- itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (to treat fungal infections). Voriconazole should only be taken after a medical evaluation.
- rifabutin (against bacterial infections)
- sildenafil, vardenafil, tadalafil (for erection problems or high blood pressure in the blood vessels in the lungs)
- amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (for treating depression and anxiety)
- maraviroc (to treat HIV – infection )
- methadone (to treat opiate addiction)
- carbamazepine, clonazepam (to prevent seizures or to prevent certain types of nerve pain)
- colchicine (to treat gout or familial Mediterranean fever)
- bosentan (to treat high blood pressure in the blood vessels of the lungs)
- buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam when taken as an injection, zolpidem (sedatives)
- perphenazine, risperidone, thioridazine (to treat psychiatric conditions).
This is not a complete list of medicines. Tell your doctor about all the medicines you are taking.
See section 3 “How to take Darunavir Mylan”.
Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant, planning to become pregnant, or breast-feeding. Pregnant or breast-feeding mothers should not take darunavir with ritonavir unless specifically prescribed by a doctor. Pregnant or breast-feeding mothers should not take darunavir with cobicistat.
HIV- infected women should not breast-feed their infants because there is both a risk of the baby becoming infected with HIV through breast milk and because you do not know how the medicine will affect your baby.
Driving and using machines
Do not use machines or drive if you feel dizzy after taking darunavir.
This medicine contains less than 1 mmol sodium (23 mg) per dose, which is essential ‘sodium-free’.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
Even if you feel better, do not stop taking Darunavir Mylan and ritonavir without talking to your doctor.
Once treatment has been started, dose one or the dosage form must not be changed and treatment must not be stopped without instructions from a doctor.
Dosage for children from 3 years of age who weigh at least 15 kg and who have not taken antiretroviral drugs before (your child’s doctor decides this)
The doctor decides on an appropriate daily single dose based on the child’s body weight (see table below). This dose should not exceed the recommended dose for adults who are 800 mg darunavir together with 100 mg ritonavir once daily.
Your doctor will tell you how many tablets of Darunavir Mylan and how much ritonavir (capsules, tablets, or solution) your child should take.
| Weight | A darunavir dose is | A ritonavir text – dose is |
| between 15 and 30 kg | 600 mg | 100 mg |
| between 30 and 40 kg | 675 mg | 100 mg |
| over 40 kg | 800 mg | 100 mg |
| a ritonavir oral solution: 80 mg / ml |
Dosage for children from 3 years of age who weigh at least 15 kg and who have taken antiretroviral drugs before (your child’s doctor decides this)
The doctor decides on a dose based on the child’s body weight (see table below). The doctor decides whether the child should be dosed once or twice daily. This dose should not exceed the recommended dose for adults, which is 600 mg darunavir with 100 mg ritonavir twice daily or 800 mg darunavir with 100 mg ritonavir once daily.
Your doctor will tell you how many tablets of Darunavir Mylan and how much ritonavir (capsules, tablets, or solution) your child should take. There are tablets with other strengths available and your doctor may have prescribed a certain combination of tablets to achieve the right dosage.
Other formulations of this drug may be more suitable for children. Consult a doctor or pharmacist.
Dosage twice-daily
| Weight | One dose is |
| between 15 and 30 kg | 375 mg darunavir + 50 mg ritonavir twice daily |
| between 30 and 40 kg | 450 mg darunavir + 60 mg ritonavir twice daily |
| over 40 kg * | 600 mg darunavir + 100 mg ritonavir twice daily |
| * For children 12 years of age and older who weigh at least 40 kg, your child’s doctor will decide if Darunavir Mylan 800 mg can be used once a day. This can not be given with these 150 mg tablets. Other strengths of Darunavir Mylan are available. |
Dosage once daily
| Weight | A darunavir dose is | A ritonavir text – dose is | |
| between 15 and 30 kg | 600 mg | 100 mg | |
| between 30 and 40 kg | 675 mg | 100 mg | |
| over 40 kg | 800 mg | 100 mg | |
| a ritonavir oral solution: 80 mg / ml | |||
Instructions for use for children
- The child should always take darunavir with ritonavir. Darunavir does not work properly without ritonavir.
- The child should take doses of darunavir and ritonavir twice daily or once daily. If darunavir has been prescribed twice daily, the child must take one dose in the morning and one dose in the evening. Your child’s doctor will determine the appropriate dosage for your child.
- The child should take darunavir with food. Darunavir does not work properly without food. The type of food is not important.
- The child should swallow the tablets with a drink such as water or milk.
Dosage for adults who have not taken antiretroviral medicines before (your doctor will decide)
You will need another dose of darunavir which cannot be given with these 75 mg tablets. Other strengths of Darunavir Mylan are available.
Dosage for adults who have taken antiretroviral medicines before (your doctor will decide)
Dose one is either:
– 600 mg darunavir (2 tablets containing 300 mg darunavir or 1 tablet containing 600 mg darunavir) together with 100 mg ritonavir twice daily.
OR
- 800 mg darunavir (2 tablets containing 400 mg darunavir or 1 tablet containing 800 mg darunavir) together with 100 mg ritonavir once daily. Darunavir 400 mg and 800 mg tablets should only be used to achieve a dose of 800 mg once daily.
Discuss with your doctor which dosage is best for you.
Instructions for use for adults a
- Always take darunavir with ritonavir. Darunavir does not work properly without ritonavir.
- Take one tablet of darunavir 600 mg in the morning with 100 mg ritonavir.
- Take one darunavir 600 mg tablet in the evening with 100 mg ritonavir.
- Take darunavir with food. Darunavir does not work properly without food. The type of food is not important.
- Swallow the tablets with a drink, e.g. water or milk.
- Darunavir Mylan 75 mg and 150 mg tablets have been developed for the treatment of children, but may also be used in adults in some cases.
Contact a doctor, pharmacist, or nurse immediately.
If you notice this within 6 hours, take the tablets immediately. Always take ritonavir tablets and food. If you notice it later than 6 hours after the missed dose, skip the tablets and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you vomit after taking Darunavir Mylan and ritonavir
If you vomit within four hours of taking the medicine, you should take Darunavir Mylan and ritonavir again with food as soon as possible. If you vomit more than four hours after taking the medicine, you do not need to take Darunavir Mylan and ritonavir again until the next regular dose.
Contact your doctor if you are not sure what to do if you miss a dose or vomit.
Anti- HIV drugs can make you feel better. Even if you feel better, do not stop taking darunavir. Talk to your doctor first.
4. Possible side effects
During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if you experience any of the following side effects:
Liver problems that can sometimes be serious have been reported. Your doctor should take a blood test before starting the darunavir treatment. If you have chronic hepatitis B or C infection, your doctor should take blood tests more often because you have an increased risk of developing liver problems. Talk to your doctor about signs and symptoms of liver problems. These may include yellowing of the skin or whites of the eyes, dark (tea-colored) urine, pale stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aches or pains, and discomfort on the right side below the ribs.
Skin rash (more often when used in combination with raltegravir), itching. The rash is usually mild to moderate. A skin rash can also be a symptom of a rare difficult situation. It is therefore important that you talk to your doctor if you get a rash. Your doctor will advise you on how to deal with your symptoms or if darunavir needs to be stopped.
Other serious side effects were diabetes (common) and inflammation of the pancreas (less common).
Very common side effects (may affect more than 1 user in 10)
- diarrhea.
Common side effects (may affect up to 1 in 10 people)
- vomiting, nausea, stomach pain or tension, indigestion, flatulence
- headache, fatigue, dizziness, drowsiness, numbness, tingling or pain in hands and feet, weakness, difficulty falling asleep.
Uncommon side effects (may affect up to 1 in 100 people)
- chest pain, electrocardiogram changes, rapid heartbeat
- impaired or abnormal sensitivity of the skin, tingling, attention deficit, memory loss, balance problems
- difficulty breathing, cough, nosebleeds, irritation of the throat
- inflammation of the stomach or mouth, heartburn, ulceration, dry mouth, abdominal discomfort, constipation, belching
- kidney failure, kidney stones, difficulty urinating, frequent or heavy urination, sometimes at night
- hives, severe swelling of the skin or other tissues (usually lips or eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, the coloring of the nails
- muscle pain, muscle cramps or muscle weakness, pain in the extremities, osteoporosis
- impaired thyroid function. This can be seen in a blood test.
- high blood pressure, hemorrhage
- red or dry eyes
- fever, swelling of the legs due to fluid, malaise, irritability, pain
- a symptom of infection, herpes simplex
- erectile dysfunction, breast enlargement
- sleep problems, drowsiness, depression, anxiety, abnormal dreams, decreased sexual drive.
Rare side effects (may affect up to 1 in 1,000 people)
- a reaction called DRESS [severe rash that may be followed by fever, fatigue, swelling of the face or lymph nodes, increased eosinophils ( white blood cell type ), the effect on liver, kidney, or lung]
- heart attack, or slow heartbeat, palpitations
- visual disturbance
- chills, feeling abnormal
- state of confusion or disorientation, altered mood, restlessness
- fainting, epileptic seizures, altered or lost sense of taste
- cold sores, vomiting, inflammation of the lips, dry lips, coating on the tongue
- Runny nose
- skin changes, dry skin
- stiffness in muscles or joints, joint pain with or without inflammation
- changes in certain blood levels. These can be seen in the results of blood and urine tests. Your doctor will explain this to you. Examples are: increase in certain white blood cells.
Some side effects are typical of anti- HIV drugs that belong to the same group as darunavir.
These are:
- muscle aches, soreness, or weakness. In rare cases, muscle problems have been severe.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and can after EXP. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
For cans: Use opened packaging within 100 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is darunavir. Each tablet contains 75 mg of darunavir.
The other ingredients are colloidal anhydrous silica, microcrystalline cellulose, crospovidone, sodium starch glycolate, hypromellose, magnesium stearate. The film coating contains polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), macrogol and talc.
What the medicine looks like and the contents of the pack
Darunavir Mylan 75 mg film-coated tablets are white to off-white, oval in shape with two curved sides marked with M on one side and DV1 on the other.
Darunavir Mylan 75 mg film-coated tablets are supplied in blister packs of 480 tablets and in plastic cans of 480 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan SAS
117 Allee des Parcs
69 800 Saint-Priest
France
Manufacturer
Mylan Hungary Kft
H-2900 Komárom, Mylan UTC 1
Hungary
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Germany GmbH
Branch drop Bad Homburg vd Hoehe, Benzstrasse 1
Bad Homburg vd Hoehe
Hessen, 61352
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine: