75 mg film-coated tablets
darunavir
What PREZISTA is and what it is used for
What PREZISTA is
PREZISTA contains the active substance darunavir. PREZISTA is an antiretroviral medicine used to treat human immunodeficiency virus ( HIV ) infection. It belongs to a group of medicines called protease inhibitors. PREZISTA works by reducing the amount of HIV in your body. This improves your immune system and reduces the risk of developing diseases associated with HIV infection.
What is it used for
PREZISTA 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.
PREZISTA 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.
What you need to know before taking PREZISTA
Do not take PREZISTA:
- 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.
Tell your doctor about all medicines you take, including medicines you take by mouth, inhale, inject or lubricate your skin.
Do not combine PREZISTA 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 taken 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 lomitapid | to lower cholesterol levels |
| Rifampicin | to treat certain infections such as tuberculosis |
| The combination drug lopinavir / ritonavir | this anti- HIV drug belongs to the same class as PREZISTA |
| 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 , tikagrelor | to prevent platelets from clotting in the treatment of patients who have had a heart attack |
| Naloxegol | to treat constipation caused by opioids |
| Dapoxetine | to treat premature ejaculation |
| Domperidone | to treat nausea and vomiting |
Do not take PREZISTA with products containing St. John’s wort ( Hypericum perforatum ).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking PREZISTA.
PREZISTA does not cure HIV infection. You can still transmit HIV infection when you take 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 PREZISTA may still develop infections or other illnesses associated with HIV infection. You must continue to have regular contact with your doctor.
People taking PREZISTA may develop a skin rash. In rare cases, a rash can be serious or potentially life-threatening. Always consult your doctor if you develop a rash.
Rash (usually mild or moderate) may occur more frequently in patients taking both PREZISTA and raltegravir (in case of HIV infection ) than in patients taking either of these medicines.
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 PREZISTA.
- Tell your doctor if you have diabetes. PREZISTA 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 who have previously had an opportunistic infection, signs, and symptoms of inflammation from a previous infection may appear shortly after starting treatment with HIV medicines. 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 infections, autoimmune disorders (conditions in which the immune system attacks healthy body tissue) can 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. PREZISTA may increase the risk of bleeding.
- Tell your doctor if you are allergic to sulphonamides (such as those used to treat certain infections ).
- Tell your doctor if you notice any problems with your 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 length of the 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
PREZISTA 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 PREZISTA.
Children
PREZISTA should not be used in children under 3 years of age or weighing less than 15 kg.
Other medicines and PREZISTA
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 PREZISTA. These are listed above under the heading “Do not combine PREZISTA with any of the following medicines”.
In most cases, PREZISTA 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). Ritonavir has not been tested with all PIs ( protease inhibitors ), and must not be used with other HIV -PIs. other medicines for HIV and carefully follow your doctor’s instructions on which medicines can be combined.
The effect of PREZISTA 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 ( for HIV infection )
- rifapentine, rifabutin (medicines to treat certain infections, such as tuberculosis )
- saquinavir (for HIV infection).
The effects of other medicines may be affected if you take PREZISTA. 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, and clopidogrel (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. PREZISTA may reduce their effect. If these are used as a method of contraception, alternative non-hormonal methods of contraception are recommended.
- ethinyl estradiol / drospirenone. PREZISTA may increase the risk of increased potassium levels caused by drospirenone.
- atorvastatin, pravastatin, and 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, and 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, and triamcinolone. These drugs are used to treat allergies, asthma, inflammatory bowel diseases, inflammation of the skin, eyes, joints, and muscles, and other inflammatory conditions. These medicines are usually taken by mouth, inhaled, injected, or applied to the skin. If alternative medicines can not be used, these medicines should only be used after a medical evaluation and under the close supervision of your doctor about the side effects of corticosteroids.
- buprenorphine / naloxone (opioid treatment drug)
- salmeterol (medicine to treat asthma )
- artemether/lumefantrine (a combination drug for 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 )
- glekaprevir / 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 PREZISTA’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, chlorazepate, diazepam , estazolam, flurazepam, midazolam when taken as an injection , zolpidem (sedatives)
- perfenazine, risperidone, and thioridazine (for the treatment of psychiatric conditions).
This is not a complete list of medicines. Tell your doctor about any medicines you take.
PREZISTA with food and drink
See section 3 “How to take PREZISTA”.
Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant, planning to become pregnant, or breastfeeding. Pregnant or breastfeeding mothers should not take PREZISTA with ritonavir unless specifically prescribed by a doctor. Pregnant or breastfeeding mothers should not take PREZISTA with cobicistat.
HIV -infected women should not breastfeed their babies because there is a risk that the baby will be 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 a car if you feel dizzy after taking PREZISTA.
PREZISTA contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take PREZISTA
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 PREZISTA 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 which is 800 mg PREZISTA together with 100 mg ritonavir once daily.
Your doctor will tell you how many PREZISTA tablets and how much ritonavir (capsules, tablets, or solution) your child should take.
| Weight | A PREZISTA dose is | A ritonavir a dose is |
|---|---|---|
| 15-30 kg | 600 mg | 100 mg |
| 30-40 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 PREZISTA with 100 mg ritonavir twice daily or 800 mg PREZISTA with 100 mg ritonavir once daily.
Your doctor will tell you how many tablets PREZISTA 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.
PREZISTA is also available as an oral suspension. Your doctor will decide if PREZISTA tablets or oral suspension are best for your child.
Dosage twice daily
| Weight | One dose is |
|---|---|
| 15-30 kg | 375 mg PREZISTA + 50 mg ritonavir twice daily |
| 30-40 kg | 450 mg PREZISTA + 60 mg ritonavir twice daily |
| over 40 kg * | 600 mg PREZISTA + 100 mg ritonavir twice daily |
| * For children 12 years and up and weighing at least 40 kg, your child’s doctor will decide if PREZISTA 800 mg can be used once a day. This can not be given with these 75 mg tablets. Other strengths of PREZISTA are available. |
Dosage once daily
| Weight | A PREZISTA dose is | A ritonavir a dose is |
|---|---|---|
| 15–30 kg | 600 mg | 100 mg |
| 30–40 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 PREZISTA with ritonavir. PREZISTA cannot function properly without ritonavir.
- The child should take the doses of PREZISTA and ritonavir twice daily or once daily. If PREZISTA 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 PREZISTA with food. PREZISTA can 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 PREZISTA that cannot be given with these 75 mg tablets. Other strengths of PREZISTA are available.
Dosage for adults who have taken antiretroviral drugs before (your doctor will decide)
Dose one is either:
- 600 mg PREZISTA together with 100 mg ritonavir twice daily.
OR
- 800 mg PREZISTA (2 tablets containing 400 mg PREZISTA or 1 tablet containing 800 mg PREZISTA) together with 100 mg ritonavir once daily. PREZISTA 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
- Always take PREZISTA with ritonavir. PREZISTA does not work properly without ritonavir.
- Take one PREZISTA 600 mg tablet in the morning with 100 mg ritonavir.
- Take one PREZISTA 600 mg tablet in the evening with 100 mg ritonavir.
- Take PREZISTA with food. PREZISTA does not work properly without food. The type of food is not important.
- Swallow the tablets with a drink, e.g. water or milk.
- PREZISTA 75 mg and 150 mg tablets and 100 mg/ml oral suspension have been developed for the treatment of children, but may also be used in adults in some cases.
How to open the child-resistant cover
| The plastic jar has a child-resistant lid and should be opened as follows: Press the plastic cap down while turning it counterclockwise. Remove the lid. |
If you take more PREZISTA than you should
Contact a doctor, pharmacist, or nurse immediately.
If you forget to take PREZISTA
If you notice this within 6 hours, take the tablets immediately. Always take the tablets with ritonavir 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 PREZISTA and ritonavir
If you vomit within 4 hours of taking the medicine, take another dose of PREZISTA and ritonavir with food as soon as possible. If you vomit more than 4 hours after taking the medicine, you do not need to take another dose of PREZISTA and ritonavir until you take the next scheduled dose.
Contact your doctor if you are not sure what to do if you miss a dose or vomit.
Do not stop taking PREZISTA without talking to your doctor
Anti – HIV drugs can make you feel better. Even if you feel better, do not stop taking PREZISTA. Talk to your doctor first.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
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 sample before starting treatment with PREZISTA. 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 the 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 PREZISTA 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, and difficulty falling asleep.
Uncommon side effects (may affect up to 1 in 100 people)
- chest pain, ECG ( 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
- symptom of infection, herpes simplex
- erectile dysfunction, breast enlargement
- sleep problems, drowsiness, depression, anxiety, abnormal dreams, and decreased sexual desire.
Rare side effects (may affect up to 1 in 1,000 people)
- a reaction called DRESS [severe rash that may be accompanied by fever, fatigue, swelling of the face or lymph nodes, increased eosinophils (type of white blood cells ), 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 an increase in certain white blood cells.
Some side effects are typical of anti – HIV medicines that belong to the same group as PREZISTA. These are:
- muscle aches, soreness, or weakness. In rare cases, muscle problems have been severe.
How to store PREZISTA
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.
No special storage instructions.
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.
Contents of the pack and other information
Content declaration
- The active substance is darunavir. Each tablet contains 75 mg of darunavir (as ethanolate).
- The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone, and magnesium stearate. The film coating contains poly (vinyl alcohol) – partially hydrolyzed, macrogol 3350, titanium dioxide (E171), and talc.
What the medicine looks like and the contents of the pack
Film-coated white oval tablet with TMC printed on one side and 75 on the other side. 480 tablets in a plastic jar.
PREZISTA is also available in strengths of 150 mg, 400 mg, 600 mg, and 800 mg film-coated tablets and as a 100 mg/ml oral suspension.
Marketing Authorisation Holder
Janssen ‑ Cilag International NV, 30 Turnhoutseweg, B-2340 Beerse, Belgium
Manufacturer:
Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy
Contact the representative of the marketing authorization holder to find out more about this medicine:
Sweden
Janssen-Cilag AB
Tel: +46 8 626 50 00
jacse@its.jnj.com