800 mg / 150 mg film-coated tablets
darunavir/cobicistat
What REZOLSTA is and what it is used for
What is REZOLSTA?
REZOLSTA contains the active substances darunavir and cobicistat.
Darunavir belongs to a group of HIV medicines called protease inhibitors that work by reducing the amount of HIV in the body to a very low level. It is given with cobicistat which increases the amount of darunavir in the blood.
Treatment with REZOLSTA strengthens your immune system (your body’s natural defenses) and reduces the risk of developing diseases associated with HIV infection, but REZOLSTA is not a cure for HIV infection.
What is it used for?
REZOLSTA is used to treat adults and adolescents who are 12 years of age or older and weigh at least 40 kg, who are infected with HIV (see “How to take REZOLSTA”).
You must take REZOLSTA with other HIV medicines. Your doctor will discuss with you which drug combination is best for you.
What you need to know before taking REZOLSTA
Do not take REZOLSTA
- if you are allergic to darunavir, cobicistat, or any of the other ingredients of this medicine (listed in section 6).
- 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 REZOLSTA with any of the following medicines:
If you take any of these, ask your doctor if you can switch to another medicine
| Drug | Purpose of the drug |
| Alfuzosin | for the treatment of enlarged prostate |
| Amiodarone , bepridil, dronedarone, ivabradine , quinidine, ranolazine | to treat certain heart diseases, e.g. irregular heartbeat |
| Carbamazepine, phenobarbital and phenytoin | to treat seizures |
| Astemizole or terfenadine | to treat allergy symptoms |
| Colchicine (if you have kidney/liver problems) | to treat gout or familial Mediterranean fever |
| Combination drugs with lopinavir / ritonavir | anti – HIV drugs |
| Rifampicin | to treat certain infections such as tuberculosis |
| Lurasidone, pimozide , quetiapine or sertindole | to treat psychiatric conditions |
| Ergotalkaloids such as ergotamine , dihydroergotamine , ergometry and methylergonovine | to treat migraine headaches |
| Cisapride | to treat certain stomach problems |
| St. John’s wort (Hypericum perforatum) | herbal medicine used for mild depression and mild anxiety |
| Elbasvir / grazoprevir | to treat hepatitis C infection |
| Lovastatin, simvastatin and lomitapid | to lower cholesterol levels |
| Triazolam or orally (taken orally) midazolam | to help you sleep and/or to relieve anxiety |
| Sildenafil | to treat a heart and lung disease called pulmonary arterial hypertension. Sildenafil has other uses. See section “Other medicines and REZOLSTA”. |
| Avanafil | to treat erection problems |
| 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 |
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking REZOLSTA.
You can still transmit HIV while taking this medicine, although the risk is reduced with effective antiretroviral therapy. Discuss with your doctor what precautions you need to take to avoid infecting others.
People taking REZOLSTA may still develop infections or other illnesses associated with HIV infection. You must have regular contact with a doctor.
People taking REZOLSTA may get a skin rash. In rare cases, the rash can be severe or potentially life-threatening. Contact your doctor if you get a rash.
Rash (usually mild or moderate) may occur more frequently in patients taking both REZOLSTA and raltegravir (in case of HIV infection ) than in patients taking only one of these medicines.
REZOLSTA 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 REZOLSTA.
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 REZOLSTA.
- Tell your doctor if you have had kidney problems before. Your doctor will carefully consider whether you should receive treatment with REZOLSTA.
- Tell your doctor if you have diabetes. REZOLSTA 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 unusual infections due to a weakened immune system ( opportunistic infection ), signs and symptoms of inflammation from previous infections may appear shortly after starting treatment with HIV drugs. It is believed that these symptoms are due to an improvement in the body’s immune response, which enables the body to fight infection. you who 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 medication 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 so that you can receive the necessary treatment.
- Tell your doctor if you have hemophilia. REZOLSTA 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 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). This may be more likely with long-term treatment for HIV, severe damage to the immune system, obesity, or the use of alcohol or other drugs called corticosteroids. 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.
Children and young people
REZOLSTA should not be used in children younger than 12 years or weighing less than 40 kg.
Other medicines and REZOLSTA
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 REZOLSTA. These are listed above under the heading “Do not combine REZOLSTA with any of the following medicines”.
REZOLSTA must not be used with another antiretroviral medicine that contains an enhancer or another antiretroviral medicine that requires amplification. In some cases, the dosage of one of the other medicines may need to be changed. Therefore, always tell your doctor if you are taking other medicines for HIV and carefully follow your doctor’s instructions on which medicines can be combined.
The effects of REZOLSTA may be reduced if you take any of the following medicines. Tell your doctor if you are taking:
- bosentan (to treat heart disease)
- dexamethasone (for injection ) ( corticosteroid )
- efavirenz, etravirine, nevirapine (to treat HIV infection )
- rifapentine, rifabutin (to treat bacterial infections ).
The effects of other medicines may be affected if you take REZOLSTA. Tell your doctor if you are taking:
- amlodipine, carvedilol, diltiazem, disopyramide, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nicardipine, nifedipine, 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 the treatment effect or side effects may change. Your doctor may need to take blood samples
- of clonazepam (to prevent seizures).
- estrogen-based hormonal contraceptives or hormonal replacement therapy. REZOLSTA may reduce their effect. If these are used as a method of contraception, alternative non-hormonal methods of contraception are recommended
- Ethinyl estradiol/drospirenone. REZOLSTA may increase the risk of increased potassium levels caused by drospirenone.
- atorvastatin, fluvastatin, pitavastatin, 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.
- 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 some 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, methadone (a drug to treat opioid dependence)
- salmeterol (medicine to treat asthma )
- artemether / lumefantrine (a combination drug for malaria )
- dasatinib, irinotecan, nilotinib, vinblastine, vincristine (medicines used to treat cancer)
- perfenazine, risperidone, thioridazine (psychiatric drugs)
- clorazepate, diazepam, estazolam, flurazepam (medicines used to treat sleep disorders or anxiety)
- sildenafil, tadalafil, vardenafil (for erection problems or to treat a heart and lung disease called pulmonary arterial hypertension )
- glekaprevir / pibrentasvir (to treat hepatitis C infection )
- fesoterodine, solifenacin (to treat urinary tract problems).
The dosage of one of the other medicines may need to be changed as the treatment effect or side effects of either the other medicine or Rezolsta may be affected if they are combined.
Tell your doctor if you are taking:
- alfentanil (powerful and short-acting injectable painkiller used in surgery)
- digoxin (to treat certain heart diseases)
- clarithromycin ( antibiotic )
- clotrimazole, fluconazole, itraconazole, isavuconazole, and posaconazole (for fungal infections). Voriconazole should only be taken after a medical evaluation
- rifabutin (against bacterial infections)
- tadalafil, sildenafil, vardenafil (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 )
- colchicine (to treat gout or familial Mediterranean fever). If you have impaired kidney and/or liver function, see section “Do not combine REZOLSTA with any of the following medicines”.
- bosentan (to treat high blood pressure in the blood vessels of the lungs)
- buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, and midazolam when taken as an injection (medicines to treat sleep problems and/or anxiety)
- metformin (to treat type 2 diabetes )
- fentanyl, oxycodone, tramadol (to treat pain)
This is not a complete list of medicines. Inform your healthcare provider about all medicines you are taking.
Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant, planning to become pregnant, or breastfeeding. Pregnant or breastfeeding mothers should not take REZOLSTA.
HIV -infected women should not breastfeed their infants because there is both a risk of the baby becoming infected with HIV through breast milk and because it is not known how the medicine affects the baby.
Driving and using machines
Do not drive or use machines if you feel dizzy after taking REZOLSTA.
REZOLSTA contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take REZOLSTA
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
You must take REZOLSTA every day and always with food. REZOLSTA does not work properly without food. You must eat a meal or snack at least 30 minutes before taking REZOLSTA. The type of food is not important.
- Swallow the tablet whole with a drink, e.g. water or milk. Tell your doctor if you have difficulty swallowing REZOLSTA. The tablet can be shared with a tablet divider. Once you have divided the tablet, take the whole dose (both halves) immediately with a drink, e.g. water or milk.
- Take the other HIV medicines you use in combination with REZOLSTA according to your doctor’s recommendation
Open the childproof cover.
| The plastic jar has a childproof lid and should be opened as follows: Press the plastic cap down while turning it counterclockwise. Remove the lid. |
If you take more REZOLSTA than you should
Contact a doctor, pharmacist, or nurse immediately.
If you forget to take REZOLSTA
If you notice this within 12 hours, take the tablets immediately. Always take the tablets with food. If you notice it later than 12 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 REZOLSTA
If you vomit within 4 hours of taking the medicine, you should take another dose of REZOLSTA with food as soon as possible. If you vomit more than 4 hours after taking the medicine, you do not need to take any additional dose of REZOLSTA until your next regular dose.
Contact a doctor if you are not sure what to do if you miss a dose or if you vomit.
Do not stop taking REZOLSTA without first talking to your doctor
After starting treatment, do not stop it unless your doctor tells you to.
Anti – HIV drugs can make you feel better. Even if you feel better, do not stop taking REZOLSTA. 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 REZOLSTA. If you have chronic hepatitis B or C‑ infection, your doctor should take blood tests more often as you are at 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.
A common side effect of REZOLSTA is skin rash (more often when used in combination with raltegravir), and itching. The rash is usually mild to moderate. A skin rash can also be a symptom of a rare, serious 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 REZOLSTA needs to be stopped.
Another serious side effects seen in up to 1 in 10 users were diabetes. Inflammation of the pancreas ( pancreatitis ) has been reported in up to 1 in 100 users.
Very common (may affect more than 1 user in 10)
- headache
- diarrhea, nausea.
Common side effects (may affect up to 1 in 10 people)
- allergic reactions such as itching
- reduced appetite
- abnormal dreams
- vomiting, pain in or swelling of the abdomen, indigestion, flatulence
- muscle pain
- fatigue
- abnormal blood test results, such as certain tests of the liver or kidneys. Your doctor will explain these to you
- weakness.
Uncommon side effects (may affect 1 in 100 people)
- symptoms of infection or autoimmune disorders (immune reactivation syndrome)
- osteonecrosis (dead skeletal tissue due to decreased blood supply to the skeleton)
- breast augmentation
- abnormal blood test results, such as certain tests of the pancreas, high sugar levels, and abnormal levels of blood fats (lipids ). Your doctor will explain these to you
- allergic reactions such as hives ( urticaria ), severe swelling of the skin or other tissues (usually lips or eyes)
- severe rash with blisters and flaky skin, especially around the mouth, nose, eyes, and genitals.
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 (type of white blood cells ), effect on liver, kidney, or lung].
Has been reported (occurs in an unknown number of users): skin rash that can be severe or potentially life-threatening:
- skin rash with blisters and scaly skin on large parts of the body
- red rashes are covered with small bumps that can spread over the body, sometimes with a fever.
Some side effects are typical of HIV medicines belonging to the same group as REZOLSTA. These are:
- muscle aches, soreness, or weakness. In rare cases, these muscle problems have been severe.
How to store REZOLSTA
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.
Do not use this medicine for more than 6 weeks after first opening the jar.
REZOLSTA does not require any 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 substances are darunavir and cobicistat. One tablet contains 800 mg darunavir (as ethanolate) and 150 mg cobicistat.
- The other ingredients are hypromellose, silicified microcrystalline cellulose, colloidal anhydrous silica, crospovidone, and magnesium stearate. The film coating contains poly (vinyl alcohol) – partially hydrolyzed, titanium dioxide, polyethylene glycol (macrogol), talc, red iron oxide, and black iron oxide.
What the medicine looks like and the contents of the pack
Film-coated, pink, oval tablet with TG embossed on one side and 800 on the other side.
30 tablets in a plastic jar.
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