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Rezolsta - patient leaflet, side effects, dosage

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Patient leaflet - Rezolsta

1. 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’ which work by reducing the amount of HIV in your body to a very low level. It is given with cobicistat, which increases the amount of darunavir in your blood.

Treatment with REZOLSTA will improve your immune system (your body’s natural defences) and reduce the risk of developing illnesses linked to HIV infection, but REZOLSTA is not a cure for HIV infection.

What it is used for?

REZOLSTA is used to treat adults and adolescents aged 12 years and older who weigh at least

40 kilograms and who are infected by HIV (see How to take REZOLSTA).

REZOLSTA must be taken in combination with other HIV medicines. Your doctor will discuss with you which combination of medicines is best for you.

2. What you need to know before you take 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 problems. Ask your doctor if you are unsure about the severity of your

liver disease. Some additional tests might be necessary.

Tell your doctor about all medicines you take including medicines taken orally, inhaled, injected or applied to the skin.

Do not combine REZOLSTA with any of the following medicines

If you are taking any of these, ask your doctor about switching to another medicine.

Medicine

Purpose of the medicine

Alfuzosin

to treat enlarged prostate

Amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine

to treat certain heart disorders e.g. abnormal heart beat

Carbamazepine, phenobarbital and phenytoin

to prevent seizures

Astemizole or terfenadine

to treat allergy symptoms

Colchicine (if you have kidney/liver problems)

to treat gout or familial Mediterranean fever

The combination product lopinavir/rito­navir

anti-HIV medicine

Rifampicin

to treat some infections such as tuberculosis

Lurasidone, pimozide , quetiapine or sertindole

to treat psychiatric conditions

Ergot alkaloids like ergotamine , dihydroergotamine , ergometrine and methylergonovine

to treat migraine headaches

Cisapride

to treat some stomach conditions

St John’s Wort (Hypericum perforatum)

a herbal product used for depression

Elbasvir/grazo­previr

to treat hepatitis C infection

Lovastatin, simvastatin, and lomitapide

to lower cholesterol levels

Triazolam or oral (taken by mouth) midazolam

to help you sleep and/or relieve anxiety

Sildenafil

to treat a heart and lung disorder called pulmonary arterial hypertension. There are other uses for sildenafil. Please see section ‘Other medicines and REZOLSTA’.

Avanafil

to treat erectile dysfunction

Dabigatran , ticagrelor

to help stop the clumping of platelets in the treatment of patients with a history of a heart attack

Naloxegol

to treat opioid induced constipation

Dapoxetine

to treat premature ejaculation

Domperidone

to treat nausea and vomiting

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking REZOLSTA.

You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your physician the precautions needed to avoid infecting other people.

People taking REZOLSTA may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor.

People taking REZOLSTA may develop a skin rash. Infrequently a rash may become severe or potentially life-threatening. Please contact your doctor whenever you develop a rash.

In patients taking REZOLSTA and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.

REZOLSTA has only been used in limited numbers of patients 65 years or older. If you belong to this age group, please discuss with your doctor if you can use REZOLSTA.

Make sure that you check the following points and tell your doctor if any of these apply to you.

  • – Tell your doctor if you have had problems with your liver before, including hepatitis B or C

infection. Your doctor may evaluate how severe your liver disease is before deciding if you can take REZOLSTA.

  • – Tell your doctor if you have had problems with your kidneys. Your doctor will carefully

consider whether to treat you with REZOLSTA.

  • – Tell your doctor if you have diabetes. REZOLSTA might increase sugar levels in the blood.

  • – Tell your doctor immediately if you notice any symptoms of infection (for example enlarged

lymph nodes and fever). In some patients with advanced HIV infection and a history of unusual infections due to a weakened immune system (opportunistic infection), signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.

  • – In addition to the opportunistic infections, autoimmune disorders (a condition that occurs

when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately so you can be given the necessary treatment.

  • – Tell your doctor if you have haemophilia. REZOLSTA might increase the risk of bleeding.

  • – Tell your doctor if you are allergic to sulphonamides (e.g. used to treat certain infections).

  • – Tell your doctor if you notice any musculoskeletal problems. Some patients taking

combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). This may be more likely with long-term HIV treatment, more severe damage to the immune system, overweight, or the use of alcohol or other medicines called corticosteroids. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Children and adolescents

REZOLSTA is not for use in children younger than 12 years, or weighing less than 40 kilograms.

Other medicines and REZOLSTA

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

There are some medicines that you must not combine with REZOLSTA. These are mentioned above under the heading ‘Do not combine REZOLSTA with any of the following medicines:’

REZOLSTA must not be used with another antiviral medicine that contains a booster or another antiviral that requires boosting. In some cases dosage of other medicines might need to be changed. Therefore, always tell your doctor if you take other anti-HIV medicines and follow your doctor’s instruc­tion carefully on which medicines can be combined.

The effects of REZOLSTA might be reduced if you take any of the following products. Tell your doctor if you take:

  • - Bosentan (to treat heart disease)

  • - Dexamethasone (injectable) (corticosteroid)

  • - Efavirenz, etravirine, nevirapine (to treat HIV infection)

  • - Rifapentine, rifabutin (to treat bacterial infections).

The effects of other medicines might be influenced if you take REZOLSTA. Tell your doctor if you take:

  • - Amlodipine, carvedilol, diltiazem, disopyramide, felodipine, flecainide, lidocaine, metoprolol,

mexiletine, nicardipine , nifedipine, propafenone , timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.

  • - Apixaban, edoxaban, rivaroxaban, warfarin, clopidogrel (to reduce clotting of the blood) as

their therapeutic effect or side effects may be altered; your doctor may have to check your blood.

  • - Clonazepam (to prevent seizures).

  • – Oestrogen-based hormonal contraceptives and hormone replacement therapy. REZOLSTA

might reduce its effectiveness. When used for birth control, alternative methods of non-hormonal contraception are recommended.

  • - Ethinylestradi­ol/drospireno­ne. REZOLSTA might increase the risk for elevated potassium

levels by drospirenone.

  • - Atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin (to lower cholesterol levels).

The risk of muscle damage might be increased. Your doctor will evaluate which cholesterol lowering regimen is best for your specific situation.

  • - Ciclosporin, everolimus, tacrolimus, sirolimus (for dampening down your immune system) as

the therapeutic effect or side effects of these medicines might be increased. Your doctor might want to do some additional tests.

  • - Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone,

triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions of the skin, eyes, joints and muscles and other inflammatory conditions. These medicines are generally taken orally, inhaled, injected or applied to the skin. If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.

  • - Buprenorphine/na­loxone , methadone (medicines to treat opioid dependence)

  • - Salmeterol (medicine to treat asthma)

  • - Artemether/lu­mefantrine (a combination medicine to treat malaria)

  • - Dasatinib, irinotecan, nilotinib, vinblastine, vincristine (medicines to treat cancer)

  • - Perphenazine, risperidone, thioridazine (psychiatric medicines)

  • - Clorazepate, diazepam, estazolam, flurazepam (medicines to treat sleeping disorders or anxiety)

  • - Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder

called pulmonary arterial hypertension)

  • - Glecaprevir/pi­brentasvir (to treat hepatitis C infection)

  • - Fesoterodine, solifenacin (to treat urologic disorders).

The dosage of other medicines might need to be changed since either their own or REZOLSTA’s the­rapeutic effect or side effects may be influenced when combined.

Tell your doctor if you take:

  • - Alfentanil (injectable, strong and short-acting, painkiller that is used for surgical procedures)

  • - Digoxin (to treat certain heart disorders)

  • - Clarithromycin (antibiotic)

  • - Clotrimazole, fluconazole, itraconazole, isavuconazole, posaconazole (against fungal

infections). Voriconazole should only be taken after medical evaluation.

  • - Rifabutin (against bacterial infections)

  • - Tadalafil, sildenafil, vardenafil (for erectile dysfunction or high blood pressure in the

pulmonary circulation)

  • - Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat

depression and anxiety)

  • - Maraviroc (to treat HIV infection)

  • - Colchicine (to treat gout or familial Mediterranean fever). If you have renal and/or hepatic

impairment see section ‘Do not combine REZOLSTA with any of the following medicines’.

  • - Bosentan (to treat high blood pressure in the pulmonary circulation)

  • - Buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, midazolam when used as

injection (medicines to treat trouble with sleeping and/or anxiety)

  • - Metformin (to treat type 2 diabetes)

  • - Fentanyl, oxycodone, tramadol (to treat pain).

This is not a complete list of medicines. Tell your healthcare provider about all medicines that you are taking.

Pregnancy and breast-feeding

Tell your doctor immediately if you are pregnant, planning to become pregnant or if you are breast-feeding. Pregnant or breast-feeding mothers should not take REZOLSTA. It is recommended that HIV infected women must not breast-feed their infants because of both 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.

Driving and using machines

Do not operate machines or drive if you feel dizzy after taking REZOLSTA.

REZOLSTA contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take REZOLSTA

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

You must take REZOLSTA every day and always with food. REZOLSTA cannot work properly without food. You must eat a meal or a snack within 30 minutes prior to taking your REZOLSTA. The type of food is not important.

  • – Swallow the tablet whole with a drink such as water or milk. If you have difficulty swallowing

REZOLSTA, tell your doctor. The tablet may be split using a tablet-cutter. After splitting the tablet, the entire dose (both halves) should then be taken right away with a drink such as water or milk.

  • – Take your other HIV medicines used in combination with REZOLSTA as recommended by

your doctor.

Removing the child resistant cap


The plastic bottle comes with a child resistant cap and must be opened as follows: – Push the plastic screw cap down while turning it counter clockwise.

  • – Remove the unscrewed cap.

If you take more REZOLSTA than you should

Contact your doctor, pharmacist or nurse immediately.

If you forget to take REZOLSTA

If you notice within 12 hours , you must take the tablet immediately. Always take with food. If you notice after 12 hours , then skip the intake and take the next doses 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, another dose of REZOLSTA should be taken with food as soon as possible. If you vomit more than 4 hours after taking the medicine, then you do not need to take another dose of REZOLSTA until the next regularly scheduled time.

Contact your doctor if you are uncertain about what to do if you miss a dose or vomit.

Do not stop taking REZOLSTA without talking to your doctor first

After therapy has started, it must not be stopped without instruction of the doctor.

Anti-HIV medicines may make you feel better. Even when you feel better, do not stop taking REZOLSTA. Talk to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you develop any of the following side effects

Liver problems that may occasionally be severe have been reported. Your doctor should do blood tests before you start REZOLSTA. 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. Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or pain and discomfort on your right side below your ribs.

A common side effect of REZOLSTA is skin rash (more often when used in combination with raltegravir), itching. The rash is usually mild to moderate. A skin rash might also be a symptom of a rare severe situation. It is, therefore, important to talk to your doctor if you develop a rash. Your doctor will advise you how to deal with your symptoms or whether REZOLSTA must be stopped.

Other severe side effects, seen up to 1 patient in 10, were diabetes. Inflammation of the pancreas (pancreatitis) has been reported in up to 1 patient in 100.

Very common side effects (may affect more than 1 in 10 people) – headache

  • – diarrhoea, nausea.

Common side effects (may affect up to 1 in 10 people)

  • – allergic reactions such as itching

  • – decreased appetite

  • – abnormal dreams

  • – vomiting, pain or swelling of the belly, indigestion, flatulence

  • – muscle pain

  • – tiredness

  • – abnormal blood test results such as some tests for your liver or kidney. Your doctor will explain

these to you.

  • – weakness.

Uncommon side effects (may affect up to 1 in 100 people)

  • – symptoms of infection or of autoimmune disorders (immune reconstitution inflammatory

syndrome)

  • – osteonecrosis (death of bone tissue caused by loss of blood supply to the bone)

  • – enlargement of breasts

  • – abnormal blood test results such as some tests for your pancreas, high level of sugar, abnormal

levels of ‘lipids’ (fats). Your doctor will explain these to you.

  • – allergic reactions such as nettle rash (urticaria), severe swelling of the skin and other tissues

(most often the lips or the eyes)

  • – severe rash with blisters and peeling skin, particularly 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, which may be accompanied by fever, fatigue, swelling of

the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung].

Side effects with unknown frequency: a rash may become severe or potentially life-threatening:

  • – rash with blisters and peeling skin over much of the body

  • – red rash covered with small pus-filled bumps that can spread over the body, sometimes with a

fever.

Some side effects are typical for HIV medicines in the same family as REZOLSTA. These are:

  • – muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have been

serious.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. 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 on the bottle after EXP. The expiry date refers to the last day of that month.

Do not use this medicine after 6 weeks of first opening the bottle.

REZOLSTA does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What REZOLSTA contains

  • – The active substances are darunavir and cobicistat. Each tablet contains 800 mg of darunavir (as

ethanolate) and 150 mg cobicistat.

  • – The other ingredients are hypromellose, silicified microcrystalline cellulose, colloidal silicon

What REZOLSTA looks like and contents of the pack

Film-coated, pink, oval shaped tablet, mentioning TG on one side, 800 on the other side.

30 tablets in a plastic bottle.

Marketing Authorisation Holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Manufacturer

Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy

For any information about this medicine, please

Authorisation Holder:

België/Belgiqu­e/Belgien

Janssen-Cilag NV

Tel/Tél: +32 14 64 94 11

Etnrapua

..^’/KOHCbH & ^■/KOHC'bH Ebarapua” EOOfl

Ten.: +359 2 489 94 00

Česká republika

Janssen-Cilag s.r.o.

Tel: +420 227 012 227

Danmark

Janssen-Cilag A/S

Tlf: +45 4594 8282

Deutschland

Janssen-Cilag GmbH

Tel: +49 2137 955 955

Eesti

UAB „JOHNSON & JOHNSON“ Eesti filiaal

Tel: +372 617 7410

EXÀàôa

Janssen-Cilag OappaKsuTiK^ A.E.B.E.

Tql: +30 210 80 90 000

España

Janssen-Cilag, S.A.

Tel: +34 91 722 81 00

France

Janssen-Cilag

Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Hrvatska

Johnson & Johnson S.E. d.o.o.

Tel: +385 1 6610 700

Ireland

Janssen Sciences Ireland UC

Tel: +353 1 800 709 122

contact the local representative of the Marketing

Lietuva

UAB „JOHNSON & JOHNSON“

Tel: +370 5 278 68 88

Luxembourg/Lu­xemburg

Janssen-Cilag NV

Tél/Tel: +32 14 64 94 11

Magyarorszag

Janssen-Cilag Kft.

Tel.: +36 1 884 2858

Malta

AM MANGION LTD

Tel: +356 2397 6000

Nederland

Janssen-Cilag B.V.

Tel: +31 76 711 1111

Norge

Janssen-Cilag AS

Tlf: +47 24 12 65 00

Österreich

Janssen-Cilag Pharma GmbH

Tel: +43 1 610 300

Polska

Janssen-Cilag Polska Sp. z o.o.

Tel.: +48 22 237 60 00

Portugal

Janssen-Cilag Farmacêutica, Lda.

Tel: +351 214 368 600

România

Johnson & Johnson România SRL

Tel: +40 21 207 1800

Slovenija

Johnson & Johnson d.o.o.

Tel: +386 1 401 18 00

Ísland

Janssen-Cilag AB c/o Vistor hf.

Sími: +354 535 7000

Slovenská republika

Johnson & Johnson, s.r.o.

Tel: +421 232 408 400

Italia

Janssen-Cilag SpA

Tel: 800.688.777 / +39 02 2510 1

Suomi/Finland

Janssen-Cilag Oy

Puh/Tel: +358 207 531 300

Kúnpog

BapváPag XaTznnavaY^g At3

Tql: +357 22 207 700

Sverige

Janssen-Cilag AB

Tfn: +46 8 626 50 00

Latvija

UAB „JOHNSON & JOHNSON“ filíale Latvija

Tel: +371 678 93561

United Kingdom (Northern Ireland)

Janssen Sciences Ireland UC

Tel: +44 1 494 567 444

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:.

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Sources: Original PDF (ema.europa.eu)