Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using PREZCOBIX?
PREZCOBIX contains two active ingredients, darunavir and cobicistat, which work in
combination to treat adults who are infected by HIV (Human Immunodeficiency Virus).
2. What should I know before I use PREZCOBIX?
Do not use if you have ever had an allergic reaction to PREZCOBIX or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions or are pregnant or plan
to become pregnant or are breastfeeding. Tell your doctor if you are taking or have
recently taken any other medicines, including medicines obtained without prescription,
as PREZCOBIX might interact with other medicines.
3. What if I am taking other medicines?
4. How do I use PREZCOBIX?
Always take this medicine exactly as your doctor has told you. You must check with
your doctor if you are not sure.
The usual dose of PREZCOBIX is one tablet orally, once daily with food and always
with food. PREZCOBIX cannot work properly without food. Swallow the tablets with a
drink such as water, milk, or any other nutritional drink
5. What should I know while using PREZCOBIX?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using PREZCOBIX.
Tell your doctor if you notice any symptoms of an infection.
Be sure to keep all your doctor's appointments so your progress can be checked.
If you are undergoing anaesthesia, tell your anaesthetist that you are taking PREZCOBIX.
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Things you should not do
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Do not stop using this medicine suddenly without talking to your doctor even if you
feel better.
Avoid doing things that can spread HIV infection since PREZCOBIX does not stop you
from passing the HIV infection to others.
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Driving or using machines
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Do not operate machines or drive if you feel dizzy after taking PREZCOBIX.
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Looking after your medicine
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Store below 30°C and in the original packaging to protect from moisture.
Keep it where children cannot reach it.
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6. Are there any side effects?
The following common side effects may occur when taking PREZCOBIX; nausea, vomiting,
headache, abdominal pain, diarrhea, passing wind, rash, itching or hives on the skin.
Active ingredient(s):
Darunavir/cobicistat
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using PREZCOBIX. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using PREZCOBIX.
Where to find information in this leaflet:
1. Why am I using PREZCOBIX?
PREZCOBIX contains the active ingredients darunavir and cobicistat. PREZCOBIX is an antiretroviral medicine that works by reducing the amount of HIV
in your body. Darunavir is the HIV medicine, which needs to be combined with another
medicine, cobicistat, that increases the amount of HIV medicine in your blood to control
your HIV infection.
PREZCOBIX is used to treat adults who are infected with HIV. PREZCOBIX must be taken with other anti-HIV medicines. Your doctor will discuss with
you which combination of medicines is best for you.
2. What should I know before I use PREZCOBIX?
Warnings
Do not use PREZCOBIX if:
you are allergic to darunavir, cobicistat, or any of the other ingredients listed
the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Do not use PREZCOBIX if you are taking any of the following medicines:
alfuzosin (to treat an enlarged prostate)
astemizole or terfenadine (to treat allergy symptoms)
cisapride (to treat some stomach conditions)
colchicine (to treat gout) if you have renal/hepatic impairment
amiodarone, bepridil, disopyramide, flecainide, systemic lidocaine, mexiletine, propafenone,
quinidine or dronedarone (to treat irregular heartbeats)
dronedarone, ivabradine or ranolazine (to treat heart disease)
lomitapide, lovastatin or simvastatin (to lower cholesterol levels)
midazolam or triazolam (to treat trouble with sleeping and/or anxiety)
lurasidone or pimozide (to treat psychiatric conditions)
apixaban (used to reduce blood clotting)
carbamazepine, phenobarbital, phenytoin (medicines to prevent seizures or to treat
trigeminal neuralgia)
ergot alkaloids i.e. dihydroergotamine, ergonovine, ergotamine, methylergonovine (to
treat migraine and headaches)
sildenafil (to treat pulmonary arterial hypertension)
rifampin (to treat some infections such as tuberculosis)
elbasvir/grazoprevir (to treat hepatitis C)
products that contain St John's wort (Hypericum perforatum)
naloxegol (to treat opioid induced constipation)
dapoxetine (to treat premature ejaculation)
If you are taking any of these, ask your doctor about switching to another medicine.
This is not a complete list of medicines. Therefore, tell your doctor about all medicines you take.
Check with your doctor if you:
have or have had any other medical conditions, especially the following:
Kidney problems or are undergoing kidney dialysis treatment.
Problems with your liver, including hepatitis B and hepatitis C. Your doctor may need
to evaluate your liver before deciding if you can take PREZCOBIX.
Diabetes. PREZCOBIX, like some other anti-HIV medicines, might increase sugar levels
in the blood.
Haemophilia. Anti-HIV medicines, such as PREZCOBIX, might increase the risk of bleeding
in patients with this blood clotting disorder.
allergy to sulfa medicines (sulphonamides) or any other medicines.
take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not take PREZCOBIX if you are pregnant or breastfeeding.
It is recommended that HIV infected women should not breastfeed because of the possibility
of the baby becoming infected with HIV through breast milk and because of the unknown
effects of the medicine on the baby.
Use in children and adolescents
PREZCOBIX should not be given to children younger than 18 years of age.
Take special care with PREZCOBIX
PREZCOBIX is not a cure for HIV infection.
Talk to your doctor about appropriate precautions to lower the chance of spreading
HIV to others.
People taking PREZCOBIX can still develop infections or other illnesses associated
with HIV. You should continue to keep in regular contact with your doctor and to monitor
your health while taking PREZCOBIX.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
There are some medicines that you must not combine with PREZCOBIX. These are mentioned
above under the subsection ‘Do not use PREZCOBIX if’.
Tell your doctor if you take other anti-HIV medicines. PREZCOBIX can be combined with
some other anti-HIV medicines while other combinations are not recommended or should
not be used.
The effects of PREZCOBIX might be reduced if you take any of the following medicines.
Tell your doctor if you take any of the following:
medicines to treat hepatitis C (telaprevir, boceprevir, glecaprevir/pibrentasvir)
medicines to prevent seizures (oxcarbazepine)
corticosteroids (dexamethasone)
medicines to treat excessive sleepiness (armodafinil, modafinil)
medicines to treat some infections such as tuberculosis (rifabutin, rifapentine)
The effects of other medicines might be influenced if you take PREZCOBIX and your
doctor might want to do some additional blood tests. Tell your doctor if you take:
medicines for heart disease (amlodipine, diltiazem, felodipine, nifedipine, nicardipine,
tadalafil, verapamil)
medicines used to reduce clotting of the blood (dabigatran etexcilate, edoxaban, rivaroxaban,
warfarin) or to prevent blood clots (ticagrelor, clopidogrel)
oestrogen-based hormonal contraceptives. PREZCOBIX might reduce the effectiveness
of hormonal contraceptives. Therefore, additional or alternative (non-hormonal) methods
of contraception are recommended. If you take a contraceptive containing drospirenone
your potassium levels might become elevated.
medicines to lower cholesterol levels (pravastatin, atorvastatin, rosuvastatin, pitavastatin).
The risk of muscle tissue disorder might be increased. Atorvastatin, rosuvastatin,
or pravastatin, at a reduced starting dose, could be used as an alternative.
medicines for your immune system (cyclosporine, tacrolimus, sirolimus, everolimus,
rapamycin). Your doctor might want to do some additional tests.
corticosteroids (betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone)
medicines to treat asthma (salmeterol)
medicines to treat gout (colchicine). If you have renal/hepatic impairment, do not
take colchicine with PREZCOBIX.
medicines to treat malaria (artemether/lumefantrine)
medicines to treat cancer (dasatinib, everolimus, irinotecan, nilotinib, vinblastine,
vincristine)
medicines to prevent seizures (clonazepam)
medicines to treat psychiatric conditions (risperidone, thioridazine, quetiapine,
perphenazine)
medicines against bacterial infections (erythromycin and telithromycin)
medicines to treat pain (fentanyl, oxycodone, tramadol)
medicines to treat urinary disorders (fesoterodine, solifenacin)
medicines to treat nausea and vomiting (domperidone).
The dosage of other medicines might need to be changed and your doctor might do some
additional blood tests. Tell your doctor if you take:
medicines to treat certain heart disorders (digoxin, carvedilol, metoprolol, timolol,
bosentan)
medicines to treat fungal infections (clotrimazole, fluconazole, isavuconazole, itraconazole,
ketoconazole, posaconazole, voriconazole)
medicines for erectile dysfunction (avanafil, vardenafil, tadalafil, sildenafil)
medicines against bacterial infections (clarithromycin)
medicines to treat depression and anxiety (paroxetine, sertraline, amitriptyline,
desipramine, imipramine, nortriptyline, and trazodone)
medicines to treat narcotic dependence (buprenorphine/ naloxone, methadone)
medicines to treat trouble sleeping and/or anxiety (buspirone, clorazepate, diazepam,
estazolam, flurazepam, zolpidem).
This is not a complete list of medicines. Tell your healthcare provider about all medicines that you are taking.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect PREZCOBIX.
4. How do I use PREZCOBIX?
How much to take
The usual dose of PREZCOBIX is one tablet orally, once daily with food.
Follow the instructions provided and use PREZCOBIX until your doctor tells you to
stop.
Always use PREZCOBIX exactly as your doctor has told you. You must check with your
doctor if you are not sure.
Make sure that you always have enough PREZCOBIX available so that you don't run out.
For example, in case you cannot return home, need to travel or stay in a hospital.
When to take PREZCOBIX
You must take PREZCOBIX every day and always with food. PREZCOBIX cannot work properly without food.
You must eat a meal or a snack within 30 minutes prior to taking your PREZCOBIX. The type of food is not important.
Even if you feel better, do not stop taking PREZCOBIX without talking to your doctor.
How to take PREZCOBIX
Take PREZCOBIX with food.
Swallow the tablets with a drink such as water, milk, or any other nutritional drink.
Do not crush or chew the tablet.
Take your other HIV medicines used in combination with PREZCOBIX as recommended by
your doctor.
Removing the child resistant cap
The plastic bottle comes with a child resistant cap and should be opened as follows:
Push the plastic screw cap down while turning it counter clockwise.
Remove the unscrewed cap.
If you forget to use PREZCOBIX
PREZCOBIX should be used regularly at the same time each day.
If you notice within 12 hours, you must take the tablets 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 the dose you missed.
Please refer to your doctor for instructions on missed doses of other HIV medicines
used in combination with PREZCOBIX.
If you use too much PREZCOBIX
If you think that you have used too much PREZCOBIX, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using PREZCOBIX?
Things you should do
Call your doctor straight away if you:
Notice any symptoms of infection. 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 anti-HIV
treatment is started. It is believed that these symptoms are due to an improvement
in the body's immune response. This improvement enables the body to fight infections
that may have been present prior to taking PREZCOBIX, with no obvious symptoms.
Be sure to keep all your doctor's appointments so your progress can be checked. Your doctor will want to do some blood, urine and other tests from time to time
to check on your progress.
If you are undergoing anaesthesia, tell your anaesthetist that you are taking PREZCOBIX.
Remind any doctor, dentist or pharmacist you visit that you are using PREZCOBIX.
Things you should not do
Do not stop taking PREZCOBIX without talking to your doctor first. HIV therapy may
increase your sense of well being. Even when you feel better, do not stop taking PREZCOBIX.
Talk to your doctor first.
Avoid doing things that can spread HIV infection since PREZCOBIX does not stop you
from passing the HIV infection to others:
Do not share needles or other injection equipment.
Do not share personal items that can have blood or body fluids on them, like toothbrushes
or razor blades.
Do not have any kind of sex without protection. Always practise safer sex by using
a latex or polyurethane condom or other barrier to reduce the chance of passing the
infection through semen, vaginal secretions, or blood.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how PREZCOBIX
affects you.
Do not operate machines or drive if you feel dizzy after taking PREZCOBIX.
Looking after your medicine
Store below 30°C and in the original packaging to protect from moisture.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on windowsills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
When treating HIV infection, it is not always easy to identify what side effects are
caused by PREZCOBIX, which are caused by other medicines you are taking, or which
are caused by the HIV infection itself.
PREZCOBIX may change some values of your blood chemistry. These can be seen in the
results of blood tests. Your doctor will explain these to you.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Infection related:
symptoms such as a fever or rashes.
Stomach or gut related:
abdominal pain, diarrhoea
passing wind
loss of appetite
Muscle related:
muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have
been serious.
Blood related:
increased blood fat levels
raised blood sugar and worsening of diabetes.
Liver related:
Liver problems that may occasionally be severe have been reported. Your doctor should
do blood tests prior to initiating PREZCOBIX. 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. Signs and symptoms of liver problems
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 sensitivity on your right side below your ribs.
Immune related:
Immune reactivation syndrome. In some patients with advanced HIV infection (AIDS)
and a history of opportunistic infection, signs and symptoms of inflammation from
previous infections may occur soon after anti-HIV treatment is started, including
PREZCOBIX. 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 treatment of your HIV infection. Autoimmune disorders
may occur many months after the start of treatment.
Other:
nausea, vomiting
headache
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Skin related:
Skin rash has been reported in patients receiving PREZCOBIX. Occasionally a rash can
be severe or potentially life threatening. In patients taking PREZCOBIX and raltegravir,
rashes (generally mild or moderate) may occur more frequently than in patients taking
either drug separately
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It is important to consult your doctor if you develop a rash. Your doctor will advise
you how to deal with your symptoms or whether PREZCOBIX must be stopped.
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Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What PREZCOBIX contains
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Active ingredient
(main ingredient)
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darunavir 800 mg (as darunavir ethanolate)
cobicistat 150 mg
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Other ingredients
(inactive ingredients)
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hypromellose
silicon dioxide
microcrystalline cellulose
crospovidone
magnesium stearate
Opadry II complete film coating system 85F140053 Pink (ARTG PI No. 109886) (Film Coating)
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Do not take this medicine if you are allergic to any of these ingredients.
What PREZCOBIX looks like
PREZCOBIX 800/150 mg film-coated tablet: Pink oval-shaped tablet, debossed with “800”
on one side and “TG” on the opposite side. Each plastic bottle contains 30 tablets.
(AUST R 231198).
Who distributes PREZCOBIX
Janssen-Cilag Pty Ltd
1-5 Khartoum Rd
Macquarie Park NSW 2113, Australia
Telephone: 1800 226 334
NZ office: Auckland New Zealand
This leaflet was prepared in May 2025.