darunavir (da-ROO-nuh-veer)
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about . It does not contain all the information that is known about . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
What PREZISTA is used for
PREZISTA is used to treat adults, and children 6 years of age or above weighing more than 20 kg, who are infected by HIV (Human Immunodeficiency Virus).
PREZISTA is an antiretroviral medicine. It belongs to a group of medicines called protease (PRO-tee-ase) inhibitors. PREZISTA works by reducing the amount of HIV in your body. Reducing the amount of HIV in your blood improves your immune system, and reduces the risk of developing illnesses as a result of HIV infection.
PREZISTA must be taken in combination with a low dose of ritonavir (NORVIR), and with other anti-HIV medicines. Your doctor will discuss with you which combination of medicines will work best with PREZISTA.
Ask your doctor if you have any questions about why PREZISTA has been prescribed for you.
This medicine is available only with a doctor's prescription.
Before you take PREZISTA
When you must not use it:
Do not take PREZISTA:
if you are allergic (hypersensitive) to darunavir, other ingredients of PREZISTA or to ritonavir.
Symptoms of an allergic reaction may include rash, itching or hives on the skin, shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body.
Do not take PREZISTA:
if the packaging is torn or shows signs of tampering.
if the expiry date (month and year) printed on the pack has passed. If you take PREZISTA after the expiry date it may not work.
PREZISTA should not be given to children younger than 6 years of age. PREZISTA should not be given to children and adolescents who have never used antiretroviral medicines before.
Do not combine PREZISTA with any of the following medicines:
amiodarone (Cordarone), bepridil, flecainide, lidocaine, lignocaine or quinidine (Kinidin Durules) (to treat irregular heartbeats)
midazolam (Hypnovel) or triazolam (Halcion) (to treat trouble with sleeping and/or anxiety)
ergot alkaloids (Cafergot) (to treat migraine and headaches)
astemizole or terfenadine (to treat allergy symptoms)
cisapride (to treat some stomach conditions)
pimozide (to treat psychiatric conditions)
alfuzosin (Xatral) (to treat an enlarged prostate)
sildenafil (Revatio) (to treat pulmonary arterial hypertension)
If you are taking any of these, ask your doctor about switching to another medicine.
There are other medicines that you need to be careful of when taking PREZISTA (see Taking other medicines).
Before you start to use it:
Take special care with PREZISTA:
PREZISTA is not a cure for HIV infection.
PREZISTA does not reduce the risk of passing HIV to others through sexual contact or blood. Therefore, you must continue to use appropriate precautions to prevent passing HIV on to others.
People taking PREZISTA 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 PREZISTA.
Tell your doctor if you have or have had any medical conditions, especially the following:
Problems with your liver, including Hepatitis B and C.
Your doctor may need to eva luate your liver before deciding if you can take PREZISTA.
Diabetes.
PREZISTA, like some other anti-HIV medicines, might increase sugar levels in the blood.
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 PREZISTA, with no obvious symptoms.
Changes in body fat.
Redistribution, accumulation or loss of body fat may occur in patients receiving a combination of antiretroviral medicines.
Haemophilia.
Anti-HIV medicines, such as PREZISTA, might increase the risk of bleeding in patients with this blood clotting disorder.
An allergy to sulfa medicines (sulphonamides).
Tell your doctor immediately if you are pregnant or breast-feeding, or intend to become pregnant or breast-feed.
During pregnancy and breast-feeding you must not take PREZISTA, unless it is specifically approved by your doctor. It is recommended that HIV infected women should not breast-feed their infants because of 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.
If you have not told your doctor about any of the above, tell them before you start treatment with PREZISTA.
Taking other medicines:
Tell your doctor if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.
Tell your doctor if you are taking any of the following: amiodarone (Cordarone), bepridil, flecainide, lidocaine, lignocaine, quinidine (Kinidin Durules), midazolam (Hypnovel), triazolam (Halcion), ergot alkaloids (Cafergot), astemizole, terfenadine, cisapride or pimozide. You must not take these medicines while taking PREZISTA.
Tell your doctor if you take other anti-HIV medicines. PREZISTA can be combined with some other anti-HIV medicines while other combinations are not recommended.
The effects of PREZISTA might be reduced if you take any of the following products. Tell your doctor if you take:
medicines to treat some infections such as tuberculosis (rifampicin, Rifadin)
products that contain St John's wort (Hypericum perforatum)
medicines to prevent seizures (phenobarbital, phenytoin, Dilantin)
steroids (dexamethasone).
The effects of other medicines might be influenced if you take PREZISTA. Tell your doctor if you take:
medicines for heart disease (bosentan, felodipine, Plendil, nifedipine, Adalat, nicardipine, tadalafil).
medicines used to reduce clotting of the blood (warfarin, Marevan, Coumadin).
Oestrogen-based hormonal contraceptives. PREZISTA might reduce the effectiveness of hormonal contraceptives. Therefore, alternative methods of non-hormonal contraception are recommended.
medicines to lower cholesterol levels (simvastatin, Lipex, Zocor, lovastatin,pravastatin, Pravachol, atorvastatin Lipitor, rosuvastatin Crestor). The risk of muscle tissue disorder might be increased. Atorvastatin (Lipitor), rosuvastatin (Crestor), or pravastatin (Pravachol), at a reduced starting dose, could be used as an alternative.
medicines for your immune system (cyclosporin, Neoral, tacrolimus, Prograf, sirolimus, Rapamune). Your doctor might want to do some additional tests.
medicines to control asthma (fluticasone propionate, Flixotide, Seretide, salmeterol).
medicines to treat gout (colchicine).
The dosage of other medicines might need to be changed. Tell your doctor if you take:
medicines to treat certain heart disorders (digoxin, Lanoxin)
medicines against fungal infections (ketoconazole, Nizoral, itraconazole, Sporanox, voriconazole, Vfend)
medicines against bacterial infections (rifabutin, Mycobutin)
medicines for erectile dysfunction (sildenafil, Viagra, vardenafil, Levitra, tadalafil, Cialis)
antibiotics (clarithromycin, Klacid)
medicines to treat depression and anxiety (paroxetine, Aropax, sertraline, Zoloft)
methadone (Physeptone)
medicines to prevent seizures or to treat trigeminal neuralgia (carbamazepine, Tegretol)
Taking PREZISTA
Adults
Always use PREZISTA 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 PREZISTA and ritonavir (Norvir) available so that you don't run out. For example in case you cannot return home, need to travel or stay in a hospital.
How much PREZISTA to take:
Adults who have never taken anti-HIV medicines before:
The usual dose of PREZISTA is 800 mg (2 tablets containing 400 mg of PREZISTA) together with 100 mg ritonavir once daily, with food.
Adults who have taken anti-HIV medicines before
The dose is EITHER
800 mg (2 tablets containing 400 mg of PREZISTA) together with 100 mg ritonavir once daily, with food
OR
600 mg (2 tablets containing 300 mg of PREZISTA or 1 tablet containing 600 mg of PREZISTA) together with 100 mg ritonavir twice daily, with food. That is two tablets containing 300 milligrams of PREZISTA in the morning and two tablets containing 300 mg in the evening, or one tablet containing 600 milligrams of PREZISTA in the morning and one tablet containing 600 mg in the evening.
Please discuss with your doctor which dose is right for you.
You must take PREZISTA every day and always in combination with 100 milligrams of ritonavir (Norvir) and with food. PREZISTA cannot work properly without ritonavir (Norvir) and food. You must eat a meal or a snack within 30 minutes prior to taking your PREZISTA and ritonavir (Norvir). The type of food is not important.
Even if you feel better, do not stop taking PREZISTA without talking to your doctor.
Instructions:
Take PREZISTA always together with 100 milligrams of ritonavir (Norvir).
Take PREZISTA with food.
Swallow the tablets with a drink such as water, milk, or any other nutritional drink.
Take your other HIV medicines used in combination with PREZISTA and ritonavir as recommended by your doctor.
Children 6 years of age and older, weighing at least 20 kg, who have taken any anti-HIV medicines before (your child's doctor will determine this)
The doctor will work out the right dose based on the weight of the child. The doctor will inform you exactly on how many PREZISTA tablets and how much ritonavir (capsules or solution) your child should take.
If your child feels better, do not stop administering PREZISTA without talking to the child's doctor.
Instructions:
Take PREZISTA always together with ritonavir (Norvir).
Take PREZISTA with food.
Swallow the tablets with a drink such as water, milk, or any other nutritional drink.
Take your other HIV medicines used in combination with PREZISTA and ritonavir as recommended by your doctor.
If your child cannot tolerate ritonavir (Norvir) oral solution, consult 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.
What do I do if I forget to take PREZISTA?
If you forget to take PREZISTA and your dosing regimen is PREZISTA with ritonavir once a day:
If you notice within 12 hours, you must take the tablets immediately. Always take with ritonavir and 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 forget to take PREZISTA and your dosing regimen is PREZISTA with ritonavir twice a day:
If you notice within 6 hours, you must take the tablet/s immediately. Always take with ritonavir and food. If you notice after 6 hours, then skip the dose and take the next doses as usual. Do not take a double dose to make up for a forgotten dose.
Please refer to your doctor for instructions on missed doses of other HIV medicines used in combination with PREZISTA and ritonavir.
What do I do if I take too much? (overdose):
If you think you or anybody else has taken too much PREZISTA, contact your doctor, pharmacist or the Poisons Information Centre who will advise you what to do.
You can contact the Poisons Information Centre by dialling:
Australia: 13 11 26
New Zealand: 0800 POISON or 0800 764 766.
While you are taking PREZISTA
Things you must do:
Do not stop taking PREZISTA without talking to your doctor first
HIV therapy may increase your sense of well being. Even when you feel better, do not stop taking PREZISTA. Talk to your doctor first.
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.
Be sure to follow up your doctor's instructions about other medicines you should take, and other things you should do.
Ask your doctor or pharmacist if you have any questions.
Tell any other doctors and pharmacists who are treating you that you are taking PREZISTA. If you are undergoing anaesthesia, tell your anaesthetist that you are taking PREZISTA.
If you are about to be started on any new medicines, tell your doctor or pharmacist that you are taking PREZISTA.
If you become pregnant while taking PREZISTA, tell your doctor immediately.
If you have any further questions on the use of this product, ask your doctor.
Things to be careful of
Driving and using machines
Do not operate machines or drive if you feel dizzy after taking PREZISTA.
Side Effects
Like all medicines, PREZISTA can have side effects. Some of these effects may be serious.
Tell your doctor or pharmacist if you do not feel well while you are being treated with PREZISTA.
When treating HIV infection, it is not always easy to identify what side effects are caused by PREZISTA, which are caused by other medicines you are taking, or which are caused by the HIV infection itself.
The most common side effects are:
nausea, vomiting
headache
abdominal pain, diarrhoea,
rash (see information below)
changes in body fat (see information below)
PREZISTA 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.
Liver problems that may occasionally be severe have been reported. Your doctor should do blood tests prior to initiating PREZISTA. 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 sensitivity on your right side below your ribs.
Skin rash has been reported in 10% of patients receiving PREZISTA. Occasionally a rash can be severe or potentially life threatening. In patients taking PREZISTA and raltegravir, rashes (generally mild or moderate) may occur more frequently that in patients taking either drug separately. 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 PREZISTA must be stopped.
Tell your doctor if you experience the following side effects:
inflammation of the pancreas
increased blood fat levels
diabetes
symptoms of infection
changes in body fat
Some side effects are typical for anti-HIV medicines in the same family as PREZISTA. These are:
raised blood sugar and worsening of diabetes.
changes in body shape due to fat redistribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (buffalo hump). The cause and long term health effects of these conditions are not known at this time.
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 PREZISTA.
increased bleeding in patients with haemophilia.
muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have been serious.
If you experience any of these side effects and they worry you, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Tell your doctor if you notice signs or symptoms of infections, such as a fever or rashes. Some people with HIV who have had infections in the past may experience a return of symptoms soon after taking anti-HIV medicines.
If you think you are having an allergic reaction to PREZISTA, tell your doctor immediately or go to Accident and Emergency at your nearest hospital.
Symptoms usually include some or all of the following:
rash, itching or hives on the skin
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
Other side effects not listed above may also occur in some people.
Product Description
Storage
PREZISTA tablets should be kept out of reach of children, in a location where the temperature stays below 30°C.
What it looks like:
PREZISTA 150 mg tablets are white, oval-shaped tablets, with TMC on one side, 150 on the other side. Each plastic bottle contains 240 tablets.
PREZISTA 300 mg tablets are orange, oval shaped tablets, with TMC114 on one side, 300MG on the other side. Each plastic bottle contains 120 tablets.
PREZISTA 400 mg tablets are light orange, oval shaped tablets, with TMC on one side, 400MG on the other side. Each plastic bottle contains 60 tablets.
PREZISTA 600 mg tablets are orange, oval shaped tablets, with TMC on one side, 600MG on the other side. Each plastic bottle contains 60 tablets.
Ingredients
Active ingredient:
darunavir 150 mg, 300 mg , 400 mg or 600 mg (as darunavir ethanolate)
Other ingredients:
microcrystalline cellulose
colloidal anhydrous silica
crospovidone
magnesium stearate
polyvinyl alcohol - partially hydrolysed
macrogol 3350
titanium dioxide (E171)
talc
[300 mg, 400 mg, 600 mg tablets] sunset yellow FCF (E110).
Sponsor
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Rd
Macquarie Park NSW 2113 Australia
Telephone: (02) 8875 3333 or Toll Free 1800 226 334
NZ Office: Auckland, New Zealand
Telephone: (09) 523 8700 or 0800 800 806
Tibotec, a division of JANSSEN-CILAG Pty Ltd
Registration numbers
150 mg tablet: AUST R 156281
300 mg tablet: AUST R 127411
400 mg tablet: AUST R 153627
600 mg tablet: AUST R 153628
This leaflet was prepared in September 2011
® PREZISTA is a registered trademark of Tibotec Pharmaceuticals Ltd.
All listed brand names are trademarks of their respective owners
