You must take APTIVUS in combination with low dose ritonavir and other antiretroviral medicines. It is therefore important that you know about these medicines too. You should therefore carefully read the Package Leaflets of ritonavir and your other antiretroviral medicines. If you have any further questions about ritonavir or the other medicines you are prescribed, please ask your doctor or pharmacist.
Do NOT take APTIVUS
- if you are allergic (hypersensitive) to tipranavir
- if you are allergic (hypersensitive) to any of the other ingredients of APTIVUS. See Section 6 for a list of other ingredients
- if you have moderate to severe liver problems. Your doctor will take a blood sample to test how well your liver is working (your liver function). Depending on your liver function you may have to delay or stop APTIVUS treatment
- if you are currently taking products containing:
- rifampicin (used to treat tuberculosis)
- cisapride (used to treat stomach problems)
- pimozide or sertindole (used to treat schizophrenia)
- triazolam or oral midazolam (taken by mouth). These medicines are used to treat anxiety or sleep disorders
- ergot derivatives (used to treat headaches)
- astemizole or terfenadine (used to treat allergies or hay fever)
- simvastatin or lovastatin (used to lower blood cholesterol)
- amiodarone, bepridil, flecainide, propafenone or quinidine (used to treat heart disorders)
- metoprolol (used to treat heart failure)
Do not take products containing St John?s wort (a herbal remedy for depression). This may stop APTIVUS from working properly.
Take special care with APTIVUS
Tell your doctor if you have:
- type A or B haemophilia
- diabetes
- liver disease.
If you have:
- high liver function test results
- hepatitis B or C infection you are at increased risk of severe and potentially fatal liver damage while taking antiretroviral therapy in general, including APTIVUS. Your doctor will monitor your liver function by blood tests before and during APTIVUS treatment. If you have liver disease or hepatitis, your doctor will decide if you need additional testing. You should inform your doctor as soon as possible if you notice the signs or symptoms of hepatitis:
- fever
- malaise (feeling generally unwell)
- nausea (feeling sick)
- vomiting
- abdominal pain
- tiredness
- jaundice (yellowing of the skin or the eyeballs)
APTIVUS is not a cure for HIV infection:
You should know that you may continue to develop infections and other illnesses associated with HIV disease. You should therefore remain in regular contact with your doctor. In addition, APTIVUS does not prevent the risk of passing on HIV to others through blood or sexual contact. You should therefore continue to use appropriate precautions to prevent HIV transmission. For example you should use a condom and you should not breast-feed or donate blood.
Rash:
Mild to moderate rash, including:
- hives
- rash with flat or raised small red spots
- sensitivity to the sun have been reported in approximately 1 in 10 patients receiving APTIVUS. Some patients who developed rash also had:
- joint pain or stiffness
- throat tightness
- generalized itching
Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat.
Your doctor may decide to monitor your levels of blood lipids (fats) before and during APTIVUS treatment.
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. 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. If you notice any symptoms of infection, please inform your doctor immediately.
Bone 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). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. 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:
APTIVUS soft capsules should not be used by children under 12 years of age.
Elderly:
If you are older than 65 years your doctor will exercise caution when prescribing APTIVUS soft capsules to you and will closely monitor your therapy.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
This is very important. If you take other medicines at the same time as APTIVUS and ritonavir, this can strengthen or weaken the effect of the medicines. These effects are called interactions, and can lead to serious side effects, or prevent proper control of other conditions you may have.
Interactions with other HIV medicines:
- Abacavir and zidovudine. These belong to a class of HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs). Your doctor will only prescribe you abacavir and zidovudine if you are unable to take other NRTIs. Otherwise, you can take APTIVUS, together with ritonavir, with HIV reverse transcriptase inhibitors including:
- stavudine
- lamivudine
- tenofovir
- didanosine:If you are taking didanosine enteric coated tablets, you should take them at least two hours before or after APTIVUS .
- Protease Inhibitors (PIs): Taking APTIVUS may cause large decreases in the blood levels of other HIV protease inhibitors. For example the protease inhibitors amprenavir, atazanavir, lopinavir and saquinavir will be decreased. Taking APTIVUS, with atazanavir, may cause the blood levels of APTIVUS and ritonavir to increase a lot. Your doctor will carefully consider whether to treat you with combinations of APTIVUS and these protease inhibitors.
Other medicines with which APTIVUS may interact include:
- oral contraceptives/hormone replacement therapy (HRT): If you are taking the contraceptive pill to prevent pregnancy you should use an additional or different type of contraception (e.g. barrier contraception like condoms). Generally, it is not recommended to take APTIVUS, with ritonavir, together with oral contraceptives or hormone replacement therapy (HRT). You should check with your doctor if you do wish to continue taking oral contraceptives or HRT. If you use oral contraceptives or HRT you have an increased chance of developing a skin rash while taking APTIVUS. If a rash occurs, it is usually mild to moderate. You should talk to your doctor as you may need to temporarily stop taking either APTIVUS or your oral contraceptives or HRT
- carbamazepine, phenobarbital and phenytoin (used to treat epilepsy). These may decrease the effectiveness of APTIVUS.
- sildenafil, vardenafil, tadalafil (medicines used to produce and maintain an erection). The effects of sildenafil and vardenafil are likely to be increased if you take them with APTIVUS. You should not be prescribed tadalafil until you have been taking APTIVUS for 7 days or more.
- omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors used to reduce the gastric acid production)
- metronidazole (used to treat infections)
- disulfiram (used to treat alcohol dependence)
The following medications are not recommended:
- fluticasone (used to treat asthma)
- atorvastatin (used to lower blood cholesterol).
APTIVUS may lead to a loss of effectiveness of some medicines including:
- methadone, meperidine (pethidine), used as morphine substitutes
Your doctor may have to increase or decrease the dose of other medicines which you take together with APTIVUS. Examples include:
- rifabutin and clarithromycin (antibiotics)
- theophylline (used to treat asthma)
- desipramine, trazodone and bupropion (used to treat depression; bupropion is also used for smoking cessation)
- midazolam (when given by injection); midazolam is a sedative used to treat anxiety and to help you sleep.
Tell your doctor if you receive medication such as antiplatelet agents and anticoagulants, or if you are taking vitamin E. Your doctor may wish to consider certain precautionary measures in such circumstances.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or planning to become pregnant. If you are pregnant you should only take APTIVUS after careful discussion with your doctor. It is not known whether APTIVUS may be used safely during pregnancy. See also Section 2, under ?Oral contraceptives/hormone replacement therapy (HRT)?.
APTIVUS contains very small amounts of alcohol (see Important information about some of the ingredients of APTIVUS).
Make sure you tell your doctor if you are breast-feeding. You must not breast-feed your baby because it is possible that the baby can become HIV-infected through the breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Some of the side effects of APTIVUS may affect your ability to drive or operate machinery (e.g. dizziness and sleepiness). If affected, you should not drive or operate machinery.
Important information about some of the ingredients of APTIVUS capsules
APTIVUS contains 7 % ethanol (alcohol), i.e. up to 400 mg per daily dose, equivalent to 8 ml of beer, or less than 4 ml of wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
APTIVUS also contains macrogolglycerol ricinoleate which may cause stomach upset and diarrhoea.
This medicine contains small amounts of sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
