Your child 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 child?s other antiretroviral medicines. If you have any further questions about ritonavir or the other medicines your child is prescribed, please ask your child?s doctor or pharmacist.
Do NOT give APTIVUS
- if your child is allergic (hypersensitive) to tipranavir
- if your child is allergic (hypersensitive) to any of the other ingredients of APTIVUS. See Section 6 for a list of other ingredients
- if your child has moderate to severe liver problems. Your child?s doctor will take a blood sample to test how well your child?s liver is working (your child?s liver function). Depending on your child?s liver function they may have to delay or stop APTIVUS treatment
- if your child is 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)
Your child must 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 child?s doctor if they have:
- type A or B haemophilia
- liver disease.
If your child has:
- high liver function tests results
- hepatitis B or C infection your child is at increased risk of severe and potentially fatal liver damage while taking antiretroviral therapy in general, including APTIVUS. Your child?s doctor will monitor their liver function by blood tests before and during APTIVUS treatment. If your child has liver disease or hepatitis, their doctor will decide if they need additional testing. You should inform your child?s doctor as soon as possible if you notice your child has the signs or symptoms of hepatitis:
- malaise (feeling generally unwell)
- nausea (feeling sick)
- abdominal pain
- jaundice (yellowing of the skin or the eyeballs)
APTIVUS is not a cure for HIV infection:
You should know that your child may continue to develop infections and other illnesses associated with HIV disease. You should therefore remain in regular contact with your child?s doctor. In addition, APTIVUS does not prevent the risk of passing on HIV to others through blood or sexual contact. Your child should therefore continue to use appropriate precautions to prevent HIV transmission. For example your child should use a condom and your child should not breast-feed or donate blood.
Mild to moderate rash, including:
- 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 child?s doctor if you notice changes in body fat.
Your child?s doctor may decide to monitor their 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 child?s 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 child?s doctor.
APTIVUS should neither be used by children under 2 years of age nor by adolescents 12 years of age or older.
APTIVUS oral solution contains vitamin E. Your child should not take any additional vitamin E supplements.
If you are older than 65 years your doctor will exercise caution when prescribing APTIVUS oral solution to you and will closely monitor your therapy.
Taking other medicines
Please tell your child?s doctor or pharmacist if they are taking or have recently taken any other medicines, including medicines obtained without a prescription.
This is very important. If your child takes 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 your child 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 child?s doctor will only prescribe them abacavir and zidovudine if they are unable to take other NRTIs. Otherwise, your child can take APTIVUS, together with ritonavir, with HIV reverse transcriptase inhibitors including:
- didanosine:If your child is taking didanosine enteric coated tablets, they 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 child?s doctor will carefully consider whether to treat them with combinations of APTIVUS and these protease inhibitors.
Other medicines with which APTIVUS may interact include:
- oral contraceptives/hormone replacement therapy (HRT): If your child is taking the contraceptive pill to prevent pregnancy they 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 child?s doctor if they do wish to continue taking oral contraceptives or HRT. If your child uses oral contraceptives or HRT they 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 child?s doctor as they may need to temporarily stop taking either APTIVUS or their 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 taken with APTIVUS. Tadalafil should not be prescribed until APTIVUS has been taken 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 child?s doctor may have to increase or decrease the dose of other medicines which they 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 your child sleep.
Tell your child?s doctor if they receive medication such as antiplatelet agents and anticoagulants, or if they are taking vitamin E. Your child?s doctor may wish to consider certain precautionary measures in such circumstances.
Pregnancy and breast-feeding
Tell your child?s doctor if they are pregnant or planning to become pregnant. If your child is pregnant they should only take APTIVUS after careful discussion with their doctor. It is not known whether APTIVUS may be used safely during pregnancy. See also Section 2, under ?Oral
contraceptives/hormone replacement therapy (HRT)?.
Make sure you tell your child?s doctor if they are breast-feeding. Your child must not breast-feed their baby because it is possible that the baby can become HIV-infected through the breast milk.
Ask your child?s doctor or pharmacist for advice before they take any medicine.
Driving and using machines
Some of the side effects of APTIVUS may affect your child?s ability to drive or operate machinery (e.g. dizziness and sleepiness). If affected, your child should not drive or operate machinery.