700 mg film-coated tablets
fosamprenavir
What Telzir is and what it is used for
Telzir is used to treat infection with HIV (human immunodeficiency virus).
Telzir is a so-called antiretroviral drug. It is taken together with low doses of another medicine, ritonavir, which increases the level of Telzir in the blood. Telzir belongs to a group of antiretroviral medicines called protease inhibitors. Protease is an enzyme produced by HIV that enables the virus to multiply in white blood cells (CD4 cells ) in your blood. By preventing the protease enzyme from working, Telzir prevents HIV from multiplying and infecting more CD4 cells.
Telzir is used together with low doses of ritonavir in combination with other antiretroviral medicines (“combination therapy”) to treat adults, adolescents, and children over 6 years of age who are infected with HIV.
HIV can become resistant to anti – HIV drugs. To prevent this and to prevent your illness from getting worse, you must regularly take all your medications exactly as prescribed.
Telzir does not prevent you from passing on HIV. HIV – infection is spread through sexual contact with someone who has the infection or through the transfer of infected blood (for example, when sharing needles).
What you need to know before you take Telzir
It is therefore important that you read the package insert found in the packaging for these medicines carefully. If you have further questions about ritonavir or the other prescribed medicines, ask your doctor or pharmacist.
Do not take Telzir:
- if you are allergic to fosamprenavir, amprenavir, or any of the other ingredients of this medicine (listed in section 6) or to ritonavir.
- if you are taking any of these medicines:
- alfuzosin (used to treat problems with the prostate )
- astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines can sometimes be bought without a prescription)
- pimozide (used to treat schizophrenia )
- quetiapine (used to treat schizophrenia, bipolar disorder, and major depression )
- lurasidone (used to treat schizophrenia and bipolar disorder )
- cisapride (used to relieve indigestion )
- ergotamine derivatives (used to treat headaches )
- rifampicin (used to treat tuberculosis )
- amiodarone , quinidine , flecainide , and propafenone ( heart medications )
- bepridil (used to treat high blood pressure )
- oral (by mouth) midazolam or triazolam (used to treat anxiety and worry )
- products containing St. John’s wort ( Hypericum perforatum )
- lovastatin, simvastatin (used to lower cholesterol )
- sildenafil when used to treat pulmonary arterial hypertension (a disease that affects the blood vessels in your lungs)
- paritaprevir (used to treat hepatitis C virus infection).
- Tell your doctor if any of these apply to you.
Be especially careful with Telzir
Talk to your doctor or pharmacist before you start using Telzir:
- If you have a known allergy to medicines containing sulfonamides. Then you may also be allergic to Telzir.
- If you have any liver disease. Your doctor may lower the dose of Telzir and ritonavir depending on the degree of your liver damage. You will be monitored while you are taking Telzir. If your liver disease worsens, you may need to stop taking Telzir for a period or forever. Patients with hepatitis B or C who are treated with combination therapy are at increased risk of serious liver problems.
- If you have hemophilia ( bleeding disease ). The risk of bleeding may increase when using protease inhibitors (such as Telzir). The cause is not known. You may need additional factor VIII preparations to control any bleeding.
- If you have diabetes , insome of the patients taking antiretroviral drugs, including protease inhibitors, increased blood sugar levels and worsening of diabetes have been reported. In addition, some patients have developed diabetes while taking these drugs.
- If you are taking other medicines. See section “Other medicines and Telzir”.
- Tell your doctor if any of these apply to you. Extra checks, including blood tests, may be needed while you are taking the medicine.
Your doctor will check your blood glucose levels before and during treatment with Telzir.
Pay attention to important symptoms
Some patients taking medicines for HIV infection develop other symptoms that can be serious. These include:
- a flare-up of old infection er
- altered body shape
- problems with the skeleton.
It is important that you know and pays attention to important signs and symptoms while taking Telzir. Read the information on “Other side effects of combination anti-HIV therapy” in section 4 of this patient information. If you have any questions about this information or the advice given there:
- Talk to your doctor.
You may get a rash
You can still take Telzir. The rash can be treated with antihistamines. In rare cases, the rash can become severe severe ( Stevens-Johnson syndrome ). If this happens, treatment with Telzir must be stopped immediately and you must never take Telzir again.
Protect other people
HIV – infection is spread through sexual contact with someone who has the infection or through infected blood (eg by sharing injection needles). You can still transmit HIV when taking this medicine, although the risk is reduced with effective antiviral treatment.
Discuss with your doctor the necessary measures to avoid infecting others.
Other medicines and Telzir
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This also applies to herbal preparations and other over-the-counter medicines. Your doctor will decide if these medicines are appropriate to take with Telzir and ritonavir. This is very important because Telzir or ritonavir can enhance or weaken the effect of other drugs, which in some cases can cause serious medical conditions.
Some medicines must not be taken with Telzir. You must check against the medicines listed under “Do not take Telzir” at the beginning of section 2 of this patient information.
These medicines are not recommended with Telzir/ritonavir:
- ketoconazole and itraconazole in doses greater than 200 mg per day (used to treat fungal infections )
- rifabutin in a dose greater than 150 mg every other day (an antibiotic )
- lidocaine in injection form
- halofantrine (used to treat malaria )
- sildenafil, vardenafil, or tadalafil (used to treat erectile dysfunction )
- atorvastatin in doses greater than 20 mg per day (used to lower cholesterol levels )
- fluticasone propionate and similar medicines are used to treat asthma, unless these are necessary. In such cases, careful monitoring is required
- lopinavir and ritonavir in combination (used to treat HIV infection )
- raltegravir (used to treat HIV infection ).
- simeprevir and daclatasvir (used to treat hepatitis C virus infection )
- maraviroc (used to treat HIV infection ).
You will be closely monitored if you take the following medicines together with Telzir/ritonavir :
- atorvastatin in doses up to 20 mg per day (used to lower cholesterol levels )
- carbamazepine, phenobarbital, phenytoin (used to treat epilepsy )
- cyclosporine, rapamycin, tacrolimus (used to suppress the immune system )
- dolutegravir (used to treat HIV infection )
- desipramine, nortriptyline, paroxetine, and similar medicines (used to treat depression )
- warfarin and other medicines that prevent blood clots
- injectable midazolam (used to treat anxiety and worry )
- clarithromycin, erythromycin (an antibiotic )
- methadone (a drug that replaces heroin )
- dasatinib, nilotinib, ibrutinib, vinblastine, and everolimus (used to treat various types of cancer ).
Your dosage of Telzir may need to be changed if you are taking
- etravirine (used to treat HIV infection ).
Hormonal contraceptive methods
If you take oral contraceptives at the same time as Telzir and ritonavir, your liver may be damaged and the effectiveness of oral contraceptives may be reduced.
- Therefore, use another non-hormonal contraceptive method such as a condom.
There have been no studies on how Telzir/ritonavir affects other hormonal treatments, such as hormone replacement therapy ( HRT ).
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby:
- Consult a doctor or pharmacist before using this medicine.
Breast-feeding
Women who are HIV -positive must not breastfeed because HIV infection can be transferred to the child through breast milk. It is not known whether the ingredients in Telzir can also pass into breast milk. If you are breastfeeding or thinking about starting to breastfeed:
- Talk to your doctor immediately
Driving ability and use of machinery
Telzir can make you feel dizzy and cause other side effects that make you less alert.
- Avoid driving or using machinery if you are unwell.
Have regular contact with your doctor
Telzir helps you keep your disease under control, but is not a cure for HIV infection. You must take the medicine every day to prevent your disease from getting worse. You can still develop other infections and diseases related to HIV infection.
- Keep in touch with your doctor and do not stop taking Telzir without first talking to your doctor.
Telzir contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to take Telzir
Always take this medicine exactly as your doctor or pharmacist has told you. You must take the full daily dose of Telzir and ritonavir as prescribed by your doctor. Do not take more than the recommended dose. Consult your doctor or pharmacist if you are unsure.
Swallow the tablets whole with a little water or other drink. Telzir tablets can be taken with or without food. Telzir is also available in liquid form ( oral suspension ) for patients who cannot swallow tablets. (Read the package insert for Telzir oral suspension for guidance on whether to take the medicine with or without food.)
Adults
The recommended dose is one 700 mg Telzir tablet twice daily together with 100 mg ritonavir twice daily.
Children from 6 years of age who weigh at least 39 kg
Children can take the adult tablet dose of one 700 mg Telzir tablet twice daily with ritonavir 100 mg twice daily if they can swallow the tablets whole.
Children from 6 years who weigh less than 39 kg
Use Telzir oral suspension.
Adults with liver disease
If you have mild liver disease, the dose is one tablet of Telzir (700 mg) twice daily together with 100 mg ritonavir only once daily. If you have moderate or severe liver disease, the dosage of Telzir must be reduced. This dose change cannot be made with Telzir tablets. You must take Telzir oral suspension.
If you have taken too much Telzir
If you have taken more than the prescribed dose of Telzir:
- Contact your doctor or pharmacist immediately for advice.
If you forget to take Telzir
If you forget to take a dose of Telzir, take it as soon as possible. Then continue the treatment as before. Do not take a double dose to make up for the missed dose.
Do not stop Telzir without first seeking advice
Take Telzir for as long as your doctor has prescribed it. Do not stop taking Telzir unless your doctor recommends it.
4. Possible side effects
During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but in the case of blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them. When treating HIV infection, it is not always possible to distinguish disease symptoms from side effects caused by Telzir or by other medicines taken at the same time. For this reason, you must inform your doctor of any changes in your state of health.
Very common side effects are
These may occur in more than 1 in 10 users :
- diarrhea
- increase in cholesterol (a type of blood fat).
Common side effects are
These may occur in up to 1 in 10 users :
- increases in triglycerides ( a type of blood fat)
- nausea or vomiting, abdominal pain, loose stools
- skin rash (red, raised, or itchy) – if the rash is severe, you may need to stop the medication
- headache, dizziness
- feeling of fatigue
- increase in enzymes called transaminases which are produced in the liver, and increase in an enzyme called lipase which is made in the pancreas.
- tingling or numbness around the lips and mouth.
Less common side effects are
These may occur in up to 1 in 100 users :
- swelling of the face, lips, and tongue ( angioedema ).
Rare side effects ar
These may occur in up to 1 in 1000 users :
- a serious or life-threatening skin reaction ( Stevens-Johnson syndrome ).
You may have muscle problems
There have been reports of muscle pain, tenderness, or weakness, particularly in association with antiretroviral therapy containing protease inhibitors and nucleoside analogs. In rare cases, these muscle problems have been severe ( rhabdomyolysis ). If this happens to you:
- Contact your doctor.
Hemophilia can suffer from more bleeding
In patients with hemophilia ( bleeding disease ) type A and B, there are reports of more bleeding during treatment with protease inhibitors.
If this happens to you:
- Contact your doctor immediately.
If you get a side effect ar
- Talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this information.
Other side effects of combination therapy against HIV
Old infections can flare up
People with advanced HIV infection ( AIDS ) have a weak immune system and are more likely to develop serious infections (opportunistic infections ). When these people start treatment, it happens that old, hidden infections flare up again and give rise to symptoms of inflammation. These symptoms are probably caused by the body’s immune system becoming stronger so that the body starts to fight these infections.
In addition to these opportunistic infections, autoimmune diseases (a condition that occurs when the immune system attacks healthy body tissue) can also occur after you start taking medication for your HIV infection. Autoimmune diseases can develop several months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands and feet and moves to the trunk, palpitations, tremors, or hyperactivity, contact your doctor immediately to get the necessary treatment.
If you develop symptoms of infection or see signs of inflammation while taking Telzir:
- Contact your doctor immediately. Do not take other anti-infective medicines without first consulting your doctor.
You may have problems with the skeleton
Some people receiving combination anti-HIV therapy develop a condition called osteonecrosis. This condition means that part of the bone tissue dies due to reduced blood supply to the skeleton.
People are more likely to develop this condition:
- if they have received combination therapy for a long time
- if they also take anti-inflammatory medicines called corticosteroids
- if they drink alcohol
- if their immune system is very weak
- if they are overweight.
Signs to watch out for are:
- stiffness in the joints
- aches and pains (mainly in hips, knees, and shoulders)
- movement difficulties.
If you notice any of these symptoms:
- Tell your doctor about it.
How to store Telzir
Store out of sight and reach of children.
Use before the expiry date stated on the can and carton.
Telzir does not require special storage conditions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active ingredient is fosamprenavir. Each tablet contains 700 mg of fosamprenavir in the form of fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir).
- Other ingredients: microcrystalline cellulose, croscarmellose sodium, povidone K30, magnesium stearate, anhydrous colloidal silicon dioxide, hypromellose, titanium dioxide (E171), glycerol triacetate, red iron oxide (E172).
Appearance and packaging of the medicine
Telzir is supplied in plastic bottles containing 60 film-coated tablets. The tablets are capsule-shaped, biconvex, pink in color, and marked with “GXLL7” on one side.
Telzir is also available as an oral suspension for those patients who cannot swallow tablets.
| Manufacturer | Marketing Authorisation Holder |
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Contact the representative of the marketing authorization holder if you want to know more about this medicine.
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