fosamprenavir
Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully before you start Telzir oral suspension.
This leaflet answers some common questions about Telzir. It does not contain all of the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking Telzir in combination with ritonavir against the expected benefits it will have for you.
As you will be taking Telzir together with low doses of ritonavir, you should also carefully read the Patient Leaflet for that product before starting treatment with this combination.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the oral suspension. You may need to read it again.
What Telzir oral suspension is used for
Telzir oral suspension contains fosamprenavir which belongs to a group of antiretroviral medicines called protease inhibitors.
The low doses of ritonavir you take together with Telzir are designed to increase the amount of the active ingredient, amprenavir, available to control your HIV infection.
Telzir, taken with ritonavir is used together with other antiretroviral medicines to slow down the progression of human immunodeficiency virus (HIV) infection, which can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (eg AIDS-related Complex or ARC).
Telzir does not cure AIDS or kill the HIV virus, but prevents further damage to the immune system by stopping production of new viruses.
Telzir does not reduce the risk of passing the infection to others. You will still be able to pass on the HIV virus by sexual activity or by contamination with infected blood. You should still use proper precautions to prevent this.
While taking Telzir and/or any other therapy for HIV disease, you may continue to develop other infections and other complications of HIV infection. You should keep in regular contact with the doctor who is looking after you.
Telzir oral suspension is not addictive.
Ask your doctor if you have any questions about why Telzir oral suspension has been prescribed for you.
Before you take Telzir
Telzir is to be taken in combination with ritonavir. It is therefore important that you carefully read the Package Leaflet that is provided with that medicine. If you have any further questions about ritonavir please ask your doctor or pharmacist.
When you must not take it
- Do not take Telzir if you have ever had an allergic or hypersensitivity reaction to fosamprenavir or amprenavir or any of the ingredients listed at the end of this leaflet.
- Do not take ritonavir if you have ever had an allergic or hypersensitivity reaction to ritonavir or any of the ingredients found in that medicine.
If you develop any of the symptoms of allergy or hypersensitivity, tell your doctor immediately. If an allergy or hypersensitivity is diagnosed then your doctor may stop your Telzir and ritonavir treatment. - Do not take Telzir if you are pregnant, trying to become pregnant or breastfeeding.
Your doctor will discuss the risks and benefits of using Telzir and ritonavir if you are pregnant or breastfeeding. - There are some medicines that must not be taken with Telzir in combination with ritonavir.
These medicines include:
- astemizole and terfenadine, which are used to treat hayfever
- rifampicin which is used to treat tuberculosis
- telaprevir which is used to treat hepatitis C
- midazolam and triazolam which are used to induce sedation
- sildenafil when used to treat increased pressure in blood vessels to your lungs
- dihydroergotamine and ergotamine which are used to treat migraine
- cisapride which is used to treat gastric reflux
- pimozide which is used to treat chronic psychotic disorders
- quetiapine used to treat schizophrenia, bipolar disorder and major depressive disorder
- flecainide which is used to treat heart conditions
- propafenone which is used to treat heart conditions
- herbal treatments such as St Johns Wort.
Please refer to the ritonavir Package Leaflet for further details of the medicines that must not be taken with ritonavir.
- Do not give Telzir oral suspension to infants below the age of 6 years.
- Do not give Telzir to anyone else, even though their symptoms may sound similar to yours.
- Do not take Telzir oral suspension after the expiry or “use by” date (EXP) printed on the bottle.
- Do not take Telzir oral suspension 28 days after the bottle was first opened.
If you’re not sure whether you should be taking Telzir oral suspension, talk to your doctor.
Before you start to take it
You must tell your doctor if:
- you are allergic to foods, dyes, preservatives such as propyl and methyl hydroxybenzoate or any other medicines (eg sulfonamide).
- you had a previous allergic reaction to Telzir (fosamprenavir) or amprenavir containing products or to ritonavir.
- you have, or have ever had, liver problems, for example jaundice, hepatitis, virus affecting the liver, enlarged liver or liver scarring (cirrhosis).
People with liver disease will need to have their dose of Telzir and/or ritonavir adjusted. As it is not possible to reduce the dose of Telzir tablets to less than 700 mg, patients with moderate or severe liver disease must not be treated with telzir tablets. Your doctor may recommend using Telzir oral suspension to achieve the doses required. If you are unsure about your level of liver disease consult your doctor who may carry out additional testing to see whether the Telzir/ritonavir combination is suitable for you. - you have any other illness, for example diabetes mellitus or haemophilia, including those that you think are not related to HIV infection.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you what to do when taking Telzir oral suspension with other medicines.
Some of the medicines that can interact with Telzir and ritonavir include astemizole, alfuzosin, terfenadine, flecainide, propafenone, cisapride, pimozide, triazolam, quetiapine, telaprevir, midazolam, sildenafil (when sildenafil is used to treat increased pressure in blood vessels to your lungs), ergot derivatives, nevirapine and rifampicin. While taking the Telzir/ritonavir combination, you must not take any of these medicines. If you are currently taking any of these medicines, ask your doctor about switching to a different medicine.
Telzir and ritonavir may interact with certain other medications. The use of the following medicines, together with the Telzir /ritonavir combination, should only take place on the basis of medical advice which may include monitoring decreased medicine effects, monitoring your blood and decreasing dosages: antibiotics (i.e. rifabutin, clarithromycin, dapsone and erythromycin), antifungals (i.e. ketoconazole, itraconazole), antimalarials (i.e. halofantrine), benzodiazepines (i.e. alprazolam and clorazepam), calcium channel blockers (i.e. diltiazem, nicardipine, nifedipine, nimodipine, felodipine, verapamil, amlodipine, and isradipine), cholesterol lowering agents (i.e. atorvastatin, lovastatin and simvastatin), erectile dysfunction agents (i.e. sildenafil, tadalafil, vardenafil), non-nucleoside reverse transcriptase inhibitors (i.e. efavirenz, nevirapine and delavirdine), opioids (i.e. methadone), steroids (i.e. oestrogens, progestogens and some glucocorticoids), Immunosuppressants (i.e. cyclosporin, tacrolimus), Inhaled/nasal steroid (ie fluticasone), and other substances (i.e. clozapine, carbamazepine, famotidine, nizatidine, ranitidine, cimetidine, paroxetine and loratadine), maraviroc (an HIV medicine) dolutegravir (an HIV medicine) and ergot derivatives (i.e. Dihydroergotamine, ergotamine).
If you are taking certain medicines that can cause serious side effects, such as amiodarone, phenobarbitone, phenytoin, lidocaine, tricyclic antidepressants, quinidine and warfarin, at the same time as you are taking the Telzir/ritonavir combination, your doctor may carry out additional blood tests to minimise any potential safety problems.
If you are taking the contraceptive pill, it is recommended that you use an alternative method (eg a condom) to prevent pregnancy while you are taking Telzir.
How to take Telzir oral suspension
Your doctor will tell you how much Telzir oral suspension to take and how often to take it. You will also find this information on the label of your medicine.
Do not take extra oral suspension. Do not take the oral suspension more often than you have been told.
How much to take
Adults (greater than or equal to 18 years of age): Adults should take the recommended dose of Telzir oral solution without food and on an empty stomach.
Therapy-Naive Patients: the dose of Telzir oral suspension is 28 mLs (1400 mg fosamprenavir) once a day with 200 mg ritonavir once daily or 14 mLs (700 mg fosamprenavir) twice daily with 100 mg ritonavir twice daily. This must be taken in combination with other antiretroviral agents.
Protease Inhibitor-Experienced Patients: the recommended dose is 14 mLs Telzir oral suspension (700 mg fosamprenavir) with 100 mg ritonavir twice daily in combination with other antiretroviral agents.
Children and adolescents (6 to 18 years of age): Paediatric patients should take the recommended dose of Telzir oral suspension with food.
Telzir oral suspension is the recommended formulation for the most accurate dosing in children based on body weight. If vomiting occurs within 30 minutes after dosing, the dose should be repeated. Take the dose as recommended by your doctor.
The recommended dose for patients older than 6 years of age is as follows: Telzir oral suspension 18 mg/kg plus ritonavir 3 mg/kg administered twice daily not to exceed the adult dose of Telzir 700 mg twice daily plus ritonavir 100 mg twice daily.
The use of Telzir oral suspension in combination with ritonavir has not been established for children less than 6 years of age.
How to take it
Use the oral dosing syringe supplied with the pack to measure your dose accurately.
- Shake the bottle vigorously before use.
- Remove the bottle cap.
- Push the plastic adapter into the neck of the bottle, while holding the bottle firmly.
- Insert the syringe firmly into the adapter.
- Invert bottle.
- Pull out syringe plunger until the correct amount is withdrawn.
- Turn the bottle the correct way up and remove the syringe from the adapter.
- Administer the dose into the mouth by placing the tip of the syringe against the inside of the cheek. Slowly depress the plunger, allowing time to swallow. Forceful squirting to the back of the throat may cause choking.
- Repeat dose as required.
- Replace and tighten bottle cap.
- After use the syringe must not be left in the bottle and should be washed thoroughly in clean water.
Fosamprenavir oral suspension should be taken without food on an empty stomach.
How long to take it
Because your medicine helps to control your condition, but does not cure it, you will need to take the oral suspension every day. Do not stop taking your medicine without first talking to your doctor.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, then go back to taking it as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to the Accident and Emergency unit at your nearest hospital, if you think you or anyone else may have taken too much Telzir oral suspension. Do this even if there are no signs of discomfort or poisoning.
If you are not sure what to do, contact your doctor or pharmacist.
While you are taking Telzir oral suspension
Things you must do
Tell your doctor or pharmacist that you are taking Telzir oral suspension if you are about to be started on any other medicines.
Tell your doctor if you become pregnant or are trying to become pregnant.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Things you must not do
Do not stop taking Telzir oral suspension or ritonavir, or change the dose without first checking with your doctor.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use Telzir oral suspension to treat any other complaints unless your doctor says to.
Side-Effects
Check with your doctor as soon as possible if you have any problems while taking Telzir oral suspension or ritonavir, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Like all medicines, Telzir and ritonavir can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and may need medical attention.
Common side-effects associated with Telzir and ritonavir treatment include:
- nausea & vomiting.
- diarrhoea.
- flatulence.
- abdominal pain.
- headache.
- rash.
- fatigue.
- altered sensation in your mouth.
- dizziness.
Occasionally the skin rash may be severe and as a result your doctor may decide that you have to stop taking this medicine.
Other side-effects that have been reported, include:
- muscle pain.
- tenderness and weakness.
These have been seen particularly with antiretrovirals therapy including protease inhibitors and nucleoside analogues.
In some individuals, treatment with a combination of antiretroviral medicines that includes a protease inhibitor has caused a change in body shape due to changes in fat distribution. These may include decreased fat under the skin, increased fat in the abdomen (belly), breast enlargement and fatty lumps on the back of the neck.
Your doctor will test your blood regularly for any abnormalities (blood lipids and sugar). Increases in liver enzymes and blood fats have been reported in patients taking Telzir and ritonavir.
Within the first few weeks of treatment with anti-HIV medicines, some people, particularly those that have been HIV positive for some time, may develop inflammatory reactions (eg pain, redness, swelling, high temperature) which may resemble an infection and may be severe. It is thought that these reactions are caused by a recovery in the body’s ability to fight infections, previously suppressed by HIV. If you become concerned about any new symptoms, or any changes in your health after starting HIV treatment, please discuss with your doctor immediately.
Some people may get other side-effects while taking Telzir and ritonavir. If you are concerned, talk to your doctor or pharmacist.
Do not be alarmed by this list of possible side-effects. You may not experience any of them.
After taking Telzir oral suspension
Storage
Keep the oral suspension where children cannot reach it.
Keep Telzir oral suspension in a cool place where it stays below 30°C. Do not freeze. Once opened, use the suspension within 28 days.
Disposal
If your doctor tells you to stop taking Telzir oral suspension, or the oral suspension has passed its expiry date, ask your pharmacist what to do with any oral suspension left over.
Product description
What Telzir oral suspension looks like
Telzir oral suspension is a clear, colourless to pale yellow suspension with bubblegum and peppermint flavouring.
Telzir oral suspension is supplied in High-Density Polyethylene (HDPE) bottles with a child resistant closure containing 225 mLs of suspension. A measuring syringe is provided in the pack.
Ingredients
Telzir oral suspension contains 50 mg of fosamprenavir, as fosamprenavir calcium in each ml of the solution. Your oral suspension also contains the following inactive ingredients:
- Hypromellose,
- sucralose,
- propylene glycol,
- methyl hydroxybenzoate,
- propyl hydroxybenzoate,
- polysorbate 80,
- calcium chloride dihydrate,
- Artificial grape bubblegum flavour,
- Natural peppermint flavour and
- purified water.
Manufacturer
Your Telzir oral suspension is supplied by:
ViiV Healthcare Pty Ltd
Level 4, 436 Johnston Street
Abbotsford, Victoria, 3067
Licensed from:
Vertex Pharmaceuticals Inc.
Cambridge. MA 02139
Further Information
Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. You may also be able to find general information about your illness and its treatment from other sources, for example from books in public libraries.
Counselling is also available from your local AIDS council.
This leaflet was prepared on 2 March 2015.
The information provided applies only to: Telzir® oral suspension.
Telzir® is a registered trade mark of the ViiV Healthcare group of companies.
Telzir oral suspension:
AUST R 101605
Version 9.0
Published by MIMS August 2015
