Details for: TELZIR
Company: VIIV HEALTHCARE ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02261553 | TELZIR | FOSAMPRENAVIR (FOSAMPRENAVIR CALCIUM) | 50 MG / ML | SUSPENSION | ORAL |
| 02261545 | TELZIR | FOSAMPRENAVIR (FOSAMPRENAVIR CALCIUM) | 700 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
The name of your medicine is TELZIR. TELZIR can only be
obtained with a prescription from your doctor. TELZIR is an
antiretroviral medication. It is used together with other antiviral
medicines to delay the progression of HIV infection in adults and
pediatrics of 6 years of age and above.
TELZIR is to be taken in combination with ritonavir. It is
therefore important that you carefully read the Consumer
Information Leaflet that is provided with that medicine. If you
have any further questions about ritonavir please ask your doctor
or pharmacist.
What it does
The Human Immunodeficiency Virus (HIV) is a retrovirus.
Infection with HIV damages the immune system and can lead to
Acquired Immune Deficiency Syndrome (AIDS) and other
related illnesses.
TELZIR is an antiretroviral medication. It belongs to a group of
medicines called protease inhibitors. TELZIR in combination
with other antiretroviral agents reduces the amount of HIV in
your blood. Response to treatment with TELZIR varies among
patients. Your doctor will be monitoring the effectiveness of
your treatment. TELZIR does not cure AIDS or kill the virus, but
may help to prevent further damage to the immune system by
slowing the production of new viruses.
When it should not be used
Do not use TELZIR if:
- You are allergic to ritonavir, fosamprenavir calcium, amprenavir or any of the other ingredients found in TELZIR or ritonavir (See What the important nonmedicinal ingredients are).
- You are taking any of the following medications with TELZIR because serious or life-threatening problems could occur. Medicines for:
- heart rhythm (e.g. flecainide, propafenone, amiodarone, lidocaine (systemic))
- prostate (e.g. alfuzosin)
- antihistamine
- infection (rifampin, as this drug reduces the effectiveness of TELZIR)
- headache (e.g. dihydroergotamine, ergonovine, ergotamine)
- indigestion
- mood (St. John’s Wort - Hypericum perforatum)
- cholesterol (e.g. lovastatin, simvastatin)
- schizophrenia (e.g. pimozide, quetiapine, lurasidone)
- bipolar disorder and major depressive disorder (e.g. quetiapine, lurasidone)
- pulmonary arterial hypertension (sildenafil)
- anxiety (e.g. midazolam, triazolam, diazepam, flurazepam)
- HIV infection (delavirdine)
What the medicinal ingredient is
TELZIR tablets are available for oral administration in a strength
of 700 mg of fosamprenavir as fosamprenavir calcium
(equivalent to approximately 600 mg of amprenavir).
TELZIR oral suspension contains 50 mg/mL fosamprenavir as
calcium salt (equivalent to approximately 43 mg/mL
amprenavir).
What the non-medicinal ingredients are
Each 700 mg tablet contains the inactive ingredients colloidal
silicon dioxide, croscarmellose sodium, magnesium stearate,
microcrystalline cellulose, and povidone K30. The tablet filmcoating contains the inactive ingredients hypromellose, iron
oxide red, titanium dioxide, and triacetin.
The oral suspension contains hypromellose, sucralose, propylene
glycol, methyl parahydroxybenzoate, propyl
parahydroxybenzoate, polysorbate 80, calcium chloride
dihydrate, artificial grape bubblegum flavour, natural peppermint
flavour and purified water.
What dosage form it comes in
TELZIR tablets, 700 mg, are available in bottles of 60 tablets.
TELZIR suspension is available in a bottle of 225 mL of
50 mg/mL fosamprenavir calcium oral suspension.
Warnings and precautions
Tell your doctor, before using TELZIR if:
- You are pregnant, planning to become pregnant, or become pregnant while taking TELZIR. It is not known if TELZIR can harm your unborn child. You and your doctor will need to decide if taking TELZIR is right for you. If you take TELZIR while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.
- You are breastfeeding. It is recommended that HIV infected women do not breastfeed their infants under any circumstances in order to avoid transmission of HIV from mother to child. The active substance in TELZIR may be found in human breast milk and there is no safety data available following treatment with TELZIR in babies. You are recommended not to breastfeed your baby while taking TELZIR.
- You have any medical conditions, including liver disease, hepatitis, as the amount of medicine you are taking may change.
- You have hemophilia. There have been reports of increased bleeding in patients with hemophilia taking protease inhibitors.
- You are taking oral contraceptives, as TELZIR may be harmful to your liver and may decrease the therapeutic effect of the oral contraceptive. Therefore, alternative nonhormonal methods of contraception (e.g. a condom) are recommended to prevent pregnancy while you are taking TELZIR.
- You are using estrogens and /or progestogens as hormone replacement therapy. No data is available on the use of TELZIR with estrogens and/or progestogens as hormone replacement therapy (HRT) for post menopausal women.
- You are allergic to sulfonamide drugs.
- You are taking or planning to take any other drug(s), including those available without a prescription, and herbal medicines such as St. John’s Wort (Hypericum perforatum). Taking this herb may reduce the effectiveness of TELZIR.
Special warnings:
TELZIR oral solution contains propyl and methyl
parahydroxybenzoate. These products may cause an allergic
reaction in some individuals. This reaction may be delayed.
TELZIR helps to control the amount of HIV found in your blood
but is not a cure for HIV infection. You will need to take
TELZIR every day. Do not stop taking TELZIR without first
talking to your doctor.
HIV is usually spread by sexual contact, blood transfer or by
contaminated needles. The risk of spreading HIV still exists
during TELZIR therapy; thus, the practice of ‘safe sex’ and
avoidance of sharing needles is necessary.
You may continue to develop other infections and other illnesses
associated with HIV disease. You should therefore keep in
regular contact with your doctor while taking TELZIR.
Mothers with HIV should not breastfeed their infants because
HIV in the breastmilk can infect the infant.
Driving and operating machinery
There is no information currently available that suggests taking
TELZIR affects the ability to drive or operate machinery.
Interactions with this medication
Some drugs may change the usefulness and safety of TELZIR. It is important that you tell your doctor about all the medicines you are taking or planning to take, including all those that you have bought yourself. This is very important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicine, causing in some cases serious medical conditions. TELZIR may interact with other medicines you are being treated with. Some of the medicines that can interact with amprenavir include:
- bosentan
- colchicines
- phenobarbital
- phenytoin
- salmeterol
- tricyclic antidepressants (e.g. amitriptyline, imipramine)
- warfarin
- PDE5 inhibitors (e.g. vardenafil, tadalafil)
- cholesterol-lowering drugs (atorvastatin)
- anticonvulsants (e.g. carbamazepine)
- anti-inflammatory drugs (e.g. dexamethasone)
- fluticasone
- paroxetine
- trazodone
- methadone
- itraconazole, ketoconazole
- immunosuppresants (e.g. cyclosporine, rapamycin and tacrolimus)
- maraviroc, dolutegravir (used to treat HIV infection)
- anti-hepatitis C drugs
- clarithromycin
- calcium channel blockers (e.g. amlodipine, diltiazem, felodipine, nifedipine, nimodipine, verapamil)
- cancer drugs (e.g. dasatinib, nilotinib, ibrutinib, vinblastine and everolimus)
See ABOUT THIS MEDICATION for a list of drugs that should not be taken with TELZIR.
Proper use of this medication
Both regimens must be administered in combination with other
antiretroviral agents.
Once-daily administration of TELZIR/ritonavir combination is
not recommended in protease inhibitor-experienced patients.
The twice-daily plus ritonavir dose is supported by
pharmacokinetic and safety data.
Take TELZIR tablets as your doctor has advised you. Take
TELZIR oral suspension as your doctor has advised you.
Adults (aged 18 years and older):
Low doses of ritonavir may be used to enhance the
pharmacokinetic profile of amprenavir. The recommended oral
dose of fosamprenavir, in combination with ritonavir is outlined
below:
Tablets:
Therapy Naïve Patients:
Once Daily: 1400 mg TELZIR and 200 mg ritonavir
Twice Daily: 700 mg TELZIR and 100 mg ritonavir
Protease Inhibitor-Experienced Patients:
Twice Daily: 700 mg TELZIR and 100 mg ritonavir
TELZIR tablets can be taken with or without food.
Oral Suspension:
Therapy Naïve Patients:
Once Daily: 1400 mg TELZIR and 200 mg ritonavir
Twice Daily: 700 mg TELZIR and 100 mg ritonavir
Protease Inhibitor-Experienced Patients:
Twice Daily: 700 mg TELZIR and 100 mg ritonavir
TELZIR oral suspension should be taken by adults without food
and on an empty stomach. Shake the bottle vigorously before
use.
Pediatric Patients (aged 6 years and older):
Pediatric patients should take this oral suspension with food to
aid in taste and better encourage compliance with dosing. If
vomiting occurs within 30 minutes of dose, the oral suspension
dose should be taken again.
Oral Suspension:
Therapy Naïve and Protease Inhibitor Experienced:
Twice daily: 18 mg/kg plus ritonavir 3 mg/kg administered twice
daily not to exceed the adult dose of 700 mg plus ritonavir
100 mg.
Tablets:
Therapy Naïve and Protease Inhibitor Experienced:
Twice daily: not to exceed 700 mg plus ritonavir 100 mg
The adult tablet regimens of TELZIR/ ritonavir may be used in
patients who weigh at least 39 kg (ritonavir tablets may be used
in patients who weigh at least 33 kg) and can swallow the tablets
whole.
The use of TELZIR has not been studied in pediatric patients
below the age of 2.
If you have a liver problem, your dose may be altered. Please
follow the instructions of your doctor.
Overdose
Missed Dose
If you forget to take TELZIR, take it as soon as you remember.
Then continue as before. Do not double dose.
Side effects and what to do about them
The following undesirable effects are thought to be related to
treatment with TELZIR: feeling sick, diarrhea, tiredness,
headache, abdominal pain, passing gas, rash, kidney stones,
higher amounts of a type of fat in the blood and vomiting, and
tingling or numbness around lips and mouth.
An increase in body fat has been seen in some patients taking
antiretroviral therapy including a protease inhibitor. The cause
and long-term health effects of these conditions are not known at
this time.
Your doctor will test your blood regularly for increases in blood
lipids (blood fat). These have been reported in patients taking
TELZIR, which may lead to an increased risk of a heart attack.
Heart attacks have occurred in some patients taking TELZIR.
Increases in liver enzymes have also been reported. Your blood
will also be checked for increases in blood sugar levels, as
occasionally protease inhibitors have been shown to cause this.
Changes in your immune system (Immune Reconstitution
Inflammatory Syndrome (IRIS)) can happen when you start
taking HIV medicines. Your immune system may get stronger
and begin to fight infections that have been hidden in your body
for a long time, or you could develop an autoimmune disease in
which your immune system reacts against your own body (e.g.
Grave's disease (which affects the thyroid gland), Guillain-Barre
syndrome (which affects the nervous system) or polymyositis
(which affects the muscles) and it may develop at any time,
sometimes months later after the start of HIV therapy).
Sometimes symptoms can be severe, so if you develop high
temperature (fever), joint or muscle pain, redness, rash, swelling,
or fatigue or any new symptoms contact your doctor straight
away.
Always tell your doctor or pharmacist about any undesirable
effects, even those not mentioned in this leaflet. If you feel ill in
any other way that you do not understand, tell your doctor or
pharmacist.
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Very Common | |||
| Hypercholesterolemia (high blood levels of fat called cholesterol) | ✔ | ||
| Common | |||
| Nausea, vomiting, rash, and hypertriglyceridemia (high blood levels of fat called triglycerides). | ✔ | ||
| Uncommon | |||
| New or worsening diabetes has been reported with the use of protease inhibitors. | ✔ | ||
| Increase in spontaneous bleeding among hemophiliacs using protease inhibitors has been reported. | ✔ | ||
| Kidney stones | ✔ | ||
| Rare | |||
| Increase in muscle wasting (rhabdomyolosis), muscle pain has been reported with protease inhibitors. | ✔ | ||
| Severe lifethreatening rash (Stevens-Johnson syndrome), angioedema (swelling of the blood vessels and surrounding tissue). | ✔ | ||
If you have a severe skin rash, check with your doctor as he may
advise you to stop taking TELZIR.
This is not a complete list of side effects. For any unexpected
effects while taking TELZIR, contact your doctor or
pharmacist.
How to store
Store TELZIR tablets between 15°C and 30°C.
Store TELZIR suspension between 2°C and 30°C. Do not freeze.
Discard the suspension 28 days after first opening.
Do not take TELZIR after the expiry date on the container.
As with all medications, keep TELZIR out of the reach and sight
of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugshealth-products/medeffect-canada/adverse-reactionreporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
Remember: TELZIR is for you. Never give it to someone
else. It may harm them even if their symptoms are the same
as yours.
This leaflet does not tell you everything about TELZIR. If you
have any questions or are not sure about anything, then ask your
doctor or pharmacist. You may need to read this leaflet again.
Please do not throw this leaflet away until you are no longer
taking TELZIR.
This document plus the full product monograph, prepared for
health professionals can be found at:
www.viivhealthcare.ca
or by contacting the sponsor, ViiV Healthcare ULC at:
245, boulevard Armand-Frappier
Laval, Quebec
H7V 4A7
1-877-393-8448
This leaflet was prepared by ViiV Healthcare ULC.
Last revised: July 5, 2019
© 2019 ViiV Healthcare group of companies or its licensor.
Trademarks are owned by or licensed to the ViiV Healthcare group of
companies.