Consumer medicine information

ODEFSEY®


Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.


1. Why am I using ODEFSEY?

ODEFSEY contains the active ingredients emtricitabine, rilpivirine and tenofovir alafenamide in one tablet. ODEFSEY is used to help control Human Immunodeficiency Virus (HIV) infection.

For more information, see Section 1. Why am I using ODEFSEY? in the full CMI.

2. What should I know before I use ODEFSEY?

Do not use if you have ever had an allergic reaction to ODEFSEY or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use ODEFSEY? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ODEFSEY and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use ODEFSEY?

  • The usual dose is one ODEFSEY tablet orally, once daily with food.

More instructions can be found in Section 4. How do I use ODEFSEY? in the full CMI.

5. What should I know while using ODEFSEY?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using ODEFSEY.
Things you should not do
  • Do not stop using this medicine suddenly.
  • Do not breastfeed.
  • Avoid doing things that can spread HIV infection.
Driving or using machines
  • Be careful driving or operating machinery until you know how ODEFSEY affects you.
Looking after your medicine
  • Keep your ODEFSEY tablets in the bottle with the cap tightly closed until you take them.
  • Keep ODEFSEY tablets in a cool, dry place where it stays below 30°C.

For more information, see Section 5. What should I know while using ODEFSEY? in the full CMI.

6. Are there any side effects?

The most common side effect of ODEFSEY is nausea.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

ODEFSEY®

Active ingredient(s): emtricitabine, rilpivirine, tenofovir alafenamide


Consumer Medicine Information (CMI)

This leaflet provides important information about using ODEFSEY. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using ODEFSEY.

Where to find information in this leaflet:

1. Why am I using ODEFSEY?
2. What should I know before I use ODEFSEY?
3. What if I am taking other medicines?
4. How do I use ODEFSEY?
5. What should I know while using ODEFSEY?
6. Are there any side effects?
7. Product details

1. Why am I using ODEFSEY?

ODEFSEY contains the active ingredients emtricitabine, rilpivirine and tenofovir alafenamide in a single tablet.

Emtricitabine and tenofovir alafenamide belong to a group of antiviral medicines known as nucleoside and nucleotide reverse transcriptase inhibitors (NRTI) and (NtRTI), respectively.

Rilpivirine belongs to a group of antiviral medicines known as non-nucleoside reverse transcriptase inhibitors (NNRTI).

ODEFSEY is used to help control Human Immunodeficiency Virus (HIV) infection.

ODEFSEY helps block HIV-1 reverse transcriptase, a viral chemical in your body (enzyme) that is needed for HIV-1 to multiply.

ODEFSEY lowers the amount of HIV in the blood (viral load). ODEFSEY may also help to increase the number of T cells (CD4+ cells), allowing your immune system to improve. Lowering the amount of HIV in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections).

HIV infection destroys CD4 T cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) may develop.

ODEFSEY is for people who do not have a resistant HIV virus to ODEFSEY.

2. What should I know before I use ODEFSEY?

Warnings

Do not use ODEFSEY if:

  • you are allergic to emtricitabine, rilpivirine or tenofovir alafenamide, or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can use this medicine.
  • you are already taking any other medicines to treat HIV infection such as:
    – tenofovir disopoxil fumarate
    – emtricitabine
    – lamivudine
    – tenofovir alafenamide
    – rilpivirine
  • you take:
    – carbamazepine (e.g. Tegretol)
    – oxcarbazepine (e.g. Trileptal)
    – phenobarbital or phenytoin (e.g. Dilantin)
    – rifampicin (e.g. Rifadin/Rimycin)
    – rifapentine (e.g. Priftin)
    – omeprazole (e.g. Losec)
    – esomeprazole (e.g. Nexium)
    – lansoprazole (e.g. Zopral)
    – dexlansoprazole
    – pantoprazole (e.g. Somac)
    – rabeprazole (e.g. Pariet)
    – St John’s Wort or products containing St John’s Wort
  • you are also taking adefovir dipivoxil to treat hepatitis B virus (HBV) infection.

This is not a complete list of medicines that you should tell your doctor about.

Check with your doctor if you:

  • have kidney problems or are undergoing kidney dialysis treatment
    – Your doctor should do blood and urine tests to check your kidneys when starting and during treatment with ODEFSEY. Your doctor may tell you to stop taking ODEFSEY if you develop new or worse kidney problems.
  • have liver problems, including hepatitis B or C virus infection
  • take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. We do not know if ODEFSEY can harm your unborn child. You and your doctor will need to decide if ODEFSEY is right for you.

Talk to your doctor if you are breastfeeding or intend to breastfeed. You should not breastfeed if you are HIV-positive because of the chance of passing the HIV virus to your baby. At least one of the active substances in this medicine (emtricitabine) have been found in breast milk at low concentrations. Talk with your doctor about the best way to feed your baby.

Use in Children

  • ODEFSEY is used to treat HIV-1 infection in adults and children 12 years of age and older.
  • ODEFSEY has not yet been studied in children under the age of 12 or weighing less than 35 kg.

Does ODEFSEY cure HIV or AIDS?

ODEFSEY does not cure HIV infection or AIDS.

The long-term effects of ODEFSEY are not known at this time.

People taking ODEFSEY may still get opportunistic infections or other conditions that happen with HIV infection.

Opportunistic infections are infections that develop because the immune system is weakened. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infection.

This medicine is only available from a pharmacist after it has been prescribed by a doctor who specialises in the treatment of HIV infection.

If you wish to continue receiving treatment with ODEFSEY it is important you remain under the care of a hospital or doctor who specialises in the treatment of HIV infection.

Does ODEFSEY reduce the risk of passing HIV to others?

It is still possible to pass on HIV to other people through sexual contact, sharing needles, or being exposed to your blood when taking ODEFSEY, although the risk is much lower with effective antiretroviral therapy.

Discuss with your doctor the precautions needed to avoid infecting other people. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom of other barrier to lower the chance of sexual contact with semen, vaginal secretions, or blood.

Never re-use or share needles.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may affect the levels of ODEFSEY or ODEFSEY may affect the levels of other medicines in the body when they are taken at the same time as ODEFSEY.

Your doctor may change your other medicines or change their doses. Other medicines, including herbal products may affect ODEFSEY.

For this reason, it is very important to let your doctor or pharmacist know what medications, herbal supplements, or vitamins you are taking.

Know the medicines you take. Keep a list of medicines and show it to your doctor and pharmacist when you get a new medicine.

Your doctor and your pharmacist can tell you if you can take these medicines with ODEFSEY.

Do not start any new medicines while you are taking ODEFSEY without first talking with your doctor or pharmacist.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ODEFSEY.

4. How do I use ODEFSEY?

How much to take

  • The usual dose is one ODEFSEY tablet orally, once daily.
  • Take ODEFSEY with food.
  • Follow the instructions provided and use ODEFSEY until your doctor tells you to stop.

If you forget to use ODEFSEY

ODEFSEY should be used regularly at the same time each day. It is important not to miss a dose of ODEFSEY. If you forget to take ODEFSEY, take your missed dose right away unless it is almost time for your next dose.

Do not take a double dose to make up for a forgotten dose.

Continue with your regular dosing schedule.

When your ODEFSEY supply starts to run low, get more from your doctor or pharmacy.

This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to ODEFSEY and become harder to treat.

If you use too much ODEFSEY

If you think that you have used too much ODEFSEY, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre by calling 13 11 26 (Australia) and 0800 764 766 (New Zealand), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using ODEFSEY?

Things you should do

Remind any doctor, dentist or pharmacist you visit that you are using ODEFSEY.

Things you should not do

  • Do not stop using this medicine suddenly.
  • Do not breastfeed.
  • Avoid doing things that can spread HIV infection.
    – Do not share needles or other injection equipment.
    – Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.
  • Always practice safer sex by using a latex or polyurethane condom or other barrier to reduce the chance of sexual contact with semen, vaginal secretions, or blood.
  • Do not take ODEFSEY is the packaging is torn or shows signs of tampering.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how ODEFSEY affects you.

If you are dizzy, have trouble concentrating, or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.

Looking after your medicine

  • Keep your ODEFSEY tablets in the bottle with the cap tightly closed until you take them. If you take ODEFSEY tablets out of their pack, they may not keep well.
  • Keep ODEFSEY in a cool, dry place where it stays below 25°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

Do not take ODEFSEY after the expiry or “use by” date (EXP) printed on the bottle.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects What to do
  • nausea
  • diarrhoea
  • fatigue
  • headaches
  • abdominal pain
  • indigestion
  • flatulence
  • dizziness
  • rash
  • vomiting
  • depression
  • weight gain
  • abnormal dreams and sleep issues
  • insomnia
  • decreased appetite
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects What to do
Hepatic Flares
If you have HIV infection and HBV infection you should not stop your ODEFSEY treatment without first discussing this with your doctor. Your HBV may get worse (flare-up) if you stop taking ODEFSEY. A “flare-up” or “hepatic flare” is when your HBV infection suddenly returns in a worse way than before. You may require medical exams and blood tests for several months after stopping treatment. ODEFSEY is not approved for the treatment of HBV, so you must discuss your HBV therapy with your doctor.

Signs and symptoms of inflammation
In some patients with advanced HIV infection (AIDS), 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, which lets the body fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please tell your doctor immediately.

Lactic Acidosis

  • you feel very weak or tired
  • you have unusual (not normal) muscle pain
  • you have trouble breathing
  • you have stomach pain with nausea and vomiting
  • you feel cold, especially in your arms and legs
  • you feel dizzy or light headed
  • you have a fast or irregular heartbeat

These side effects may be due to a condition called lactic acidosis (build-up of an acid in the blood).
Lactic acidosis can be a medical emergency and may need to be treated in the hospital.

Serious Liver Problems (hepatotoxicity)

  • your skin or the white part of your eyes turns yellow (jaundice)
  • your urine turns dark
  • your bowel movements (stools) turn light in colour
  • you don’t feel like eating food for several days or longer
  • you feel sick to your stomach (nausea)
  • you have lower stomach area (abdominal) pain

These side effects may be due to a condition called hepatotoxicity with liver enlargement (hepatomegaly) and fat deposits in the liver (steatosis) which sometimes occurs in patients taking anti-HIV medicines.
Allergy
Some people are allergic to medicines. If you have any of the following symptoms soon after taking your medicine, DO NOT TAKE ANY MORE ODEFSEY and tell your doctor IMMEDIATELY or go to the accident and emergency department at your nearest hospital:

  • skin troubles such as lumpy skin rash or “hives”
  • swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
  • wheezing, chest pain or tightness
  • fainting

These are very serious effects. If you have them, you may have a serious allergic reaction. You may need urgent medical attention or hospitalisation.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Ask your doctor or pharmacist for a more complete list of side effects of ODEFSEY and all the medicines you will take.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What ODEFSEY contains

Active ingredient
(main ingredient)
emtricitabine
rilpivirine
tenofovir alafenamide
Other ingredients
(inactive ingredients)
lactose
microcrystalline cellulose
povidone
polysorbate 20
croscarmellose sodium
magnesium stearate
polyvinyl alcohol (E1203)
titanium dioxide (E171)
polyethylene glycol
talc (E553b)
iron oxide black (E172)
Potential allergens N/A

Do not take this medicine if you are allergic to any of these ingredients.

What ODEFSEY looks like

The 200/25/25 mg ODEFSEY tablets are oval-shaped, film-coated and grey in colour.

Each tablet is debossed with “GSI” on one side and the number “255” on the other side.

ODEFSEY tablets are supplied in bottles containing 30 tablets.

AUST R 260634

Who distributes ODEFSEY

Australia

Gilead Sciences Pty Ltd
Level 6, 417 St Kilda Road
Melbourne, Victoria 3004

New Zealand

c/- Grant Thornton New Zealand Limited,
L4, 152 Fanshawe Street
Auckland 1010

This leaflet was prepared in November 2021.

ATRIPLA, EMTRIVA, EVIPLERA, GENVOYA, STRIBILD, TRUVADA, and VIREAD are trademarks of Gilead Sciences, Inc. or one of its related companies. All other trademarks referenced herein are the property of their respective owners.

Published by MIMS February 2022