Patient Medication Information: uses, side effects, how to take - Odefsey
Serious Warnings and Precautions
- “Flare-ups” of Hepatitis B Virus infection, in which the disease suddenly returns in a worse way than before, can occur if you also have hepatitis B and stop taking Odefsey. Do not stop taking Odefsey without your doctor’s advice. If you stop taking Odefsey, tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment. After you stop taking Odefsey, your doctor will still need to check your health and take blood tests to check your liver. Odefsey is not approved for the treatment of hepatitis B virus infection.
What is Odefsey used for?
Odefsey is used to treat people with Human Immunodeficiency Virus (HIV) infection. Odefsey is for adults.
Odefsey is for people who do not have an HIV virus that is resistant to Odefsey. Odefsey has not been studied in children under 18 years of age.
How does Odefsey work?
Odefsey lowers the amount of HIV in the blood (viral load).
HIV infection destroys CD4+ (T) cells. These cells are important to help the immune system fight infections. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops.
Odefsey may help increase the count of CD4+ (T) cells. Lowering the amount of HIV in the blood and increasing the CD4+ (T) cells lower the chance of getting infections that happen when your immune system is weak.
Odefsey does not cure HIV infection or AIDS. The long-term effects of Odefsey are not known. People taking Odefsey may still get infections or other conditions that happen with HIV infection. Some of these conditions are pneumonia and Mycobacterium avium complex (MAC) infections. It is very important that you see your doctor on a regular basis while taking Odefsey.
Odefsey has not been shown to reduce the risk of passing HIV to others through sexual contact or blood. Continue to practice safe sex. Use condoms to lower the chance of sexual contact with body fluids such as semen, vaginal secretions, or blood. Do not re-use or share needles.
What are the ingredients in Odefsey?
Medicinal ingredients: emtricitabine, rilpivirine*, tenofovir alafenamide** (*as rilpivirine hydrochloride, **as tenofovir alafenamide hemifumarate)
Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20 and povidone. The coating of the tablets contains polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol, talc, and iron oxide black.
Odefsey comes in the following dosage forms:
Odefsey comes in tablets. Each tablet contains emtricitabine (200 milligrams), rilpivirine (25 milligrams) (as 27.5 milligrams of rilpivirine hydrochloride) and tenofovir alafenamide (25 milligrams) (as 28.0 milligrams of tenofovir alafenamide hemifumarate). Odefsey tablets are gray. They have a capsule-shape. The tablets say “GSI” on one side and “255” on the other side. Each bottle contains 30 tablets. The bottle has a cap that children cannot open. The bottle also contains some polyester coil (which looks white and fluffy) and a small packet of silica gel drying agent. Do NOT eat the coil or drying agent. They are meant to keep your medicine fresh.
Do not use Odefsey if:
- you are allergic to emtricitabine, rilpivirine, tenofovir alafenamide or any of the other ingredients in this product. (Read also “What are the ingredients in Odefsey?” above.)
- you are taking any of the following drugs:
Drugs that must not be taken with Odefsey (contraindicated):
| Drug Class | Medicinal Ingredient (Brand Name) |
|---|---|
| Anticonvulsants | carbamazepine (Tegretol®, Tegretol CR®), oxcarbazepine (Trileptal®), phenobarbital (Phenobarb®) and phenytoin (Dilantin®, Tremytoine®) |
| Antimycobacterial | rifampin (Rifadin®, Rifamate®*, Rifater®, Rofact®), and rifapentine* |
| Drug Class | Medicinal Ingredient (Brand Name) |
|---|---|
| Glucocorticoid | systemic dexamethasone (more than 1 dose) or dexamethasone sodium phosphate |
| Herbal products | Hypericum perforatum (St. John’s wort) |
| Proton pump inhibitor | dexlansoprazole (Dexilant®), esomeprazole (Nexium®, Vimovo®), lansoprazole (Prevacid®), omeprazole (Losec®, Olex®), pantoprazole sodium (Pantoloc®, Panto IV®), rabeprazole (Pariet®) |
*Not available in Canada
The following drugs should also not be taken with Odefsey:
- Adefovir dipivoxil (HEPSERA®).
- Any other medicines to treat HIV-1 infection.
- Any other medicines that contain tenofovir alafenamide (BIKTARVY®, GENVOYA®, DESCOVY®, Symtuza™, VEMLIDY®).
- Any other medicines that contain tenofovir disoproxil fumarate (ATRIPLA®, COMPLERA®, STRIBILD®, TRUVADA®, VIREAD®).
- Any other medicines that contain emtricitabine or lamivudine (3TC®, ATRIPLA, BIKTARVY, COMPLERA, GENVOYA, EMTRIVA®, STRIBILD, Symtuza, TRUVADA; Combivir®, Heptovir®, Kivexa®, Triumeq®, Trizivir®).
- Any other medicines that contain rilpivirine (COMPLERA, Edurant®).
To help avoid side effects and ensure proper use, talk to your doctor before you take Odefsey. Talk about any health conditions or problems you may have, including if you:
- Also have a hepatitis B virus (HBV) infection at the same time and take Odefsey. Your HBV infection may get worse (flare-up) and symptoms worsen if you stop taking Odefsey (see Serious Warnings and Precautions box and Serious Side Effects table).
- Have a history of pancreatitis (swelling of the pancreas). If you develop symptoms of pancreatitis, such as nausea, vomiting and severe pain in the abdomen and/or back, contact your doctor.
- Have serious liver problems or kidney problems.
- Have bone problems.
- Have heart problems (eg, irregular heartbeat, QT prolongation).
- Have lactic acidosis (high levels of acid in the blood). See the Serious Side Effects table for symptoms and contact your doctor right away if you get these symptoms.
- Have severe liver problems including enlarged or fatty liver. See the Serious Side Effects table for symptoms and contact your doctor right away if you get these symptoms.
- Were born with the rare problem of not being able to tolerate galactose (severe lack of lactase or cannot absorb glucose or galactose). Odefsey has lactose.
Do not run out of Odefsey. Refill your prescription or talk to your doctor before your Odefsey is all gone.
- Do not stop taking Odefsey without first talking to your doctor. If you stop taking Odefsey, your doctor will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your doctor about any new or unusual symptoms you may have after you stop taking Odefsey.
Other warnings you should know about:
If you are pregnant or plan to become pregnant:
It is not known if Odefsey can harm your unborn child. Your doctor will decide if you should take Odefsey.
Pregnancy Registry: There is a pregnancy registry for women who take HIV-1 medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become pregnant while taking Odefsey, talk with your doctor taking part in this registry.
If you are breastfeeding or plan to breastfeed:
Do not breastfeed if you take Odefsey. You should not breastfeed if you have HIV because of the chance of passing the HIV virus to your baby. At least one of the medicines, emtricitabine, can pass to your baby in your breast milk and may cause harm to the baby. It is not known if the other medicines in Odefsey can pass into your breast milk. If you are a woman who has or will have a baby, talk with your doctor about the best way to feed your baby.
Grapefruit or grapefruit juice can affect how Odefsey works. Avoid eating grapefruit or drinking grapefruit juice while you are taking Odefsey.
Blood Sugar and Fat Levels Your blood sugar levels (glucose) or level of fats (lipids) in your blood may increase with HIV treatment. Your doctor may order blood tests for you.
Kidney Tests Your healthcare professional should do blood and urine tests to check your kidneys before you start and during treatment with ODEFSEY.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Drugs that interact with Odefsey and where the dose of Odefsey or the dose of the other drug should be changed or other direction is needed:
| Drug Class | Medicinal Ingredient (Brand Name) |
|---|---|
| Antacids | antacids containing aluminum hydroxide, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or 4 hours after you take Odefsey. |
| Antimycobacterials | rifabutin (Mycobutin®) |
| Antifungals | fluconazole (Diflucan®, Monicure®), itraconazole (Sporanox®), ketoconazole (Nizoral®), posaconazole (Posanol®) and voriconazole (Vfend®) |
| H2-Receptor antagonists | cimetidine, famotidine, nizatidine, ranitidine. Take H2-receptor antagonists at least 12 hours before or 4 hours after you take Odefsey. |
| Immunosuppressants | cyclosporine (Neoral®), sirolimus (Rapamune®) and tacrolimus (Prograf®) |
| Antibacterials | clarithromycin (Biaxin®) and telithromycin (Ketek®) |
| Narcotic analgesics | methadone (Metadol®, Methadose) |
These are not all the medicines that may cause problems if you take Odefsey. Be sure to tell your doctor about all the medicines you take.
Keep a complete list of all the prescription, nonprescription, and herbal medicines that you are taking, how much you take and how often you take them. Make a new list when medicines or herbal medicines are added or stopped, or if the dose changes. Give copies of this list to all your doctors and pharmacists every time you visit them or fill a prescription. This will give your doctor a complete picture of the medicines you use. Then he or she can decide the best approach for the situation.
How to take Odefsey:
Stay under a doctor’s care when taking Odefsey. Do not change your treatment or stop treatment without first talking with your doctor.
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. If Odefsey is not taken on a regular basis, as prescribed, the HIV virus may become harder to treat.
Only take medicine that has been prescribed specifically for you.
Do not give Odefsey to others or take medicine prescribed for someone else.
Do not use if seal over bottle opening is broken or missing.
Usual dose: Adults:
- Take one tablet (by mouth) once each day with a meal. Try to take the tablet at the same time each day. Swallow with plenty of water.
Always take Odefsey with a meal. A meal is important to get the right drug levels in your body. A protein drink alone does not replace a meal.
Overdose:
| If you think you have taken too much Odefsey, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose:
It is important to take Odefsey each day.
- If you miss a dose of Odefsey and you notice within 12 hours, take a tablet with a meal as soon as you can. Then take the next dose at your usual time.
- If you miss a dose of Odefsey and you notice after 12 hours, wait and take the next dose at your usual time. Do NOT take a double dose (two doses close together).
What to do if you vomit (throw up):
- If you vomit less than 4 hours after taking Odefsey, take another tablet with a meal.
- If you vomit more than 4 hours after taking Odefsey, wait. Do NOT take another tablet until you are scheduled to take the next tablet.
Call your doctor or pharmacists if you are not sure what to do.
What are possible side effects from using Odefsey?
These are not all the possible side effects you may feel when taking Odefsey. If you get any side effects not listed here, contact your doctor. Please also see Serious Warnings and Precautions box.
The common side effects of Odefsey are:
- Trouble sleeping (insomnia).
- Headache.
- Nausea.
- Tiredness.
- Depression.
Additional side effect may include:
- Gas.
- Hives (urticaria).
- Abdominal discomfort.
Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.
Autoimmune disorders (when the immune system attacks healthy body tissue), may also occur after you start taking medicines for HIV infection. Examples of this include: Grave's disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system), polymyositis (which affects the muscles), or autoimmune hepatitis (which affects the liver). Autoimmune disorders may occur many months after the start of treatment. Look for any other symptoms such as:
- high temperature (fever), redness, rash or swelling
- joint or muscle pain
- numbness or weakness beginning in the hands and feet and moving up towards the trunk of the body
- palpitations (chest pain) or rapid heart rate
If you notice these or any symptoms of inflammation or infection, tell your doctor immediately.
Bone problems can happen in some people who take Odefsey. Bone problems may include bone pain, softening or thinning (which may lead to fractures). Your doctor may need to do tests to check your bones.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Odefsey. For more information, ask your doctor or pharmacist.
Serious side effects and what to do about them
| Symptoms / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
COMMON Effect: Depression or mood changes Symptoms:
| ✓ ✓ ✓ | ||
UNCOMMON Effect: Severe skin rash and allergic reactions Symptoms:
| ✓ ✓ ✓ ✓ | ||
RARE Effect: Lactic acidosis Symptoms:
| ✓ ✓ ✓ ✓ ✓ ✓ ✓ | ||
Serious side effects and what to do about them
| Symptoms / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
VERY RARE Effect: Flare-ups of hepatitis B virus infection following drug discontinuation Symptoms:
| ✓ ✓ ✓ ✓ ✓ ✓ | ||
VERY RARE Effect: Hepatobiliary toxicity (severe liver or gallbladder problems) with hepatomegaly (liver enlargement) and steatosis (fat in the liver) Symptoms:
| ✓ ✓ ✓ ✓ ✓ ✓ ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store Odefsey below 30 °C (86 °F).
- Keep Odefsey in its original container and keep the container tightly closed.
- Keep this medication where children cannot reach it or see it.
If you want more information about Odefsey:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database); the manufacturer’s website www.gilead.ca, or by calling 1-866-207-4267.
Last Revised: November 13, 2019
Gilead Sciences, Inc.
Foster City, CA 94404
USA
Gilead Sciences Canada, Inc.
Mississauga, ON L5N 2W3
ATRIPLA®, BIKTARVY®, ODEFSEY®, DESCOVY®, GENVOYA®, STRIBILD®, COMPLERA®, EMTRIVA®, TRUVADA®, VIREAD®, HEPSERA® and VEMLIDY® are trademarks of Gilead Sciences, Inc. or its related companies.
All other marks referenced herein are the property of their respective owners.
© 2019 Gilead Sciences, Inc. All rights reserved.
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