What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Odefsey (Emtricitabine / Rilpivirine / Tenofovir Alafenamide)
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Product Details
Description
Odefsey (emtricitabine, rilpivirine, tenofovir alafenamide) is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and children who weigh at least 77 pounds (35 kg):
- who have not received any HIV-1 medications and who have less than or equal to 100,000 copies/mL HIV-1 in the blood, or
- to replace their current HIV-1 regimen in those who meet certain requirements per their doctor
Odefsey contains 200 mg of Emtricitabine, 25 mg of Rilpivirine, and 25 mg of Tenofovir alafenamide.
Fact Table
Formula
C8H10FN3O3S
License
US DailyMed, EU EMA
Bioavailability
93%
Legal status
RX-only
Chemical Name
Emtricitabine / Rilpivirine / Tenofovir Alafenamide
Elimination half-life
10 hours
Dosage (Strength)
200mg / 25mg / 25mg
Pregnancy
Consult Doctor
Brands
Odefsey
Protein binding
Very low (less than 4%)
PubChem CID
60877
MedlinePlus
a604004
ChEBI
31536
ATC code
J05AF09
DrugBank
DB00879
KEGG
D01199
Routes of administration
By Mouth
Directions
Take one tablet by mouth once daily with food.
Ingredients
The active ingredients in each tablet include Emtricitabine, Rilpivirine, and Tenofovir-alafenamide.
Contraindications
Do not take Odefsey with drugs that can cause decreases in rilpivirine plasma concentrations.
Cautions
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
See full prescribing information for complete boxed warnings.
Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of ODEFSEY. Hepatic function should be monitored closely in these patients. If appropriate, anti-hepatitis B therapy may be warranted. (5.1)
Talk to your doctor about any allergies you may have. Skin and hypersensitivity reactions can occur if you are allergic to Odefsey or any of the ingredients or excipients.
Tell your doctor about any medications you take. Odefsey can interact with certain medications that can cause severe reactions.
Once you are prescribed and buy Odefsey, then it is important to know that Odefsey can cause liver damage. Liver enzymes should be monitored.
Depression or mood changes have been reported with Odefsey treatment. Tell your doctor right away if you experience sadness, hopelessness, anxiety, or suicidal thoughts or ideations.
Odefsey can cause kidney damage or worsen kidney function. Kidney function and labs should be monitored.
Taking Odefsey with other medications that can cause QT prolongation can increase the risk of Torsade de Pointes.
Lactic acidosis or liver enlargement may occur with Odefsey treatment. Your doctor may discontinue Odefsey if you develop symptoms or lab findings of lactic acidosis or liver damage.
Your immune system may change with the use of Odefsey.
Tell your doctor if you are pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed.
Side Effects
The most common side effects of Odefsey include:
- Headache
- Sleep problems
These may not be all of the possible side effects, so tell your doctor right away if you experience side effects or if your side effects become bothersome or won't go away.References:
- Odefsey (emtricitabine, rilpivirine, tenofovir alafenamide) Patient Information. Foster City, CA: Gilead Sciences, Inc.; 2021.
- Odefsey (emtricitabine, rilpivirine, tenofovir alafenamide) Prescribing Information. Foster City, CA: Gilead Sciences, Inc.; 2021.
Frequently Asked Questions about Odefsey
What is Odefsey?
Odefsey is a single-tablet medication used to treat HIV-1 infection in adults and adolescents (over 12 years old and weighing at least 77 lb). It combines three antiretroviral drugs: emtricitabine, rilpivirine, and tenofovir alafenamide.
Does Odefsey cure HIV?
No, Odefsey does not cure HIV, but it can help control the virus and keep you healthy. Taking it regularly can significantly reduce the amount of HIV in your blood (viral load) and strengthen your immune system.
Who can take Odefsey?
Adults and adolescents with HIV-1 infection who haven't taken any HIV medications before (with a specific viral load limit). HIV-positive individuals on a stable antiretroviral regimen with suppressed viral load for at least 6 months, meeting specific criteria.
How do I take Odefsey?
Take one tablet daily with food, ideally at the same time each day. Do not split, crush, or chew the tablet.
What are the side effects of Odefsey?
Common side effects include nausea, headache, dizziness, and fatigue. More serious side effects are rare but possible.
Can I take Odefsey with other medications?
Some medications can interact with Odefsey, so inform your doctor about all your medications and supplements before starting Odefsey.
Can I drink alcohol while taking Odefsey?
Heavy alcohol consumption is not recommended while taking Odefsey as it can worsen side effects like dizziness and liver problems.
Can I become pregnant while taking Odefsey?
Talk to your doctor about safe pregnancy options if you are considering becoming pregnant while taking Odefsey.
Can I breastfeed while taking Odefsey?
Breastfeeding is not recommended while taking Odefsey due to the potential risk of harm to the baby.
What should I do if I miss a dose of Odefsey?
If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and continue your regular schedule. Do not take a double dose.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 13230
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