WARNING

Odefsey is a medication used to treat HIV-1 infection in adults and adolescents weighing at least 35 kg. While Odefsey can be effective in managing the virus, like any medication, it carries certain risks and potential side effects. Here are some of the risks associated with taking Odefsey:

• Drug Interactions: Odefsey can interact with other medications, including over-the-counter drugs and herbal supplements, which may reduce its effectiveness or increase the risk of side effects. It is important to inform your healthcare provider about all the medications you are taking to avoid potential interactions.
• Adverse Reactions: Some individuals may experience adverse reactions while taking Odefsey. These can include nausea, diarrhea, headache, fatigue, abnormal dreams, trouble sleeping, dizziness, and skin rashes. If you experience severe or persistent side effects, it is important to consult your doctor.
• Immune Reconstitution Inflammatory Syndrome (IRIS): In some cases, when starting HIV treatment, including Odefsey, individuals with advanced HIV infection may develop an inflammatory response to certain infections. This condition is known as IRIS and may result in the worsening of symptoms or the appearance of new symptoms. If you notice any unusual symptoms after starting Odefsey, inform your healthcare provider immediately.
• Kidney and Liver Problems: Odefsey can cause kidney and liver problems, including kidney failure, liver enlargement, and increased levels of liver enzymes. Regular monitoring of kidney and liver function is important while taking Odefsey.
• Bone Loss: Some HIV medications, including Odefsey, have been associated with bone loss and an increased risk of osteoporosis. Your healthcare provider may recommend monitoring bone health and, if necessary, taking supplements or other measures to support bone health.
• Resistance and Treatment Failure: In some cases, the virus may develop resistance to Odefsey or other HIV medications, leading to treatment failure. It is crucial to take the medication as prescribed and follow up with your healthcare provider for regular monitoring of viral load and overall treatment effectiveness.

It’s important to note that the above list is not exhaustive, and there may be other risks associated with taking Odefsey. If you are considering this medication or have specific concerns, it is best to consult with your healthcare provider, who can provide personalized information and guidance based on your medical history and individual circumstances.

Why is this medication prescribed?

Odefsey is prescribed for the treatment of HIV-1 infection in adults and adolescents weighing at least 35 kg. It is a combination medication that contains three active ingredients:

• Emtricitabine: It is a nucleoside reverse transcriptase inhibitor (NRTI) that works by blocking the reverse transcriptase enzyme, which is necessary for the replication of the HIV virus.
• Tenofovir alafenamide: It is also an NRTI that inhibits the reverse transcriptase enzyme and helps prevent the virus from multiplying.
• Rilpivirine: It is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that inhibits the reverse transcriptase enzyme, similar to emtricitabine and tenofovir alafenamide.

By combining these three active ingredients, Odefsey helps suppress the replication of the HIV virus, reduce the viral load (the amount of HIV in the blood), and increase the CD4 cell count (a type of immune cell that is attacked by HIV). The goal of treatment with Odefsey, as with other antiretroviral therapies, is to achieve and maintain viral suppression, allowing individuals with HIV to lead longer and healthier lives while reducing the risk of transmitting the virus to others.

Odefsey is typically prescribed as part of a comprehensive HIV treatment regimen, which may also include other antiretroviral medications based on individual needs and treatment guidelines. The specific dosage and treatment plan are determined by a healthcare provider based on factors such as the individual’s viral load, CD4 count, medical history, and potential drug interactions.

How should this medicine be used?

Odefsey should be used exactly as prescribed by your healthcare provider. It is important to follow the recommended dosage and instructions for use. Here are some general guidelines for using Odefsey:

• Dosage: The usual adult and adolescent dosage of Odefsey is one tablet taken orally once daily with a meal. It is important to take Odefsey consistently at the same time each day to maintain a steady level of medication in your body.
• Food Intake: Odefsey should be taken with a meal that contains food. This helps with the absorption of the medication and reduces the risk of gastrointestinal side effects.
• Swallowing: Swallow the tablet whole with water. Do not chew, crush, or break the tablet.
• Adherence: It is important to take Odefsey every day as prescribed, even if you feel well or have no noticeable symptoms. Skipping doses or not taking the medication as directed can lead to treatment failure, the development of drug resistance, and reduced effectiveness in controlling the HIV virus.
• Other Medications: Inform your healthcare provider about all the medications, including prescription drugs, over-the-counter medications, and herbal supplements, that you are taking. Some medications may interact with Odefsey, potentially affecting its effectiveness or increasing the risk of side effects. Your healthcare provider can advise you on any necessary adjustments or precautions.
• Regular Monitoring: While taking Odefsey, it is important to have regular follow-up appointments with your healthcare provider for monitoring of your viral load, CD4 count, and overall treatment effectiveness. They may also conduct blood tests to assess kidney and liver function and monitor for any potential side effects or complications.

Always consult your healthcare provider if you have any questions or concerns about the proper use of Odefsey. They can provide personalized guidance based on your specific needs and medical history.

Other uses for this medicine

Odefsey is specifically approved for the treatment of HIV-1 infection and should be used only for its indicated purpose. It is not intended for other uses. The medication’s safety and effectiveness have not been established for conditions other than HIV-1 infection.

What special precautions should I follow?

Regarding special precautions with Odefsey, here are some important considerations:

• HIV Testing: Odefsey should only be used in individuals who have confirmed HIV-1 infection. It is not suitable for HIV-negative individuals or as a preventive measure for HIV. Proper testing and diagnosis of HIV are necessary before initiating Odefsey treatment.
• Resistance Testing: Before starting Odefsey, your healthcare provider may perform resistance testing to determine if you have any existing HIV strains resistant to the active ingredients in the medication. This helps ensure the most appropriate and effective treatment plan.
• Pregnancy and Breastfeeding: Odefsey may cause harm to an unborn baby. If you are pregnant or planning to become pregnant, it is essential to discuss the potential risks and benefits of Odefsey with your healthcare provider. Similarly, it is recommended to avoid breastfeeding while taking Odefsey, as the medication may pass into breast milk and potentially harm the infant.
• Kidney and Liver Function: Odefsey can affect kidney and liver function. Your healthcare provider will assess your kidney and liver health before prescribing Odefsey and monitor these functions during treatment. Inform your doctor if you have a history of kidney or liver problems.
• Bone Health: Some HIV medications, including Odefsey, have been associated with bone loss and increased risk of osteoporosis. If you have a history of bone problems or are at risk for osteoporosis, your healthcare provider may consider appropriate measures to monitor and support your bone health.
• Drug Interactions: Odefsey can interact with other medications, including prescription drugs, over-the-counter medications, and herbal supplements. It is important to inform your healthcare provider about all the medications you are taking to avoid potential interactions that could affect Odefsey’s effectiveness or increase the risk of side effects.
• Allergic Reactions: Some individuals may experience allergic reactions to Odefsey, characterized by symptoms such as rash, swelling, or difficulty breathing. If you develop any signs of an allergic reaction, seek immediate medical attention.

It is crucial to discuss your medical history, current medications, and any specific concerns with your healthcare provider before starting Odefsey. They can provide you with personalized advice, precautions, and monitoring based on your individual circumstances and needs.

What special dietary instructions should I follow?

Special dietary instructions for Odefsey include taking the medication with a meal that contains food. This helps with the absorption of the medication and reduces the risk of gastrointestinal side effects. It is recommended to take Odefsey consistently at the same time each day, with a meal. Following a healthy, balanced diet as recommended by your healthcare provider is generally beneficial for overall health and well-being while taking Odefsey.

What should I do if I forget a dose?

If you forget to take a dose of Odefsey, take it as soon as you remember, as long as it is within a few hours of the usual dosing time. If you remember when it is close to the time of your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.

What side effects can this medication cause?

Odefsey, like any medication, can cause side effects in some individuals. Not everyone will experience these side effects, and their severity can vary. It’s important to note that the following list of side effects is not exhaustive, and you may experience different or additional side effects.

Common side effects of Odefsey can include:

• Nausea
• Diarrhea
• Headache
• Fatigue (tiredness)
• Abnormal dreams
• Trouble sleeping (insomnia)
• Dizziness
• Skin rash or itching

These side effects are usually mild and temporary, resolving on their own as your body adjusts to the medication. However, if any of these side effects persist or become bothersome, it is recommended to inform your healthcare provider.

In some cases, Odefsey can cause more serious side effects that require medical attention. These can include:

• Allergic reactions: Signs of an allergic reaction may include rash, swelling, or difficulty breathing. Seek immediate medical attention if you experience any of these symptoms.
• Liver problems: Odefsey can cause liver-related side effects, such as elevated liver enzymes or liver enlargement. Symptoms may include yellowing of the skin or eyes (jaundice), dark urine, abdominal pain, or persistent nausea and vomiting. It is important to notify your healthcare provider if you experience any signs of liver problems.
• Kidney problems: Odefsey can affect kidney function and may lead to kidney problems or kidney failure. Symptoms of kidney problems can include decreased urine production, swelling in the legs or feet, or fatigue. Inform your healthcare provider if you experience any kidney-related symptoms.
• Changes in bone density: Some HIV medications, including Odefsey, have been associated with bone loss and an increased risk of osteoporosis. Long-term use may contribute to a higher risk of fractures. Your healthcare provider may monitor your bone health or recommend measures to support bone density.
• Immune Reconstitution Inflammatory Syndrome (IRIS): In some cases, individuals starting HIV treatment, including Odefsey, may develop an exaggerated immune response to certain infections, resulting in the worsening of symptoms or the appearance of new symptoms. Notify your healthcare provider if you experience any unusual symptoms after starting Odefsey.

It is important to report any side effects or concerns to your healthcare provider. They can provide appropriate guidance, advice, or adjustments to your treatment plan if needed.

What should I know about storage and disposal of this medication?

• Storage: Keep Odefsey in its original bottle at room temperature, away from excessive heat, moisture, and light. Do not store it in the bathroom. Follow any specific storage instructions provided by your healthcare provider or the medication’s packaging.
• Childproofing: Keep Odefsey out of reach of children and pets. The medication should be stored in a secure location to prevent accidental ingestion.
• Disposal: When disposing of Odefsey or any unused/expired medications, it is recommended to follow local regulations and guidelines for proper disposal. You can check with your local pharmacy or healthcare facility for information on medication disposal programs or take-back options in your area.

In case of emergency/overdose

• Contact emergency services: If someone has overdosed or is experiencing severe symptoms, call emergency services or your local poison control center immediately.
• Inform healthcare professionals: When seeking emergency help, make sure to inform the healthcare professionals about the medication involved, including the name (Odefsey) and the dosage if possible.
• Do not induce vomiting: Unless instructed by a healthcare professional, do not try to induce vomiting in the case of overdose.

What other information should I know?

• Adherence: It is crucial to take Odefsey exactly as prescribed by your healthcare provider. Skipping doses or not following the prescribed regimen can reduce the effectiveness of the medication and increase the risk of HIV treatment failure or drug resistance.
• Side effects: Odefsey may cause side effects, although not everyone experiences them. Common side effects include headache, diarrhea, nausea, trouble sleeping, and abnormal dreams. Contact your healthcare provider if you experience any persistent or severe side effects.
• Drug interactions: Odefsey can interact with other medications, including over-the-counter drugs and herbal supplements. Inform your healthcare provider about all the medications and supplements you are taking to avoid potential interactions.
• Pregnancy and breastfeeding: If you are pregnant or planning to become pregnant, or if you are breastfeeding, discuss with your healthcare provider about the potential risks and benefits of taking Odefsey.

Remember, this information is not exhaustive, and it’s important to consult your healthcare provider or pharmacist for specific guidance on storage, disposal, emergencies, and any other concerns related to your particular situation.