WARNING

Epclusa is a medication used to treat chronic hepatitis C virus (HCV) infection in adults. While it can be effective in treating the infection, like any medication, it carries certain risks and side effects. Here are some of the potential risks associated with taking Epclusa:

• Allergic reactions: Some individuals may experience allergic reactions to the components of Epclusa, which can manifest as rash, itching, swelling, dizziness, or difficulty breathing.
• Liver problems: Epclusa can sometimes cause worsening of liver problems, especially in individuals with advanced liver disease. Monitoring liver function during treatment is essential.
• Drug interactions: Epclusa can interact with other medications, potentially leading to adverse effects or reducing the effectiveness of either medication. It’s important to inform your healthcare provider about all medications you are taking before starting Epclusa.
• Side effects: Common side effects of Epclusa may include headache, fatigue, nausea, diarrhea, and trouble sleeping. These side effects are usually mild and temporary but can occasionally be severe.
• Risk of reactivation of hepatitis B: For individuals with a current or previous hepatitis B virus (HBV) infection, there’s a risk of HBV reactivation during or after treatment with Epclusa. Close monitoring is required in such cases.
• Pregnancy and breastfeeding: The safety of Epclusa during pregnancy and breastfeeding hasn’t been established. Women who are pregnant or breastfeeding should discuss the risks and benefits with their healthcare provider before starting treatment.
• Other considerations: Epclusa may also have other less common side effects or risks. It’s important to discuss any concerns or questions with your healthcare provider before starting treatment.

Overall, while Epclusa can be an effective treatment for hepatitis C, it’s essential to be aware of the potential risks and to closely follow your healthcare provider’s recommendations for monitoring and managing them during treatment.

Why is this medication prescribed?

Epclusa is prescribed for the treatment of chronic hepatitis C virus (HCV) infection in adults. It is a combination medication containing two active ingredients: sofosbuvir and velpatasvir. Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor, while velpatasvir is an NS5A inhibitor. Together, these drugs work by interfering with the replication of the hepatitis C virus, ultimately helping to clear the infection from the body.

Epclusa is typically prescribed for individuals with chronic hepatitis C infection, regardless of the genotype (strain) of the virus. It is approved for use in patients with or without compensated cirrhosis (scarring of the liver) and for those with decompensated cirrhosis when used in combination with other medications.

How should this medicine be used?

Epclusa is a medication used to treat chronic hepatitis C virus (HCV) infection in adults. Here’s how it should be used:

• Dosage: The standard dosage of Epclusa is one tablet taken orally once daily. The tablet contains a combination of two active ingredients: sofosbuvir (400 mg) and velpatasvir (100 mg).
• Administration: Epclusa tablets should be swallowed whole with water. They can be taken with or without food. It’s essential to take the medication at the same time each day to maintain consistent blood levels.
• Duration of Treatment: The duration of treatment with Epclusa may vary depending on factors such as the severity of the infection, the genotype of the hepatitis C virus, and the patient’s overall health condition. Your healthcare provider will determine the appropriate duration of treatment for you.
• Adherence: It’s crucial to adhere to the prescribed dosage and treatment schedule. Missing doses or stopping treatment prematurely can reduce the effectiveness of the medication and increase the risk of the virus becoming resistant to treatment.
• Other Medications: Before starting treatment with Epclusa, inform your healthcare provider about all other medications you are taking, including prescription drugs, over-the-counter medications, herbal supplements, and vitamins. Some medications can interact with Epclusa, potentially affecting its effectiveness or increasing the risk of side effects.
• Monitoring: During treatment with Epclusa, your healthcare provider will monitor your progress regularly. This may include blood tests to assess liver function, measure viral load, and check for any potential side effects or complications. Follow-up appointments with your healthcare provider are essential to ensure the effectiveness and safety of treatment.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of Epclusa treatment with your healthcare provider. The safety of Epclusa during pregnancy and breastfeeding has not been established.

Always follow your healthcare provider’s instructions and guidance regarding the use of Epclusa. If you have any questions or concerns about your treatment, don’t hesitate to discuss them with your healthcare provider.

Other uses for this medicine

Off-label uses of Epclusa may include:

• Treatment of hepatitis C in pediatric patients (under the age of 18) in certain cases.
• Treatment of hepatitis C in patients with HIV co-infection.
• Treatment of hepatitis C in patients with renal impairment.

What special precautions should I follow?

As for special precautions to follow when using Epclusa:

• Medical History: Before starting treatment with Epclusa, inform your healthcare provider about your complete medical history, including any existing liver or kidney problems, other medical conditions, and any medications you are currently taking.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of Epclusa treatment with your healthcare provider. The safety of Epclusa during pregnancy and breastfeeding has not been established.
• Liver Function Monitoring: During treatment with Epclusa, your healthcare provider will likely monitor your liver function regularly through blood tests. This is particularly important for individuals with existing liver disease.
• Drug Interactions: Epclusa can interact with certain medications, potentially affecting their effectiveness or increasing the risk of side effects. Inform your healthcare provider about all medications you are taking, including prescription drugs, over-the-counter medications, herbal supplements, and vitamins.
• Adherence: It’s crucial to adhere to the prescribed dosage and treatment schedule. Missing doses or stopping treatment prematurely can reduce the effectiveness of the medication and increase the risk of the virus becoming resistant to treatment.
• Side Effects: Be aware of potential side effects of Epclusa, and promptly report any unusual symptoms or adverse reactions to your healthcare provider.

Always follow your healthcare provider’s instructions and guidance regarding the use of Epclusa and any precautions specific to your individual circumstances. If you have any questions or concerns, don’t hesitate to discuss them with your healthcare provider.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with taking Epclusa. However, maintaining a healthy and balanced diet can support overall health and liver function. If you have any dietary concerns or restrictions, discuss them with your healthcare provider or a registered dietitian.

What should I do if I forget a dose?

If you forget to take a dose of Epclusa, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you have questions about missed doses or need further guidance, consult your healthcare provider or pharmacist. It’s essential to maintain consistency in taking Epclusa to ensure its effectiveness in treating hepatitis C.

What side effects can this medication cause?

Epclusa, like any medication, can cause side effects in some individuals. However, not everyone will experience these side effects, and their severity can vary. Common side effects of Epclusa may include:

• Headache: Mild to moderate headaches are a common side effect reported by some individuals taking Epclusa.
• Fatigue: Feeling tired or fatigued is another common side effect that may occur during Epclusa treatment.
• Nausea: Some people may experience nausea or an upset stomach while taking Epclusa.
• Insomnia: Difficulty sleeping or changes in sleep patterns can occur in some individuals.
• Diarrhea: Epclusa treatment may lead to diarrhea in some patients.
• Decreased Appetite: Some individuals may experience a decreased appetite while taking Epclusa.
• Skin Reactions: Skin rash or itching may occur as a side effect of Epclusa treatment.
• Dizziness: Feeling lightheaded or dizzy is another potential side effect, although it is less common.
• Muscle Weakness: Some individuals may experience muscle weakness or discomfort while taking Epclusa.
• Irritability: Changes in mood, including irritability or mood swings, can occur in some patients.

It’s important to note that the above side effects are generally mild to moderate and often improve as the body adjusts to the medication. However, if you experience severe or persistent side effects, or if you develop any new symptoms while taking Epclusa, it’s essential to inform your healthcare provider promptly. They can provide guidance on managing side effects and may adjust your treatment if necessary.

In addition to the common side effects listed above, Epclusa may also rarely cause more serious side effects, such as liver problems or allergic reactions. If you experience symptoms such as yellowing of the skin or eyes (jaundice), dark urine, persistent fatigue, or signs of an allergic reaction (such as rash, itching, swelling, or difficulty breathing), seek medical attention immediately.

As always, it’s essential to discuss any concerns or questions about potential side effects with your healthcare provider before starting treatment with Epclusa. They can provide personalized guidance based on your medical history and individual risk factors.

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

Storage and Disposal:

Storage:

• Store Epclusa tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the medication in its original packaging or container to protect it from light and moisture.
• Store Epclusa out of reach of children and pets.
• Do not use Epclusa if it has passed the expiration date printed on the packaging.

Disposal:

• Dispose of unused or expired Epclusa tablets properly.
• Do not flush Epclusa down the toilet or pour it down the drain unless instructed to do so by a healthcare professional or local waste disposal authority.
• Consult your healthcare provider or pharmacist for instructions on how to safely dispose of Epclusa.

In case of emergency/overdose

• In case of an overdose or emergency situation related to Epclusa, seek immediate medical attention or call your local poison control center at 1-800-222-1222 (USA).
• Provide healthcare professionals with information about the medication taken, dosage, and any symptoms experienced.
• If possible, bring the Epclusa packaging or container to the healthcare facility for reference.

What other information should I know?

• Keep all appointments with your healthcare provider for monitoring and follow-up during Epclusa treatment.
• Inform your healthcare provider about all medications you are taking, including prescription drugs, over-the-counter medications, herbal supplements, and vitamins, to avoid potential drug interactions.
• Follow your healthcare provider’s instructions and guidance regarding the use of Epclusa, including dosage, administration, and duration of treatment.
• Report any new or worsening symptoms to your healthcare provider promptly.
• Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding, as the safety of Epclusa during pregnancy and breastfeeding has not been established.
• Be aware of potential side effects of Epclusa and know when to seek medical attention if they occur.
• Do not share Epclusa with others, even if they have similar symptoms or medical conditions.
• Store Epclusa in a secure location away from heat, moisture, and direct light.

Following these guidelines can help ensure the safe and effective use of Epclusa and minimize the risk of adverse events or complications. If you have any questions or concerns about Epclusa, don’t hesitate to discuss them with your healthcare provider or pharmacist.