WARNING

Glecaprevir and pibrentasvir are direct-acting antiviral medications used in combination to treat chronic hepatitis C virus (HCV) infection. While these drugs are generally effective and well-tolerated, there are some potential risks associated with their use:

• Drug Interactions: Glecaprevir and pibrentasvir can interact with other medications, potentially leading to adverse effects or reduced effectiveness. It’s essential to inform your healthcare provider about all the medications you are taking to avoid harmful interactions.
• Liver Problems: Individuals with severe liver impairment may be at an increased risk of experiencing liver-related adverse effects while taking these medications. Close monitoring is necessary for patients with advanced liver disease.
• Side Effects: Common side effects of glecaprevir and pibrentasvir may include fatigue, headache, nausea, and diarrhea. These side effects are usually mild and temporary but can occasionally be severe.
• Allergic Reactions: Some people may experience allergic reactions to glecaprevir and pibrentasvir, although this is rare. Signs of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing.
• Pregnancy Risks: The safety of glecaprevir and pibrentasvir during pregnancy is not well-established. Pregnant women or those planning to become pregnant should discuss the risks and benefits of these medications with their healthcare provider.
• Resistance: As with any antiviral medication, there is a risk of developing resistance to glecaprevir and pibrentasvir. It’s crucial to follow the prescribed treatment regimen carefully to minimize this risk.
• Other Medical Conditions: Individuals with certain medical conditions, such as kidney disease or HIV infection, may require dose adjustments or additional monitoring while taking glecaprevir and pibrentasvir.

Always consult with a healthcare professional for personalized advice and to discuss any potential risks or concerns before starting treatment with glecaprevir and pibrentasvir.

Why is this medication prescribed?

Glecaprevir and pibrentasvir are prescribed together as a combination therapy for the treatment of chronic hepatitis C virus (HCV) infection in adults. This combination medication is specifically indicated for patients with HCV genotypes 1 through 6, including those with compensated cirrhosis, and for patients with specific genotypes and subtypes who have previously failed treatment with other HCV medications.

How should this medicine be used?

The recommended dosage of glecaprevir and pibrentasvir is typically one tablet taken orally once daily with food. The duration of treatment may vary depending on factors such as the patient’s HCV genotype, prior treatment history, and the presence of liver cirrhosis. It’s essential to follow the dosage and administration instructions provided by your healthcare provider.

Here are some key points regarding the use of glecaprevir and pibrentasvir:

• Dosage: The standard dosage is typically one tablet containing glecaprevir (100 mg) and pibrentasvir (40 mg), taken orally once daily with food.
• Administration: The tablets should be swallowed whole with water. They can be taken with or without food, but it’s recommended to take them with food to improve absorption and reduce the risk of gastrointestinal side effects.
• Duration of Treatment: The duration of treatment with glecaprevir and pibrentasvir can vary depending on factors such as the patient’s HCV genotype, treatment history, and the presence of liver cirrhosis. Treatment duration typically ranges from 8 to 16 weeks.
• Adherence: It’s crucial to take glecaprevir and pibrentasvir exactly as prescribed by your healthcare provider. Skipping doses or not completing the full course of treatment may reduce the effectiveness of the medication and increase the risk of treatment failure or developing drug-resistant strains of HCV.
• Monitoring: Patients undergoing treatment with glecaprevir and pibrentasvir may require regular monitoring of liver function tests and HCV viral load to assess treatment response and detect any potential adverse effects.

Always consult with your healthcare provider for personalized dosing instructions and recommendations regarding the use of glecaprevir and pibrentasvir for the treatment of hepatitis C infection.

Other uses for this medicine

Glecaprevir and pibrentasvir are specifically approved for the treatment of chronic hepatitis C virus (HCV) infection and are not indicated for other medical conditions. These medications work by targeting specific proteins involved in the replication of the hepatitis C virus, helping to eliminate the virus from the body.

What special precautions should I follow?

Special precautions should be observed when using glecaprevir and pibrentasvir. Here are some key points to consider:

• Medical History: Before starting treatment with glecaprevir and pibrentasvir, inform your healthcare provider about your complete medical history, including any pre-existing medical conditions, allergies, or medications you are currently taking. This information will help your healthcare provider assess the safety and suitability of glecaprevir and pibrentasvir for you.
• Pregnancy and Breastfeeding: Glecaprevir and pibrentasvir may cause harm to a developing fetus. Therefore, it is essential to avoid pregnancy during treatment and for a period after treatment completion. If you are pregnant or planning to become pregnant, discuss the risks and benefits of glecaprevir and pibrentasvir with your healthcare provider. It is also not known whether glecaprevir and pibrentasvir pass into breast milk, so breastfeeding is not recommended during treatment.
• Liver Function: Patients with severe liver impairment should use glecaprevir and pibrentasvir with caution, as the safety and effectiveness of these medications in this population have not been well-established. Close monitoring of liver function may be necessary during treatment.
• Drug Interactions: Glecaprevir and pibrentasvir can interact with other medications, potentially affecting their effectiveness or increasing the risk of side effects. Before starting treatment, inform your healthcare provider about all the medications, supplements, and herbal products you are taking to avoid potential drug interactions.
• Adherence: It is crucial to take glecaprevir and pibrentasvir exactly as prescribed by your healthcare provider. Skipping doses or not completing the full course of treatment may reduce the effectiveness of the medication and increase the risk of treatment failure or developing drug-resistant strains of HCV.
• Monitoring: During treatment with glecaprevir and pibrentasvir, your healthcare provider may periodically monitor your liver function, HCV viral load, and other relevant parameters to assess treatment response and detect any potential adverse effects.

Always follow your healthcare provider’s instructions and recommendations regarding the use of glecaprevir and pibrentasvir, and do not hesitate to discuss any concerns or questions you may have about your treatment.

What special dietary instructions should I follow?

• Food Intake: Glecaprevir and pibrentasvir can be taken with or without food. However, taking them with food may improve absorption and reduce the risk of gastrointestinal side effects. Follow your healthcare provider’s instructions regarding food intake while taking these medications.

What should I do if I forget a dose?

• Missed Dose: If you forget to take a dose of glecaprevir and pibrentasvir, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and take your next dose at the regular time.
• Do Not Double Dose: Do not take a double dose to make up for a missed dose. Taking extra medication can increase the risk of side effects without providing additional benefit.
• Notify Your Healthcare Provider: If you frequently forget doses or have difficulty adhering to your treatment schedule, inform your healthcare provider. They can provide guidance and support to help you stay on track with your medication regimen.

What side effects can this medication cause?

Glecaprevir and pibrentasvir, like all medications, can potentially cause side effects. While many people may not experience any side effects or may only experience mild ones, it’s essential to be aware of possible adverse reactions. Common side effects associated with glecaprevir and pibrentasvir may include:

• Fatigue: Feeling tired or lacking energy is a common side effect reported by some individuals taking glecaprevir and pibrentasvir.
• Headache: Headaches are another common side effect that may occur during treatment with glecaprevir and pibrentasvir.
• Nausea: Some people may experience feelings of nausea, which may be mild or moderate in intensity.
• Diarrhea: Diarrhea is another gastrointestinal side effect that may occur while taking glecaprevir and pibrentasvir.
• Itching: Itching or mild skin irritation may occur in some individuals as a side effect of glecaprevir and pibrentasvir.
• Insomnia: Difficulty sleeping or changes in sleep patterns may occur as a side effect of glecaprevir and pibrentasvir treatment.
• Abdominal Pain: Some individuals may experience abdominal discomfort or pain as a side effect of glecaprevir and pibrentasvir.
• Decreased Appetite: A decrease in appetite leading to reduced food intake may occur in some people taking glecaprevir and pibrentasvir.
• Muscle Weakness: Weakness or fatigue in the muscles may occur as a side effect of glecaprevir and pibrentasvir treatment.
• Irritability: Some individuals may experience mood changes, including irritability or mood swings, while taking glecaprevir and pibrentasvir.

It’s important to note that not everyone will experience these side effects, and some individuals may experience side effects not listed here. Additionally, some side effects may be severe or persistent, requiring medical attention. If you experience any unusual or concerning symptoms while taking glecaprevir and pibrentasvir, contact your healthcare provider promptly. They can provide guidance and support to help manage any side effects you may experience during treatment.

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

Storage:

• Room Temperature: Store glecaprevir and pibrentasvir at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Container Closed: Keep the medication in its original container with the lid tightly closed to protect it from moisture and light.
• Out of Reach of Children: Store glecaprevir and pibrentasvir out of reach of children and pets to prevent accidental ingestion.
• Avoid Extreme Conditions: Avoid storing the medication in extreme temperatures, such as in the freezer or in direct sunlight.

Disposal:

• Unused Medication: Dispose of any unused glecaprevir and pibrentasvir properly according to local regulations or guidelines. Do not keep unused medication beyond the prescribed treatment duration.
• Guidelines: Follow any specific disposal guidelines provided by your healthcare provider or pharmacist. You can also inquire about local medication disposal programs or take-back initiatives.

In case of emergency/overdose

• Seek Medical Attention: In case of an emergency or suspected overdose of glecaprevir and pibrentasvir, seek immediate medical attention or contact your local poison control center.
• Symptoms: Overdose symptoms may include severe nausea, vomiting, abdominal pain, or other unusual symptoms. Be prepared to provide information about the amount of medication ingested and any symptoms experienced.

What other information should I know?

• Follow-up Appointments: Attend all follow-up appointments with your healthcare provider as scheduled to monitor your response to treatment and assess for any potential side effects or complications.
• Lab Tests: Your healthcare provider may order regular lab tests, including liver function tests and HCV viral load tests, during treatment with glecaprevir and pibrentasvir to monitor your progress and response to treatment.
• Avoid Alcohol and Certain Substances: Avoid consuming alcohol or taking certain substances that may interact with glecaprevir and pibrentasvir. Follow your healthcare provider’s instructions regarding dietary restrictions and lifestyle modifications during treatment.
• Inform Healthcare Providers: Inform all healthcare providers involved in your care, including dentists and specialists, about your use of glecaprevir and pibrentasvir to prevent potential drug interactions or complications.
• Patient Education: Stay informed about your condition and treatment by asking questions and seeking reliable information from reputable sources. Understanding your treatment plan and following it as prescribed can help improve treatment outcomes.

Always follow your healthcare provider’s instructions and recommendations regarding the use, storage, disposal, and handling of glecaprevir and pibrentasvir. If you have any questions or concerns about your medication, don’t hesitate to discuss them with your healthcare provider or pharmacist.