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Sofosbuvir And Velpatasvir- Velpatasvir And Sofosbuvir Tablet, Film Coated 400Mg/100Mg

  • Manufacturer Name : ASEGUA THERAPEUTICS LLC
  • MFG # : 72626270101
  • NDC : 72626270101
  • Distributor Name : AmeriSource Bergen
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Additional Information

Product NameSofosbuvir And Velpatasvir - Velpatasvir And Sofosbuvir Tablet, Film Coated 400mg/100mg
ApplicationHCV Antiviral
Generic Drug NameSofosbuvir / Velpatasvir
Mechanism of ActionSofosbuvir inhibits HCV NS5B polymerase; Velpatasvir inhibits NS5A, preventing viral replication
Dosage FormTablet
Strength400 mg - 100 mg
Dosing ScheduleOnce daily
Side EffectsFatigue, headache, nausea, insomnia
Serious RisksLiver problems, allergic reactions, liver failure
Drug InteractionsAntacids, rifampin, St. John's Wort, amiodarone
Pregnancy CategoryCategory C (Use only if clearly needed during pregnancy)
PrecautionsMonitor for liver function, renal function, and blood tests during treatment
Storage RequirementsStore in a cool, dry place; protect from moisture and heat
Container TypeBlister Pack
Quantity28 Tablets
IndicationsChronic Hepatitis C infection, treatment of HCV Genotypes 1-6

Description

Sofosbuvir and Velpatasvir are antiviral medications combined in a single tablet, designed to treat chronic hepatitis C virus (HCV) infection in adults. Sofosbuvir is a nucleotide analogue inhibitor of HCV NS5B polymerase, while Velpatasvir is an NS5A inhibitor. Together, they work synergistically to block two key stages of the HCV replication cycle, thereby reducing the virus's ability to replicate and spread in the body.

The combination tablet is typically administered once daily, with or without food, for a treatment duration based on the patient's specific genotype and medical history. This therapy is used in patients with HCV infection who have not previously been treated or have experienced treatment failure with other regimens.

Common side effects of Sofosbuvir and Velpatasvir include fatigue, headache, nausea, and insomnia. Serious side effects are rare but may include liver problems or serious allergic reactions. Patients should be monitored regularly for any signs of adverse effects during treatment.

Product Properties:

Description -
Description I
DESI Drug Ind -; -
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category I
Drug Category USES: This medication is a combination of sofosbuvir and velpatasvir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It may sometimes be used with another antiviral medication (ribavirin). These drugs work by reducing the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (including the use of latex condoms) to lower the risk of passing the virus to others.
Drug Type Code COMMON BRAND NAME(S): Epclusa
Drug Type Code 1
FDA Approval Date 06/28/2016
FDA Therap Equiv NR
HCPCS -
HCPCS 1
Market Entry Date 01/02/2019
Medical Coverage -
Medical Coverage -
Termination Date (soe-FOS-bue-vir/vel-PAT-as-vir)
Termination Date -
Unit TAB
Units Per Pkg 28
Active Ingredients 15326 sofosbuvir; 16909 velpatasvir
Active Ingredients 15326 sofosbuvir; 16909 velpatasvir
AHFS Class 8184016 HCV POLYMERASE INHIBITOR ANTIVIRALS; 8184024 HCV REPLICATION COMPLEX INHIBITORS
AHFS Class 8184016 HCV POLYMERASE INHIBITOR ANTIVIRALS; 8184024 HCV REPLICATION COMPLEX INHIBITORS
DEA Class NC
DEA Class NC
Dose Form TABLET
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 76305 sofosbuvir/velpatasvir ORAL TABLET 400-100 MG
Gen Code and Des 76305 sofosbuvir/velpatasvir ORAL TABLET 400-100 MG
Inactive Ingredients 2537 povidone 9003398
Inactive Ingredients 2537 povidone 9003398
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 400-100MG
Strength 400-100MG
Common Brand Name COMMON BRAND NAME(S): Epclusa
Common Brand Name -
Drug Interaction -
Drug Interaction DRUG INTERACTIONS: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: amiodarone. This medication can slow down the removal of other medications from your body, which may affect how they work. One example is topotecan, among others. Other medications can affect the removal of sofosbuvir/velpatasvir from your body, which may affect how this medication works. Examples include apalutamide, efavirenz, rifamycins (such as rifampin, rifabutin), St. John's wort, tipranavir/ritonavir, drugs used to treat seizures (such as phenobarbital, carbamazepine, phenytoin, primidone), among others. Do not take this medication with other products that contain sofosbuvir.
Allocation Period -
Allocation Period -
Case Quantity 36
Case Quantity 36
Drug Form Pack Size 28
Drug Form Pack Size 28
Form TABLET
Form TABLET
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 20 Cool-Store Cont Temp
Temp Zone 20 Cool-Store Cont Temp
Unit EA
Unit EA
Unit Size 2X14
Unit Size 2X14
How to Use HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking sofosbuvir/velpatasvir and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. Children's dosage is based on age and weight. The manufacturer recommends that children younger than 6 years old take the pellet form of this medication with food to improve taste of the medication. If you are using the pellet form of this medication, gently shake the packet before use. To take this medication without food, open the packet and pour the pellets directly into your mouth. To prevent a bitter taste, swallow the pellets without chewing. You may drink water after swallowing the pellets if needed. Repeat these steps if your dose is for more than one packet. If you are taking this medication with food, open the packet(s) and pour the pellets into a small bowl with one or more spoonfuls of non-acidic soft food (such as pudding, mashed potato, ice cream). The soft food should be at or below room temperature. After gently mixing, take all of the mixture without chewing within 15 minutes. Chewing or waiting to give the dose may make this medication taste bitter. This medication works best when the amount of drug in your body is kept at a constant level. Take this drug at evenly spaced intervals. To help you remember, take it at the same time each day. Continue to take sofosbuvir/velpatasvir for the full length of time prescribed, even if symptoms disappear after a short time. Stopping the medication too early may result in a return of the infection. Antacids lower the absorption of velpatasvir. If you are taking an antacid, take it at least 4 hours before or 4 hours after this medication. Other acid-lowering medications for indigestion, heartburn, or ulcers (such as prescription or over-the-counter medications including famotidine, omeprazole) may prevent velpatasvir from working. Ask your doctor or pharmacist how to use these medications safely.
How to Use -
Missed Dose 28
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. Lab tests (such as liver function, tests for hepatitis B and C) should be done before you start using this medication, while you are using it, and after completing treatment. Keep all medical and lab appointments. If you are using this medication with ribavirin, it is recommended that female patients or female partners of male patients take a pregnancy test before starting this medication. Pregnancy tests should continue to be done while using this medication and for some time after this medication is stopped to make sure no pregnancy occurs (for 9 months for female patients and for 6 months for female partners of male patients).
Notes TAB
Overdose NR
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation -
Phonetic Pronunciation (soe-FOS-bue-vir/vel-PAT-as-vir)
Precautions -
Precautions PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to sofosbuvir or velpatasvir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: other liver problems (such as hepatitis B), diabetes. If you have diabetes, your blood sugar may be lower with hepatitis C treatment. This can increase your risk of low blood sugar, so your doctor may adjust your diabetes treatment plan. Tell your doctor right away if you have symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children may be more sensitive to the side effects of this drug, especially vomiting. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Sofosbuvir/velpatasvir, in combination with ribavirin, must not be used during pregnancy by either the pregnant woman or her male partner. The combination may harm an unborn baby. Reliable forms of birth control must be used whenever at least one sexual partner is using these medicines together. Female patients should continue using birth control for 9 months after stopping treatment. Male patients should continue using birth control for 6 months after stopping treatment. If you or your partner becomes pregnant, or if you think you or your partner may be pregnant, tell your doctor right away. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Side Effects -
Side Effects SIDE EFFECTS: See also Warning section. Tiredness, headache, nausea, diarrhea, or difficulty sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression), unusual tiredness. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage 06/28/2016
Storage STORAGE: Store at room temperature away from light and moisture in the original container. Keep the pellets in the packets and do not open the packets until ready for use. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: This medication is a combination of sofosbuvir and velpatasvir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It may sometimes be used with another antiviral medication (ribavirin). These drugs work by reducing the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (including the use of latex condoms) to lower the risk of passing the virus to others.
Uses -

Frequently Asked Questions(FAQs)

The cost of Sofosbuvir And Velpatasvir- Velpatasvir And Sofosbuvir Tablet, Film Coated 400Mg/100Mg is available for registerd members only .
Sofosbuvir And Velpatasvir- Velpatasvir And Sofosbuvir Tablet, Film Coated 400Mg/100Mg is manufactured by ASEGUA THERAPEUTICS LLC.
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