Ledipasvir and Sofosbuvir

Uses

The combination of ledipasvir and sofosbuvir is used alone or in combination with ribavirin (Copegus, Rebetol, Ribasphere, others) to treat certain types of chronic hepatitis C (an ongoing viral infection that damages the liver) in adults and children 3 years of age and older. Sofosbuvir is in a class of antiviral medications called nucleotide polymerase inhibitors. It works by decreasing the amount of hepatitis C virus (HCV) in the body.

Ledipasvir is in a class of antiviral medications called HCV NS5A inhibitors. It works by stopping the virus that causes hepatitis C from spreading inside the body.

Side Effects Of Ledipasvir and Sofosbuvir

Ledipasvir and sofosbuvir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • tiredness
  • headache
  • difficulty falling asleep or staying asleep
  • nausea
  • diarrhea
  • cough
  • dizziness
  • muscle pain
  • irritability

Some side effects can be serious. If you experience any of these symptoms or those listed in the WARNING section, call your doctor immediately or get emergency treatment:

  • rash
  • blisters
  • swelling of the face, arms, or legs
  • shortness of breath
  • hoarseness
  • difficulty swallowing or breathing

Ledipasvir and sofosbuvir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Warnings & Precautions

Before taking ledipasvir and sofosbuvir:

  • tell your doctor and pharmacist if you are allergic to ledipasvir or sofosbuvir, any other medications, or any of the ingredients in ledipasvir and sofosbuvir tablets or pellets. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amiodarone (Nexterone, Pacerone); digoxin (Lanoxin); certain medications for cancer; medications for diabetes; certain medications for seizures such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Oxtellar XR, Trileptal), phenobarbital, or phenytoin (Dilantin, Phenytek); medications for heartburn and ulcers; medications for HIV taken together such as efavirenz (Sustiva, in Atripla), emtricitabine (Emtriva, in Atripla) and tenofovir (Viread, in Atripla); elvitegravir (Sustiva, in Atripla), cobicistat (Tybost, in Stribild), emtricitabine (Emtriva, in Stribild), and tenofovir (Viread, in Stribild); tenofovir (Viread), atazanavir (Reyataz) and ritonavir (Norvir); tenofovir (Viread), darunavir (Prezista) and ritonavir (Norvir); tenofovir (Viread), lopinavir (in Kaletra), and ritonavir (Norvir, in Kaletra); or tipranavir (Aptivus) and ritonavir (Norvir); certain medications that suppress the immune system; rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); rifapentine (Priftin); rosuvastatin (Crestor); simeprevir (Olysio); sofosbuvir (Sovaldi); and warfarin (Coumadin, Jantoven). Your doctor may tell you not to take ledipasvir and sofosbuvir if you are taking one or more of these medications or may monitor you carefully for side effects. Many other medications may also interact with ledipasvir and sofosbuvir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • if you are taking antacids containing aluminum hydroxide or magnesium hydroxide (Maalox, Mylanta, Tums, others), take them 4 hours before or 4 hours after taking ledipasvir and sofosbuvir.
  • tell your doctor if you are taking a medication for indigestion, heartburn, or ulcers (H2 blockers) such as cimetidine, ranitidine (Zantac), famotidine (Pepcid, in Duexis) or nizatidine. Your doctor may tell you to take them 12 hours before or 12 hours after ledipasvir and sofosbuvir, or at the same time that you take ledipasvir and sofosbuvir.
  • tell your doctor what herbal products you are taking, especially St. John’s wort. You should not take St. John’s wort during your treatment with ledipasvir and sofosbuvir.
  • tell your doctor if you have had a liver transplant or if you have human immunodeficiency virus (HIV). Also, tell your doctor if you have or have ever had any type of liver disease other than hepatitis C, kidney disease, or are on dialysis.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ledipasvir and sofosbuvir, call your doctor. If ledipasvir and sofosbuvir are used in combination with ribavirin, be sure to read information about pregnancy precautions in the ribavirin monograph.

Ledipasvir and Sofosbuvir Dosage

The combination of ledipasvir and sofosbuvir comes as a tablet and pellets to take by mouth. It is usually taken with or without food once daily. Take ledipasvir and sofosbuvir at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ledipasvir and sofosbuvir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Ledipasvir and sofosbuvir pellets can be swallowed (without chewing) or they can be taken with food. To prepare a dose of ledipasvir and sofosbuvir pellets with food, sprinkle the entire packet of pellets on one or more spoonfuls of cold or room temperature non-acidic soft food such as pudding, chocolate syrup, mashed potato, or ice cream. Take the entire mixture within 30 minutes of sprinkling the pellets on food. To avoid a bitter aftertaste, do not chew the pellets.

Continue to take ledipasvir and sofosbuvir even if you feel well. The length of your treatment (8 to 24 weeks) depends on your condition, how well you respond to the medication, and whether you experience severe side effects. Do not stop taking ledipasvir and sofosbuvir without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

Other

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Source

All information has been provided courtesy of MedLinePlus from the National Library of Medicine and from the FDA.