How does this medication work? What will it do for me?
This combination product contains 2 medications: ledipasvir and sofosbuvir. Ledipasvir and sofosbuvir both belong to a class of medications known as anti-virals. Ledipasvir - sofosbuvir in combination are used to treat a specific genetic variation of chronic (long-term) hepatitis C virus (HCV) infection.
Ledipasvir and sofosbuvir work in different ways to prevent the hepatitis C virus from reproducing. This quickly reduces the levels of HCV in the body.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each orange, diamond-shaped, film-coated tablet debossed with "GSI" on one side and "7985" on the other side of the tablet contains 90 mg of ledipasvir and 400 mg of sofosbuvir. Nonmedicinal ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose; film coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and FD&C Yellow No. 6/Sunset Yellow FCF Aluminum Lake.
How should I use this medication?
The recommended adult dose of ledipasvir - sofosbuvir is one tablet, taken by mouth, once a day. It may be taken with or without food. You will need to take this medication for 12 or 24 weeks, depending on your personal health history and condition.
If you vomit less than 5 hours after taking the medication, take another dose. If it is more than 5 hours after taking the dose, continue with your regular dosing schedule.
Finish all this medication, even if you have started to feel better.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose and it is more than 6 hours before your next dose, take it as soon as possible and continue with your regular schedule. If it is less than 6 hours until your next dose, 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 are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication in its original package at room temperature. Keep out of reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you are allergic to ledipasvir - sofosbuvir or any ingredients of the medication.
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
December 1, 2016
Health Canada has issued new restrictions concerning the use of Harvoni® (ledipasvir - sofosbuvir). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
A previous advisory on ledipasvir - sofosbuvir with amiodarone in combination with another direct acting antiviral (DAA) was issued on April 2, 2015.
To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if ledipasvir - sofosbuvir passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
What other drugs could interact with this medication?
There may be an interaction between ledipasvir - sofusbuvir and any of the following:
- abiraterone acetate
- antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
- "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
- "gliptin" diabetes medications (e.g., linagliptin, saxagliptin, sitagliptin)
- grapefruit juice
- H2 antagonists (e.g., famotidine, ranitidine)
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- medications to treat cancer (e.g., carboplatin, cyclophosphamide, doxorubicin, ifosfamide, vincristine)
- proton pump inhibitors (e.g., lansoprazole, omeprazole)
- St. John's wort
- "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
- tyrosine kinase inhibitors (e.g., crizotinib, imatinib, nilotinib)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.