Harvoni

$60.00
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SKU
Harvoni

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Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Harvoni

Descriptions

 

Ledipasvir and sofosbuvir combination is used with or without ribavirin to treat chronic hepatitis C infection in adults and children 12 years of age and older (including liver transplant patients, with or without cirrhosis).

 

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

Drug information provided by: IBM Micromedex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

 

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ledipasvir and sofosbuvir combination in children younger than 12 years of age and weighing less than 35 kg. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ledipasvir and sofosbuvir combination in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Rifampin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aluminum Carbonate, Basic
  • Aluminum Hydroxide
  • Aluminum Phosphate
  • Amiodarone
  • Calcium Carbonate
  • Carbamazepine
  • Cimetidine
  • Dexlansoprazole
  • Digoxin
  • Dihydroxyaluminum Aminoacetate
  • Dihydroxyaluminum Sodium Carbonate
  • Esomeprazole
  • Famotidine
  • Fosphenytoin
  • Lansoprazole
  • Magaldrate
  • Magnesium Carbonate
  • Magnesium Hydroxide
  • Magnesium Oxide
  • Magnesium Trisilicate
  • Nizatidine
  • Omeprazole
  • Oxcarbazepine
  • Pantoprazole
  • Phenobarbital
  • Phenytoin
  • Rabeprazole
  • Ranitidine
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Rosuvastatin
  • Simeprevir
  • Sodium Bicarbonate
  • St John's Wort
  • Tenofovir Disoproxil Fumarate
  • Tipranavir
  • Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Hepatitis B, history of—Use with caution. May cause this condition to become active again.
  • Liver problems or
  • Liver transplant, history of—Use with caution. May make these conditions worse.

Proper Use

Drug information provided by: IBM Micromedex

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

 

This medicine should come with a patient information leaflet. Read and follow the information carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

To help clear up your infection completely, ledipasvir and sofosbuvir combination must be taken for the full time of treatment, even if you begin to feel better after a few days. Also, it is important to keep the amount of medicine in your body at a steady level. To help keep the amount constant, this medicine must be used on a regular schedule.

If you are taking an antacid containing aluminum or magnesium hydroxide, take it 4 hours before or after taking ledipasvir and sofosbuvir combination.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For hepatitis C virus infection:
      • Adults—1 tablet once a day, taken for 12 or 24 weeks. Each tablet contains ledipasvir 90 milligrams (mg) and sofosbuvir 400 mg.
      • Children 12 years of age and older or weighing at least 35 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is usually 1 tablet once a day, taken for 12 weeks.
      • Children younger than 12 years of age or weighing less than 35 kg—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Do not take more than 1 tablet per day.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep the medicine in the original bottle that you were given at the pharmacy.

Precautions

Drug information provided by: IBM Micromedex

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

 

Do not take this medicine together with other products containing sofosbuvir (eg, Sovaldi®).

Using this medicine together with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using these medicines, tell your doctor right away.

Amiodarone can cause serious side effects (such as cardiac arrest, slow heartbeat, conditions that need pacemaker) if used together with Harvoni® and another antiviral drug, or if you have used it recently. This is more likely to occur in patients with heart disease or advanced liver disease. Tell your doctor if you are taking amiodarone before using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects

Drug information provided by: IBM Micromedex

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

 

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

  1. Chest pain or discomfort
  2. lightheadedness, dizziness, or fainting
  3. slow or irregular heartbeat
  4. trouble breathing
  5. unusual tiredness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Cough
  2. diarrhea
  3. headache
  4. irritability
  5. lack or loss of strength
  6. muscle pain
  7. nausea
  8. trouble sleeping

Less common

  1. Discouragement
  2. dizziness
  3. feeling sad or empty
  4. lack of appetite
  5. loss of interest or pleasure
  6. trouble concentrating

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Harvoni

Harvoni treats chronic hepatitis C infection. Harvoni is officially the first interferon-free and ribavirin-free hepatitis C treatment.

 
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Antivirals

Harvoni Overview

Harvoni is a prescription medication used to treat chronic hepatitis C virus (HCV) genotype 1, 4, 5 or 6 infection. Harvoni is also used to treat people simultaneously infected with HCV and HIV. Harvoni may also be used with the medication ribavirin to treat people with HCV and cirrhosis.

It comes as a single tablet that contains 2 medications: ledipasvir and sofosbuvir. Harvoni belongs to a group of drugs called antiviral medications. It works by targeting certain proteins in the Hep C virus to keep it from reproducing in the body.

This medication comes in tablet form and is taken once daily.

Common side effects of Harvoni include tiredness, headache, and weakness.

 
 

Patient Ratings for

 

Harvoni Cautionary Labels

precautionsprecautionsprecautions
 

Uses of Harvoni

Harvoni is a prescription medication used to treat the following:

  • Chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection
  • Chronic HCV/HIV co-infections

Harvoni is given with ribavirin to treat: 

  • HCV genotype 1 infection with advanced cirrhosis, or
  • HCV genotype 1 or 4 infection with or without cirrhosis who have had a liver transplant

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

 
 

Manufacturer

 

Generic

 

Harvoni Drug Class

Harvoni is part of the drug class:

 

Side Effects of Harvoni

Common side effects of Harvoni include the following:

  • fatigue (tiredness)
  • headache
  • weakness

This is not a complete list of Harvoni side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

 
 

Harvoni Interactions

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Harvoni may affect the way other medicines work, and other medicines may affect how Harvoni works.

You should not take Harvoni if you also take other medicines that contain sofosbuvir (Sovaldi).

Especially tell your healthcare provider if you take any of the following medicines: 

  • amiodarone (Cordarone)
  • an antacid that contains aluminum or magnesium hydroxide. If you take an antacid during treatment with Harvoni, take the antacid 4 hours before or 4 hours after you take Harvoni. 
  • carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
  • digoxin (Lanoxin)
  • efavirenzemtricitabinetenofovir disoproxil fumarate (Atripla)
  • elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate (Stribild)
  • medicines for indigestion, heartburn, or stomach ulcers, such as nizatidine (Axid), famotidine (Pepcid AC), cimetidine (Tagamet), ranitidine (Zantac), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), rabeprazole (Aciphex), or pantoprazole (Protonix)
  • oxcarbazepine (Trileptal, Oxtellar XR)
  • phenytoin (Dilantin, Phenytek)
  • phenobarbital (Luminal)
  • rifabutin (Mycobutin)
  • rifampin (Rifadin, Rifamate, Rifater, Rimactane)
  • rifapentine (Priftin)
  • rosuvastatin (Crestor) and atorvastatin (Monitor for statin-related adverse reactions such as myopathy (issues with the muscles that can lead to muscle weakness) and rhabdomyolysis (a rare but serious side effect in which the muscle tissue breaks down)
  • simeprevir (Olysio)
  • St. John’s wort (Hypericum perforatum) or a product that contains St. John’s wort
  • tipranavir (Aptivus) used in combination with ritonavir (Norvir)
  • tenofovir disoproxil fumarate (VireadTruvada) used in combination with atazanavir (Reyataz) and ritonavir (Norvir), darunavir (Prezista) and ritonavir (Norvir), or used in combination with lopinavir and ritonavir (Kaletra
  • warfarin (International normalized ratio (INR) values may rise and fall irregularly in those taking warfarin. As a result, frequent monitoring of INR values is recommended in patients taking warfarin)

This is not a complete list of Harvoni drug interactions. Ask your doctor or pharmacist for more information.

 

Harvoni Precautions

Contact your healthcare provider immediately if you develop weakness, fatigue, nausea, vomiting, yellow eyes or skin, loss of appetite, or light-colored stools. These may be signs and symptoms of a serious liver problem. 

Do not take Harvoni if you:

  • are allergic to Harvoni or to any of its ingredients
  • are taking medications containing sofosbuvir, including Solvadi
 

Harvoni Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Harvoni, there are no specific foods that you must exclude from your diet when receiving this medication.

 

Inform MD

Before taking Harvoni, tell your healthcare provider if you:

  • have liver problems other than hepatitis C infection
  • if you have a history of hepatitis B infection
  • have severe kidney problems or you are on dialysis
  • have any other medical condition
  • are pregnant or plan to become pregnant. It is not known if Harvoni will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Harvoni passes into your breast milk.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Harvoni may affect the way other medicines work, and other medicines may affect how Harvoni works.

 

Harvoni and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Harvoni falls into category B. There are no well-done studies that have been done in humans with this medication. In animal studies, pregnant animals were given Harvoni, and the babies did not show any medical issues related to this medication.

 

Harvoni and Lactation

It is not known if Harvoni crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Harvoni.

 

Harvoni Usage

Take Harvoni exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to.

  • Do not stop taking Harvoni without first talking with your healthcare provider. If you think there is a reason to stop taking it, talk to your healthcare provider before doing so.
  • Take Harvoni once daily, with or without food.
  • If you miss a dose, take the missed dose as soon as you remember the same day. Do not take more than 1 tablet of Harvoni in a day. Take your next dose at your regular time the next day.
 
 

Harvoni Dosage

Harvoni is a two-drug fixed-dose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet.

The recommended dosage of Harvoni is one tablet taken orally once daily with or without food.

 

Harvoni Overdose

If you take too much Harvoni call your local poison control center or seek medical attention right away.

 

Other Requirements

  • Store this medication at room temperature below 86°F (30°C).
  • Keep it in its original container.
  • Do not use the medication within if the seal over the bottle opening is broken or missing.

 

 

Harvoni FDA Warning

There is a risk of hepatitis B virus (HBV) becoming an active infection in those who have a current or previous infection with HBV and is treated with a certain antiviral medication (a direct-acting antiviral) to treat hepatitis C virus. Your healthcare provider will screen and monitor for HBV in those taking a direct-acting antiviral. Tell your healthcare provider if you have a history of hepatitis B infection or other liver problems before you are treated for hepatitis C. 

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