Ledipasvir and Sofosbuvir (Oral)

Overview

Ledipasvir and sofosbuvir is a drug combination that is used in the treatment of chronic hepatitis C infection. It can be used with or without ribavirin. It is used to treat adults (including liver transplant patients, who may or may not suffer from cirrhosis). You cannot obtain this medication on your own. It is only available via a prescription from your doctor. This product is available in the dosage form of a tablet for oral consumption.

Conditions treated

  • Chronic Infection of Genotype 6 Hepatitis C Virus

Type of medication

  • Oral tablet

Side effects

Alongside treating chronic hepatitis C, this drug can also produce some unwanted side effects. Not all of these side effects may be present, but if any do occur, you may need to seek medical attention.

You should contact your doctor for advice if you suffer from any of the following side effects whilst taking this drug combination.

Incidence not known

  • Unusual tiredness

Some of the side effects that may occur with this drug combination don't typically require medical attention. Usually, these side effects begin to diaper once your body begins to adjust to the new treatment. However, if you finding these side effects bothersome, your pharmacist or doctor may be able to suggest some ways to reduce or prevent them. You should seek advice from a healthcare professional if any of the following side effects linger or become bothersome.

More common

  • Muscle pain

Less common

  • Lack of appetite

You may suffer from other side effects that are not listed above. You should seek the advice of a healthcare professional or your doctor if you notice anything strange or unusual. If you wish, you can report all your side effects to the FDA on 1-800-FDA-1088.

Dosage

Your final dose of this medication will depend upon personal factors and specifics of the medication in question. Your doctor will consider things such as your weight, age and height, any other medical conditions you may suffer from and any other medicines you are taking to treat those conditions. They will also take into account the strength of the medication given, the frequency in which you are to use it and your reaction to the first dose. It's important that you do not change your dose without speaking with your doctor first. If you take too much of this medication you could increase your risk of severe side effects, or if you take too little, you could decrease its treatment.

For oral dosage form (tablets) for the treatment of hepatitis C virus.

Adults:

1 tablet once daily, taken for twelve to twenty-four weeks. Each tablet contains 400 mg of sofosbuvir and 90 mg of ledipasvir.

Children:

The final use and dose will be determined by a doctor.

Missed Dose

If you miss a dose of Ledipasvir and Sofosbuvir, you should take it as soon as possible. Although, if it's almost time for your next scheduled dose, you should skip the dose you have missed and return to your original dosing schedule. Don't double your doses to make up for a missed dose.

Don't take more than one tablet daily.

Proper Use

This medication will come with a patient information leaflet. It's important you read this carefully and if you have any concerns or questions, ask your doctor for more information or clarification.

You can take this medication with or without the consumption of food.

To help completely clear up your infection, ledipasvir and sofosbuvir combination needs to be taken for the full amount of time you have been prescribed, even if you are beginning to feel a little better after a couple of days. It's also important to keep the amount of medication in your body at a consistent level. To help ensure the amount is constant, this medication should be used on a regular schedule.

If you are taking an antacid containing magnesium hydroxide or aluminum, you should take it four hours before or after taking this drug combination.

Interactions

This drug can interact with a number of other medications. These interactions can produce unwanted side effects and reduce the effectiveness of the drug in treatment. To help limit these interactions from occurring it's important that you give your doctor a full list of any medications you are currently taking. This should include all prescription and nonprescription drugs, all vitamins, and herbal products. It's also good to make your doctor aware of any other health conditions you may suffer from as these too can increase your risk of interactions occurring. In most cases, your doctor will avoid treating you with this drug if it increases your risk of an interaction, but in some cases, treatment may still be necessary.

The use of this medication alongside any of the following medications is not typically recommended. However, in some cases, it may be required. If you are given both medications at the same time, your doctor may change the dose or frequency in which you use wither medication.

  • Mitotane

You should let your doctor know if you are taking any of the following drugs:

  • Sodium bicarbonate

Other Medical Conditions

The presence of other medical conditions can increase your risk of interactions and reduce the effect of this drug in treatment. You should make your doctor aware of any other medical conditions you may suffer from including:

  • Liver transplant, history of: Caution should be exercised as the consumption of this drug combination could make this condition worse.

Warnings

Allergies

It's important to make your doctor or healthcare team aware if you have ever suffered an allergic reaction to this medication or other medicines. It's also a good idea to let them know about any other allergies you may suffer from, including to, animals, dyes, foods, and preservatives.

Pediatric population

Appropriate studies have not been conducted on the relationship of age to the effects of this drug combination in the pediatric population. Therefore efficacy and safety have not been established.

Geriatric population

Appropriate studies conducted to date have not indicated a geriatric-specific problem that could limit the usefulness of ledipasvir and sofosbuvir combination in the older population.

Use in pregnancy and breastfeeding

You should tell your doctor if you are pregnant or intend on becoming pregnant. You will need to discuss the risks and benefits of using this medication. You should also let your doctor know if you are currently breastfeeding as you will again need to discuss any risks towards your baby from using this medication.

It's extremely important that your doctor monitors your progress at regular appointments whilst taking this drug combination. This is to ensure that this medication is working corrected and to monitor for unwanted side effects.

Don't take this medication together with other products that contain sofosbuvir (eg, Sovaldi®).

The use of amiodarone alongside this drug combination could produce severe side effects (such as slow heartbeat, cardiac arrest, conditions that need a pacemaker) if used in combination with Harvoni® or if it has been consumed recently. This is more likely to occur in those who suffer from advanced liver disease or heart disease. Let your doctor know if you are taking amiodarone before you use this medication.

Storage

Ledipasvir and Sofosbuvir should be stored in a closed container at room temperature. You should ensure it is kept away from moisture, heat and direct light. Prevent this medication from freezing. Make sure you keep this drug out of the reach of children. Dispose of medication you no longer require or has passed its expiry date. Your local pharmacist can give you specific advice on the best method of disposal for any medication you no longer need. Keep the medication in the original bottle that you were given by the pharmacist.

Summary

When used as directed, this drug combination is successful in the prevention of chronic hepatitis C infection. However, due to a large number of interactions that can occur, it's important to disclose all medications you are taking to your healthcare team. You should exercise caution if you suffer from any kind of liver problems. The safety and efficacy of this drug have not been established in the use of children. You should let your doctor know if you are pregnant or intend on becoming pregnant whilst using this drug. You will need to discuss risks and benefits. You should also let them know if you are breastfeeding a child. It's unknown if this treatment can prevent you from passing the hepatitis C virus to others. Don't exchange needles, and practice safe to help lessen the risk of passing hepatitis C virus to other people. If you require any further information about the practical uses of this drug combination, or you have any other questions, then contact your local healthcare professional or doctor for more information.