What happens if I overdose Ledipasvir and sofosbuvir?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir):
Store Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir) at room temperature below 86 degrees F (30 degrees C). Keep Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir) in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir) out of the reach of children and away from pets.
Overdose of Ledipasvir and sofosbuvir in details
No specific antidote is available for overdose with Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir) Tablets. If overdose occurs, the patient must be monitored for evidence of toxicity. Treatment of overdose with Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir) Tablets consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. Hemodialysis is unlikely to result in significant removal of Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) since Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) is highly bound to plasma protein. Hemodialysis can efficiently remove the predominant circulating metabolite of Sofosbuvir (Ledipasvir and sofosbuvir), GS-331007, with an extraction ratio of 53%.
What should I avoid while taking Ledipasvir and sofosbuvir?
Avoid taking an antacid within 4 hours before or 4 hours after you take Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir). This especially includes antacids that contain aluminum or magnesium (Acid Gone, Aldroxicon, Alternagel, Di-Gel, Gaviscon, Gelusil, Genaton, Maalox, Maldroxal, Milk of Magnesia, Mintox, Mylagen, Mylanta, Pepcid Complete, Rolaids, Rulox, and others).
Avoid taking an herbal supplement containing St. John's wort while you are taking Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir).
Taking this medication will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
Ledipasvir and sofosbuvir warnings
Serious Symptomatic Bradycardia When Coadministered with Amiodarone
Postmarketing cases of symptomatic bradycardia, as well as fatal cardiac arrest and cases requiring pacemaker intervention, have been reported when amiodarone is coadministered with Ledipasvir and sofosbuvir. Bradycardia has generally occurred within hours to days, but cases have been observed up to 2 weeks after initiating HCV treatment. Patients also taking beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease, may be at increased risk for symptomatic bradycardia with coadministration of amiodarone. Bradycardia generally resolved after discontinuation of HCV treatment. The mechanism for this effect is unknown.
Coadministration of amiodarone with Ledipasvir and sofosbuvir is not recommended. For patients taking amiodarone who have no other alternative, viable treatment options and who will be coadministered Ledipasvir and sofosbuvir:
- Counsel patients about the risk of serious symptomatic bradycardia
- Cardiac monitoring in an in-patient setting for the first 48 hours of coadministration is recommended, after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.
Patients who are taking Ledipasvir and sofosbuvir who need to start amiodarone therapy due to no other alternative, viable treatment options should undergo similar cardiac monitoring as outlined above.
Due to amiodarone's long half-life, patients discontinuing amiodarone just prior to starting Ledipasvir and sofosbuvir should also undergo similar cardiac monitoring as outlined above.
Patients who develop signs or symptoms of bradycardia should seek medical evaluation immediately. Symptoms may include near-fainting or fainting, dizziness or lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pains, confusion or memory problems.
Risk of Reduced Therapeutic Effect Due to Use with P-gp Inducers
The concomitant use of Ledipasvir and sofosbuvir and P-gp inducers (e.g., rifampin, St. John's wort) may significantly decrease Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir) plasma concentrations and may lead to a reduced therapeutic effect of Ledipasvir and sofosbuvir. Therefore, the use of Ledipasvir and sofosbuvir with P-gp inducers (e.g., rifampin or St. John's wort) is not recommended.
Risks Associated with Ribavirin Combination Treatment
If Ledipasvir and sofosbuvir is administered with ribavirin, the warnings and precautions for ribavirin, in particular the pregnancy avoidance warning, apply to this combination regimen. Refer to the ribavirin prescribing information for a full list of the warnings and precautions for ribavirin.
Related Products Not Recommended
The use of Ledipasvir and sofosbuvir with other products containing Sofosbuvir (Ledipasvir and sofosbuvir) is not recommended.
What should I discuss with my healthcare provider before taking Ledipasvir and sofosbuvir?
Some medical conditions may interact with Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have liver problems other than HCV (eg, cirrhosis)
- if you have kidney problems or you are on dialysis
- if you are taking tenofovir with HIV medicines
Some MEDICINES MAY INTERACT with Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir). Tell your health care provider if you are taking any other medicines, especially any of the following:
- Simeprevir because it may increase the risk of Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir)'s side effects
- Carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, St. John's wort, or tipranavir because they may decrease Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir)'s effectiveness
- Digoxin or rosuvastatin because the risk of their side effects may be increased by Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir)
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Ledipasvir and sofosbuvir precautions
Serious Symptomatic Bradycardia When Co-Administered with Amiodarone: Post-marketing cases of symptomatic bradycardia, as well as fatal cardiac arrest and cases requiring pacemaker intervention, have been reported when amiodarone is co-administered with Ledipasvir and sofosbuvir. Bradycardia has generally occurred within hours to days, but cases have been observed up to 2 weeks after initiating HCV treatment. Patients also taking β-blockers or those with underlying cardiac comorbidities and/or advanced liver disease may be at increased risk for symptomatic bradycardia with co-administration of amiodarone. Bradycardia generally resolved after discontinuation of HCV treatment. The mechanism for this effect is unknown.
Co-administration of amiodarone with Ledipasvir and sofosbuvir is not recommended. For patients taking amiodarone who have no other alternative, viable treatment options and who will be co-administered Ledipasvir and sofosbuvir: Counsel patients about the risk of serious symptomatic bradycardia; cardiac monitoring in an in-patient setting for the first 48 hrs of co-administration is recommended, after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.
Patients who are taking Ledipasvir and sofosbuvir who need to start amiodarone therapy due to no other alternative, viable treatment options should undergo similar cardiac monitoring as outlined previously.
Due to long t½ of amiodarone, patients discontinuing amiodarone just prior to starting Ledipasvir and sofosbuvir should also undergo similar cardiac monitoring as outlined in the previous text.
Patients who develop signs or symptoms of bradycardia should seek medical evaluation immediately. Symptoms may include near-fainting or fainting, dizziness or lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pains, confusion or memory problems.
Risk of Reduced Therapeutic Effect Due to P-gp Inducers: The concomitant use of Ledipasvir and sofosbuvir and P-gp inducers (eg, rifampin, St. John’s wort) may significantly decrease Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir) plasma concentrations and may lead to a reduced therapeutic effect of Ledipasvir and sofosbuvir. Therefore, the use of Ledipasvir and sofosbuvir with P-gp inducers (eg, rifampin or St. John’s wort) is not recommended.
Related Products Not Recommended: The use of Ledipasvir and sofosbuvir with other products containing Sofosbuvir (Ledipasvir and sofosbuvir) (Sovaldi) is not recommended.
Renal Impairment: No dosage adjustment of Ledipasvir and sofosbuvir is required for patients with mild or moderate renal impairment. The safety and efficacy of Ledipasvir and sofosbuvir have not been established in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) or ESRD requiring hemodialysis. No dosage recommendation can be given for patients with severe renal impairment or ESRD.
Hepatic Impairment: No dosage adjustment of Ledipasvir and sofosbuvir is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B or C). Safety and efficacy of Ledipasvir and sofosbuvir have not been established in patients with decompensated cirrhosis.
Use in pregnancy: Pregnancy Category B: There are no adequate and well-controlled studies with Ledipasvir and sofosbuvir in pregnant women. Because animal reproduction studies are not always predictive of human response, Ledipasvir and sofosbuvir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Animal Data: Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)): No effects on fetal development have been observed in rats and rabbits at the highest doses tested. In the rat and rabbit, AUC exposure to Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) was approximately 4- and 2-fold, respectively, the exposure in humans at the recommended clinical dose.
Sofosbuvir (Ledipasvir and sofosbuvir): No effects on fetal development have been observed in rats and rabbits at the highest doses tested. In the rat and rabbit, AUC exposure to the predominant circulating metabolite GS-331007 increased over the course of gestation from approximately 3- to 6-fold and 7- to 17-fold the exposure in humans at the recommended clinical dose, respectively.
Use in lactation: It is not known whether Ledipasvir and sofosbuvir and its metabolites are present in human breast milk. When administered to lactating rats, Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) was detected in the plasma of suckling rats likely due to the presence of Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) in milk. Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) had no clear effects on the nursing pups. The predominant circulating metabolite of Sofosbuvir (Ledipasvir and sofosbuvir) (GS-331007) was the primary component observed in the milk of lactating rats, without effect on nursing pups. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ledipasvir and sofosbuvir and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.
Use in children: Safety and effectiveness of Ledipasvir and sofosbuvir have not been established in pediatric patients.
Use in
Elderly: Clinical trials of Ledipasvir and sofosbuvir included 117 subjects ≥65 years. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment of Ledipasvir and sofosbuvir is warranted in the elderly.
What happens if I miss a dose of Ledipasvir and sofosbuvir?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DailyMed. "LEDIPASVIR; SOFOSBUVIR: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "Ledipasvir". http://www.drugbank.ca/drugs/DB09027 (accessed September 17, 2018).
- MeSH. "Antiviral Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
