Sofab LP Dosage

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Dosage of Sofab LP in details

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Sofab LP Dosage

Generic name: Ledipasvir (Sofab LP) 90mg, Sofosbuvir (Sofab LP) 400mg

Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Recommended Dosage

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

​Relapse rates are affected by baseline host and viral factors and differ between treatment durations for certain subgroups.

​Table 1 shows the recommended Sofab LP treatment regimen and duration based on patient population.

​For patients with HCV/HIV-1 co-infection, follow the dosage recommendations in Table 1. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs.

Table 1 Recommended Treatment Regimen and Duration for Sofab LP in Patients with Genotype 1, 4, 5 or 6 HCV
Patient Population Treatment Regimen and Duration
*
Sofab LP for 8 weeks can be considered in treatment-naïve genotype 1 patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL.
Treatment-experienced patients include those who have failed a peginterferon alfa + ribavirin based regimen with or without an HCV protease inhibitor.
Sofab LP+ribavirin for 12 weeks can be considered in treatment-experienced genotype 1 patients with cirrhosis who are eligible for ribavirin. See footnote ¶ for ribavirin dosage recommendations.
§
In patients with decompensated cirrhosis, the starting dosage of ribavirin is 600 mg and can be titrated up to 1000 mg for patients <75 kg and 1200 mg for those ≥75 kg in two divided doses with food. If the starting dosage of ribavirin is not well tolerated, the dosage should be reduced as clinically indicated based on hemoglobin levels.
The daily dosage of ribavirin is weight-based (1000 mg for patients <75 kg and 1200 mg for those ≥75 kg) administered orally in two divided doses with food.
​Genotype 1 Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A) Sofab LP 12 weeks*
Treatment-experienced† without cirrhosis Sofab LP 12 weeks
Treatment-experienced† with compensated cirrhosis (Child-Pugh A) Sofab LP 24 weeks‡
Treatment-naïve and treatment-experienced† with decompensated cirrhosis (Child-Pugh B or C) Sofab LP + ribavirin§ 12 weeks
​Genotype 1 or 4 Treatment-naïve and treatment-experienced† liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh A) Sofab LP + ribavirin¶ 12 weeks
​Genotype 4, 5 or 6 Treatment-naïve and treatment-experienced†, without cirrhosis or with compensated cirrhosis (Child-Pugh A) Sofab LP 12 weeks

​For further information on ribavirin dosing and dosage modifications, refer to the ribavirin prescribing information.

Severe Renal Impairment and End Stage Renal Disease

No dosage recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] less than 30 mL/min/1.73 m2) or with end stage renal disease (ESRD) due to higher exposures (up to 20-fold) of the predominant Sofosbuvir (Sofab LP) metabolite.

More about Sofab LP (Ledipasvir (Sofab LP) / Sofosbuvir (Sofab LP))

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What other drugs will affect Sofab LP?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Sofab LP, especially:

This list is not complete. Other drugs may interact with Sofab LP, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Sofab LP interactions

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Potential For Drug Interaction

As Sofab LP contains Sofab LP, any interactions that have been identified with these agents individually may occur with Sofab LP.

After oral administration of Sofab LP, Sofosbuvir (Sofab LP) is rapidly absorbed and subject to extensive first-pass hepatic extraction. In clinical pharmacology studies, both Sofosbuvir (Sofab LP) and the inactive metabolite GS-331007 were monitored for purposes of pharmacokinetic analyses. Ledipasvir (Sofab LP) is an inhibitor of the drug transporters P-gp and breast cancer resistance protein (BCRP) and may increase intestinal absorption of coadministered substrates for these transporters.

Sofab LP are substrates of drug transporters P-gp and BCRP while GS-331007 is not. P-gp inducers (e.g., rifampin or St. John's wort) may decrease Sofab LP plasma concentrations, leading to reduced therapeutic effect of Sofab LP, and the use with P-gp inducers is not recommended with Sofab LP.

Established And Potentially Significant Drug Interactions

Table 4 provides a listing of established or potentially clinically significant drug interactions. The drug interactions described are based on studies conducted with either Sofab LP, the components of Sofab LP (Sofab LP) as individual agents, or are predicted drug interactions that may occur with Sofab LP.

Table 4 : Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction These interactions have been studied in healthy adults.

Drugs Without Clinically Significant Interactions With Sofab LP

Based on drug interaction studies conducted with the components of Sofab LP (Ledipasvir (Sofab LP) or Sofosbuvir (Sofab LP)) or Sofab LP, no clinically significant drug interactions have been either observed or are expected when Sofab LP is used with the following drugs : abacavir, atazanavir/ritonavir, cyclosporine, darunavir/ritonavir, dolutegravir, efavirenz, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, lamivudine, methadone, oral contraceptives, pravastatin, raltegravir, rilpivirine, tacrolimus, or verapamil. See Table 4 for use of Sofab LP with certain HIV antiretroviral regimens.


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References

  1. 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).
  2. FDA/SPL Indexing Data. "013TE6E4WV: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
  3. MeSH. "Antiviral Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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The results of a survey conducted on ndrugs.com for Sofab LP are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Sofab LP. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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