Sofab LP Side effects

• Side effects of Sofab LP in details
• Sofab LP contraindications
• Sofab LP reviews

What are the possible side effects of Sofab LP?

Get emergency medical help if you have signs of an allergic reaction to Sofab LP: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

If you also take a heart medication called amiodarone, call your doctor at once if you have:

• extreme tiredness;

• unusual weakness or lack of energy;

• confusion or memory problems;

• a light-headed feeling, like you might pass out;

• slowed breathing; or

• chest pain, slow heartbeats, weak pulse.

Common Sofab LP side effects may include:

• weakness;

• headache; or

• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Sofab LP in details

The following serious adverse reactions are described below and elsewhere in labeling:

• Serious Symptomatic Bradycardia When Coadministered with Amiodarone.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

If Sofab LP is administered with ribavirin, refer to the prescribing information for ribavirin for a description of ribavirin-associated adverse reactions.

The safety assessment of Sofab LP was based on pooled data from three randomized, open-label Phase 3 clinical trials (ION-3, ION-1 and ION-2) of subjects with genotype 1 HCV with compensated liver disease (with and without cirrhosis) including 215, 539, and 326 subjects who received Sofab LP once daily by mouth for 8, 12 and 24 weeks, respectively.

The proportion of subjects who permanently discontinued treatment due to adverse events was 0%, less than 1%, and 1% for subjects receiving Sofab LP for 8, 12, and 24 weeks, respectively.

The most common adverse reactions (at least 10%) were fatigue and headache in subjects treated with 8, 12, or 24 weeks of Sofab LP.

Table 2 lists adverse reactions (adverse events assessed as causally related by the investigator, all grades) observed in at least 5% of subjects receiving 8, 12, or 24 weeks treatment with Sofab LP in clinical trials. The majority of adverse reactions presented in Table 2 occurred at severity of grade 1. The side-by-side tabulation is to simplify presentation; direct comparison across trials should not be made due to differing trial designs.

Table 2 : Adverse Reactions (All Grades) Reported in ≥ 5% of Subjects Receiving 8, 12, or 24 Weeks of Treatment with Sofab LP

	Sofab LP 8 weeks N=215	Sofab LP 12 weeks N=539	Sofab LP 24 weeks N=326
Fatigue	16%	13%	18%
Headache	11%	14%	17%
Nausea	6%	7%	9%
Diarrhea	4%	3%	7%
Insomnia	3%	5%	6%

The safety assessment of Sofab LP was also based on pooled data from three open-label trials (Study 1119, ION-4 and ELECTRON-2) in 118 subjects with chronic HCV genotype 4, 5 or 6 infection with compensated liver disease (with or without cirrhosis). The subjects received Sofab LP once daily by mouth for 12 weeks. The safety profile in subjects with chronic HCV genotype 4, 5 or 6 infection with compensated liver disease was similar to that observed in subjects with chronic HCV genotype 1 infection with compensated liver disease. The most common adverse reactions occurring in at least 10% of subjects were asthenia (18%), headache (14%) and fatigue (10%).

Adverse Reactions In Subjects With Cirrhosis

The safety assessment of Sofab LP with or without ribavirin was based on a randomized, double-blind and placebo-controlled trial in treatment-experienced genotype 1 subjects with compensated cirrhosis and was compared to placebo in the SIRIUS trial. Subjects were randomized to receive 24 weeks of Sofab LP once daily by mouth without ribavirin or 12 weeks of placebo followed by 12 weeks of Sofab LP once daily by mouth + ribavirin. Table 3 presents the adverse reactions, as defined above, that occurred with at least 5% greater frequency in subjects treated with 24 weeks of Sofab LP or 12 weeks of Sofab LP + ribavirin, compared to those reported for 12 weeks of placebo. The majority of the adverse reactions presented in Table 3 were Grade 1 or 2 in severity.

Table 3 : Adverse Reactions with ≥ 5% Greater Frequency Reported in Treatment-Experienced Subjects with Cirrhosis Receiving Sofab LP for 24 Weeks or Sofab LP + RBV for 12 Weeks Compared to Placebo for 12 weeks

	Sofab LP 24 weeks (N=78)	Sofab LP + RBV 12 weeks (N=76)	Placebo 12 weeks (N=77)
Asthenia	31%	36%	23%
Headache	29%	13%	16%
Fatigue	18%	4%	1%
Cough	5%	11%	1%
Myalgia	9%	4%	0
Dyspnea	3%	9%	1%
Irritability	8%	7%	1%
Dizziness	5%	1%	0

Adverse Reactions In Subjects Co-infected With HIV-1

The safety assessment of Sofab LP was based on an open-label clinical trial in 335 genotype 1 or 4 subjects with HCV/HIV-1 co-infection who were on stable antiretroviral therapy in Study ION-4. The safety profile in HCV/HIV-1 co-infected subjects was similar to that observed in HCV mono-infected subjects. The most common adverse reactions occurring in at least 10% of subjects were headache (20%) and fatigue (17%).

Adverse Reactions In Liver Transplant Recipients And/Or Subjects With Decompensated Cirrhosis

The safety assessment of Sofab LP with ribavirin (RBV) in liver transplant recipients and/or those who had decompensated liver disease was based on pooled data from two Phase 2 open-label clinical trials including 336 subjects who received Sofab LP plus RBV for 12 weeks. Subjects with Child-Pugh-Turcotte (CPT) scores greater than 12 were excluded from the trials.

The adverse events observed were consistent with the expected clinical sequelae of liver transplantation and/or decompensated liver disease, or the known safety profile of Sofab LP and/or ribavirin.

Decreases in hemoglobin to less than 10 g/dL and 8.5 g/dL during treatment were observed in 38% and 13% of subjects treated with Sofab LP plus RBV for 12 weeks, respectively. Ribavirin was permanently discontinued in 11% of subjects treated with Sofab LP plus RBV for 12 weeks.

Liver Transplant Recipients With Compensated Liver Disease

Among the 174 liver transplant recipients with compensated liver disease who received Sofab LP with RBV for 12 weeks, 2 (1%) subjects permanently discontinued Sofab LP due to an adverse event.

Subjects With Decompensated Liver Disease

Among the 162 subjects with decompensated liver disease (pre-or post-transplant) who received Sofab LP with RBV for 12 weeks, 7 (4%) subjects died, 4 (2%) subjects underwent liver transplantation, and 1 subject ( < 1%) underwent liver transplantation and died during treatment or within 30 days after discontinuation of treatment. Because these events occurred in patients with advanced liver disease who are at risk of progression of liver disease including liver failure and death, it is not possible to reliably assess the contribution of drug effect to outcomes. A total of 4 (2%) subjects permanently discontinued Sofab LP due to an adverse event.

Less Common Adverse Reactions Reported in Clinical Trials (less than 5%): The following adverse reactions occurred in less than 5% of subjects receiving Sofab LP in any one trial. These events have been included because of their seriousness or assessment of potential causal relationship.

Psychiatric disorders: depression (including in subjects with pre-existing history of psychiatric illness). Depression (particularly in subjects with pre-existing history of psychiatric illness) occurred in subjects receiving Sofosbuvir (Sofab LP) containing regimens. Suicidal ideation and suicide have occurred in less than 1% of subjects treated with Sofosbuvir (Sofab LP) in combination with ribavirin or pegylated interferon/ribavirin in other clinical trials.

Laboratory Abnormalities

Bilirubin Elevations: Bilirubin elevations of greater than 1.5xULN were observed in 3%, less than 1%, and 2% of subjects treated with Sofab LP for 8, 12, and 24 weeks, respectively. Bilirubin elevations of greater than 1.5xULN were observed in 3%, 11% and 3% of subjects with compensated cirrhosis treated with placebo, Sofab LP + ribavirin for 12 weeks and Sofab LP for 24 weeks, respectively, in the SIRIUS trial.

Lipase Elevations: Transient, asymptomatic lipase elevations of greater than 3xULN were observed in less than 1%, 2%, and 3% of subjects treated with Sofab LP for 8, 12, and 24 weeks, respectively. Transient, asymptomatic lipase elevations of greater than 3x ULN were observed in 1%, 3% and 9% of subjects with compensated cirrhosis treated with placebo, Sofab LP + ribavirin for 12 weeks and Sofab LP for 24 weeks, respectively, in the SIRIUS trial.

Creatine Kinase: Creatine kinase was not assessed in Phase 3 trials ION-3, ION-1 or ION-2 of Sofab LP. Creatine kinase was assessed in the ION-4 trial. Isolated, asymptomatic creatine kinase elevations of greater than or equal to 10xULN was observed in 1% of subjects treated with Sofab LP for 12 weeks in the ION-4 trial and has also been previously reported in subjects treated with Sofosbuvir (Sofab LP) in combination with ribavirin or peginterferon/ribavirin in other clinical trials.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Sofab LP. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac Disorders

Serious symptomatic bradycardia has been reported in patients taking amiodarone who initiate treatment with Sofab LP.

Skin And Subcutaneous Tissue Disorders

Skin rashes, sometimes with blisters or angioedema-like swelling

What is the most important information I should know about Sofab LP?

• Tell your doctor or dentist that you take Sofab LP before you receive any medical or dental care, emergency care, or surgery.
• Sofab LP does not stop the spread of HCV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HCV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HCV to others.
• Do not change your dose or stop taking Sofab LP or any of your medicines without checking with your doctor.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sofab LP while you are pregnant. It is not known if Sofab LP is found in breast milk. If you are or will be breast-feeding while you use Sofab LP, check with your doctor. Discuss any possible risks to your baby.

Sofab LP contraindications

If Sofab LP Tablets are administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin.

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. NCIt. "Ledipasvir: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
3. KEGG. "Antiinfectives". http://www.genome.jp/kegg-bin/get_ht... (accessed September 17, 2018).

Reviews

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.

User reports

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Information checked by Dr. Sachin Kumar, MD Pharmacology