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  4. CytoDyn Inc (CYDY) Message Board

Oh, and one of the most important other difference

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Post# of 155128
(Total Views: 438)
Posted On: 08/27/2019 10:07:27 PM
Posted By: sjacobs26
Re: NuGilead #6779
Oh, and one of the most important other differences is the safety profile. Leronlimab has not one single SAE related to the drug in over 800 patients. Most common minor side effect is inject sight reaction and this is very minor. Negligible toxicity and no or very little resistance.

Common side effects of Selzentry include stomach pain, diarrhea, constipation, tiredness, lightheadedness or dizziness while standing, cold symptoms (stuffy nose, sneezing, cough, sore throat), sleep problems (insomnia), swelling, problems with urination, muscle or joint pain, or skin rash.

Additional disclosures from:

https://aidsinfo.nih.gov/drugs/408/maraviroc-...ofessional

WARNINGS AND PRECAUTIONS
•
Hepatotoxicity accompanied by severe rash or systemic allergic reaction, including potentially life-threatening events, has been reported. Hepatic laboratory parameters including ALT, AST, and bilirubin should be obtained prior to starting SELZENTRY and at other time points during treatment as clinically indicated. If rash or symptoms or signs of hepatitis or allergic reaction develop, hepatic laboratory parameters should be monitored and discontinuation of treatment should be considered. When administering SELZENTRY to patients with pre-existing liver dysfunction or who are co-infected with hepatitis B and/or C virus, additional monitoring may be warranted. (5.1)
•
Severe and potentially life-threatening skin and hypersensitivity reactions have been reported in patients taking SELZENTRY. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction, and toxic epidermal necrolysis. Immediately discontinue SELZENTRY and other suspected agents if signs or symptoms of severe skin or hypersensitivity reactions develop and monitor clinical status, including liver aminotransferases, closely. (5.2)
•
More cardiovascular events, including myocardial ischemia and/or infarction, were observed in treatment-experienced subjects who received SELZENTRY. Additional monitoring may be warranted. (5.3)
•
If patients with severe renal impairment or ESRD receiving SELZENTRY (without concomitant CYP3A inducers or inhibitors) experience postural hypotension, the dose of SELZENTRY should be reduced from 300 mg twice daily to 150 mg twice daily. (5.3)

ADVERSE REACTIONS
•
The most common adverse events in treatment-experienced adult subjects (greater than 8% incidence) which occurred at a higher frequency compared with placebo are upper respiratory tract infections, cough, pyrexia, rash, and dizziness. (6.1)
•
The most common adverse events in treatment-naive adult subjects (greater than 8% incidence) which occurred at a higher frequency than the comparator arm are upper respiratory tract infections, bronchitis, flatulence, bloating and distention, upper respiratory tract signs and symptoms, and gastrointestinal atonic and hypomotility disorders. (6.1)
•
The most common adverse reactions in treatment-experienced pediatric subjects (greater than or equal to 3% incidence) are vomiting, abdominal pain, diarrhea, nausea, and dizziness. (6.1)


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