ING INFORMATION
PACKAGE LABEL - PRINCIPAL DISPLAY - FULYZAQ 125 mg Tablets, 60 Tablets Bottle Label
*
Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
FULYZAQ is indicated for symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy.
2 DOSAGE AND ADMINISTRATION
The recommended dose of FULYZAQ is one 125 mg delayed-release tablet taken orally two times a day, with or without food. FULYZAQ tablets should not be crushed or chewed. Tablets should be swallowed whole.
3 DOSAGE FORMS AND STRENGTHS
FULYZAQ is a white, oval, enteric-coated 125 mg delayed-release tablet printed on one side with 125SLXP.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5. 1 Risks of Treatment in Patients with Infectious Diarrhea
If infectious etiologies are not considered, and FULYZAQ is initiated based on a presumptive diagnosis of non-infectious diarrhea, then there is a risk that patients with infectious etiologies will not receive the appropriate treatments, and their disease may worsen. Before starting FULYZAQ, rule out infectious etiologies of diarrhea. FULYZAQ is not indicated for the treatment of infectious diarrhea.
6 ADVERSE REACTIONS
6.1 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.
A total of 696 HIV-positive patients in three placebo-controlled trials received FULYZAQ for a mean duration of 78 days. Of the total population across the three trials, 229 patients received a dose of 125 mg twice a day for a mean duration of 141 days, 69 patients received a dose of 250 mg twice a day for a mean duration of 139 days, 102 patients received a dose of 250 mg four times a day for a mean duration of 14 days, 54 patients received a dose of 500 mg twice a day for a mean duration of 146 days, and 242 patients received a dose of 500 mg four times a day for a mean duration of 14 days.
Adverse reactions for FULYZAQ that occurred in at least 2% of patients and at a higher incidence than placebo are provided in Table 1.
Table 1: Adverse Reactions Occurring in at Least 2% of Patients in the 125 mg Twice Daily Group
Adverse Reaction
Crofelemer 125 mg BID*
N = 229
n (%)
Placebo
N = 274
n (%)
Upper respiratory tract infection
13 (5.7)
4 (1.5)
Bronchitis
9 (3.9)
0
Cough
8 (3.5)
3 (1.1)
Flatulence
7 (3.1)
3 (1.1)
Increased bilirubin
7 (3.1)
3 (1.1)
Nausea
6 (2.6)
4 (1.5)
Back pain
6 (2.6)
4 (1.5)
Arthralgia
6 (2.6)
0
Urinary tract infection
5 (2.2)
2 (0.7)
Nasopharyngitis
5 (2.2)
2 (0.7)
Musculoskeletal pain
5 (2.2)
1 (0.4)
Hemorrhoids
5 (2.2)
0
Giardiasis
5 (2.2)
0
Anxiety
5 (2.2)
1 (0.4)
Increased alanine aminotransferase
5 (2.2)
3 (1.1)
Abdomina |
