Crofelemer Delayed-release Tablets, for Oral Use
Name: Crofelemer Delayed-release Tablets, for Oral Use
- Crofelemer Delayed-release Tablets, for Oral Use 125 mg
- Crofelemer Delayed-release Tablets, for Oral Use tablet
- Crofelemer Delayed-release Tablets, for Oral Use drug
- Crofelemer Delayed-release Tablets, for Oral Use dosage
Description
MYTESI (crofelemer) delayed-release tablets is an anti-diarrheal, enteric-coated drug product for oral administration. It contains 125 mg of crofelemer, a botanical drug substance that is derived from the red latex of Croton lechleri Mull. Arg. Crofelemer is an oligomeric proanthocyanidin mixture primarily composed of (+)– catechin, (–)–epicatechin, (+)–gallocatechin, and (–)–epigallocatechin monomer units linked in random sequence, as represented below. The average degree of polymerization for the oligomers ranges between 5 and 7.5, as determined by phloroglucinol degradation.
R = H or OH rangen =3 to 5.5
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.
Coating ingredients: ethylacrylate and methylacrylate copolymer dispersion, talc, triethyl citrate, and white dispersion which contains xanthan gum, titanium dioxide, propyl paraben, and methyl paraben.
Indications
MYTESI is indicated for symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.
Side effects
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 MYTESI for a mean duration of 78 days. Of the total population across the three trials, 229 patients received a dosage of 125 mg twice a day for a mean duration of 141 days, and 171 patients received one of four higher than recommended dosages for a mean duration of 139 days (N=69) 14 days (N=102), 146 days (N=54), and 14 days (N=242), respectively.
Adverse reactions in patients treated with MYTESI 125 mg twice daily that occurred in at least 2% of patients and at a higher incidence than placebo are provided in Table 1.
Table 1: Common Adverse Reactions* in HIV-Positive Patients in Three Placebo-Controlled Trials
| Adverse Reaction | MYTESI 125 mg Twice Daily N = 229 n (%) | Placebo N = 274 n (%) |
| Upper respiratory tract infection | 13 (6) | 4 (2) |
| Bronchitis | 9 (4) | 0 |
| Cough | 8 (4) | 3 (1) |
| Flatulence | 7 (3) | 3 (1) |
| Increased bilirubin | 7 (3) | 3 (1) |
| Nausea | 6 (3) | 4 (2) |
| Back pain | 6 (3) | 4 (2) |
| Arthralgia | 6 (3) | 0 |
| Urinary tract infection | 5 (2) | 2 (1) |
| Nasopharyngitis | 5 (2) | 2 (1) |
| Musculoskeletal pain | 5 (2) | 1 (<1) |
| Hemorrhoids | 5 (2) | 0 |
| Giardiasis | 5 (2) | 0 |
| Anxiety | 5 (2) | 1 (<1) |
| Increased alanine aminotransferase | 5 (2) | 3 (1) |
| Abdominal distension | 5 (2) | 1 (<1) |
| * occurring in at least 2% of patients and at a higher incidence than placebo | ||
Less common adverse reactions that occurred in between 1% and 2% of patients taking 125 mg twice daily of MYTESI were abdominal pain, acne, increased aspartate aminotransferase, increased conjugated bilirubin, increased unconjugated blood bilirubin, constipation, depression, dermatitis, dizziness, dry mouth, dyspepsia, gastroenteritis, herpes zoster, nephrolithiasis, pain in extremity, pollakiuria, sinusitis and decreased white blood cell count.
Overdose
No Information provided
Patient information
Instruct patients that MYTESI tablets may be taken with or without food.
Instruct patients to swallow MYTESI tablets whole and not to crush or chew the tablets.