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NAPOCARES PATIENT ASSISTANCE PROGRAM APPLICATION

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1
P.O. BOX 7613 OVERLAND PARK, KS 66207
TELEPHONE: (888) 527-NAPO (6276) | FAX: (415) 963-9830
napocares@napopharma.com
napocares.com
NAPOCARES™ PATIENT ASSISTANCE PROGRAM APPLICATION
PATIENT INFORMATION
PATIENT FIRST NAME
||
PATIENT LAST NAME
||
DATE OF BIRTH
PATIENT STREET ADDRESS
CITY
||
STATE
||
ZIP CODE
PATIENT PHONE NUMBER
||
PATIENT EMAIL ADDRESS
PHONE NUMBER TYPE: n Home n Mobile n Work
OKAY TO LEAVE MESSAGE?: n Yes n No
BEST TIME TO CALL:
n Morning n Afternoon
PREFERRED CONTACT METHOD: n Phone n Email
GENDER:
n Male
n Female
n Nonbinary
FINANCIAL ASSISTANCE:
OPT OUT OF
COMMUNICATIONS:
n Please check here if
you do not wish to
receive communications
other than those
related to the program.
PATIENT AUTHORIZATION
PATIENT SIGNATURE (PLEASE SIGN HERE AND ON PAGE 2)
||
DATE
PATIENT LEGAL REPRESENTATIVE (IF APPROPRIATE)
||
RELATIONSHIP TO PATIENT (OPTIONAL)
By signing this Authorization, I authorize each of my healthcare providers, pharmacists, including any specialty pharmacy that receives my prescription for Mytesi (crofelemer), other
healthcare providers (together “Healthcare Providers”), and any of my health insurers (together, “Insurers”) to disclose my Protected Health Information to Napo Pharmaceuticals,
Inc., its aliated companies, vendors, agents, collaboration partners, and representatives (together, “Napo Pharmaceuticals, Inc.”), including providers of alternate sources of
funding for prescription drug costs, and other service providers supporting NapoCares (the “Program”) for Healthcare Providers and patients for the purposes described below.
Protected Health Information may include, but is not limited to, medical records, information related to my medical condition and treatment, health insurance coverage, my name,
address, telephone number, Social Security number, insurance plan, and/or group numbers (together, “Protected Health Information”).
By my signature below, I conrm that I am a US resident—but not a resident of Puerto Rico or other US territories—and that I understand and that I authorize NapoCares and
any entity that may be contracted to be the Program’s administrator (“Administrator”) of NapoCares to receive and to have access to the following Information: (1) Information
contained in this application, (2) Information on the prescription medications that my healthcare provider has provided or will provide to me, (3) other Information that NapoCares
or the Administrator may obtain about me in managing the NapoCares program (collectively, the “Information”), and (4) Information about my diagnosis and related treatment
plan.
By my signature below, I further authorize NapoCares to use the Information in the following manner: (1) to review my application and to contact me or my healthcare provider, as
necessary, to conduct such review, (2) for purposes relating to the management of the NapoCares program, and (3) for NapoCares internal purposes involving patient assistance
programs and charitable programs generally. I understand that personally identiable information will not be shared with third parties, however that certain de-identied
portions of the Information (for example, general location, age, gender) may be shared with third parties for purposes of managing NapoCares. I understand that I have the right
to revoke this Authorization at any time by sending written notice to NapoCares at the address set forth in this application. If I revoke this Authorization, I will no longer be eligible
for the services provided by the NapoCares program. Revocation of this Authorization will prohibit disclosures of my personal Information to the aforementioned third parties
after the date such revocation is received and processed but will not aect disclosures made before that time.
I authorize any pharmacy and/or healthcare provider who is in possession of my health Information to use and/or disclose to NapoCares and the Administrator all Information,
health or otherwise, relating to my participation in NapoCares. I understand that if my Information is disclosed in this manner by a pharmacy or healthcare provider, federal
privacy laws may no longer protect the Information from further disclosure.
I authorize use of my demographic Information to access my credit Information and Information derived from public and other sources to estimate my income in conjunction with
the eligibility determination process. I understand this is a soft inquiry that will not aect my credit score or be visible to lenders viewing a credit report.
I authorize use of my demographic Information to access reports on my individual credit history from consumer reporting agencies. I understand that upon request, I will be
informed whether an individual consumer report was requested and the name and address of the agency that furnished it.
I certify that the Information I have set forth in this application is true, correct, and complete, and I agree to abide by the rules, procedures, and above-referenced conditions of
this program. I understand that eligibility under the NapoCares program is subject to approval by NapoCares and/or the Administrator and that application to the NapoCares
program does not guarantee inclusion in the NapoCares program. I understand that I am responsible for notifying NapoCares if I have a change in income or insurance coverage
that may impact my eligibility. I understand that the NapoCares program may be changed or terminated at any time and without prior notice.
YEARLY HOUSEHOLD INCOME
||
# OF PERSONS IN HOUSEHOLD
(TOTAL COMBINED YEARLY INCOME FOR ALL HOUSEHOLD MEMBERS FOR PRIOR CALENDAR YEAR;
PLEASE NOTE IF THERE ARE INCOME CHANGES FOR CURRENT YEAR)
$
CAREGIVER NAME (OPTIONAL)
||
CAREGIVER PHONE NUMBER (OPTIONAL)
||
RELATIONSHIP TO PATIENT (OPTIONAL)
PREFERRED LANGUAGE (IF OTHER THAN ENGLISH)
SIGN
HERE
SIGN
HERE
PRESCRIBER INFORMATION
PRESCRIBER FIRST NAME
||
PRESCRIBER LAST NAME
STREET ADDRESS
||
CITY / STATE
||
ZIP CODE
NPI #
OFFICE CONTACT NAME
||
OFFICE PHONE NUMBER
OFFICE EMAIL ADDRESS
||
OFFICE FAX NUMBER
PREFERRED METHOD
OF COMMUNICATION:
n Phone
n Email
n Fax
2
NAPOCARES™ PATIENT ASSISTANCE PROGRAM APPLICATION (CONTINUED)
P.O. BOX 7613 OVERLAND PARK, KS 66207
TELEPHONE: (888) 527-NAPO (6276) | FAX: (415) 963-9830
napocares@napopharma.com
napocares.com
OVERVIEW NapoCares Patient Assistance Program is designed to provide Mytesi to those for whom it is appropriate and a medical need has been established, who cannot aord the cost
of therapy and who are below the maximum income requirements adjusted by household size and have no other insurance coverage or federally funded health benet options available
to access Mytesi.
DEFINITIONS For the purpose of this enrollment form and NapoCares Patient Assistance Program, the following denitions shall apply: “Patient” means one on whose behalf an
application has been submitted for Benets under NapoCares; “Applicant” means a person who submits an application for Benets under NapoCares; “Beneciary” means an Applicant
whose application for access to Mytesi at no cost has been granted in full or part pursuant to the NapoCares program; “Benets” means Mytesi Delayed-Release Tablets that are provided
pursuant to the NapoCares program; “You” means the Applicant and/or a Beneciary, as appropriate from the context of this use; and “NapoCares” means the NapoCares Patient
Assistance Program.
SIGNATURES REQUIRED In order to be considered for Benets under NapoCares, both You (or your legal representative) and your prescribing healthcare provider must complete and
sign the appropriate sections of the application form.
ACCESS TO INFORMATION Your application for Benets allows access to nancial, medical, and other information about You. In order for NapoCares to receive certain medical
information about You in your application, the Health Insurance Portability and Accountability Act of 1996 and the related Privacy Rule 45 CFR Parts 160 and 164 (collectively “HIPAA”)
require NapoCares to obtain your written authorization. If You do not sign the enrollment form, NapoCares cannot process your application and You will not be able to participate in
NapoCares.
ELIGIBILITY For purposes of this enrollment form, the determination of whether a person can aord Mytesi is considered with respect to the individual and, if applicable, family/
household members and/or any other person having legal responsibility for the Patient (if the Patient is a dependent adult). NapoCares is intended for Patients who are nancially
disadvantaged and have no other insurance coverage or federally funded health benets options that would enable the Patient to access Mytesi. Only Patients whose annual household
income (all household members’ incomes must be included) meets income eligibility criteria adjusted by household size are eligible for participation in NapoCares for Mytesi at no cost.
US RESIDENTS ONLY Only US Residents (excluding Puerto Rico and other US territories) are eligible for Benets under NapoCares.
LIMIT ON SUPPLY A maximum of 1 initial prescription ll and up to 11 prescription rells of Mytesi over a 12-month period may be awarded to a Beneciary for each application
submitted. Prescribing physicians and Patients must reapply annually if additional supplies are required. If Patient’s enrollment occurs on or after November 1st, Patient will be considered
as enrolled for both the remainder of the current calendar year and the entirety of the following calendar year. However, if Patient’s enrollment occurs prior to November 1st, Patient will
need to re-enroll at the appropriate time for the following calendar year.
NO RIGHT TO ASSISTANCE An applicant for Benets under NapoCares has no legal right to receive assistance from NapoCares. Any award of Benets from NapoCares will involve the
assessment of many criteria among potentially qualied Applicants. Therefore, we reserve the right to grant or deny an application, in whole or in part, on the basis of such criteria as we
deem appropriate. In particular, the fact that an Applicant may be granted an award of Benets at one time does not mean that the Applicant is entitled to, or will be granted, an award of
Benets at any time. Napo Pharmaceuticals, Inc. reserves the right to rescind, revoke, or amend this program at any time without notice.
DISTRIBUTION NapoCares uses contracted partners for all of its distribution activities, including distribution of Mytesi. NapoCares’ contracted distributors are responsible for the
distribution activities provided, including any delays in shipment or other problems that might occur with the delivery of Mytesi.
DRUG SHORTAGE NapoCares will attempt to provide You with sucient quantities of Mytesi to cover your needs while You are enrolled in the NapoCares program. However, in the event
that a shortage of drug exists at any time during the period of time for which You have been awarded the drug under NapoCares, NapoCares will give You written or verbal notice of such
shortage.
WAITING LISTS NapoCares may receive numerous applications, resulting in requests for more Mytesi than is available through the NapoCares program. Therefore, NapoCares may not
be able to approve all applications for Benets. Moreover, a waiting list of Applicants may accrue, which may delay processing applications until a sucient supply of Mytesi becomes
available through the NapoCares program.
RIGHT TO MODIFY BENEFIT We, during the time period of any award to Beneciary, reserve the right to review the award and/or the Patient’s medical and nancial situation. Based on
that review, we reserve the right to increase, decrease, or terminate Benets previously awarded to You.
ADDITIONAL RESTRICTIONS In the course of reviewing an application and/or administering an award of Benets under NapoCares, we reserve the right to impose such other conditions
and/or require that You provide such other information and/or that You take such actions as we deem appropriate.
NO WARRANTIES NapoCares does not make any representations or warranties, either expressed or implied, concerning any aspect of NapoCares.
TERMINATION OF PROGRAM NapoCares may be amended or terminated, without prior notice, at any time.
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PATIENT SIGNATURE
||
DATE
PATIENT LEGAL REPRESENTATIVE (IF APPROPRIATE)
||
RELATIONSHIP TO PATIENT (OPTIONAL)
SIGN
HERE
PRESCRIBER AUTHORIZATION
By signing below, I certify that (1) the above therapy is appropriate and medically necessary and in the best interest of the named patient; (2) I have received the appropriate
permission from the patient (or the patient’s Legal Representative) and met any other applicable legal or regulatory requirements such as those imposed under the Health
Insurance Portability and Accountability Act of 1996 and/or state law needed to release the above information to Napo Pharmaceuticals, Inc. (Napo) and its agents; (3) I have
obtained the patient’s authorization to release the above information and such other information as may be required by AssistRx, as Napo Pharmaceuticals, Inc.’s agent, and
its employees to assist in obtaining coverage for Mytesi; and (4) I appoint AssistRx as my agent for the purpose of conveying this prescription to the appropriate dispensing
pharmacy, verifying the patient’s insurance coverage for MYTESI (crofelemer) 125 mg tablets, providing information regarding payer coverage and benets and how to prepare
prior authorization requests, coverage determination appeals, or other coverage issues, and providing my patient and me with educational and support services associated with
MYTESI (crofelemer).
I certify that I have reviewed the additional terms available at https://ebvterms.com, which are specically incorporated herein by reference, and acknowledge and consent to their
application and enforceability in regard to this certication.
PRESCRIBER SIGNATURE
||
DATE
SIGN
HERE
PRESCRIPTION
DRUG SELECTION:
Mytesi 125 mg (crofelemer) delayed-released tablets Qty: 60 Rells: 11 SIG: One (1) tablet BID
PRESCRIBER SIGNATURE (DISPENSE AS WRITTEN)
||
DATE
PATIENT FIRST NAME / LAST NAME
SIGN
HERE
SIGN
HERE
© Napo Pharmaceuticals, Inc. 2020
NP-380-2, Revised 05/15/2020
3
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
MYTESI is indicated for symptomatic relief of non-infectious diarrhea
in adult patients with HIV/AIDS on anti-retroviral therapy.
2 DOSAGE AND ADMINISTRATION
Before starting MYTESI, rule out infectious etiologies of diarrhea [see
Warnings and Precautions (5.1)].
The recommended adult dosage of MYTESI is 125 mg taken orally
two times a day, with or without food.
Do not crush or chew MYTESI tablets. Swallow whole.
3 DOSAGE FORMS AND STRENGTHS
Delayed-Release Tablets: 125 mg of crofelemer as a white, oval,
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
Before starting MYTESI, rule out infectious etiologies of diarrhea. If
infectious etiologies are not considered, and MYTESI 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. MYTESI 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 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.
7 DRUG INTERACTIONS
7.1 Nelfinavir, Zidovudine, and Lamivudine
MYTESI administration did not have a clinically relevant interaction
with nelfinavir, zidovudine, or lamivudine in a drug-drug interaction trial
[see Clinical Pharmacology (12.3)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C
Reproduction studies performed with crofelemer in rats at oral
doses up to 177 times the recommended daily human dose of 250 mg
(approximately 4.2 mg/kg) revealed no evidence of impaired fertility
or harm to the fetus. In pregnant rabbits, crofelemer at an oral dose of
about 96 times the recommended daily human dose of 4.2 mg/kg caused
abortions and resorptions of fetuses. However, it is not clear whether
these effects are related to the maternal toxicity observed. A pre- and
postnatal development study performed with crofelemer in rats at oral
doses of up to 177 times the recommended daily human dose of 4.2
mg/kg revealed no evidence of adverse pre- and postnatal effects in
offspring. There are, however, no adequate, well-controlled studies in
pregnant women. Because animal reproduction studies are not always
predictive of human response, this drug should be used during pregnancy
only if clearly needed.
8.3 Nursing Mothers
It is not known whether crofelemer is excreted in human milk.
Because many drugs are excreted in human milk and because of the
potential for adverse reactions in nursing infants from MYTESI, a decision
should be made whether to discontinue nursing or to discontinue the
drug, taking into account the importance of the drug to the mother.
8.4 Pediatric Use
The safety and effectiveness of MYTESI have not been established in
pediatric patients.
8.5 Geriatric Use
Clinical studies with MYTESI did not include sufficient numbers of
patients aged 65 and over to determine whether they respond differently
than younger patients.
8.6 Use in Patients with Low CD4 Counts and High Viral Loads
No dose modifications are recommended with respect to CD4 cell
count and HIV viral load, based on the findings in subgroups of patients
defined by CD4 cell count and HIV viral load.
The safety profile of MYTESI was similar in patients with baseline
CD4 cell count less than 404 cells/microL (lower limit of normal range)
(N=388) and patients with baseline CD4 cell counts greater than or equal
to 404 cells/microL (N=289).
The safety profile of crofelemer was similar in patients with baseline
HIV viral loads less than 400 copies/mL (N = 412) and patients with
baseline HIV viral loads greater than or equal to 400 copies/mL (N = 278).
11 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 Müll. 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.
n
R
O
HO
OH
OH
OH
OH
R
O
HO
OH
OH
OH
OH
R
O
HO
OH
OH
OH
OH
R = H or OH range n = 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.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Crofelemer is an inhibitor of both the cyclic adenosine
monophosphate (cAMP)-stimulated cystic fibrosis transmembrane
conductance regulator (CFTR) chloride ion (Cl¯) channel, and the calcium-
activated Cl¯ channels (CaCC) at the luminal membrane of enterocytes.
The CFTR Cl¯ channel and CaCC regulate Cl¯ and fluid secretion by
intestinal epithelial cells. Crofelemer acts by blocking Cl¯ secretion and
accompanying high volume water loss in diarrhea, normalizing the flow of
Cl¯ and water in the gastrointestinal tract.
12.2 Pharmacodynamics
Consistent with the mechanism of action of crofelemer (i.e.,
inhibition of CFTR and CaCC in the gastrointestinal lumen), data suggest
stool chloride concentrations decreased in patients treated with
crofelemer 500 mg four times daily (8-times the recommended daily
dosage) (n=25) for four days relative to placebo (n=24); stool chloride
concentrations decreased in both African American patients treated with
crofelemer (n=3) relative to placebo (n=5) and non-African American
patients treated with MYTESI (n=22) relative to placebo (n=19).
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
MYTESI safely and effectively. See full prescribing information for
MYTESI.
MYTESI
®
(crofelemer) delayed-release tablets, for oral use
Initial U.S. Approval: 2012
---------------------RECENT MAJOR CHANGES-----------------------
Dosage and Administration (2) 02/2018
Warnings and Precautions (5.1) 02/2018
------------------INDICATIONS AND USAGE---------------------------
MYTESI is an anti-diarrheal indicated for the symptomatic relief of
non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral
therapy. (1)
-------------------DOSAGE AND ADMINISTRATION-------------------
Before starting MYTESI, rule out infectious etiologies of diarrhea. (2, 5.1)
The recommended adult dosage is 125 mg taken orally twice a day, with
or without food. (2)
Do not crush or chew the tablets. Swallow whole. (2)
---------------DOSAGE FORMS AND STRENGTHS-------------------
Delayed-Release Tablets: 125 mg (3)
------------------------CONTRAINDICATIONS------------------------
None (4)
-----------------WARNINGS AND PRECAUTIONS--------------------
Risks of Treatment in Patients with Infectious Diarrhea: Consider
infectious etiologies of diarrhea before starting treatment to reduce the
risk of inappropriate therapy and worsening disease. (2, 5.1)
--------------------------ADVERSE REACTIONS---------------------
Most common adverse reactions (≥ 3%) are: upper respiratory tract
infection, bronchitis, cough, flatulence and increased bilirubin. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Napo
Pharmaceuticals at 1-844-722-8256 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION
Revised 02/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5. 1 Risks of Treatment in Patients with Infectious Diarrhea
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Nelfinavir, Zidovudine, and Lamivudine
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Use in Patients with Low CD4 Counts and High Viral Loads
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information
are not listed.
MYTESI
(CROFELEMER) DELAYED-
RELEASE TABLETS
REV: February 2018
70036891
70036891.indd 1 10/1/18 9:40 AM
4
Cardiac Electrophysiology
At a dose 10 times the maximum recommended dose, crofelemer
does not prolong the QTc interval to any clinically relevant extent.
12.3 Pharmacokinetics
Absorption
The absorption of crofelemer is minimal following oral dosing
in healthy adults and HIV–positive patients and concentrations of
crofelemer in plasma are below the level of quantitation (50 ng/mL).
Therefore, standard pharmacokinetic parameters such as area under the
curve, maximum concentration, and half-life cannot be estimated.
Effect of Food
Administration of crofelemer with a high-fat meal was not
associated with an increase in systemic exposure of crofelemer in
healthy subjects. In the clinical trial, a single 500 mg dose of crofelemer
(4-times the recommended dose) was administered one-half hour before
the morning and evening meals [see Dosage and Administration (2)].
Drug Interaction Studies
In vitro studies have shown that crofelemer has the potential to
inhibit cytochrome P450 isoenzyme 3A and transporters MRP2 and
OATP1A2 at concentrations expected in the gut. Due to the minimal
absorption of crofelemer, crofelemer is unlikely to inhibit cytochrome
P450 isoenzymes 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1 and CYP3A4
systemically.
Nelfinavir, Zidovudine, Lamivudine
Results of a crossover study in healthy subjects showed crofelemer
500 mg administered four times daily (8-times the recommended
dosage) for five days had no effect on the exposure of zidovudine and
nelfinavir when administered as a single dose. A 20% decrease in
lamivudine exposure was also observed in the same study but was not
considered to be clinically important.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Long-term studies in animals have not been performed to evaluate
the carcinogenic potential of crofelemer.
Mutagenesis
Crofelemer was negative in the bacterial reverse mutation assay,
chromosomal aberration assay, and rat bone marrow micronucleus
assay.
Impairment of Fertility
Crofelemer, at oral doses of up to 738 mg/kg/day (177 times the
recommended human daily dose of 125 mg twice daily), had no effects
on fertility or reproductive performance of male and female rats.
14 CLINICAL STUDIES
The efficacy of MYTESI was evaluated in a randomized, double-
blind, placebo-controlled (one month) and placebo-free (five month),
multi-center study. The study enrolled 374 HIV-positive patients on stable
anti-retroviral therapy with a history of diarrhea for one month or more.
Diarrhea was defined as either persistently loose stools despite regular
use of anti-diarrheal medication (e.g., loperamide, diphenoxylate, and
bismuth subsalicylate) or one or more watery bowel movements per day
without regular anti-diarrheal medicine use.
Patients were excluded if they had a positive gastrointestinal
biopsy, gastrointestinal culture, or stool test for multiple bacteria
(Salmonella, Shigella, Campylobacter, Yersinia, Mycobacterium), bacterial
toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba,
Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses
(Cytomegalovirus). Patients were also excluded if they had a history of
ulcerative colitis, Crohn’s disease, celiac sprue (gluten-enteropathy),
chronic pancreatitis, malabsorption, or any other gastrointestinal disease
associated with diarrhea.
The study had a two-stage adaptive design. In both stages,
patients received placebo for 10 days (screening period) followed by
randomization to crofelemer or placebo for 31 days of treatment (double-
blind period). Only patients with 1 or more watery bowel movements
per day on at least 5 of the last 7 days in the screening period were
randomized to the double-blind period. Each stage enrolled patients
separately; the dose for the second stage was selected based on an
interim analysis of data from the first stage. In the first stage, patients
were randomized 1:1:1:1 to one of three crofelemer dosage regimens
(125 mg twice daily, or one of two higher dosage regimens) or placebo.
In the second stage, patients were randomized 1:1 to MYTESI 125 mg
twice daily or placebo. The efficacy analysis was based on results from
the double-blind portion of both stages.
Each study stage also had a five month period (placebo-free period)
that followed the double-blind period. Patients treated with MYTESI
continued the same dose in the placebo-free period. In the first stage,
patients that received placebo were re-randomized 1:1:1 to one of the
three crofelemer dosage regimens (125 mg twice daily, or one of the two
higher dosage regimens) in the placebo-free period. In the second stage,
patients that received placebo were treated with MYTESI 125 mg twice
daily in the placebo-free period.
The median time since diagnosis of HIV was 12 years. The
percentage of patients with a CD4 cell count of less than 404 was 39%.
The percentage of patients with a HIV viral load greater than or equal to
1000, 400 to 999, and less than 400 HIV copies/mL was 7%, 3%, and
9%, respectively; the remainder had a viral load that was not detectable.
The median time since diarrhea started was 4 years. The median number
of daily watery bowel movements was 2.5 per day.
Most patients were male (85%). The percentage of patients that
were Caucasian was 46%; the percentage of patients that were African-
American was 32%. The median age was 45 years with a range of 21
to 68 years.
In the double-blind period of the study, 136 patients received
MYTESI 125 mg twice daily, 101 patients received one of the two higher
dosage regimens and 138 patients received placebo. The percentages of
patients that completed the double-blind period were 92% in the MYTESI
125 mg group and 94% in the placebo arm.
Most patients received concomitant protease inhibitors during the
double-blind period (Table 2). The most frequently used anti-retroviral
therapies in the MYTESI 125 mg and placebo groups were tenofovir/
emtricitabine, ritonavir, and lopinavir/ritonavir.
Table 2: Concomitant Anti-Retroviral Therapy Used in the
Double-Blind Period in Patients with HIV
MYTESI
125 mg twice
daily
(N = 136)n (%)
Placebo
N = 138
n (%)
Any antiretroviral therapy 135 (99) 134 (97)
Any protease inhibitor 87 (64) 97 (70)
Tenofovir/Emtricitabine 45 (33) 52 (38)
Ritonavir 46 (34) 49 (36)
Lopinavir/Ritonavir 30 (22) 40 (29)
Efavirenz/Tenofovir/Emtricitabine 30 (22) 21 (15)
Tenofovir disoproxil
fumarate
18 (13) 14 (10)
Atazanavir sulfate 19 (14) 22 (16)
Abacavir w/ lamivudine 17 (13) 18 (13)
Darunavir 19 (14) 14 (10)
Raltegravir 16 (12) 11 (8)
Valaciclovir hydrochloride 12 (9) 16 (12)
Fosamprenavir 12 (9) 13 (9)
Zidovudine w/lamivudine 12 (9) 15 (11)
Lamivudine 7 (5) 6 (4)
Nevirapine 8 (6) 9 (7)
Atazanavir 5 (4) 2 (1)
The primary efficacy endpoint was the proportion of patients with
a clinical response, defined as less than or equal to 2 watery bowel
movements per week during at least 2 of the 4 weeks of the placebo-
controlled phase. Patients who received concomitant anti-diarrheal
medications or opiates were counted as clinical non-responders.
A significantly larger proportion of patients in the MYTESI 125 mg
twice daily group experienced clinical response compared with patients
in the placebo group (18% vs. 8%, 1–sided p < 0.01). In the randomized
clinical study, examination of duration of diarrhea, baseline number of
daily watery bowel movements, use of protease inhibitors, CD4 cell count
and age subgroups did not identify differences in the consistency of the
crofelemer treatment effect among these subgroups. There were too
few female patients and patients with an HIV viral load > 400 copies/
mL to adequately assess differences in effects in these populations.
Among race subgroups, there were no differences in the consistency of
the crofelemer treatment effect except for the subgroup of African-
Americans; crofelemer was less effective in African-Americans than
non-African-Americans.
Although the CD4 cell count and HIV viral load did not appear
to change over the one month placebo-controlled period, the clinical
significance of this finding is unknown because of the short duration of
the placebo-controlled period.
Of the 24 clinical responders to MYTESI 125 mg twice daily, 22
entered the placebo-free period; 16 were responding at the end of month
3, and 14 were responding at the end of month 5.
16 HOW SUPPLIED/STORAGE AND HANDLING
MYTESI (crofelemer) 125 mg delayed-release tablets are white,
oval tablets printed on one side with 125SLXP. They are available in the
following package size:
Bottles of 60: NDC 70564-802-60
Store at 20°C-25°C (68°F-77°F); excursions permitted between
15°C-30°C (59°F-86°F). See USP Controlled Room Temperature.
17 PATIENT COUNSELING 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.
Manufactured by Patheon, Inc. for
Napo Pharmaceuticals, Inc., San Francisco, CA 94105
Copyright © Napo Pharmaceuticals, Inc.
US Patent Nos. 7,341,744 and 7,323,195.
NP-367-1 02/2018
70036891
The botanical drug substance of MYTESI is extracted from Croton
lechleri (the botanical raw material) that is harvested from the wild in
South America.
70036891.indd 2 10/1/18 9:40 AM
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