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Rx Item-Endari Glutamine Oral Powder Packets 60 By Emmaus Medical

RX42457-0420-60Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Endari Glutamine Oral Powder Packets 60 By Emmaus Medical

$1452.00$1382.86

NDC No. 42457-0420-60 42457-420-60 4245742060 42457042060 UPC/GTIN No. 342457420605 3-42457-42060-5 342457-420605 MPN No.042060 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, & Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item.

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342457-420605
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ENDARITM safely and effectively. See full prescribing information
for ENDARI.
ENDARI (L-glutamine oral powder )
Initial U.S. Approval: 2017
-----------------------------INDICATIONS AND USAGE--------------------------
ENDARI is an amino acid indicated to reduce the acute complications
of sickle cell disease in adult and pediatric patients 5 years of age and
older. (1)
------------------------DOSAGE AND ADMINISTRATION----------------------
� 5 grams to 15 grams orally, twice daily based on body weight. (2)
� Each dose of Endari should be mixed in 8 oz. (240 mL) of cold or
room temperature beverage or 4 oz. to 6 oz. of food before
ingestion. (2)
---------------------DOSAGE FORMS AND STRENGTHS----------------------
Oral Powder: 5 grams of L-glutamine powder per paper-foil-plastic
laminate packet. (3)

-------------------------------CONTRAINDICATIONS------------------------------
None (4)
-------------------------------ADVERSE REACTIONS------------------------------
Most common adverse reactions (incidence > 10%) are constipation,
nausea, headache, abdominal pain, cough, pain in extremity, back
pain, and chest pain. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Emmaus
Medical, Inc. at 1-877-420-6493 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
2.2 Preparation of Product
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
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
14.1 Clinical Studies
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are
not listed.
Reference ID: 4121272
2
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric
patients 5 years of age and older.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
Administer Endari orally, twice per day at the dose based on body weight according to Table 1.

Table 1. Recommended Dosing
Weight in
kilograms
Weight in
pounds
Per dose in
grams
Per day in
grams
Packets per
dose
Packets per
day
less than 30 less than 66 5 10 1 2
30 to 65 66 to 143 10 20 2 4
greater than 65 greater than 143 15 30 3 6
2.2 Preparation of Product
Mix Endari immediately before ingestion with 8 oz. (240 mL) of cold or room temperature beverage,
such as water, milk or apple juice, or 4 oz. to 6 oz. of food such as applesauce or yogurt. Complete
dissolution is not required prior to administration.
3 DOSAGE FORMS AND STRENGTHS
Oral powder: 5 grams of L�glutamine as a white crystalline powder in paper-foil-plastic laminate
packets
4 CONTRAINDICATIONS
None
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.
Reference ID: 4121272
3
The data described below reflect exposure to Endari in 187 patients, including 136 exposed for 6
months and 109 exposed for ≥1 year. Endari was studied in 2 placebo-controlled clinical trials (a
phase 3 study, n=230 and a phase 2 study, n=70). In these trials, patients with sickle cell anemia or
sickle β0
-thalassemia were randomized to receive Endari (n=187) or placebo (n=111) orally twice
daily for 48 weeks followed by 3 weeks of tapering. Both studies included pediatric and adult patients
(5-58 years of age) and 54% were female. The majority of patients were black (97.3%), had a
diagnosis of sickle cell anemia (89.9%) and were receiving hydroxyurea at baseline (63.4%).
Treatment discontinuation due to adverse reactions was reported in 2.7% (n=5) of patients receiving
Endari. These adverse reactions included one case each of hypersplenism, abdominal pain,
dyspepsia, burning sensation, and hot flash.
Serious adverse reactions were reported in both treatment groups, more frequently in the placebo
group, and were consistent with the underlying disease.
Three deaths (3/187=1.6%) occurred during the study in the Endari treatment group as compared to
none in the placebo treatment group. None of the deaths were considered to be related to Endari
treatment. Adverse reactions occurring in greater than 10% of patients treated with Endari are shown
in Table 2 below.
Table 2. Adverse Reactions Occurring at an Incidence > 10% in Clinical
Studies of Endari
Adverse reaction
Endari
N = 187
(%)
Placebo
N = 111
(%)
Constipation 21 18
Nausea 19 14
Headache 18 15
Abdominal Pain1 17 16
Cough 16 14
Pain in extremity 13 7
Back pain 12 5
Chest pain 12 8
1
Abdominal pain = abdominal pain and abdominal pain, upper
Reference ID: 4121272
4
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no available data on Endari use in pregnant women to inform a drug-associated risk of
major birth defects and miscarriage. Animal reproduction studies were not conducted with Endari.
Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of
medications. The background risk of major birth defects and miscarriage for the indicated population
are unknown. In the U.S. general population, the estimated background risk of major birth defects
and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
8.2 Lactation
Risk Summary
There are no data on the presence of Endari in human milk, the effect on the breastfed infant or the
effect on milk production. The developmental and health benefits from breastfeeding should be
considered along with the mother's clinical need for Endari and any potential adverse effects on the
breastfed child from Endari or from the underlying maternal condition.
8.4 Pediatric Use
The safety and effectiveness of Endari have been established in pediatric patients 5 years and older.
Use of Endari is supported by evidence from 2 placebo-controlled studies in adult and pediatric
patients with sickle cell disease. The clinical studies enrolled 110 pediatric patients in the following
age groups: 46 children (5 years up to less than 12 years) and 64 adolescents (12 years to less than
17 years).
The safety and effectiveness of Endari in pediatric patients with sickle cell disease younger than
5 years old has not been established.
8.5 Geriatric Use
Clinical studies of Endari did not include sufficient numbers of subjects aged 65 and over to
determine whether they respond differently from younger subjects. Other reported clinical experience
has not identified differences in responses between the elderly and younger patients. In general, dose
selection for an elderly patient should be cautious, usually starting at the low end of the dosing range,
reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant
disease or other drug therapy.
10 OVERDOSAGE
Single oral doses of L-glutamine at about 20 g/kg to 22 g/kg, 8 g/kg to 11 g/kg, and 19 g/kg were
lethal in mice, rats, and rabbits, respectively. Supportive measures should be undertaken in the
event of overdose of Endari.
Reference ID: 4121272
5
11 DESCRIPTION
Endari (L-glutamine) is an amino acid. L-glutamine is designated chemically as
(S)-2-aminoglutaramic acid, L-glutamic acid 5-amide, or (S)-2,5-diamino-5-oxopentanoic acid. The
molecular formula is C5H10N2O3 with the molecular weight of 146.15 g/mol and the following structural
formula:

H2N OH
O O
NH2
Endari is formulated as a white crystalline powder and is packaged as 5 grams in a paper-foil-plastic
laminate packet for oral administration.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The mechanism of action of the amino acid L-glutamine in treating sickle cell disease (SCD) is not
fully understood. Oxidative stress phenomena are involved in the pathophysiology of SCD. Sickle
red blood cells (RBCs) are more susceptible to oxidative damage than normal RBCs, which may
contribute to the chronic hemolysis and vaso-occlusive events associated with SCD. The pyridine
nucleotides, NAD+ and its reduced form NADH, play roles in regulating and preventing oxidative
damage in RBCs. L-glutamine may improve the NAD redox potential in sickle RBCs through
increasing the availability of reduced glutathione.
12.2 Pharmacodynamics
In vivo analyses demonstrated that L-glutamine supplementation improved NAD redox potential.
12.3 Pharmacokinetics
The pharmacokinetics of L-glutamine has been studied in healthy subjects and a variety of disease
states. Relevant results from published literature are summarized below.
Absorption
Following single-dose oral administration of L-glutamine at 0.1 g/kg, mean peak L-glutamine
concentration was 1028 μM (or 150 mcg/mL) occurring approximately 30 minutes after administration.
The pharmacokinetics following multiple oral doses has not been characterized.
Distribution
After an intravenous (IV) bolus dose, the volume of distribution was estimated to be approximately
200 mL/kg.
Elimination
After an intravenous bolus dose, the terminal half-life of L-glutamine was approximately one hour.
Reference ID: 4121272
6
Metabolism
Endogenous L-glutamine participates in various metabolic activities, including the formation of
glutamate, and synthesis of proteins, nucleotides, and amino sugars. Exogenous L-glutamine is
anticipated to undergo similar metabolism.
Excretion
Metabolism is the major route of elimination for L-glutamine. Although L-glutamine is eliminated by
glomerular filtration, it is almost completely reabsorbed by the renal tubules.
Specific Populations
The safety of Endari has not been established in patients with renal or hepatic impairment.
Drug Interactions
No drug interaction studies have been conducted.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of
L-glutamine.
L-glutamine was not mutagenic in a bacterial mutagenicity (Ames) assay, nor clastogenic in a
chromosome aberration assay in mammalian (Chinese Hamster Lung CHL/IU) cells.
Animal reproduction studies and its potential for impairment of fertility have not been conducted with
L-glutamine . It is also not known whether L-glutamine can cause fetal harm when administered to a
pregnant woman or whether it can affect reproductive capacity.
14 Clinical Studies
The efficacy of Endari in sickle cell disease was evaluated in a randomized, double-blind, placebocontrolled, multi-center clinical trial entitled "A Phase III Safety and Efficacy Study of L-Glutamine to
Treat Sickle Cell Disease or Sickle βo
-thalassemia" [NCT01179217] (see Table 3).
The clinical trial evaluated the efficacy and safety of Endari in 230 patients (5 to 58 years of age) with
sickle cell anemia or sickle β0
-thalassemia who had 2 or more painful crises within 12 months prior to
enrollment. Eligible patients stabilized on hydroxyurea for at least 3 months continued their therapy
throughout the study. The trial excluded patients who had received blood products within 3 weeks,
had renal insufficiency or uncontrolled liver disease, or were pregnant (or planning pregnancy) or
lactating. Study patients received Endari or placebo for a treatment duration of 48 weeks followed by
3 weeks of tapering.
Efficacy was demonstrated by a reduction in the number of sickle cell crises through Week 48 and
prior to the start of tapering among patients that received Endari compared to patients who received
placebo. A sickle cell crisis was defined as a visit to an emergency room/medical facility for sickle cell
disease-related pain which was treated with a parenterally administered narcotic or parenterally
administered ketorolac. In addition, the occurrence of chest syndrome, priapism, and splenic
Reference ID: 4121272
7
sequestration were considered sickle cell crises. Treatment with Endari also resulted in fewer
hospitalizations due to sickle cell pain at Week 48, fewer cumulative days in hospital and a lower
incidence of acute chest syndrome.
Table 3. Results from the Endari Clinical Trial in Sickle Cell Disease
Event
Endari
(n = 152)
Placebo
(n = 78)
Median number of sickle cell crises (min,max)
1 3 (0, 15) 4 (0, 15)
Median number of hospitalizations for sickle cell pain (min, max)
1 2 (0, 14) 3 (0, 13)
Median cumulative days in hospital (min, max)
1, 6.5 (0, 94) 11 (0, 187)
Median time (days) to first sickle cell crisis (95% CI) 1,2 84 (62, 109) 54 (31, 73)
Patients with occurrences of acute chest syndrome (%)
1 13 (8.6%) 18 (23.1%)
1. Measured through 48 weeks of treatment 2. Hazard Ratio=0.69 (95% CI=0.52, 0.93), estimated based on unstratified Cox's proportional model.Median time and
95% CI were estimated based on the Kaplan Meier method.
The recurrent crisis event time analysis (Figure 1) yielded an intensity rate ratio (IRR) value of 0.75
with 95% CI= (0.62, 0.90) and (0.55, 1.01) based on unstratified models using the Andersen-Gill and
Lin, Wei, Yang and Ying methods, respectively in favor of Endari, suggesting that over the entire 48-
week period, the average cumulative crisis count was reduced by 25% from the Endari group over the
placebo group.
Figure 1. Recurrent Event Time for Sickle Cell Crises by Treatment Group
Intensity Rate Ratio = 0.75*
*Anderson-Gill: 95% CI (0.62, 0.90); Lin-Wei-Yang-Ying: 95% CI (0.55, 1.01)
Reference ID: 4121272
8
16 HOW SUPPLIED/STORAGE AND HANDLING
Endari is supplied in paper-foil-plastic laminate packets containing 5 grams of L-glutamine white
crystalline powder.
� Carton of 60 packets: NDC 42457-420-60
Store at 20o
C to 25o
C (68o
F to 77o
F) away from direct sunlight.
17 PATIENT COUNSELING INFORMATION
Dosage and Administration
Advise patient to take a missed dose as soon as they remember. Patient should not double the dose
that they take.
Instruct patient to mix each dose in 8 oz. (240 mL) of cold or room temperature beverage or 4 to 6 oz.
of food.
Advise patient that complete dissolution is not required prior to administration.
Manufactured for:
Emmaus Medical, Inc
Torrance, CA 90503
Reference ID: 4121272

RX42457-0420-60
Rx Item-Endari Glutamine Oral Powder Pac
RX42457-0420-60

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-Endari Glutamine Oral Powder Pac
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
AmericanPharmaWholesale.com
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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