Triptorelin Pamoate (Trelstar)

Trade Name : Trelstar

Allergan, Inc.

KIT

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Triptorelin Pamoate (Trelstar) which is also known as Trelstar and Manufactured by Allergan, Inc.. It is available in strength of per ml. Read more

Triptorelin Pamoate (Trelstar) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

Warnings and Precautions, Embryo-Fetal Toxicity () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a012/2018

TRELSTAR is indicated for the palliative treatment of advanced prostate cancer [n ].
TRELSTAR is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced prostate cancer.u00a0 ()

TRELSTAR is administered as a single intramuscular injection in either buttock. u00a0Due to different release characteristics, the dosage strengths are not additive and must be selected based upon the desired dosing schedule. ()

3.75 mg every 4 weeks. u00a0()n
11.25 mg every 12 weeks. u00a0()n
22.5 mg every 24 weeks. u00a0()

Injectable suspension: 3.75 mg, 11.25 mg, 22.5 mg.
Injectable suspension: 3.75 mg, 11.25 mg, 22.5 mg.u00a0 ()

TRELSTAR is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH [n ].

Known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH.u00a0 ()

No data

Hypersensitivity: Anaphylactic shock, hypersensitivity, and angioedema have been reported.u00a0 In the event of a reaction, discontinue TRELSTAR and initiate appropriate medical management.u00a0 ()n
Tumor Flare: Transient increase in serum testosterone levels can occur within the first few weeks of treatment.u00a0 This may worsen prostate cancer and result in spinal cord compression and urinary tract obstruction. Monitor patients at risk and manage as appropriate.u00a0 ( and )n
Effect on QT/QTc Interval: Androgen deprivation therapy mayu00a0prolong the QT interval.u00a0 Consider risks and benefits.u00a0()n
Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receivingu00a0GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. ()n
Cardiovascular Diseases: Increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in men. Monitor for cardiovascular disease and manage according to current clinical practice. ()

No data

3.75 mg: The most common adverse reactions (u2265 5%) during TRELSTAR 3.75 mg therapy included hot flushes, skeletal pain, impotence, and headache. ()n
11.25 mg: The most common adverse reactions (u2265 5%) during TRELSTAR 11.25 mg therapy included hot flushes, skeletal pain, headache, edema in legs, and leg pain. ()n
22.5 mg: The most common adverse reactions (u2265 5%) during TRELSTAR 22.5 mg therapy included hot flushes, erectile dysfunction, and testicular atrophy. ()

No drug-drug interaction studies involving triptorelin have been conducted.
Human pharmacokinetic data with triptorelin suggest that C-terminal fragments produced by tissue degradation are either degraded completely within tissues or are rapidly degraded further in plasma, or cleared by the kidneys. Therefore, hepatic microsomal enzymes are unlikely to be involved in triptorelin metabolism. However, in the absence of relevant data and as a precaution, hyperprolactinemic drugs should not be used concomitantly with triptorelin since hyperprolactinemia reduces the number of pituitary GnRH receptors.
None. ()
u00a0u00a0u00a0u00a0u00a0u00a0

Pregnancy: TRELSTAR can cause fetal harm. (, )
Females and males of reproductive potential: TRELSTAR may impair fertility. ()

There is no experience of overdosage in clinical trials.u00a0 In single dose toxicity studies in mice and rats, the subcutaneous LD of triptorelin was 400 mg/kg in mice and 250 mg/kg in rats, approximately 500 and 600 times, respectively, the estimated monthly human dose based on body surface area.u00a0 If overdosage occurs, therapy should be discontinued immediately and the appropriate supportive and symptomatic treatment administered.

TRELSTAR is a white to slightly yellow lyophilized cake.u00a0 When reconstituted, TRELSTAR has a milky appearance.u00a0 It contains a pamoate salt of triptorelin, a synthetic decapeptide agonist analog of gonadotropin releasing hormone (GnRH). The chemical name of triptorelin pamoate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-tryptophyl-L-leucyl-L-arginyl-L-prolylglycine amide (pamoate salt). u00a0The empirical formula is CHNO u00b7 CHO and the molecular weight is 1699.9. The structural formula is:
Structural formula for TRELSTAR (triptorelin pamoate).
The TRELSTAR products are sterile, lyophilized biodegradable microgranule formulations supplied as single dose vials.u00a0 Refer to Table 5 for the composition of each TRELSTAR product.
When 2 mL sterile water is added to the vial containing TRELSTAR and mixed, a suspension is formed which is intended as an intramuscular injection.u00a0 TRELSTAR is available in a u00a0vial plus a MIXJECT vial adapter, and a separate pre-filled syringe that contains sterile water for injection, USP, 2 mL, pH 6 to 8.5.

No data

In rats, triptorelinu00a0doses of 120, 600, and 3000 mcg/kg given every 28 days (approximately 0.3, 2, and 8 times the human monthly dose based on body surface area) resulted in increased mortality with a drug treatment period of 13 u2013 19 months.u00a0 The incidences of benign and malignant pituitary tumors and histiosarcomas were increased in a dose-related manner.u00a0 No oncogenic effect was observed in mice administered triptorelin for 18 months at doses up to 6000 mcg/kg every 28 days (approximately 8 times the human monthly dose based on body surface area).
Mutagenicity studies performed with triptorelin using bacterial and mammalian systems ( Ames test and chromosomal aberration test in CHO cells and an mouse micronucleus test) provided no evidence of mutagenic potential.
After 60 days of subcutaneous treatment followed by a minimum of four estrus cycles prior to mating, triptorelin, at doses of 2, 20, and 200 mcg/kg/day in saline (approximately 0.2, 2, and 16u00a0times the estimated human daily dose based on body surface area) or 2 monthly injections as slow release microspheres (~20u00a0mcg/kg/day), had no effect on the fertility or general reproductive function of female rats.u00a0
No studies were conducted to assess the effect of triptorelin on male fertility.u00a0

TRELSTAR 3.75 mg
TRELSTAR 3.75 mg was studied in a randomized, active control trial of 277 men with advanced prostate cancer.u00a0 The clinical trial population consisted of 59.9% Caucasian, 39.3% Black, and 0.8% Other.u00a0 There was no difference observed with triptorelin response between racial groups.u00a0 Men were between 47 and 89 years of age (mean = 71 years).u00a0 Patients received either TRELSTAR 3.75 mg (N = 140) or an approved GnRH agonist monthly for 9u00a0months.u00a0 The primary efficacy endpoints were both achievement of castration by Day 29 and maintenance of castration from Day 57 through Day 253.
Castration levels of serum testosterone (u2264 1.735 nmol/L; equivalent to 50 ng/dL) in patients treated with TRELSTAR 3.75 mg were achieved at Day 29 in 125 of 137 (91.2%) patients and at Day 57 in 97.7% of patients. Maintenance of castration levels of serum testosterone from Day 57 through Day 253 was found in 96.2% of patients treated with TRELSTAR 3.75u00a0mg.
The presence of an acute-on-chronic flare phenomenon was also studied as a secondary efficacy endpoint.u00a0 Serum LH levels were measured at 2 hours after repeat TRELSTAR 3.75u00a0mg administration on Days 85 and 169.u00a0 One hundred twenty-four of the 126 evaluable patients (98.4%) on Day 85 had a serum LH level of u2264 1.0 IU/L at 2 hours after dosing, indicating desensitization of the pituitary gonadotroph receptors.
TRELSTAR 11.25 mg
TRELSTAR 11.25 mg was studied in a randomized, active control trial of 346 men with advanced prostate cancer.u00a0 The clinical trial population consisted of 48% Caucasian, 38% Black, and 15% Other.u00a0 There was no difference observed with triptorelin response between racial groups.u00a0 Men were between 45 and 96 years of age (mean = 71 years).u00a0 Patients received either TRELSTAR 11.25 mg (N = 174) every 12 weeks for a total of up to 3 doses (maximum treatment period of 253 days) or TRELSTAR 3.75 mg (N = 172) every 28 days for a total of up to 9 doses.u00a0 The primary efficacy endpoints were both achievement of castration by Day 29 and maintenance of castration from Day 57 through Day 253.
Castration levels of serum testosterone (u2264 1.735 nmol/L; equivalent to 50 ng/dL) were achieved at Day 29 in 167 of 171 (97.7%) patients treated with TRELSTAR 11.25 mg, and maintenance of castration levels of serum testosterone from Day 57 through Day 253 was found in 94.4% of patients treated with TRELSTAR 11.25 mg.
TRELSTAR 22.5 mg
TRELSTAR 22.5 mg was studied in a non-comparative trial of 120 men with advanced prostate cancer.u00a0 The clinical trial population consisted of 64% Caucasian, 23% Black, and 13% Other, with a mean age of 71.1 years (range 51-93). u00a0u00a0Patients received TRELSTAR 22.5 mg (Nu00a0=u00a0120) every 24 weeks for a total of 2 doses (maximum treatment period of 337 days).u00a0 The primary efficacy endpoints included achievement of castration by Day 29 and maintenance of castration from Day 57 through Day 337.
Castration levels of serum testosterone (u2264 1.735 nmol/L; equivalent to 50 ng/dL) were achieved at Day 29 in 97.5% (117 of 120) ofu00a0patients treated with TRELSTAR 22.5 mg. Castration was maintained in 93.3% of patients in the period from Day 57 to Day 337.
A summary of the clinical studies for TRELSTAR is provided in Table 7.

TRELSTAR is supplied in the TRELSTAR MIXJECT single-dose delivery system consisting of a vial with a Flip-Off seal containing sterile lyophilized triptorelin pamoate microgranules incorporated in a biodegradable copolymer of lactic and glycolic acids, a MIXJECT vial adapter, and a pre-filled syringe containing sterile water for injection, USP, 2u00a0mL, pH 6 to 8.5.
TRELSTAR 3.75 mg
TRELSTAR 11.25 mg
TRELSTAR 22.5 mg
Storage

Hypersensitivity
Tumor Flare
Hyperglycemian- and n- Diabetes
Cardiovascular Disease
Urogenital Disorders
Infertility
Continuation of TRELSTAR Treatment
For all medical inquiries contact:AllerganMedical Communications1-800-678-1605
Distributed By: Allergan USA, Inc.Madison, NJ 07940
Manufactured By:Debiopharm Research & Manufacturing SACH-1920 Martigny, Switzerland
MIXJECT is manufactured by:West Pharma. Services IL, Ltd.Ra'anana, Israel
The pre-filled syringe containing sterile water for injection is manufactured by:Baxter Pharmaceutical Solutions, LLC 927 South Curry Pike Bloomington, Indiana 47403
TRELSTARu00ae and its design are registered trademarks of Allergan Sales, LLC
MIXJECTu00ae is a registered trademark of West Pharma. Services IL, Ltd.
u00a9 2018 Allergan. All rights reserved.
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Triptorelin Pamoate (Trelstar)

Trade Name : Trelstar

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Triptorelin Pamoate (Trelstar)

Trade Name : Trelstar

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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