triptorelin (Rx)

Brand and Other Names:Trelstar Depot, Triptodur, more...Trelstar, Trelstar LA
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for reconstitution (Trelstar)

  • Reconstitution results in suspension for IM injection
  • 3.75mg/vial
  • 11.25mg/vial
  • 22.5mg/vial

Advanced Prostate Cancer

Trelstar: Due to different release characteristics, the dosage strengths are not additive and must be selected based upon the desired dosing schedule

22.5 mg IM q6Months, OR

11.25 mg IM q3Months, OR

3.75 mg IM 1Month

Dosing Considerations

Monitor serum testosterone and PSA

Dosage Forms & Strengths

lyophilized powder for reconstitution (Triptodur)

  • 22.5mg/vial; reconstitution results in suspension for IM injection
  • Each single-use (6 month) kit contains drug vial, prefilled diluent syringe, and 21 gauge needle

Central Precocious Puberty

Triptodur: Indicated for central precocious puberty, in patients aged ≥2 yr

<2 years: Safety and efficacy not established

≥2 years: 22.5 mg IM q6Months

Also see Administration

Dosage Modifications

Renal impairment: Not studied

Hepatic impairment: Not studied

Dosing Considerations

Discontinue at appropriate age of puberty onset

Monitor

  • Monitor LH levels beginning 1-2 months following therapy initiation, during therapy, and with each subsequent dose
  • Measure height every 3-6 months; monitor bone age periodically
  • Noncompliance or inadequate dosing may result in irregular gonadotropins and/or sex steroids levels affecting preputial process; inadequate dosing may require switching to GnRH agonist alternative
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Interactions

Interaction Checker

and triptorelin

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      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Trelstar

            • Hot flushes (82%)
            • Skeletal pain (17%)

            Triptodur

            • Injection site pain (45%)
            • Nasopharyngitis (14%)
            • Headache (14%)
            • Injection site redness (14%)

            1-10%

            Trelstar

            • Impotence (10%)
            • Headache (7%)
            • Hypertension (5%)
            • Injection site pain (5%)
            • Generalized pain (3%)
            • Vomiting (3%)
            • Fatigue (3%)
            • Insomnia (3%)
            • UTI (3%)
            • Diarrhea (2%)
            • Pruritus (2%)
            • UTI (2%)
            • Spinal cord compression (rare)

            Triptodur

            • Upper respiratory infection (9%)
            • Vaginal bleeding (8%)
            • Cough (7%)
            • Hot flushes (5%)
            • Injection site pruritus (2.3%)
            • Injection site swelling (2.3%)

            Postmarketing Reports

            Pituitary apoplexy

            Convulsions

            Thromboembolic events including pulmonary emboli, CVA, MI, DVT, TIA, and thrombophlebitis

            Interstitial lung disease

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            Warnings

            Contraindications

            Hypersensitivity

            Pregnancy or women who may become pregnant

            Cautions

            Risk of pituitary apoplexy (rare)

            Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists

            Cases of spinal cord compression, which may contribute to weakness or paralysis with or without fatal complications, have been reported with GnRH agonists

            Reports of MI, sudden cardiac death, and stroke in men treated with GnRH agonists

            QT prolongation

            • Androgen deprivation therapy may prolong the QT/QTc interval; consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval
            • Electrolyte abnormalities should be corrected
            • Consider periodic monitoring of ECG and electrolytes

            Triptodur

            • Gonadotropin and sex steroid levels may initially rise above baseline during initial therapy or subsequent doses owing to transient stimulatory effect of drug; puberty signs and symptoms (eg vaginal bleeding) may transiently increase
            • Psychiatric events: Monitor development or worsening psychiatric symptoms (eg, crying, irritability, impatience, anger, and aggression)
            • Convulsion episodes: Increase risk with history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and concomitant use of medications associated with convulsions (eg, SSRIs)
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            Pregnancy & Lactation

            Pregnancy

            Based on findings in animal studies and mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; expected hormonal changes that occur with treatment increase risk for pregnancy loss; in animal developmental and reproductive toxicology studies, daily administration of drug to pregnant rats during period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times estimated human daily dose based on body surface area; advise pregnant patients and females of reproductive potential of potential risk to fetus

            Based on mechanism of action, treatment may impair fertility in males of reproductive potential

            Lactation

            The safety and efficacy not established in females; there are no data on presence of drug in human milk, effects of drug on milk production, or on breastfed child; because of potential for serious adverse reactions in a breastfed child from treatment, a decision should be made to either discontinue breastfeeding, or discontinue drug taking into account importance of drug to mother

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            GnRH analog; decreases levels of LH and FSH resulting in suppression of steroidogenesis with subsequent decrease in testosterone (male) and estrogen (female) levels; a sustained decrease in LH and FSH secretion occurs after chronic and continuous administration

            Pharmacokinetics

            Trelstar

            • Half-life: 3 hr
            • Protein bound: None
            • Vd: 30-33 L
            • Time to peak: 1-3 hr
            • Metabolism: Unknown; may involve CYP metabolism
            • Metabolites: Not identified
            • Clearance: 150 mL/min
            • Excretion: urine (42%)

            Triptodur

            • Time to peak: 4 hr
            • Metabolism: Unknown
            • Metabolites: Not identified
            • Clearance: 212 mL/min
            • Excretion: urine
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            Administration

            IM Preparation

            Reconstitution lyophilized powder with diluent provided

            Gently swirl vial until milk suspension forms

            IM Administration

            Must be administered under physician supervision

            Use suspension immediately; avoid partial or combination syringe use

            Alternate injection sites

            Trelstar: Administer as single IM injection in either buttock

            Triptodur: Inject entire syringe content into either buttock or thigh

            Storage

            Store at room temperature 20-25°C (68-77°F)

            Do not freeze

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.