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TRELSTAR is a brand name for Triptorelin, supplied as a powder for suspension, sustained-release. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TRELSTAR (triptorelin for injectable suspension) is indicated for: • The management and relief of chronic pain associated with endometriosis. • The palliative treatment of hormone dependent advanced carcinoma of the prostate gland (stage D2). For the management and relief of chronic pain in endometriosis, experience…
Verbatim from this product's HC label. Tap a section to expand.
3 Pediatrics [01/2024] TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
5 1 INDICATIONS ............................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 15 5 OVERDOSAGE............................................................................................................
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). • Teratogenic Risk Based on findings in animals, TRELSTAR may cause fetal harm if administered to pregnant women (see 16 NON-CLINICAL TOXICOLOGY). 1 Pregnant Women). Endometriosis General During the early phase of therapy, sex hormones usually rise above baseline levels because of the physiologic effect of the drug.
An increase in clinical signs and symptoms of endometriosis is often observed during the initial days of therapy. These will subside with continued treatment. Worsening of the clinical condition may occasionally require discontinuation of therapy.
Retreatment cannot be recommended since safety data beyond 6 months are not available. 5 Post-Market Adverse Reactions). Signs and symptoms of idiopathic intracranial hypertension include severe or recurrent headache, papilledema, blurred vision, diplopia, loss of vision, pain behind the eye or pain with eye movement, dizziness, nausea, and tinnitus.
If idiopathic intracranial hypertension occurs, discontinuation of triptorelin should be considered. Genitourinary Vaginal bleeding Since menstruation should stop with effective doses of TRELSTAR, the patient should notify her health professional if regular menstruation persists.
Patients missing successive doses of TRELSTAR may experience breakthrough bleeding. Ovarian Cysts As with other drugs that stimulate the release of gonadotropin or that induce ovulation, ovarian cysts have been reported to occur, usually within the first 2 months of treatment.
In most cases, these enlargements resolve spontaneously in 4 to 6 weeks. However, in some cases they may require discontinuation of drug and/or surgical intervention. Musculoskeletal Changes in bone density Bone loss can be expected as part of natural aging and can also be anticipated during the hypoestrogenic state caused by long-term use of TRELSTAR.
3 Pediatrics [01/2024] TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
5 1 INDICATIONS ............................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 15 5 OVERDOSAGE............................................................................................................
15 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 16 7 WARNINGS AND PRECAUTIONS ................................................................................ 21 8 ADVERSE REACTIONS ................................................................................................
30 9 DRUG INTERACTIONS ................................................................................................ 32 10 CLINICAL PHARMACOLOGY .......................................................................................
33 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 36 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 36 PART II: SCIENTIFIC INFORMATION .......................................................................................
TRELSTAR is contraindicated in: • Patients with hypersensitivity to luteinizing hormone-releasing hormone [LHRH; also known as gonadotropin-releasing hormone (GnRH)] or LHRH agonist analogs, or any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
5 Post-Market Adverse Reactions). For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Women who are or may become pregnant while receiving the drug. TRELSTAR may cause fetal harm when administered to a pregnant woman.
If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, she should be apprised of the potential hazard to the fetus (see 7 WARNINGS AND PRECAUTIONS). • Nursing women (see 7 WARNINGS AND PRECAUTIONS).
• Women with undiagnosed abnormal vaginal bleeding.
Product Monograph Master Template Template Date:
September 2020 TRELSTAR® (triptorelin for injectable suspension) Page 6 of 55
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Treatment with triptorelin for a period up to 6 months can lead to a reduction in bone mineral density, but this is generally reversible after the end of treatment. Some of the bone density loss over the course of TRELSTAR therapy may not be reversible.
Product Monograph Master Template Template Date:
September 2020 TRELSTAR® (triptorelin for injectable suspension) Page 19 of 55 It has been shown in patients treated with LHRH analogues for endometriosis that the addition of estrogen and progestogen therapy reduces bone mineral density loss and vasomotor symptoms.
Therefore, if appropriate, consider co-administering estrogen and progestogen therapy with LHRH analogues while taking into account the risks and benefits of each treatment. In patients with significant risk factors for decreased bone mineral content and/or bone mass such as family history of osteoporosis, chronic use of corticosteroids or anticonvulsants or chronic use of alcohol or tobacco, TRELSTAR may pose additional risk.
In these patients, risk versus benefit must be weighted carefully before initiation of TRELSTAR therapy. Repeated courses of therapy with LHRH analogs beyond 6 months are not advisable for patients with major risk factors for loss of bone mineral content.
Prostate Cancer General TRELSTAR, like other LHRH agonists, causes a transient increase in serum concentration of testosterone during the first weeks of treatment. Patients may experience worsening of symptoms or onset of new symptoms, including bone pain, neuropathy, hematuria, or ureteral or bladder outlet obstruction.
Cases of spinal cord compression, which may contribute to paralysis with or without fatal complications, have been reported with LHRH agonists. If spinal cord compression or renal impairment due to ureteral obstruction develops, standard treatment of these complications should be instituted.
Patients with metastatic vertebral lesions and/or with urinary tract obstruction should begin TRELSTAR therapy under close supervision. Cardiovascular There may be a relationship between androgen deprivation therapy and cardiovascular risk in men with prostate cancer on the basis of the demonstrated adverse impact of androgen deprivation on traditional cardiovascular risk factors, including serum lipoproteins, insulin sensitivity, and obesity.
Reports of events related to cardiovascular ischemia including myocardial infarction, stroke and cardiovascular-related deaths have been received in patients treated with LHRH agonists. Health professionals should consider whether the benefits of androgen deprivation therapy outweigh the potential cardiovascular risk.
Assessment of cardiovascular risk and management according to local clinical practice and guidelines should be considered (see Monitoring and Laboratory Tests). Effect on QT/QTc interval The following effects have been reported with drugs in this class.
Not all the effects listed below have necessarily been associated with TRELSTAR therapy. 2 Pharmacodynamics). QT prolongation is a physiologic consequence of hormonal therapies that induce androgen ablation in males with prostate cancer and should be considered in assessing the risk-benefit of treatment with hormonal therapy.
Health professionals should consider whether the benefits of androgen deprivation therapy outweigh the potential risk in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking medications that might prolong the QT interval (see
37 13 PHARMACEUTICAL INFORMATION ............................................................................ 37 14 CLINICAL TRIALS ........................................................................................................
38 Endometriosis […]