Triptorelin Acetate (DECAPEPTYL)

1. Health Canada Product Monograph — Triptorelin Acetate

• Triptorelin acetate is used in women undergoing controlled ovarian hyperstimulation for assisted reproductive technologies, such as in vitro fertilization, to prevent a premature surge in luteinizing hormone that could interfere with egg retrieval.

Contraindicated in pregnancy. Confirm pregnancy status and discuss alternative therapy with the prescriber before dispensing.

• Triptorelin acetate is contraindicated during pregnancy.
• Pregnancy must be ruled out before starting treatment, and a non-hormonal method of contraception should be used until periods resume.
• If pregnancy occurs during treatment, triptorelin acetate should be stopped.
• Very limited human data have not shown an increased risk of birth defects, but a possible disadvantageous effect on pregnancy cannot be excluded based on the drug's hormonal action.

• Triptorelin acetate is contraindicated during breastfeeding.

• Triptorelin acetate is not authorized for use in patients 65 years of age or older, since it is used only in women undergoing fertility treatment.

• Triptorelin acetate is not authorized for use in patients under 18 years of age; no pediatric safety or efficacy data are available.

• The usual dose is one 0.1 mg injection under the skin of the lower abdomen once daily.
• Treatment is typically started on day 2 or 3 of the menstrual cycle, or alternatively on day 21 to 23 (or 5-7 days before the expected start of a period).
• Hormone injections to stimulate follicle growth are usually added after about 2 to 4 weeks of triptorelin acetate treatment, once hormone suppression is confirmed.
• Treatment continues until the ovarian follicles have reached a suitable size, which typically takes 4 to 7 weeks in total, after which a trigger injection is given and triptorelin acetate/gonadotropin treatment is stopped.
• No specific dose adjustment is recommended for kidney or liver impairment, since the risk of drug accumulation in these patients is considered small.
• If a dose is missed on its scheduled day, the patient should take it as soon as remembered that same day and not double the next dose.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• Experience with overdose in humans is limited, and no adverse reactions have been specifically linked to triptorelin acetate overdose.
• Overdose may prolong the drug's duration of action.
• If overdose occurs, triptorelin acetate treatment should be temporarily discontinued.

• Headache is common.
• Abdominal pain is common.
• Nausea is common.
• Vaginal bleeding or spotting is common, especially early in treatment.
• Hot flushes and increased sweating may occur.
• Injection site redness, pain, or inflammation is common.
• Dizziness may occur.
• Breast pain may occur.
• Fatigue or flu-like symptoms may occur.
• Back pain may occur.
• Mood changes or altered mood may occur.
• Reduced interest in sex may occur.
• Weight gain may occur.
• Muscle spasms or joint pain (arthralgia) may occur.
• Upper respiratory tract infection or sore throat (pharyngitis) may occur.
• Vomiting or diarrhea may occur.
• Painful periods (dysmenorrhea) may occur before treatment fully suppresses the cycle.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Ovarian hyperstimulation syndrome (OHSS) can occur when triptorelin acetate is combined with fertility hormones, causing marked ovarian enlargement, abdominal pain and bloating, nausea, vomiting, shortness of breath, and fluid buildup in the abdomen or chest; severe cases require hospitalization.
• Ovarian cysts may develop early in treatment; these are usually harmless and resolve on their own, but occasionally require treatment or surgery.
• Severe allergic reactions, including generalized allergic reactions after injection, have been reported.
• An increased risk of depression, which may be severe, has been reported with this class of drug.
• Rarely, pituitary apoplexy (sudden bleeding or blocked blood flow to the pituitary gland), presenting as sudden headache, vomiting, and vision changes, has been reported.
• Assisted reproduction itself carries risks of multiple pregnancy, ectopic pregnancy, pregnancy loss, and congenital malformations, which remain relevant when triptorelin acetate is used as part of fertility treatment.
• Vision disturbances or blurred vision have been reported.
• Bone mineral density can decrease during treatment with this class of drug, though it generally recovers after treatment stops; this is more of a concern with repeated or prolonged treatment courses.
• Seek urgent medical attention for severe abdominal pain or swelling, difficulty breathing, signs of a severe allergic reaction, or sudden severe headache with vision changes.

• Use with caution in women with known allergic conditions or a history of allergic predisposition; treatment is not advised in women with severe allergic conditions.
• Use with caution in women at higher risk of ovarian hyperstimulation syndrome, such as those with polycystic ovarian syndrome.
• Use with caution in patients with reduced kidney or liver function, since triptorelin acetate clearance may be prolonged.
• Use with caution in patients taking other drugs that affect pituitary hormone secretion, since hormonal status should be monitored closely.
• Use with caution in women with personal or family risk factors for abnormal heart rhythms, such as congenital long QT syndrome, heart disease, electrolyte imbalances, or a slow heart rate, since this class of medicine has been linked to QT interval changes.
• The first injection should be given under medical supervision with at least 30 minutes of observation afterward, in case of an allergic or pseudo-allergic reaction.
• Vary the injection site with each dose to reduce the risk of fat loss under the skin (lipoatrophy) at the injection site.

• Contraindicated in patients with known hypersensitivity to triptorelin or any ingredient in the formulation.
• Contraindicated during pregnancy.
• Contraindicated during breastfeeding.

• Interactions with other medicines have not been formally studied for this indication, but the possibility of interaction with histamine-releasing drugs cannot be excluded.
• Drugs that affect pituitary secretion of gonadotropins should be used with caution alongside triptorelin acetate, with hormonal status monitored closely.

• Triptorelin acetate is given by injection under the skin, not taken by mouth, so food timing does not apply.

• Triptorelin acetate is injected once daily at approximately the same time each day, as directed by the fertility clinic; since it is not an oral medication, there is no relationship to meal timing.

• Store triptorelin acetate pre-filled syringes in a refrigerator between 2°C and 8°C.
• Do not freeze.
• Store in the original package to protect from light, and keep out of reach and sight of children.

• Triptorelin acetate is a daily self-injected hormone medicine used during fertility treatment to prevent a premature hormone surge that could disrupt egg retrieval.
• Treatment is closely supervised by a fertility specialist, with regular ultrasound and hormone monitoring.
• Seek urgent care for severe abdominal pain, swelling, or difficulty breathing, which can signal ovarian hyperstimulation syndrome.
• Use non-hormonal contraception during treatment and tell your healthcare professional right away if you think you might be pregnant.