Version May 2024
Primary hypothalamic amenorrhea: Females: IV, SubQ.: Initial dose: 5 mcg every 90 minutes via suitable pulsatile pump. Dosage adjustments may be made every 21 days if necessary. An increase in dosage may be necessary if no response after 3 treatment intervals. In clinical trials, doses of 1-20 mcg were successfully administered. Treatment should be continued for 2 weeks after ovulation to maintain the corpus luteum.
Note: Appropriate vial should be selected for individualized treatment. Typical dose (5 mcg) is delivered with use of 0.8 mg vial.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Cardiovascular: Superficial thrombophlebitis
Local: Injection site irritation
<1%, postmarketing, and/or case reports: Abdominal pain, anaphylactic shock, anaphylaxis, antibody development (with long-term therapy, resulting in therapy failure), erythema at injection site, fever, headache, hypermenorrhea, inflammation at injection site (mild and severe), nausea, ovarian hyperstimulation syndrome (moderate)
Hypersensitivity to gonadorelin or any component of the formulation; women with any condition (eg, pituitary prolactinoma) that could be exacerbated by pregnancy; patients who have ovarian cysts; any condition (eg, hormone-dependent tumor) that may be worsened by reproductive hormones
Concerns related to adverse effects:
• Hypersensitivity/anaphylactic reactions: Hypersensitivity and anaphylactic reactions have been reported rarely.
• Ovarian cancer: [Canadian Boxed Warning]: Ovarian cancer has been reported in a very small number of infertile women treated with fertility drugs. A causal relationship has not been established.
• Ovarian hyperstimulation syndrome: [Canadian Boxed Warning]: Ovarian hyperstimulation syndrome (OHSS) is a risk of ovulation induction therapy although it is rare with pulsatile gonadotropin releasing hormone (GnRH) therapy. Discontinue therapy if OHSS occurs; spontaneous resolution may be expected. OHSS is a rare exaggerated response to ovulation induction therapy (Corbett 2014; Fiedler 2012). This syndrome may begin within 24 hours of treatment but may become most severe 7 to 10 days after therapy (Corbett 2014). Symptoms of mild/moderate OHSS may include abdominal distention/discomfort, diarrhea, nausea, and/or vomiting. Severe OHSS symptoms may include severe abdominal pain, anuria/oliguria, ascites, severe dyspnea, hypotension, or nausea/vomiting (intractable). Decreased creatinine clearance, hemoconcentration, hypoproteinemia, elevated liver enzymes, elevated WBC, and electrolyte imbalances may also be present (ASRM 2016; Corbett 2014; Fiedler 2012). Treatment is primarily symptomatic and includes fluid and electrolyte management, analgesics, and prevention of thromboembolic complications (ASRM 2016; SOGC-CFAS 2011).
Other warnings/precautions:
• Experienced physician: Therapy should only be conducted by clinicians familiar with infertility problems and their management.
• Multiple births: May result from the use of these medications; advise patients of the potential risk of multiple births before starting treatment.
Not available in the US
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Injection:
Lutrepulse: 0.8 mg (1 ea)
IV, SubQ: Lutrepulse vials for IV or SubQ use: Following reconstitution, administer IV or SubQ using a suitable pulsatile pump. Set the pump to deliver 25 or 50 mcL of solution, based upon the dose required and vial strength used. When using the 0.8 mg vial, the pump can be set to deliver a dose of 2.5 mcg (25 mcL) per pulse or 5 mcg (50 mcL) per pulse. When using the 3.2 mg vial, the pump can be set to deliver a dose of 10 mcg (25 mcL) per pulse or 20 mcg (50 mcL) per pulse. Pump should deliver dose over a pulse period of 1 minute and a pulse frequency of 90 minutes.
Note: Not approved in the US
Induction of ovulation in females with hypothalamic amenorrhea
ALERT: Canadian Boxed Warning: Health Canada-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling.
None known.
There are no known significant interactions.
The risk of fetal harm appears remote if gonadorelin is used during pregnancy. Clinical studies of pregnant women have not demonstrated an increased risk of fetal abnormalities during the first trimester. Follow-up reports of infants born to exposed mothers revealed no adverse effects or complications attributed to gonadorelin therapy. Based on its indicated use, gonadorelin treatment is continued for 2 weeks following ovulation to maintain the corpus luteum; initiation of treatment is not appropriate if pregnancy has been established.
It is not known if gonadorelin is excreted into breast milk. Not indicated for use in nursing women.
Ovarian ultrasound at baseline and at least weekly while on therapy or until ovulation is confirmed; LH, FSH, estradiol, progesterone (midluteal phase); basal body temperature; pelvic exam; injection site
OHSS: Monitoring of hospitalized patients should include abdominal circumference, albumin, cardiorespiratory status, electrolytes, fluid balance, hematocrit, hemoglobin, serum creatinine, urine output, urine specific gravity, vital signs, weight (all daily or as necessary) and liver enzymes (weekly) (SOGC-CFAS 2011)
Stimulates the release of luteinizing hormone (LH) from the anterior pituitary gland
Onset of action: Response to therapy usually observed within 2-3 weeks
Distribution: Vd: ~10-15 L
Metabolism: Primarily renal
Half-life elimination: Terminal: ~10-40 minutes; increased in patients with renal impairment
Excretion: Urine (as inactive metabolites)
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
