ORGALUTRAN

1 Dosing Considerations Prior to therapy with Orgalutran® (ganirelix injection), patients should be informed of the length of treatment and monitoring procedures that will be required. The risk of possible reactions to the drug should be discussed (see ADVERSE REACTIONS).

2 Recommended Dose and Dosage Adjustment Health Canada has not authorized an indication for pediatric use. 4 Administration After initiating FSH therapy on Day 2 or 3 of the cycle, ORGALUTRAN® 250 mcg should be administered subcutaneously once daily during the early to mid follicular phase to take advantage of endogenous pituitary FSH secretion and therefore to potentially reduce the requirement for exogenously administered FSH.

Treatment with ORGALUTRAN® should be continued daily until the day of hCG administration. In normal practice, this period is usually around 5 days, although ORGALUTRAN® treatment has ranged from 1 to 19 days in clinical trials. When an appropriate number of follicles of ORGALUTRAN® (Ganirelix Injection) Page 5 of 26 [Organon] Confidential Unclassified / Non classifié adequate size (≥ 17 mm in diameter) are present, as assessed by ultrasound, final maturation of follicles could be induced by administering hCG.

The time between two Orgalutran® injections as well as between the last Orgalutran® injection and the hCG injection should not exceed 30 hours, otherwise a premature ovulation may occur. Therefore, if the patient normally injects Orgalutran® in the morning, the last of the ORGALUTRAN® injections in the series should be given on the same day as the hCG is given.

If the patient normally injects ORGALUTRAN® in the afternoon, the last Orgalutran® injection should be given in the afternoon prior to the day the hCG is given. The administration of hCG should be withheld in cases where the ovaries are abnormally enlarged on the last day of FSH therapy.

This will reduce the chance of developing OHSS. Air bubble(s) may be seen in the pre-filled syringe. This is expected, and removal of the air bubble(s) is not needed. 5 Missed Dose If a patient forgot a dose, it should be administered as soon as possible.

A double dose should not be administered to make up for forgotten individual doses. If the patient is more than 6 hours late (so the time between two injections is longer than 30 hours), the dose should be administered as soon as possible.

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The safety of ORGALUTRAN® was evaluated in two randomized, parallel-group, multicenter controlled clinical studies.

Treatment duration for ORGALUTRAN® ranged from 1 to 14 days.

Table 2:

Incidence of AEs (All-subjects-treated group). represents maternal adverse events (AEs) from first day of ORGALUTRAN® administration until confirmation of pregnancy by ultrasound in ORGALUTRAN® treated subjects without regard to causality.

Table 2:

Incidence of AEs (All-subjects-treated group). 3) n = number of subjects with AEs or drug-related AEs and N = total number of subjects in the group. 1 Less Common Clinical Trial Adverse Reactions – Pediatrics Not applicable. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Not applicable.

5 Post-Market Adverse Reactions During post-marketing surveillance, very rare cases of hypersensitivity reactions, including rash, facial swelling and dyspnea, anaphylaxis (including anaphylactic shock), angioedema, and urticaria have been reported, as early as with the first dose, among patients administered ORGALUTRAN®.

Drug Abuse and Dependence There have been no reports of abuse or dependence of ORGALUTRAN®.

01/2025 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES............................................................................................ 2 TABLE OF CONTENTS ..............................................................................................................

2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS ..............................................................................................................

1 Pediatrics .............................................................................................................. 2 Geriatrics...............................................................................................................

4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ...........................................................................................

2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration....................................................................................................... 5 Missed Dose ..........................................................................................................

5 5 OVERDOSAGE ............................................................................................................. 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 5 7 WARNINGS AND PRECAUTIONS ..................................................................................

1 Special Populations................................................................................................ 1 Pregnant Women ......................................................................................... 2 Breast-feeding..............................................................................................

ORGALUTRAN® is contraindicated in patients who are: • Hypersensitivity to the active substance or to any similar peptides (such as GnRH or other GnRH analog) or to any components including dry natural rubber/latex which may be contained in the needle shield.

For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Known or suspected pregnancy or lactation. • Moderate or severe impairment of hepatic or renal function.