Orgalutran^® (Solution) Instructions for Use

Marketing Authorization Holder

N.V. Organon (Netherlands)

Manufactured By

Vetter Pharma-Fertigung, GmbH & Co. KG (Germany)

Packaging and Quality Control Release

N.V. ORGANON (Netherlands)

ATC Code

H01CC01 (Ganirelix)

Active Substance

Ganirelix (Rec.INN registered by WHO)

Dosage Form

Orgalutran®

Solution for subcutaneous injection 0.25 mg/0.5 ml: syringes 1 or 5 pcs.

Dosage Form, Packaging, and Composition

Solution for subcutaneous injection transparent, colorless.

Excipients : mannitol – 23.5 mg, glacial acetic acid 100% – 0.1 mg, glacial acetic acid and/or sodium hydroxide – to adjust pH to 5.0, water for injection – q.s. to 0.5 ml.

0.5 ml – disposable syringes (1) – plastic container (1) – cardboard packs with first opening control.
0.5 ml – disposable syringes (1) – plastic container (5) – cardboard packs with first opening control.

Clinical-Pharmacological Group

Gonadotropin-releasing hormone antagonist

Pharmacotherapeutic Group

Gonadotropin-releasing hormone antagonist

Pharmacological Action

GnRH antagonist. A synthetic decapeptide with high antagonistic activity against natural GnRH. It modulates the functional activity of the hypothalamic-pituitary-gonadal axis by competitively binding to GnRH receptors in the pituitary gland. As a result, there is a profound, rapid, and reversible suppression of the secretion of endogenous gonadotropins without initial stimulation of their release.

It has been shown that superovulation stimulation using ganirelix is usually accompanied by a faster initial growth of ovarian follicles during the first days of stimulation, compared to GnRH agonists. However, subsequently, at the final stages of treatment, the cohort of leading follicles in number is on average only slightly smaller, although serum estradiol concentration values are somewhat lower, compared to GnRH agonists. These differences require that the FSH dose selection when using ganirelix be based primarily on the number and size of follicles, and to a lesser extent on the blood estradiol level.

Pharmacokinetics

Ganirelix is rapidly absorbed after subcutaneous injection, bioavailability is about 91%. It is metabolized by enzymatic hydrolysis and about 75% of the dose is excreted as metabolites in the feces. It is detected unchanged in the urine. The T_1/2 of ganirelix is about 13 hours.

Indications

Prevention of premature peak LH secretion in women during ovulation induction (superovulation) in infertility treatment programs using assisted reproductive technologies.

ICD codes

Dosage Regimen

Administer Orgalutran^® only under the supervision of a specialist experienced in infertility treatment and assisted reproductive technologies.

Initiate treatment on day 6 of ovarian stimulation with follicle-stimulating hormone (FSH). Alternatively, commence administration when the leading follicle reaches a diameter of 12-14 mm, as determined by ultrasound monitoring.

Inject a single daily dose of 250 mcg (0.5 ml) subcutaneously. Continue treatment daily until adequate follicular development is achieved, which is typically prior to the induction of final oocyte maturation with human chorionic gonadotropin (hCG).

Do not mix Orgalutran^® with other medications in the same syringe. Use a different injection site if other concomitant subcutaneous medications are prescribed.

Adhere strictly to the prescribed FSH stimulation protocol. Adjust the FSH dose based primarily on the number and size of developing follicles, with less reliance on serum estradiol levels compared to GnRH agonist protocols.

Discontinue Orgalutran^® on the day of hCG administration. The duration of treatment should not exceed the period necessary for successful follicular growth prior to oocyte retrieval.

Ensure proper aseptic technique for subcutaneous injection. Rotate injection sites to minimize local skin reactions. Monitor for signs of hypersensitivity during and immediately following administration.

Adverse Reactions

Frequently headache, nausea.

Possible abdominal pain, ovarian hyperstimulation syndrome, ectopic pregnancy, spontaneous abortion.

Rarely dizziness, weakness, malaise.

Local reactions skin reaction (most often redness with or without swelling).

Contraindications

Moderate or severe liver dysfunction; moderate or severe renal dysfunction; pregnancy; lactation (breastfeeding); hypersensitivity to ganirelix; hypersensitivity to GnRH or any other GnRH analogue.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in moderate or severe liver dysfunction.

Use in Renal Impairment

Contraindicated in moderate or severe renal dysfunction.

Pediatric Use

Not applicable.

Geriatric Use

Not applicable.

Special Precautions

Use with particular caution in patients with allergy symptoms. Use is not recommended in cases of severe allergic reactions due to the lack of clinical experience with its use in this category of patients.

Ovarian hyperstimulation syndrome may occur during or after drug-induced ovarian stimulation (when using r-hCG preparations). In such cases, symptomatic treatment is carried out (bed rest, intravenous infusion of electrolyte and colloid solutions and heparin).

The safety and efficacy of ganirelix in women with body weight less than 50 kg or more than 90 kg have not been established.

In experimental studies, no teratogenic properties of ganirelix were identified.

Drug Interactions

When ganirelix is used concomitantly with other drugs, including agents that stimulate histamine release, the possibility of drug interaction cannot be excluded.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.