Ovidrel250 mcg/0.5 ml

Ovidrel is a recombinant form of human chorionic gonadotropin (hCG) used in the management of infertility as part of assisted reproductive technology (ART) and ovulation induction protocols. Its established indications include:

• Final oocyte/follicular maturation and triggering of ovulation in infertile women undergoing superovulation as part of an ART program (e.g., in-vitro fertilization), administered after adequate follicular development has been achieved with follicle-stimulating hormone (FSH) therapy.
• Induction of ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure, used as part of a combined ovulation-induction regimen together with gonadotropin therapy (adjunct/combination use, not as monotherapy).

Ovidrel is intended for use only under the supervision of a physician experienced in the treatment of infertility, with appropriate ultrasound and hormonal monitoring. It is not indicated for use in males or for weight loss, and such uses are not supported by evidence.

Each pre-filled syringe/vial of Choriogonadotropin Alpha contains recombinant human chorionic gonadotropin (r-hCG) produced by recombinant DNA technology, typically formulated as 250 mcg (approximately equivalent to 6,500 international units) per dose, along with pharmaceutical excipients required for a sterile injectable solution or lyophilized powder. Strength and pack size may vary by manufacturer; refer to the specific product label for exact composition.

Ovidrel is a recombinant human chorionic gonadotropin (hCG) analogue produced using recombinant DNA technology in mammalian cell culture. Structurally and functionally similar to naturally occurring hCG, it mimics the mid-cycle luteinizing hormone (LH) surge, thereby triggering the final stages of follicular maturation, oocyte release (ovulation), and luteinization required for successful conception in assisted reproduction and ovulation-induction protocols. It is administered by injection under specialist supervision as part of a structured fertility treatment cycle.

Ovidrel belongs to the therapeutic class of gonadotropins, specifically ovulation-inducing agents / fertility hormones (recombinant human chorionic gonadotropin).

Choriogonadotropin Alpha is a recombinant human chorionic gonadotropin (hCG) that binds to the same receptor as luteinizing hormone (LH) - the LH/hCG receptor - on ovarian granulosa and theca cells. By mimicking the natural LH surge, it triggers resumption of meiosis in the oocyte, follicular rupture (ovulation), and luteinization of the granulosa cells, which supports progesterone production by the resulting corpus luteum.

Pharmacokinetics

• Absorption: Well absorbed after subcutaneous injection; peak serum concentrations are reached within approximately 12-24 hours.
• Distribution: Distributes primarily within the extracellular fluid compartment.
• Elimination half-life: Approximately 29-30 hours (terminal half-life), allowing detectable hCG levels for up to 7-10 days after administration, which is relevant to pregnancy test interpretation.
• Excretion: Eliminated mainly via the kidneys.

Ovidrel is given as a subcutaneous injection, usually into the lower abdomen. Patients or caregivers may be trained by the treating clinic to self-administer the pre-filled syringe at home at the precise time instructed, since correct timing relative to egg retrieval or intercourse is essential. The injection site should be rotated, and the solution should be inspected visually; it should not be used if discolored or containing particulate matter. Do not administer if pregnancy is confirmed or suspected (see Contraindications).

Formal drug-interaction studies with Ovidrel are limited, reflecting its specialized use within controlled fertility treatment protocols. Clinically significant considerations include:

• Other fertility medications (e.g., FSH, hMG, GnRH agonists/antagonists): Ovidrel is used in combination with these agents by design as part of a controlled ovarian stimulation protocol; the combination itself increases the risk of ovarian hyperstimulation syndrome (OHSS) and multiple pregnancy, and must be managed by a fertility specialist (see Precautions and Warnings).
• Interference with laboratory pregnancy testing: Because Ovidrel is itself detected by hCG-based pregnancy tests, testing performed too soon after administration can give a false-positive result; the treating clinic will advise on the correct timing for a reliable pregnancy test.

The most commonly reported side effects of Ovidrel include:

• Injection site reactions (pain, redness, bruising, or swelling) - the most frequently reported adverse effect.
• Abdominal pain or discomfort, bloating.
• Nausea, vomiting, headache.
• Post-procedural pelvic pain (in ART cycles).

Less common but serious effects include ovarian hyperstimulation syndrome (OHSS), multiple pregnancy, ectopic pregnancy, and (rarely) thromboembolic events or hypersensitivity/anaphylactic reactions - see Precautions and Warnings for details.

Ovidrel is contraindicated for use during established pregnancy; it has no indication for use once pregnancy is confirmed, and treatment is intended only to trigger ovulation prior to conception. If pregnancy is suspected during a treatment cycle, contact the treating physician promptly.

Data on the use of Ovidrel during breastfeeding are limited. Because it is used only as part of a defined pre-conception fertility protocol, breastfeeding women should use Ovidrel only if clearly needed and under the direct guidance of their physician, who can weigh the potential benefit against any potential risk.

Use of Ovidrel requires close specialist supervision because of the following important safety considerations:

• Ovarian hyperstimulation syndrome (OHSS): A potentially serious and rapidly progressive complication of assisted reproductive technology. Symptoms include abdominal pain and distension, nausea, vomiting, rapid weight gain, and decreased urination. Patients should be monitored closely and instructed to seek prompt medical evaluation if these symptoms occur; severe OHSS may require hospitalization.
• Multiple pregnancy: A recognized and significant risk with ovulation-induction therapies, including Ovidrel; patients should be counseled about this risk before treatment.
• Thromboembolic events: Thromboembolic events have been reported in association with OHSS, and rarely independent of it; patients with additional risk factors for thrombosis warrant careful evaluation.
• Ectopic pregnancy: Patients with a history of tubal disease are at increased risk of ectopic pregnancy following successful conception with ART or ovulation induction.
• Specialist administration and monitoring: Ovidrel requires individualized dosing by a fertility/reproductive endocrinology specialist, with ultrasound and hormone-level monitoring; it is not a general-practice or self-titrated medication.
• Injection site reactions can occur and are usually mild and self-limiting.

Overdose of Ovidrel may increase the risk of ovarian hyperstimulation syndrome (OHSS). There is no specific antidote. If an overdose is suspected or symptoms of severe OHSS (severe abdominal pain, marked abdominal distension, persistent vomiting, difficulty breathing, or markedly decreased urination) develop, seek immediate medical attention or contact emergency services; do not attempt to manage this at home.

Store Ovidrel in a refrigerator (2°C to 8°C), protected from light, unless the product labeling specifically permits room-temperature storage for a limited period before use - follow the instructions provided with your specific product. Do not freeze. Keep out of reach of children. Discard any unused solution after the labeled expiry date or as advised by your pharmacist.

Renal or hepatic impairment: The safety, efficacy, and pharmacokinetics of Ovidrel have not been established in patients with renal or hepatic impairment; use with caution and under specialist guidance if prescribed.

Elderly (geriatric use): Ovidrel is not indicated for use in elderly patients, as it is used exclusively in women of reproductive age undergoing fertility treatment; safety and effectiveness in this population have not been established.

Use in males: Ovidrel is indicated for female infertility treatment only under this labeling; use in males falls outside the scope of the established indications discussed here.

Ovidrel is given as a single dose (one injection) to trigger final oocyte maturation/ovulation at the precise point in a monitored fertility treatment cycle determined by the treating physician, rather than as a continuous or repeated-dose therapy. The overall duration of the fertility treatment cycle in which it is used is determined and monitored by the fertility specialist.

If Ovidrel is supplied as a lyophilized powder, reconstitute using only the diluent supplied with the product, gently swirling (do not shake) until the powder is fully dissolved. Use the reconstituted solution immediately and discard any unused portion, unless the product labeling specifically states otherwise. Pre-filled syringe formulations of Ovidrel are ready to use and do not require reconstitution.

Gonadotropins; ovulation-inducing agents; recombinant human chorionic gonadotropin (r-hCG) analogues.

Choriogonadotropin Alpha acts as an LH-receptor agonist. It binds to and activates the same G-protein-coupled LH/hCG receptor on ovarian granulosa and theca cells that endogenous luteinizing hormone (LH) activates during the natural mid-cycle LH surge. This triggers resumption of meiosis I in the oocyte, follicular wall rupture and oocyte release (ovulation), and transformation of the ruptured follicle into a corpus luteum that secretes progesterone to support the luteal phase and early pregnancy if fertilization occurs.

The safety and effectiveness of Ovidrel have not been established in pediatric patients. Ovidrel is indicated only for use in adult women undergoing fertility treatment and is not used in children or adolescents outside of specialist-directed evaluation of specific pediatric endocrine conditions, which is outside the scope of this labeling.