Product image of Ovaleap (Follitropin Alfa (Genetical Recombination)) supplied by GNH India

Ovaleap

Active Ingredient:
Follitropin Alfa (Genetical Recombination)
Origin:
EU

Ovaleap (Follitropin Alfa (Genetical Recombination))

Follitropin alfa, the active ingredient in Ovaleap, is a gonadotropin presented as a 75 IU/0.5 ml solution for subcutaneous injection use. It stimulates ovarian follicle development in women undergoing assisted reproductive technology.

GNH India supplies Ovaleap as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, fertility clinics and pharmacies worldwide.

Manufacturer / TM Owner

Theramex Ireland Limited

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Indications & Clinical Uses

Ovaleap is a recombinant follicle‑stimulating hormone used in the gonadotropin pathway to support assisted reproduction and ovulation induction.

  • In vitro fertilisation (IVF) cycles: promotes the growth of multiple ovarian follicles to enable egg retrieval.
  • Intracytoplasmic sperm injection (ICSI) cycles: enhances follicular development for precise sperm injection procedures.
  • Ovulation induction in anovulatory women: facilitates follicular maturation when combined with other agents such as hCG.

How It Works

  • Follitropin alfa is a recombinant form of human follicle‑stimulating hormone (FSH) that binds to FSH receptors on ovarian granulosa cells, activating adenylate cyclase and increasing intracellular cAMP. This signaling cascade promotes granulosa cell proliferation, estrogen synthesis, and the maturation of ovarian follicles, thereby preparing the ovary for ovulation or assisted reproductive procedures.

Side Effects

Common Side Effects

  • Injection site pain or erythema: mild discomfort at the subcutaneous site.
  • Ovarian hyperstimulation syndrome (mild): abdominal bloating and mild discomfort.
  • Headache: transient, often resolves without intervention.
  • Nausea: mild gastrointestinal upset.
  • Mood changes: occasional irritability or emotional lability.
  • Vaginal spotting: light bleeding unrelated to menstrual cycle.

Serious or Rare Side Effects

  • Severe ovarian hyperstimulation syndrome: rapid weight gain, shortness of breath, or significant abdominal distension.
  • Ovarian torsion: sudden severe pelvic pain requiring emergency evaluation.
  • Thromboembolic events: rare clot formation in veins or arteries.
  • Allergic reaction: rash, itching, or anaphylaxis.
  • Visual disturbances: blurred vision or ocular discomfort.
  • Persistent ovarian cysts: cysts lasting beyond the treatment cycle.

Precautions & Warnings

Before using Ovaleap, consider the following precautions:

  • Assess ovarian reserve: evaluate baseline hormone levels and antral follicle count.
  • Monitor for OHSS: schedule regular ultrasound and estradiol assessments.
  • Adjust dosage in renal or hepatic impairment: follow prescriber guidance.
  • Avoid use in uncontrolled thyroid disease: stabilize thyroid function first.
  • Counsel on signs of severe OHSS: educate patients to report rapid weight gain or shortness of breath.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Major Interactions (Avoid)

  • hCG or LH analogues administered concurrently: may exacerbate ovarian hyperstimulation.
  • Estrogen‑containing oral contraceptives: can blunt FSH response if not discontinued appropriately.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (e.g., warfarin): monitor for increased bleeding risk if OHSS occurs.
  • Thyroid hormone therapy: adjust dosing if thyroid function changes during treatment.
  • Glucocorticoids: may affect ovarian response; monitor follicular development.
  • Diuretics: can mask early signs of OHSS; observe fluid balance closely.
  • Antidepressants (SSRIs): monitor for mood changes that could be confused with hormonal effects.

Frequently Asked Questions

Ovaleap is a recombinant follicle‑stimulating hormone used to stimulate the development of ovarian follicles in women undergoing assisted reproductive technologies such as in‑vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI), and to induce ovulation in anovulatory women when combined with other hormonal agents.

Follitropin alfa mimics natural human follicle‑stimulating hormone (FSH). It binds to FSH receptors on ovarian granulosa cells, activating intracellular cAMP pathways that promote cell proliferation, estrogen production, and the maturation of ovarian follicles, thereby preparing the ovary for ovulation or egg retrieval.

The specific dose of Ovaleap is individualized by the prescribing clinician based on the patient’s ovarian reserve, treatment protocol, and response to therapy. Dosing regimens are adjusted throughout the stimulation cycle according to ultrasound and hormonal monitoring.

Ovaleap is intended for use before pregnancy to achieve conception. Its safety in established pregnancy has not been established, and it is not recommended during breastfeeding. Women should discuss any concerns with their healthcare provider before starting treatment.

To order Ovaleap, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain logistics if needed) and required import documentation.

Ovaleap is a recombinant FSH product, offering high purity and consistent activity compared with urinary‑derived gonadotropins. It provides predictable dosing and lower risk of immunogenic reactions, making it a preferred option for many fertility specialists when precise follicular control is required.

Ovaleap must be stored refrigerated at 2‑8 °C, protected from light, and should never be frozen or shaken. Before use, allow the vial to reach room temperature for a few minutes, inspect for particulate matter, and use aseptic technique for subcutaneous injection.

Ovaleap is supplied as a sterile solution for subcutaneous injection. The prescribed dose is drawn into a sterile syringe and injected into the abdominal wall or thigh, rotating injection sites to minimise local reactions. Administration is performed by the patient or a trained healthcare professional.

The most serious risks include severe ovarian hyperstimulation syndrome (OHSS), which can cause rapid weight gain, abdominal pain, shortness of breath, and, in rare cases, thromboembolic events or ovarian torsion. Prompt medical attention is required if these symptoms develop.

Ovaleap should not be used in women with known hypersensitivity to any component of the product, uncontrolled thyroid disease, active ovarian cysts, or severe ovarian failure. It is also contraindicated in patients with a history of severe OHSS or those who are pregnant.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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