Product image of Kyleena (Levonorgestrel) supplied by GNH India

Kyleena

Active Ingredient:
Levonorgestrel
Origin:
EU

Kyleena (Levonorgestrel)

Levonorgestrel, the active ingredient in Kyleena, is a progestin presented as a 19.5 mg intrauterine system for intrauterine use. It provides hormonal contraception by preventing pregnancy in women of reproductive age, releasing levonorgestrel locally to create an environment that inhibits fertilization and implantation.

GNH India supplies Kyleena as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable global distribution for this contraceptive device.

Manufacturer / TM Owner

Bayer Ag

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Indications & Clinical Uses

Kyleena (levonorgestrel) is a hormonal contraceptive used within the reproductive system to prevent pregnancy.

  • Contraception (prevention of pregnancy): provides long‑acting reversible birth control for women of childbearing age.
  • Hormonal intrauterine contraception: delivers continuous low‑dose levonorgestrel directly to the uterine lining for up to five years.
  • Management of menstrual bleeding: can reduce heavy menstrual bleeding and improve cycle regularity in users.

How It Works

  • Levonorgestrel released from the intrauterine system acts locally on the endometrium and cervical mucus. It thickens cervical mucus, impairs sperm motility and function, suppresses endometrial proliferation, and may inhibit ovulation. By maintaining these effects within the uterine environment, the device prevents fertilization and implantation, providing effective contraception for an extended period.

Side Effects

Common and serious adverse reactions have been reported with Kyleena.

Common Side Effects

  • Irregular vaginal bleeding or spotting
  • Amenorrhea (absence of periods)
  • Pelvic or abdominal cramping
  • Breast tenderness
  • Headache
  • Mood changes

Serious or Rare Side Effects

  • Uterine perforation
  • Device expulsion
  • Pelvic inflammatory disease
  • Ectopic pregnancy
  • Severe allergic reaction (anaphylaxis)
  • Infection at insertion site

Precautions & Warnings

Before using Kyleena, consider the following precautions and warnings.

  • Pregnancy: contraindicated; product is classified as Pregnancy Category X.
  • Current pelvic infection: avoid insertion until infection resolved.
  • History of uterine perforation or abnormal uterine anatomy: requires careful assessment.
  • Breastfeeding: generally acceptable, but discuss with healthcare provider.
  • Use of other hormonal contraceptives: may increase hormonal exposure; monitor for side effects.
  • Store at ambient temperature below 25 °C: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levonorgestrel may interact with other medicines, affecting its efficacy or safety.

Major Interactions (Avoid)

  • Enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin): may reduce levonorgestrel levels and contraceptive effectiveness.
  • Rifampin or other strong CYP3A4 inducers: can decrease hormonal activity of the IUS.
  • Concurrent use of hormonal therapies that increase estrogen exposure: may raise risk of thromboembolic events.

Moderate Interactions (Monitor Closely)

  • Antifungal agents such as ketoconazole: may increase levonorgestrel concentrations.
  • St John’s wort (hypericum perforatum): may modestly reduce contraceptive efficacy.
  • Certain antibiotics (e.g., griseofulvin): may have a mild effect on hormone levels.

Frequently Asked Questions

Kyleena is a levonorgestrel‑containing intrauterine system indicated for hormonal contraception. It is inserted into the uterus to provide long‑acting reversible birth control, preventing pregnancy for up to five years in women of reproductive age.

Levonorgestrel released from the device acts locally on the cervical mucus and endometrium. It thickens mucus to block sperm entry, impairs sperm motility, suppresses the growth of the uterine lining, and may inhibit ovulation, together preventing fertilization and implantation.

The dose of Kyleena is fixed; each device contains 19.5 mg of levonorgestrel and is designed for a five‑year duration. The prescribing clinician determines suitability and timing of insertion; no oral dosing regimen is required.

Kyleena is contraindicated in pregnancy and is classified as Pregnancy Category X. It may be inserted in breastfeeding women after discussing risks and benefits with a healthcare professional, as the device releases low systemic hormone levels.

To request Kyleena, visit the product page on gnhindia.com, submit an enquiry with the desired quantity, and provide institutional or trade credentials. GNH India’s sales team will verify eligibility, then respond with pricing, availability, shipping options, and required import documentation.

Compared with copper IUDs, Kyleena releases levonorgestrel, which can reduce menstrual bleeding and cause fewer cramping episodes. Compared with Mirena, Kyleena contains a lower hormone dose and is approved for a slightly shorter duration (up to five years versus five‑seven years), offering a smaller device profile.

Kyleena should be stored at ambient temperature below 25 °C, in its original sealed packaging, protected from moisture and direct sunlight. The device must be handled only by trained healthcare professionals during insertion and removal to maintain sterility.

Kyleena is a flexible, T‑shaped intrauterine system that a qualified clinician inserts through the cervix into the uterine cavity using a sterile inserter. The procedure is performed in a clinical setting under aseptic conditions, and the device remains in place for up to five years unless removal is required.

Serious risks include uterine perforation during insertion, device expulsion, pelvic inflammatory disease, and ectopic pregnancy if contraception fails. Users should seek immediate medical attention for severe abdominal pain, abnormal bleeding, fever, or signs of infection.

Kyleena is not suitable for women who are pregnant, have active pelvic infections, a known or suspected uterine perforation, untreated cervical or uterine cancer, unexplained vaginal bleeding, or a history of severe allergic reaction to levonorgestrel or device components.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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