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 long‑acting reversible contraception and prevents pregnancy in women of reproductive age by locally releasing hormone over up to five years.

GNH India supplies Kyleena as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with a focus on quality assurance, regulatory compliance and reliable global logistics for high‑volume medical product distribution and timely delivery to meet clinical demand.

Manufacturer / TM Owner

Bayer Ag

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Indications & Clinical Uses

  • Kyleena, a levonorgestrel-releasing intrauterine system, is used within the hormonal contraceptive pathway for birth control.
  • Contraception: Provides highly effective, long‑acting reversible birth control for women of reproductive age.
  • Prevention of pregnancy: Reduces the risk of unintended pregnancy through continuous intrauterine hormone release.
  • Family planning support: Enables women to plan and space pregnancies by offering reliable contraception for up to five years.
  • Management of menstrual bleeding: May reduce menstrual blood loss and associated symptoms in some users.

How It Works

  • Levonorgestrel released from the intrauterine system acts locally on the cervical mucus, endometrium and tubal motility. It thickens cervical mucus, creating a barrier to sperm entry, suppresses endometrial proliferation, and impairs sperm motility and function. The hormone may also inhibit ovulation in some cycles, collectively preventing fertilisation and implantation. These actions are confined to the uterine environment, resulting in minimal systemic exposure.

Side Effects

Kyleena may be associated with a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Irregular bleeding or spotting
  • Amenorrhea (absence of periods)
  • Pelvic or abdominal pain
  • Headache

Serious or Rare Side Effects

  • Uterine perforation
  • Device expulsion
  • Ectopic pregnancy
  • Pelvic inflammatory infection

Precautions & Warnings

  • Prior to Kyleena insertion and during use, several precautions should be observed to ensure patient safety.
  • Confirm non‑pregnancy: Verify the patient is not pregnant before device placement.
  • Assess uterine anatomy: Contraindicated in significant uterine abnormalities such as bicornuate uterus.
  • Screen for infection: Avoid insertion in the presence of active pelvic infection.
  • Evaluate hormonal contraindications: Not recommended for women with active breast cancer or severe liver disease.
  • Store at room temperature: Keep the device in its original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levonorgestrel released from Kyleena can interact with other medicines that affect hormone levels or metabolic pathways.

Major Interactions (Avoid)

  • Enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin): May markedly reduce contraceptive efficacy.
  • Rifampin and other strong enzyme inducers: Can lower levonorgestrel concentrations.

Moderate Interactions (Monitor Closely)

  • Antifungal azoles (e.g., ketoconazole): May increase hormone exposure.
  • St. John’s wort: May modestly decrease effectiveness.
  • Combined hormonal therapies: May lead to additive hormonal effects.

Frequently Asked Questions

Kyleena is a levonorgestrel‑releasing intrauterine system indicated for contraception and the prevention of pregnancy in women of reproductive age. It provides a highly effective, long‑acting reversible birth‑control method that can remain in place for up to five years, reducing the need for daily or monthly dosing.

Levonorgestrel released from the intrauterine system acts locally within the uterus. It thickens cervical mucus, creating a barrier that hinders sperm entry, suppresses the growth of the endometrium, and impairs sperm motility and function. In some cycles it may also inhibit ovulation, together preventing fertilisation and implantation.

Kyleena contains a total of 19.5 mg of levonorgestrel that is released continuously over a period of up to five years. The specific dosing regimen, including timing of insertion and follow‑up, is determined by the prescribing clinician based on the patient’s medical history and contraceptive needs.

Kyleena is contraindicated in women who are pregnant; it must be removed if pregnancy occurs. Limited data are available for use during breastfeeding, and most guidelines recommend postponing insertion until after the postpartum period and after lactation has been established, unless a clinician determines it is appropriate.

To order Kyleena, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets, and will request verification of trade or institutional credentials. The sales team then replies with pricing, availability, shipping details and any required import documentation.

The primary alternative intrauterine system is Mirena, which contains 52 mg of levonorgestrel and is approved for up to five years of use. Kyleena delivers a lower total hormone dose (19.5 mg), which may result in fewer hormonal side effects for some users while providing comparable contraceptive efficacy. Choice depends on individual patient factors and clinician judgment.

Kyleena should be stored at room temperature, below 25 °C, in its original sealed packaging. Protect the device from moisture, direct sunlight and extreme temperatures. Handling should be performed by trained healthcare professionals using aseptic technique during insertion, and the packaging should remain intact until the time of use.

Kyleena is inserted by a qualified healthcare provider into the uterine cavity using a specialized applicator. The procedure is performed in a clinical setting under sterile conditions. Once placed, the device releases levonorgestrel continuously; no further dosing is required until removal or replacement, typically after up to five years.

Serious risks associated with Kyleena include uterine perforation during insertion, device expulsion, ectopic pregnancy if contraception fails, and pelvic inflammatory infection. Patients should be instructed to seek immediate medical attention if they experience severe abdominal pain, abnormal bleeding, fever, or signs of infection following insertion.

Kyleena is contraindicated in women who are currently pregnant, have active pelvic infection, unexplained vaginal bleeding, known or suspected uterine anomalies (e.g., bicornuate uterus), untreated cervical cancer, or a history of breast cancer or severe liver disease. It should also be avoided in individuals with known hypersensitivity to levonorgestrel or any component of the device.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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