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 hormonal contraception by releasing levonorgestrel directly into the uterine cavity, thereby preventing pregnancy in women of reproductive age. It works through multiple mechanisms that affect sperm function and the endometrium.

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 regulatory documentation for each shipment.

Manufacturer / TM Owner

Bayer Hispania Sl

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Indications & Clinical Uses

  • Kyleena, a levonorgestrel‑based intrauterine system, is indicated for hormonal contraception.
  • Contraception (prevention of pregnancy): Provides highly effective, reversible birth control for up to five years in women of reproductive age.

How It Works

  • Levonorgestrel released from the intrauterine system thickens cervical mucus, reduces sperm motility and viability, suppresses endometrial proliferation, and may inhibit ovulation. These combined actions create an environment that prevents fertilisation and implantation, thereby providing reliable contraception.

Side Effects

Kyleena may cause a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Irregular menstrual bleeding or spotting
  • Amenorrhea (absence of periods)
  • Headache
  • Breast tenderness
  • Mood changes
  • Abdominal or pelvic pain

Serious or Rare Side Effects

  • Pelvic inflammatory disease
  • Uterine perforation during insertion
  • Ectopic pregnancy
  • Severe allergic reaction (anaphylaxis)

Precautions & Warnings

  • Before using Kyleena, consider the following precautions.
  • Pregnancy testing: Ensure the patient is not pregnant before insertion.
  • Uterine abnormalities: Evaluate for fibroids, congenital anomalies, or scarring.
  • Recent pelvic infection: Treat any active infection prior to placement.
  • Breastfeeding: Discuss benefits and risks with the prescriber.
  • Follow‑up: Schedule post‑insertion check to confirm correct positioning.
  • Store at ambient temperature: Keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Kyleena may interact with other medications that affect hormonal balance or uterine environment.

Major Interactions (Avoid)

  • Anticonvulsants (e.g., carbamazepine, phenytoin): May reduce levonorgestrel effectiveness.
  • Rifampin or other enzyme‑inducing antibiotics: Can lower hormone levels.

Moderate Interactions (Monitor Closely)

  • Hormonal therapies (e.g., estrogen‑containing contraceptives): May increase risk of thromboembolic events.
  • Antifungal agents (e.g., ketoconazole): Potentially increase levonorgestrel concentrations.
  • Herbal supplements (e.g., St. John’s wort): May alter hormone metabolism.

Frequently Asked Questions

Kyleena is a levonorgestrel‑releasing intrauterine system indicated for the prevention of pregnancy. It provides a long‑acting, reversible method of hormonal contraception for women of reproductive age, typically effective for up to five years after insertion.

Levonorgestrel released from Kyleena thickens cervical mucus, impairs sperm motility and function, suppresses the growth of the uterine lining, and may inhibit ovulation. These actions together create conditions that prevent fertilisation and implantation.

Kyleena is supplied as a single intrauterine system containing 19.5 mg of levonorgestrel. The device is inserted by a qualified healthcare professional and releases a controlled amount of hormone over several years. The specific dosing regimen is determined by the prescriber.

Kyleena is contraindicated in pregnancy and is classified as pregnancy category X. It should not be used by women who are pregnant or planning to become pregnant. While breastfeeding is not an absolute contraindication, the prescriber should evaluate risks and benefits before use.

To order Kyleena, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Compared with other levonorgestrel‑based IUS such as Mirena, Kyleena contains a lower total hormone load (19.5 mg vs. 52 mg) and is approved for a slightly shorter duration of up to five years. Both provide effective contraception, but Kyleena may be preferred for women seeking a lower hormone exposure.

Kyleena should be stored at ambient temperature, below 25 °C, in its original sealed packaging. Protect the device from moisture, direct sunlight and extreme temperatures to maintain its integrity until insertion.

Kyleena is inserted into the uterine cavity by a trained healthcare professional using a specialized inserter. The procedure is performed in a clinical setting under aseptic conditions, and the device remains in place to release levonorgestrel continuously for up to five years.

Serious risks include uterine perforation during insertion, pelvic inflammatory disease, ectopic pregnancy if contraception fails, and severe allergic reactions such as anaphylaxis. Patients should be monitored for signs of infection, abnormal bleeding, or severe abdominal pain.

Kyleena is contraindicated in women who are pregnant, have known or suspected uterine abnormalities (e.g., fibroids, congenital malformations), active pelvic infections, unexplained vaginal bleeding, or a history of breast cancer. It should also be avoided in individuals with hypersensitivity to levonorgestrel or any device components.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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