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 synthetic progestin presented as a 19.5 mg intrauterine system (IUS) for intrauterine use. It provides long‑acting hormonal contraception by releasing levonorgestrel locally to prevent pregnancy in women of reproductive age, with up to five years of approved use after insertion by a qualified clinician.

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

Manufacturer / TM Owner

Bayer Ab

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Indications & Clinical Uses

  • Kyleena, a hormonal intrauterine contraceptive, is indicated for prevention of pregnancy.
  • Contraception (prevention of pregnancy): provides highly effective, reversible birth control for women of reproductive age, offering up to five years of protection after insertion.

How It Works

  • Levonorgestrel released from the intrauterine system acts locally on the cervical mucus, endometrium and sperm. It thickens cervical mucus to impede sperm entry, reduces sperm motility and viability, and suppresses endometrial proliferation, thereby preventing implantation and achieving contraception without significant systemic hormone levels.

Side Effects

Common Side Effects

  • Irregular bleeding or spotting
  • Amenorrhea (absence of periods)
  • Pelvic or abdominal cramping
  • Vaginal discharge
  • Headache
  • Breast tenderness

Serious or Rare Side Effects

  • Uterine perforation during insertion
  • Device expulsion or displacement
  • Pelvic inflammatory infection
  • Ectopic pregnancy if fertilization occurs
  • Ovarian cyst formation
  • Severe allergic reaction

Precautions & Warnings

  • Before insertion, evaluate patient suitability and counsel on risks.
  • Screen for contraindications: ensure no active pelvic infection, unexplained vaginal bleeding, or uterine anomalies.
  • Pregnancy status: confirm the patient is not pregnant prior to placement.
  • Breastfeeding: consider alternative contraception during the first six weeks postpartum.
  • Smoking: advise cessation, especially in women over 35 years of age.
  • Follow‑up: schedule a post‑insertion visit to confirm correct device positioning.
  • Store at room temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Major Interactions (Avoid)

  • Rifampin and other strong enzyme inducers that may lower levonorgestrel levels.
  • Certain antiretroviral drugs (e.g., protease inhibitors) that affect hormone metabolism.
  • St. John's wort, a herbal inducer of hepatic enzymes.

Moderate Interactions (Monitor Closely)

  • Other hormonal therapies that could alter bleeding patterns.
  • Some antibiotics (e.g., griseofulvin) with potential enzyme‑inducing effects.
  • Antifungal agents (e.g., ketoconazole) that may increase levonorgestrel exposure.
  • Herbal supplements such as ginseng that could affect hormone activity.

Frequently Asked Questions

Kyleena is a hormonal intrauterine system that provides long‑acting reversible contraception. It is used to prevent pregnancy in women of reproductive age and can remain effective for up to five years after insertion by a qualified healthcare professional.

Levonorgestrel released from Kyleena acts locally within the uterus. It thickens cervical mucus, reduces sperm motility and viability, and suppresses the growth of the endometrial lining, thereby preventing fertilization and implantation without requiring systemic hormone exposure.

The dose of levonorgestrel in Kyleena is fixed at 19.5 mg within the intrauterine system. The prescribing clinician determines the appropriate use and insertion schedule; no patient‑initiated dosing adjustments are required.

Kyleena is contraindicated in pregnancy and should not be inserted in a woman who is pregnant. For breastfeeding women, it may be used after the initial six‑week postpartum period, but clinicians often discuss alternative methods during early lactation.

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

Compared with copper IUDs, Kyleena releases a low dose of levonorgestrel, which often results in reduced menstrual bleeding and fewer cramping episodes. Its hormone‑based mechanism offers contraceptive efficacy similar to other hormonal IUS devices while providing a smaller size suitable for a broader range of uterine dimensions.

Kyleena should be stored at room temperature, ideally below 25 °C. Keep the device in its original packaging, protect it from moisture and direct sunlight, and avoid exposing it to extreme temperatures that could affect the integrity of the hormone reservoir.

Kyleena is inserted into the uterine cavity by a trained healthcare professional during a brief outpatient procedure. The device is placed through the cervix using a specialized inserter, after which the hormone‑releasing system remains in place for up to five years.

Serious risks include uterine perforation during insertion, device expulsion or displacement, pelvic inflammatory infection, and the rare possibility of ectopic pregnancy if fertilization occurs. Patients should seek immediate medical attention for severe abdominal pain, abnormal bleeding or signs of infection.

Kyleena is not recommended for women with active pelvic infections, unexplained vaginal bleeding, known or suspected uterine abnormalities, current pregnancy, or a history of breast cancer. Additionally, women who are allergic to levonorgestrel or any component of the device should avoid its use.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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