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 13.5 mg intrauterine system for intrauterine use. It prevents pregnancy by acting locally within the uterus to thicken cervical mucus, inhibit sperm function, and alter the endometrium.

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

Manufacturer / TM Owner

Bayer Austria Gmbh

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Indications & Clinical Uses

Kyleena, a hormonal contraceptive delivered via an intrauterine system, is indicated for the prevention of pregnancy.

  • Prevention of pregnancy: provides long‑acting reversible contraception for up to five years.

How It Works

  • Levonorgestrel released from the intrauterine system binds to progesterone receptors in the cervical mucus, endometrium, and tubal epithelium, thickening mucus, reducing sperm motility, and creating a hostile endometrial environment that prevents implantation; it may also suppress ovulation in some users.

Side Effects

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

Common Side Effects

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

Serious or Rare Side Effects

  • Uterine perforation during insertion
  • Expulsion of the device
  • Severe pelvic infection (e.g., tubo‑ovarian abscess)
  • Ectopic pregnancy if contraception fails
  • Allergic reaction (rash, swelling, anaphylaxis)

Precautions & Warnings

Prior to insertion and during use, several safety considerations should be observed.

  • Confirm non‑pregnancy: verify the patient is not pregnant before insertion.
  • Screen for uterine abnormalities: assess for fibroids, septa, or other malformations.
  • Evaluate for active pelvic infection: postpone insertion if infection is present.
  • Review concomitant medications: consider drugs that may reduce efficacy.
  • Provide follow‑up counseling: schedule post‑insertion check and advise on signs of complications.
  • Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levonorgestrel released from Kyleena can be affected by other medicines.

Major Interactions (Avoid)

  • Enzyme inducers (e.g., rifampin, carbamazepine, phenytoin): may markedly reduce levonorgestrel levels.
  • Antiretroviral drugs (e.g., efavirenz): can decrease contraceptive effectiveness.

Moderate Interactions (Monitor Closely)

  • Antifungal agents (e.g., ketoconazole, itraconazole): may increase levonorgestrel exposure.
  • St. John's wort: may modestly lower hormone concentrations.
  • Certain antibiotics (e.g., griseofulvin): potential modest reduction in efficacy.

Frequently Asked Questions

Kyleena is an intrauterine system that provides long‑acting reversible contraception. It is prescribed to prevent pregnancy for up to five years by releasing levonorgestrel directly into the uterine cavity.

Levonorgestrel released from the device thickens cervical mucus, impairs sperm motility, and alters the uterine lining, creating conditions that prevent fertilisation and implantation. In some users it may also suppress ovulation.

The dosage of Kyleena is set by the prescribing clinician. The device contains a fixed 13.5 mg of levonorgestrel and is inserted once, providing contraception for up to five years without the need for daily dosing.

Kyleena is contraindicated in pregnancy and should not be inserted in a pregnant woman. Women who become pregnant while using Kyleena should consult their healthcare provider. Limited data are available for breastfeeding; discuss risks with a clinician.

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 oral contraceptive pills, Kyleena offers continuous, low‑maintenance protection without daily adherence. Unlike copper IUDs, it releases a progestin, which may reduce menstrual bleeding and cramping. Its efficacy and safety profile are comparable to other levonorgestrel‑releasing IUS devices.

Kyleena should be stored at ambient temperature, below 25 °C, in its original sealed packaging. Protect the device from moisture, direct sunlight and physical damage until the time of insertion.

Kyleena is inserted by a qualified healthcare professional into the uterine cavity through the cervix. The procedure is performed in a clinical setting using a sterile insertion device and typically takes only a few minutes.

Serious risks include uterine perforation during insertion, expulsion of the device, severe pelvic infection, ectopic pregnancy if contraception fails, and rare allergic reactions. Prompt medical attention is required if any of these events occur.

Kyleena should not be used by women who are pregnant, have active pelvic infections, unexplained vaginal bleeding, known or suspected uterine abnormalities, or a history of breast cancer. Contraindications also include severe liver disease and hypersensitivity to levonorgestrel.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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