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 an intrauterine system for intrauterine use. The device releases levonorgestrel locally to provide continuous contraception, preventing pregnancy in women of reproductive age for up to five years.

GNH India supplies Kyleena as a licensed, GDP‑compliant international pharmaceutical supplier, providing the intrauterine system to hospitals, pharmacies and clinics worldwide, and supporting global procurement with regulatory expertise and reliable logistics. Our network ensures timely delivery and compliance with local health authority requirements, and we also offer technical assistance for device insertion and patient counseling.

Manufacturer / TM Owner

Bayer Ab

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Indications & Clinical Uses

  • Kyleena, containing levonorgestrel, is used in the hormonal contraceptive pathway to prevent pregnancy.
  • Contraception: provides continuous prevention of pregnancy for up to five years.
  • LARC (Long‑acting reversible contraception): offers a reversible, hormone‑based intrauterine method.
  • Family planning: enables women to plan pregnancies with a single insertion and minimal maintenance.

How It Works

  • Levonorgestrel released from the intrauterine system diffuses into the endometrium and cervical mucus, binding to progesterone receptors. This action thickens cervical mucus, impairs sperm motility and function, and suppresses endometrial development, thereby preventing fertilisation and implantation.

Side Effects

Side effects are reported by some users of the intrauterine system.

Common Side Effects

  • Irregular bleeding or spotting
  • Amenorrhea (absence of periods)
  • Pelvic or cramping pain
  • Breast tenderness
  • Headache
  • Acne or oily skin

Serious or Rare Side Effects

  • Uterine perforation
  • Device expulsion
  • Pelvic inflammatory infection
  • Ectopic pregnancy
  • Ovarian cyst formation
  • Severe allergic reaction (anaphylaxis)

Precautions & Warnings

  • Before insertion, several precautions should be observed.
  • Screen for pregnancy: confirm the patient is not pregnant prior to device placement.
  • Assess uterine anatomy: avoid use in women with known uterine anomalies or fibroids that distort the cavity.
  • Check for active infection: postpone insertion if pelvic infection or sexually transmitted disease is present.
  • Consider hormonal contraindications: do not use in patients with estrogen‑dependent tumours or severe liver disease.
  • Monitor device position: schedule follow‑up examinations to detect displacement or expulsion.
  • Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levonorgestrel may interact with other medicines that affect hormone metabolism.

Major Interactions (Avoid)

  • Enzyme inducers (e.g., rifampin, carbamazepine, phenytoin): may markedly reduce levonorgestrel efficacy.
  • Antifungal azoles (e.g., ketoconazole, itraconazole): can increase levonorgestrel levels and risk of side effects.
  • HIV protease inhibitors (e.g., ritonavir): may alter hormone concentrations.

Moderate Interactions (Monitor Closely)

  • Certain antibiotics (e.g., rifampicin, griseofulvin): may modestly decrease contraceptive effectiveness.
  • Antiepileptic drugs with mixed enzyme activity: require clinical monitoring of contraceptive reliability.

Frequently Asked Questions

Kyleena is a hormonal intrauterine system that provides long‑acting reversible contraception, preventing pregnancy for up to five years after a single insertion by releasing levonorgestrel directly into the uterus.

Levonorgestrel released from the device binds to progesterone receptors in the cervical mucus and endometrium, thickening the mucus, inhibiting sperm motility, and suppressing the growth of the uterine lining, which together block fertilisation and implantation.

The dosage regimen of Kyleena is determined by the prescribing healthcare professional; the device contains a fixed amount of levonorgestrel that provides continuous release for up to five years and is not adjusted by the patient.

Kyleena must not be inserted in a woman who is already pregnant. Women who become pregnant after insertion should have the device removed. Limited data are available for breastfeeding; clinicians should evaluate risks and benefits on an individual basis.

To place an order, submit an enquiry on the Kyleena 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 necessary import documentation.

Compared with copper IUDs, Kyleena releases a progestin rather than copper, resulting in fewer menstrual bleeding changes and a lower incidence of dysmenorrhoea. Compared with Mirena, Kyleena contains a lower levonorgestrel dose and is slightly smaller, making it suitable for women who have not previously given birth.

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

Kyleena is inserted by a qualified clinician into the uterine cavity through the cervical canal using a specialised inserter. The procedure is performed in a clinical setting under aseptic conditions and does not require anesthesia in most cases.

The most serious complications include uterine perforation during insertion, device expulsion, pelvic inflammatory infection, and the rare possibility of ectopic pregnancy if fertilisation occurs despite the device.

Kyleena is contraindicated in women who are currently pregnant, have active pelvic infection, unexplained vaginal bleeding, known or suspected uterine anomalies, estrogen‑dependent tumours, severe liver disease, or who are allergic to levonorgestrel or any component of the device.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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