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 progestogen presented as a 19.5 mg levonorgestrel‑releasing intrauterine system for intrauterine use. It provides long‑acting hormonal contraception by releasing levonorgestrel locally within the uterus, thereby preventing pregnancy in women of reproductive age.

GNH India supplies Kyleena as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality‑assured products that meet regulatory standards for intrauterine contraceptive devices. The company provides reliable logistics, regulatory support and after‑sales service to healthcare providers across multiple regions.

Manufacturer / TM Owner

Bayer Ab

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Indications & Clinical Uses

Kyleena, a levonorgestrel‑releasing intrauterine system, is indicated for hormonal contraception.

  • Contraception (prevention of pregnancy): provides up to five years of reliable birth control.
  • Reversible contraception: fertility typically returns promptly after device removal.
  • User‑controlled method: does not require daily dosing or routine compliance.

How It Works

  • Levonorgestrel released from the intrauterine system diffuses into the endometrium and cervical mucus. Locally high concentrations thicken cervical mucus, impair sperm motility and viability, and suppress endometrial proliferation. In some cycles the hormone also inhibits ovulation, collectively preventing fertilisation and implantation. The device delivers approximately 20 µg/day initially, decreasing gradually over the approved five‑year lifespan, ensuring sustained local hormone levels while systemic exposure remains low, which contributes to its favorable safety profile.

Side Effects

Levonorgestrel released from Kyleena may be associated with a range of adverse reactions.

Common Side Effects

  • Irregular bleeding: changes in menstrual pattern, spotting or prolonged bleeding.
  • Amenorrhea: absence of periods during use.
  • Pelvic pain: cramping or discomfort.
  • Vaginal discharge: mild discharge.

Serious or Rare Side Effects

  • Uterine perforation: rare injury during insertion.
  • Expulsion: device may be expelled from the uterus.
  • Infection: pelvic inflammatory disease or severe infection.

Precautions & Warnings

Before using Kyleena, healthcare providers should consider several precautionary measures.

  • Contraindications: avoid in women with active pelvic infection, uterine anomalies, or known hypersensitivity to levonorgestrel.
  • Pregnancy status: must not be inserted in pregnant women; confirm negative pregnancy test prior.
  • Breastfeeding: discuss risks and benefits; levonorgestrel is excreted in small amounts in breast milk.
  • Follow‑up: schedule pelvic exam after insertion to confirm correct placement.
  • Smoking: advise smokers to quit, as smoking increases thrombotic risk with hormonal devices.
  • Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levonorgestrel may interact with other medicines, affecting its efficacy or safety.

Major Interactions (Avoid)

  • CYP3A4 inducers: drugs such as rifampin, carbamazepine, phenytoin can reduce levonorgestrel levels, decreasing contraceptive effectiveness.
  • Antifungal azoles: strong inhibitors like ketoconazole may increase levonorgestrel exposure, potentially raising side‑effect risk.

Moderate Interactions (Monitor Closely)

  • Antiretrovirals: certain protease inhibitors may alter hormone metabolism; monitor for breakthrough bleeding.
  • Anticonvulsants: enzyme‑inducing agents may lower hormone levels; consider alternative contraception.
  • Herbal supplements: St. John’s wort can decrease levonorgestrel concentrations.

Frequently Asked Questions

Kyleena is a levonorgestrel‑releasing intrauterine system that provides long‑acting hormonal contraception. It is inserted into the uterus to prevent pregnancy for up to five years, offering a reversible, user‑independent birth‑control option for women of reproductive age.

Levonorgestrel released from the device acts locally on the cervix and endometrium. It thickens cervical mucus, reduces sperm motility, suppresses the growth of the uterine lining, and may inhibit ovulation, together preventing fertilisation and implantation.

Kyleena contains a total of 19.5 mg of levonorgestrel that is released at a controlled rate, starting at about 20 µg per day and gradually decreasing over its approved five‑year lifespan. The exact dosing schedule is set by the prescribing clinician.

Kyleena must not be inserted in a woman who is pregnant, and it is contraindicated for use during pregnancy. For breastfeeding mothers, levonorgestrel is excreted in small amounts in breast milk; clinicians should weigh benefits against potential risks before recommending use.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying 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 required import documentation.

Kyleena delivers a lower total levonorgestrel dose (19.5 mg) compared with some alternatives such as Mirena (52 mg), resulting in a smaller uterine size and potentially fewer hormonal side effects, while still offering up to five years of effective contraception.

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 it is inserted by a qualified healthcare professional.

Kyleena is inserted into the uterus by a trained clinician using a specialized inserter. The procedure is performed in a clinical setting, typically after confirming a negative pregnancy test and ensuring the patient meets all eligibility criteria.

Serious risks include uterine perforation during insertion, device expulsion, and pelvic infection such as pelvic inflammatory disease. These events are rare but require prompt medical evaluation and management if they occur.

Kyleena is contraindicated in women with active pelvic infection, known or suspected uterine anomalies, untreated cervical cancer, current pregnancy, or a documented hypersensitivity to levonorgestrel or any component of the device.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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