Progestin

Progestin-containing Intrauterine System

<section class="Section" data-sectioncode="34089-3"><a name="_11_Description"></a><a name="section-9"></a><h1>11        DESCRIPTION</h1><div class="Section" data-sectioncode="42229-5"><a name="section-9.1"></a><h2>11.1        LILETTA</h2>LILETTA (levonorgestrel-releasing intrauterine system) contains 52 mg of levonorgestrel, a progestin, and is intended to provide an initial release rate of 20.4 mcg/day of levonorgestrel.Levonorgestrel USP, (-)-13-ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, the active ingredient in LILETTA, is the levorotatory form of norgestrel, which consists of a racemic mixture of D-(–)-norgestrel (levonorgestrel) and L-(+)-norgestrel (dextronorgestrel). It has a molecular weight of 312.45, a molecular formula of C21H28O2, and the following structural formula:<img alt="the following structural formula: Levonorgestrel USP, (-)-13-ethyl-17-hydroxy-18,19-dinor-17-pregn-4-en-20-yn-3-one, the active ingredient in LILETTA, is the levorotatory form of norgestrel, which consists of a racemic mixture of D-(–)-norgestrel (levonorgestrel) and L-(+)-norgestrel (dextronorgestrel). It has a molecular weight of 312.45, a molecular formula of C21H28O2." src="liletta-shi-11.jpg"/>LILETTA consists of a T-shaped polyethylene frame (T-frame) with a drug reservoir around the vertical stem (Figure 15). The T-frame has a loop at one end of the vertical stem and two horizontal arms at the other end. The drug reservoir consists of a cylinder, made of a mixture of 52 mg levonorgestrel and polydimethylsiloxane (PDMS) formed from silicone base, tetra-n-propyl silicate, and stannous octoate. The drug reservoir is covered by a translucent PDMS membrane. The low-density polyethylene of the T-frame is compounded with barium sulfate, which makes it radio-opaque. A blue polypropylene monofilament removal thread is attached to an eyelet at the end of the vertical stem of the T-frame. The polypropylene of the removal thread contains a copper-containing pigment as a colorant. The components of LILETTA, including its packaging, are not manufactured using natural rubber latex.  Figure 15:  Diagram of LILETTA<img alt="Figure 15" src="liletta-shi-12.jpg"/></div><div class="Section" data-sectioncode="42229-5"><a name="section-9.2"></a><h2>11.2        Inserter</h2>The inserter device provided with LILETTA is a single-use, disposable, sterile insertion system (tube, flange, handle; Figure 16), partially preloaded with the IUS product for intrauterine administration.Once LILETTA has been inserted, the inserter is discarded.Figure 16:  Diagram of Inserter<img alt="Figure 16" src="liletta-shi-13.jpg"/></div></section>

LILETTA

levonorgestrel 0.000813 MG/HR Intrauterine System

Liletta

levonorgestrel 0.000813 MG/HR Intrauterine System [Liletta]

levonorgestrel

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

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Cosentyx

Siliq

Tremfya

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Stelara

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Ilumya

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Aimovig

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Opzelura

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Lorbrena

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Alunbrig

NSCLC cMET Mutation

Xalkori

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Xeljanz

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COVID-19 Treatment

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Entyvio

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Prescribing Information

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About Liletta

What To Expect with Liletta

FAQs: Pregnancy Prevention

Doctor Discussion Guide

Instructions For Use: Pregnancy Prevention

Billing & Coding Guide