Iclevia

Last updated on RxList: 5/18/2020
Iclevia Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Iclevia?

Iclevia (levonorgestrel and ethinyl estradiol kit) is a combined oral contraceptive (COC) indicated for use by females of reproductive potential to prevent pregnancy.

What Are Side Effects of Iclevia?

Side effects of Iclevia include:

Dosage for Iclevia

Iclevia are available in Extended-Cycle Wallets, each containing a 13-week supply of tablets. Patients are instructed to take Iclevia once a day by mouth at the same time every day for 91 days. To achieve maximum contraceptive effectiveness, Iclevia should be taken exactly as directed and at intervals not exceeding 24 hours.

Iclevia In Children

Safety and efficacy of Iclevia have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. Use of Iclevia before menarche is not indicated.

What Drugs, Substances, or Supplements Interact with Iclevia?

Iclevia may interact with other medicines such as:

  • phenytoin,
  • barbiturates,
  • carbamazepine,
  • bosentan,
  • felbamate,
  • griseofulvin,
  • oxcarbazepine,
  • rifampicin,
  • topiramate,
  • rifabutin,
  • rufinamide,
  • aprepitant,
  • St. John's wort,
  • colesevelam,
  • atorvastatin or rosuvastatin,
  • itraconazole,
  • voriconazole,
  • fluconazole,
  • ketoconazole,
  • grapefruit juice,
  • HIV or HCV protease inhibitors,
  • cyclosporine,
  • prednisolone,
  • theophylline,
  • tizanidine,
  • acetaminophen,
  • clofibric acid,
  • morphine,
  • salicylic acid,
  • temazepam,
  • lamotrigine,
  • thyroid hormone replacement therapy, and
  • HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

Tell your doctor all medications and supplements you use.

Iclevia During Pregnancy and Breastfeeding

Iclevia is intended for use to prevent pregnancy. Nursing mothers are advised to use other forms of contraception, when possible, until they have weaned their children. COCs such as Iclevia can reduce milk production in breastfeeding mothers. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Iclevia (levonorgestrel and ethinyl estradiol kit) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Which of the following are methods for contraception? See Answer
Iclevia Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using birth control pills and call your doctor at once if you have:

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, swelling or redness in an arm or leg;
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • liver problems--loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;
  • swelling in your hands, ankles, or feet;
  • changes in the pattern or severity of migraine headaches;
  • a breast lump; or
  • symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

  • mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;
  • breast tenderness or swelling, nipple discharge;
  • freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
  • changes in weight or appetite;
  • problems with contact lenses;
  • vaginal itching or discharge; or
  • changes in your menstrual periods, decreased sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Iclevia (Levonorgestrel and Ethinyl Estradiol Tablets)

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Iclevia Professional Information

SIDE EFFECTS

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

  • Serious cardiovascular events and stroke [see BOX WARNING and WARNINGS AND PRECAUTIONS]
  • Vascular events [see WARNINGS AND PRECAUTIONS]
  • Liver disease [see WARNINGS AND PRECAUTIONS]

Adverse reactions commonly reported by COC users are:

  • Irregular uterine bleeding
  • Nausea
  • Breast tenderness
  • Headache

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The clinical trial that evaluated the safety and efficacy of Iclevia was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18 to 40, of whom 456 took at least one dose of Iclevia (345.14 woman-years of exposure) [see Clinical Studies].

Adverse Reactions Leading To Study Discontinuation

14.9% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions (≥ 1% of women) leading to discontinuation in the Iclevia group were menorrhagia (5.7%), mood swings (1.9%), weight/appetite increase (1.5%), and acne (1.3%).

Common Adverse Reactions (≥ 2% Of Women)

headache (20.6%), menorrhagia (11.6%), nausea (7.5%), dysmenorrhea (5.7%), acne (4.6%), migraine (4.4%), breast tenderness (3.5%), weight increased (3.1%), and depression (2.1%).

Serious Adverse Reactions

pulmonary embolus, cholecystitis.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Iclevia. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal disorders: abdominal distension, vomiting

General disorders and administration site conditions: chest pain, fatigue, malaise, edema peripheral, pain

Immune system disorder: hypersensitivity reactions, including itching, rash, and angioedema

Investigations: blood pressure increased

Musculoskeletal and connective tissue disorders: muscle spasms, pain in extremity

Nervous system disorders: dizziness, loss of consciousness

Psychiatric disorders: insomnia

Reproductive and breast disorders: dysmenorrhea

Skin and subcutaneous tissue disorders: alopecia

Vascular disorders: thrombosis, pulmonary embolism, pulmonary thrombosis

Read the entire FDA prescribing information for Iclevia (Levonorgestrel and Ethinyl Estradiol Tablets)

© Iclevia Patient Information is supplied by Cerner Multum, Inc. and Iclevia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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