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Gianvi

Last reviewed on RxList: 3/22/2019
Gianvi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 3/22/2019

Gianvi (drospirenone/ethinyl estradiol) is an estrogen/progestin combined oral contraceptive (COC), indicated for use by women to prevent pregnancy, to treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception, and to treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. Common side effects of Gianvi include:

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.

The dose of Gianvi is one tablet taken daily by mouth at the same time every day, taken in the order directed on the blister pack. Gianvi may interact with seizure medications, barbiturates, bosentan, griseofulvin, rifampin, St. John's wort, ascorbic acid (vitamin C), acetaminophen, azole antifungals, verapamil, antibiotics, diltiazem, grapefruit juice, HIV/HCV protease inhibitors, HCV drug combinations containing ombitasvir/paritaprevir/ritonavir (with or without dasabuvir), non-nucleoside reverse transcriptase inhibitors (NNRTIs), midazolam, omeprazole, theophylline tizanidine, and thyroid hormone replacement therapy. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Gianvi; it is not intended for use during pregnancy. Gianvi may decrease milk production in lactating women and is not recommended for use while breastfeeding.

Our Gianvi (drospirenone/ethinyl estradiol) Tablets for Oral Use 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.

QUESTION

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

Get emergency medical help if you have signs of an allergic reaction: hives; difficult 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), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
  • 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, 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;
  • a change in the pattern or severity of migraine headaches; or
  • symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

  • nausea, vomiting;
  • breast tenderness;
  • headache, mood changes, feeling tired or irritable;
  • weight gain; 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 Gianvi (Drospirenone/Ethinyl Estradiol)

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Gianvi Professional Information

SIDE EFFECTS

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

Adverse reactions commonly reported by COC users are:

  • Irregular uterine bleeding
  • Nausea
  • Breast tenderness
  • Headache

Clinical Trials 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Contraception And Acne Clinical Trials

The data provided reflect the experience with the use of Gianvi in the adequate and well-controlled studies for contraception (N=1,056) and for moderate acne vulgaris (N=536).

For contraception, a Phase 3, multicenter, multinational, open-label study was conducted to evaluate safety and efficacy up to one year in 1,027 women aged 17 - 36 who took at least one dose of Gianvi. A second Phase 3 study was a single center, open-label, active-controlled study to evaluate the effect of 7 28-day cycles of Gianvi on carbohydrate metabolism, lipids and hemostasis in 29 women aged 18-35. For acne, two multicenter, double-blind, randomized, placebo-controlled studies, in 536 women aged 14-45 with moderate acne vulgaris who took at least one dose of Gianvi, evaluated the safety and efficacy during up to 6 cycles.

The adverse reactions seen across the 2 indications overlapped, and are reported using the frequencies from the pooled dataset. The most common adverse reactions (≥ 2% of users) were: headache/migraine (6.7%), menstrual irregularities (including vaginal hemorrhage [primarily spotting] and metrorrhagia (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4%) and mood changes (mood swings, depression, depressed mood and affect lability) (2.2%).

PMDD Clinical Trials

Safety data from trials for the indication of PMDD are reported separately due to differences in study design and setting in the Contraception and Acne studies as compared to the PMDD clinical program.

Two (one parallel and one crossover designed) multicenter, double-blind, randomized, placebocontrolled trials for the secondary indication of treating the symptoms of PMDD evaluated safety and efficacy of Gianvi during up to 3 cycles among 285 women aged 18-42, diagnosed with PMDD and who took at least one dose of Gianvi.

Common adverse reactions (≥ 2% of users) were: menstrual irregularities (including vaginal hemorrhage [primarily spotting] and metrorrhagia) (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%).

Adverse Reactions (≥1%) Leading To Study Discontinuation

Contraception Clinical Trials

Of 1,056 women, 6.6% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reactions leading to discontinuation were headache/migraine (1.6%) and nausea/vomiting (1.0%).

Acne Clinical Trials

Of 536 women, 5.4% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reaction leading to discontinuation was menstrual irregularities (including menometrorrhagia, menorrhagia, metrorrhagia and vaginal hemorrhage) (2.2%).

PMDD Clinical Trials

Of 285 women, 11.6% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reactions leading to discontinuation were: nausea/vomiting (4.6%), menstrual irregularity (including vaginal hemorrhage, menorrhagia, menstrual disorder, menstruation irregular and metrorrhagia) (4.2%), fatigue (1.8%), breast tenderness (1.4%), depression (1.4%), headache (1.1%), and irritability (1.1%).

Serious Adverse Reactions

Contraception Clinical Trials: migraine and cervical dysplasia

Acne Clinical Trials: none reported in the clinical trials

PMDD Clinical Trials: cervical dysplasia

Postmarketing Experience

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

Adverse reactions are grouped into System Organ Classes, and ordered by frequency.

Vascular disorders: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, cerebral thrombosis, retinal thrombosis, myocardial infarction and stroke), hypertension (including hypertensive crisis)

Hepatobiliary disorders: Gallbladder disease, liver function disturbances, liver tumors

Immune system disorders: Hypersensitivity (including anaphylactic reaction)

Metabolism and nutrition disorders: Hyperkalemia, hypertriglyceridemia, changes in glucose tolerance or effect on peripheral insulin resistance (including diabetes mellitus)

Skin and subcutaneous tissue disorders: Chloasma, angioedema, erythema nodosum, erythema multiforme

Gastrointestinal disorders: Inflammatory bowel disease

Musculoskeletal and connective tissue disorders: Systemic lupus erythematosus

Read the entire FDA prescribing information for Gianvi (Drospirenone/Ethinyl Estradiol)

Related Resources for Gianvi

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

QUESTION

Which of the following are methods for contraception? See Answer

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