provider Use of SSRIs, may cause symptoms of sexual dysfunction; in male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction In female patients, SSRI/SNRI use may result in decreased libido and delayed or absent orgasm Important for prescribers to inquire about sexual function prior to initiation of therapy and to inquire specifically about changes in sexual function during treatment, because sexual function may not be spontaneously reported When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including underlying psychiatric disorder Discuss potential management strategies to support patients in making informed decisions about treatment Pregnancy There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants Prolonged experience with fluvoxamine in pregnant women over decades, based on published observational studies, have not identified a clear drug-associated risk of major birth defects or miscarriage; there are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of newborn (PPHN) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including fluvoxamine, during pregnancy Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants; consider risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum Neonates exposed to therapy and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding; such complications can arise immediately upon delivery; reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying; these features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome; it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome Animal findings suggest fertility may be impaired while taking fluvoxamine Animal data Pregnant rats treated orally with throughout period of organogenesis, increased embryofetal death and increased incidences of fetal eye abnormalities (folded retinas) was observed at doses ≥3 times maximum recommended human dose (MRHD) of 300 mg/day given to adolescents on a mg/m2 basis; in addition, decreased fetal body weight was seen at a dose 6 times MRHD given to adolescents on a mg/m2 basis There were no adverse developmental effects in rabbits treated with fluvoxamine during period of organogenesis up to a dose 2 times MRHD given to adolescents on a mg/m2 basis; when drug was administered orally to rats during pregnancy and lactation, increased pup mortality at birth was seen at dose 2 times MRHD given to adolescents on a mg/m2 basis; in addition, decreases in pup body weight and survival were observed at doses that are ≥0.13 times MRHD given to adolescents Persistent pulmonary hypertension of the newborn Potential risk of persistent pulmonary hypertension of the newborn when used during pregnancy Initial Public Health Advisory in 2006 was based on a single published study; since then, there have been conflicting findings from new studies, making it unclear whether use of SSRIs during pregnancy can cause PPHN FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN FDA recommendation: FDA advises healthcare professionals not to alter their current clinical practice of treating depression during pregnancy and to report any adverse events to the FDA MedWatch program A meta-analysis of 7 observational studies, found exposure to SSRIs in late pregnancy (ie, >20 weeks' gestation) more than doubled the risk of PPHN that could not be explained by other etiologies (eg, congenital malformations, meconium aspiration) (BMJ 2014;348:f6932) Lactation Data from published literature report presence of drug in human milk; no adverse effects on breastfed infant have been reported in most cases of maternal use of fluvoxamine during breastfeeding; however, there are reports of diarrhea, vomiting, decreased sleep, and agitation; there are no data on effect of fluvoxamine on milk production Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for fluvoxamine and any potential adverse effects on breastfed child from drug or from the underlying maternal condition Monitor infants exposed to fluvoxamine through breast milk for diarrhea, vomiting, decreased sleep, and agitationPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Selective serotonin reuptake inhibitor; little or no affinity for dopamine, alpha-adrenergic histamine, or cholinergic receptor Absorption Bioavailability: 53% Peak plasma time: 3-8 hr Peak plasma concentration: 88-546 ng/mL (nonlinear) Distribution Protein bound: 80% Vd: 25 L/kg Metabolism Metabolism: Hepatic oxidative demethylation, deamination Metabolites: Inactive Enzymes inhibited: Hepatic CYP1A2, CYP2C9, CYP3A4 Elimination Half-life: 15.6 hr; 17.4-25.9 hr (elderly) Dialyzable: No Excretion: Urine (85%) Pharmacogenomics Several SSRIs (eg, fluoxetine, fluvoxamine, paroxetine, sertraline) are metabolized by CYP2D6 CYP2D6 is involved in the metabolism of approximately 20% of drugs in clinical use and displays large individual-to-individual variability in activity due to genetic polymorphisms More than 80 CYP2D6 variant alleles have been identified; however, 4 of the most prevalent alleles, CYP2D6*3, *4, *5, and *6, account for 93-97% of CYP2D6 poor metabolizers (PMs) CYP2D6*4, the most common variant (~25% frequency in whites), causes a splicing defect; CYP2D6*3 (2.7% frequency) causes a frameshift mutation; and CYP3D6*5 (2.6%) is an entire deletion of the CYP2D6 gene; individuals homozygous for these alleles have no CYP2D6 activity The impact of CYP2D6 activity is further complicated in some SSRIs (eg, fluoxetine, fluvoxamine, paroxetine, sertraline) that, in addition to being substrates for CYP2D6, are also known to moderately inhibit CYP2D6 activity Genetic testing laboratories Genotyping tests for CYP2D6 variants are commercially available through Applied Biosystems (http://www.appliedbiosystems.com/) and GenPath Diagnostics (http://www.genpathdiagnostics.com/) Oral Administration May take with or without food BRAND FORM. UNIT PRICE PILL IMAGE fluvoxamine oral- 50 mg tabletfluvoxamine oral- 100 mg tabletfluvoxamine oral- 25 mg tabletfluvoxamine oral- 50 mg tabletfluvoxamine oral- 100 mg tabletfluvoxamine oral- 100 mg tabletfluvoxamine oral- 150 mg capsulefluvoxamine oral- 100 mg capsulefluvoxamine oral- 100 mg tabletfluvoxamine oral- 50 mg tabletfluvoxamine oral- 100 mg capsulefluvoxamine oral- 50 mg tabletfluvoxamine oral- 25 mg tabletfluvoxamine oral- 150 mg capsulefluvoxamine oral- 25 mg tabletfluvoxamine oral- 50 mg tabletfluvoxamine oral- 25 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationfluvoxamine oral FLUVOXAMINE - ORAL (floo-VOX-a-meen) COMMON BRAND NAME(S): Luvox WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed. USES: Fluvoxamine is used to treat obsessive-compulsive disorder (OCD). It helps decrease thoughts that are unwanted or that don't go away (obsessions), and it helps to reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, checking) that interfere with daily living. Fluvoxamine is known as a selective serotonin reuptake inhibitor (SSRI). This medication works by helping to restore the balance of a certain natural substance (serotonin) in the brain. HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking fluvoxamine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily at bedtime, or twice daily (once in the morning and once at bedtime). If you are taking this medication twice daily and the doses are not equal, then the larger of the 2 doses should be taken at bedtime.The dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). In children, the dosage may also be based on their age and gender. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as mood swings, headache, tiredness, sleep changes, and brief feelings similar to electric shock. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.It may take up to several weeks before you get the full benefit of this drug.Tell your doctor if your condition does not improve or if it worsens. SIDE EFFECTS: See also Warning section.Nausea, vomiting, drowsiness, dizziness, loss of appetite, trouble sleeping, weakness, and sweating may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, shaking (tremor), decreased interest in sex, changes in sexual ability.Get medical help right away if you have any very serious side effects, including: fainting, irregular heartbeat, black stools, vomit that looks like coffee grounds, seizures, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night, blurred vision).This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual restlessness.Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for