Brintellix Package Insert

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Sanny Olafeso

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Aug 3, 2024, 3:30:48 PM8/3/24

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TRINTELLIX is an immediate-release tablet for oral administration that contains the beta () polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol.

Monoamine Oxidase Inhibitors (MAOIs):
Do not use MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX. Do not use TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start TRINTELLIX in a patient who is being treated with linezolid or intravenous methylene blue.Precautions WARNINGS AND PRECAUTIONS

>Strong CYP Inducers: Consider increasing TRINTELLIX dose when a strong CYP inducer (e.g., rifampin, carbamazepine, or phenytoin) is coadministered for more than 14 days. The maximum recommended dose should not exceed 3 times the original dose.

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2013 Takeda Pharmaceuticals America, Inc.
LUN205M R1 September 2013Reference(s) National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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Vortioxetine is an antidepressant that is FDA approved for the indicationType of major depressive disorder. There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea, constipation and vomiting.

#ask: Page Name::Vortioxetine

SSRIs (sertraline/Zoloft, fluoxetine/Prozac, citalopram/Celexa, escitalopram/Lexapro, fluvoxamine/Luvox, paroxetine/Paxil) are used to treat depression and anxiety (as well as other conditions such as obsessive compulsive disorder/OCD, panic disorders, and posttraumatic stress disorder/PTSD).1 They are often used in combination with psychotherapy, such as cognitive behavioral therapy (CBT). All SSRIs have been detected in human milk. Generally, if the lactating individual has been stable on an SSRI, they should be continued on the medication that has been effective for them. Available data on long-term effects on neurobehavior and development of breastfeeding infants are overall reassuring although infants should be monitored for side effects with certain medications in this class as noted below. While milk production and infant weight gain should be monitored and infants should be monitored for side effects with specific agents as noted below, there is no absolute indication to pump and dump with this class of medications.

Sertraline/Zoloft is commonly used in the management of perinatal mood and anxiety disorders (PMADs) and is widely used due to the larger amount of available data. This medication has low to undetectable levels in milk and is undetectable in infant serum from available data. A weakly active metabolite of sertraline, norsertraline, has been found in very low levels in infants. There are small 2 case series where decreased milk production and delayed lactogenesis II were noted postpartum with the use of this medication.2,3 While lactating parents should be monitored for low milk production and onset of lactogenesis II with early intervention if needed, there is no absolute indication to pump and dump.

Paroxetine/Paxil is commonly used in lactating individuals. This medication has low to undetectable levels in milk and is undetectable in infant serum. There are case reports of insomnia, restlessness, and increased crying among breastfeeding infants whose lactating parents are on paroxetine so infants should be monitored for these symptoms. There is no absolute indication to pump and dump.

Citalopram/Celexa has a relatively high relative infant dose (RID) or high milk levels compared to other SSRIs so it is not preferred if a new agent is being prescribed for a lactating individual. If a lactating individual has been stable on this medication and continues on it, then the breastfeeding infant should be monitored closely for side effects including poor sleep, bruxism, irritability, colic, poor feeding, and drowsiness. There is one recent case report of bruxism (teeth grinding) while sleeping in a 9 month old infant after their lactating parent started citalopram which resolved with discontinuation of the citalopram.4 While infants should be monitored closely for side effects, there is no absolute indication to pump and dump.

Available data on escitalopram/Lexapro suggests doses up to 20 mg/day produce low levels in milk. This medication has a favorable side effect profile and tight therapeutic range for the lactating individual so may be a good choice for some lactating individuals. There is a case report of a seizure with the use of escitalopram in combination with bupropion 5 Infants should be monitored closely for side effects including drowsiness, agitation, restlessness, poor feeding, and poor weight gain especially with doses greater than 20 mg/day, with concurrent use with bupropion, and in younger infants. While infants should be closely monitored for possible side effects, there is no absolute indication to pump and dump.

There is limited data on Fluvoxamine/Luvox during lactation. According to Lactmed, doses up to 300 mg daily produce low levels in breastmilk and would be unlikely to cause side effects in infants, particularly after 2 months of age. A recently published 2 dyad case series found low levels of fluvoxamine in breastmilk which the authors stated was consistent with previously published data.6 There is one case report of an infant with elevated blood levels with fluvoxamine.7 Another case report noted diarrhea, vomiting, and stimulation in an infant after their breastfeeding mother started on this medication.8 While alternatives are preferred due to limited data on this medication during lactation and infants should be closely monitored for side effects including diarrhea, vomiting, decreased sleep, and agitation, there is no absolute indication to pump and dump. Shared decision making should be used regarding the use of milk from lactating individuals who are taking fluvoxamine.

Vortioxetine is a serotonin reuptake inhibitor and receptor modulator. Levels in breastmilk appear to be low and no adverse events have been reported in infants.9 While there is no absolute indication to pump and dump, this medication should be used with caution and monitoring of the infant for side effects due to limited data.

SNRIs (duloxetine/Cymbalta, venlafaxine/Effexor, desvenlafaxine/Pristiq) are commonly used in the management of depression as well as other conditions, such as chronic pain and neuropathic pain. The infant should be monitored for sedation and poor weight gain, especially among newborns and premature infants, as a recent case of venlafaxine toxicity in an infant has been reported and a small amount of milk transfer may occur.10 While alternative medications are preferred and the infant should be closely monitored for side effects with use of this class of medications by the lactating individual, there is not an absolute indication to pump and dump. Shared decision making should be used regarding the use of milk from lactating individuals who are taking SNRIs.

Heterocyclic antidepressants, including TCAs (amitriptyline/Elavil, nortriptyline/Pamelor, doxepin/Silenor), are one of the oldest classes of antidepressant medications. The anti-cholinergic properties of tricyclic antidepressants have been observed to decrease milk production, especially with higher doses although data are limited. There are also reports of infant side effects, including sedation, with certain medications in this class.

In general, breastfed infants should be closely monitored for side effects (such as sedation) with use of this class of medication by the lactating individual and parents should be informed of the risk to milk production and the risk for side effects in their infants. There is no absolute indication to pump and dump, but providers should engage lactating individuals in shared decision making regarding the use of TCAs (with the exception of doxepin, which should be avoided).

There has been one case report of infant sedation with low dose amitriptyline.11 Breastfed infants should be closely monitored for side effects (such as sedation) with use of this medication by the lactating individual and parents should be informed of the risk to milk production and the risk for side effects in their infants. There is no absolute indication to pump and dump, but providers should engage lactating individuals in shared decision making regarding the use of this medication.

This TCA is less anticholinergic than amitriptyline and theoretically carries a lower risk of side effects. Breastfed infants should be monitored for side effects (such as sedation) with use of this medication by the lactating individual and parents should be informed of the risk to milk production and the risk for side effects in their infants. There is no absolute indication to pump and dump, but providers should engage lactating individuals in shared decision making regarding the use of this medication.