Pregnancy of Naxdu in details
Naxdu crosses the placenta (Boyce 2011; Briggs 2009; Collin-Lévesque 2018).
Nonteratogenic adverse events have been observed with venlafaxine or other SNRIs/SSRIs when used during pregnancy. Cyanosis, apnea, respiratory distress, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypo- or hypertonia, hyper-reflexia, jitteriness, irritability, constant crying, and tremor have been reported in the neonate immediately following delivery after exposure to venlafaxine, SSRIs, or other SNRIs late in the third trimester. Prolonged hospitalization, respiratory support, or tube feedings may be required. Some symptoms may be due to the toxicity of the SNRIs/SSRIs or a discontinuation syndrome and may be consistent with serotonin syndrome associated with treatment.
Naxdu may impair platelet aggregation, resulting in an increased risk of bleeding; the risk of postpartum hemorrhage may be increased when used within the month prior to delivery.
Untreated or inadequately treated mental illness may lead to poor compliance with prenatal care. The ACOG recommends that therapy with SSRIs or SNRIs during pregnancy be individualized. Use of a single agent is preferred. According to their recommendations, treatment of depression during pregnancy should incorporate the clinical expertise of the mental health clinician, obstetrician, primary care provider, and pediatrician (ACOG 2008). If treatment for major depressive disorder is initiated for the first time during pregnancy, agents other than Naxdu are preferred (Larsen 2015; MacQueen 2016).
Untreated fibromyalgia may be associated with adverse pregnancy outcomes, including placental abruption, venous thrombosis, premature rupture of membranes, preterm birth, and intrauterine growth restriction/small for gestational age. It is not known if these outcomes are due specifically to fibromyalgia or comorbid conditions. Due to limited data, use of Naxdu for the treatment of fibromyalgia syndrome (FMS) in pregnancy should be reserved for women with severe forms of FMS complicated by depressive symptoms which worsen during pregnancy. Close monitoring is recommended (Gentile 2019).
Health care providers are encouraged to enroll women exposed to Naxdu during pregnancy in the Cymbalta Pregnancy Registry (866-814-6975 or http://cymbaltapregnancyregistry.com).
Pregnant women exposed to antidepressants during pregnancy are encouraged to enroll in the National Pregnancy Registry for Antidepressants (NPRAD). Women 18 to 45 years of age or their health care providers may contact the registry by calling 844-405-6185. Enrollment should be done as early in pregnancy as possible.
Naxdu breastfeeding
Use is not recommended Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown. If used, the infant should be monitored for drowsiness, adequate weight gain, and developmental milestones, particularly younger, exclusively breastfed infants, and when using combinations of psychotropic drugs.
In lactating women receiving Naxdu 40 mg orally every 12 hours and 60 mg orally once a day the daily infant dose, on a mg per kg basis, is estimated at approximately 0.14% and 0.82% of the maternal dose, respectively. If the benefit is considered to outweigh the risk, no dosage adjustment is required as lactation does not influence Naxdu pharmacokinetics.
See references
References for pregnancy information
- "Product Information. Cymbalta (Naxdu)." Lilly, Eli and Company, Indianapolis, IN.
- Cerner Multum, Inc. "Australian Product Information." O 0
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
References for breastfeeding information
- Cerner Multum, Inc. "Australian Product Information." O 0
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- "Product Information. Cymbalta (Naxdu)." Lilly, Eli and Company, Indianapolis, IN.
- Lobo ED, Loghin C, Knadler MP, et al. "Pharmacokinetics of Naxdu in breast milk and plasma of healthy postpartum women." Clin Pharmacokinet 47 (2008): 103-9
- United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
References
- PubMed Health. "Cymbalta: This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
- Human Metabolome Database (HMDB). "Duloxetine: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB0... (accessed September 17, 2018).
- FDA Pharm Classes. "FDA Pharmacological Classification: FDA published a final rule that amended the requirements for the content and format of approved labeling (prescribing information) for human prescription drug and biological products in January 2006.". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
