Natalizumab (Tysabri) is a recombinant humanized antibody to α4-integrin that is approved by the Food and Drug Administration for the treatment of multiple sclerosis (MS) and Crohn disease. This is a ...case report of a 28-year-old woman with MS who was taking natalizumab (300 mg intravenously infused over 1 hour every 4 weeks) while breastfeeding her 11.5-month-old daughter 3 times a day. Breast milk samples were collected over a 50-day period after the patient’s first drug infusion. The average concentration of natalizumab was 0.93 µg/mL/d, and the relative infant dose was 1.74% of the weight-adjusted maternal dose. Transfer of natalizumab into human milk increased over time and with subsequent injections, with the highest concentration of 2.83 µg/mL at day 50 with a relative infant dose of 5.3%. Because these data suggest continued accumulation of natalizumab in milk, and because we cannot provide an accurate assessment of levels of this drug at 24 weeks (steady state), we are unable to determine safety at this time.
This article reviews the necessary skills required for clinicians to make informed decisions about the use of medications in women who are breastfeeding. Even without specific data on certain ...medications, this review of kinetic principles, mechanisms of medication entry into breast milk, and important infant factors can aid in clinical decision making. In addition, common medical conditions and suitable treatments of depression, hypertension, infections and so forth for women who are breastfeeding are also reviewed.
In the United States, 5% of breastfeeding mothers report using cannabis. Frequent cannabis use results in higher delta-9-tetrahydrocannabinol (THC) in breast milk, and mode of cannabis use may also ...impact risk to the infant. The aim of this study was to understand how breastfeeding mothers use cannabis and factors related to frequency of its use.
An anonymous online survey was conducted among mothers who used cannabis while breastfeeding. Frequency of cannabis use was ascertained along with modes of and reasons for cannabis use. Respondents were grouped by frequency of use: less-than-daily (
= 686), low-daily (1-3 times/day;
= 423), and high-daily (≥4 times/day;
= 218). Chi-square and analysis of variance tested between-group differences, and ordinal logistic regression examined factors associated with cannabis use frequency.
Smoking (88%) was the most common mode of cannabis consumption, followed by vaping (48%) and oral/edibles (36%). Smoking and vaping differed by cannabis use frequency. Only 54% used cannabis to get high, but was reported more among frequent users. In contrast, 89% of mothers used cannabis for mental or physical health symptoms, including anxiety, depression, gastrointestinal symptoms, chronic pain, and posttraumatic stress disorder. These symptoms differed by cannabis use frequency. Reporting more symptoms was associated with higher frequency of use. The odds of increasing cannabis use frequency was 2.7 for those reporting 1-2 health reasons, 5.6 for those reporting 3-4 health reasons, and 13.1 for reporting ≥5 health reasons.
Strategies are needed to address maternal mental and physical health, which may be key to reducing cannabis use among breastfeeding mothers.
Now in its 17th Edition, Medications and Mothers’ Milk, is the worldwide best selling drug reference on the use of medications in breastfeeding mothers. This book provides you with the most current, ...complete, and easy-to-read information on thousands of medications in breastfeeding mothers. This massive update has numerous new drugs, diseases, vaccines, and syndromes. It also contains new tables, and changes to hundreds of existing drugs. Written by a world-renown clinical pharmacologist, Dr. Thomas Hale, and Clinical Pharmacy Specialist Dr. Hilary Rowe, this drug reference provides the most comprehensive review of the data available regarding the transfer of various medications into human milk. This new and expanded reference has data on 1,115 drugs, vaccines, and herbals, with many other drugs and substances included in the appendices.
OBJECTIVETo determine the transfer of rituximab, an anti-CD20 monoclonal antibody widely used for neurologic conditions, into mature breast milk.
METHODSBreast milk samples were collected from 9 ...women with MS who received rituximab 500 or 1,000 mg intravenous once or twice while breastfeeding from November 2017 to April 2019. Serial breast milk samples were collected before infusion and at 8 hours, 24 hours, 7 days, and 18–21 days after rituximab infusion in 4 patients. Five additional patients provided 1–2 samples at various times after rituximab infusion.
RESULTSThe median average rituximab concentration in mature breast milk was low at 0.063 μg/mL (range 0.046–0.097) in the 4 patients with serial breast milk collection, with an estimated median absolute infant dose of 0.0094 mg/kg/d and a relative infant dose (RID) of 0.08% (range 0.06%–0.10%). Most patients had a maximum concentration at 1–7 days after infusion. The maximum concentration occurred in a woman with a single breast milk sample and was 0.29 μg/mL at 11 days postinfusion, which corresponds with an estimated RID of 0.33%. Rituximab concentration in milk was virtually undetectable by 90 days postinfusion.
CONCLUSIONSWe determined minimal transfer of rituximab into mature breast milk. The RID for rituximab was less than 0.4% and well below theoretically acceptable levels of less than 10%. Low oral bioavailability would probably also limit the absorption of rituximab by the newborn. In women with serious autoimmune neurologic conditions, monoclonal antibody therapy may afford an acceptable benefit to risk ratio, supporting both maternal treatment and breastfeeding.
Dimethyl fumarate transfer into human milk Ciplea, Andrea I.; Datta, Palika; Rewers-Felkins, Kathleen ...
Therapeutic advances in neurological disorders,
2020, Letnik:
13
Journal Article
Recenzirano
Odprti dostop
Dimethyl fumarate (DMF) is approved for the treatment of relapsing-remitting multiple sclerosis. It is unknown whether DMF or its primary metabolite monomethyl fumarate (MMF) are excreted into human ...milk. We present two cases of lactating patients who donated milk samples to study the transfer of MMF into human milk following a week of 2 × 240 mg daily oral dose. Samples were analyzed using liquid chromatography mass spectrometry. The calculated relative infant dose was 0.019% and 0.007%. This is the first study to demonstrate that MMF is transferred into human milk, with only limited exposure to an infant.
Transfer of Low Dose Aspirin Into Human Milk Datta, Palika; Rewers-Felkins, Kathleen; Kallem, Raja Reddy ...
Journal of human lactation,
05/2017, Letnik:
33, Številka:
2
Journal Article
Recenzirano
Background:
Aspirin has antipyretic and anti-inflammatory properties and is frequently used by pregnant and lactating women. However, its transfer in human milk when administered at low dose has not ...been reported.
Research aim:
This study aimed to evaluate the transfer of acetylsalicylic acid and its metabolite, salicylic acid, into human milk following the use of low dose aspirin.
Methods:
In this study, milk samples were collected at 0, 1, 2, 4, 8, 12, and 24 hours from seven breastfeeding women after a steady-state daily dose of 81 mg of aspirin. Milk levels of acetylsalicylic acid and salicylic acid were determined by liquid chromatography–tandem mass spectrometry.
Results:
Acetylsalicylic acid levels were below the limit of quantification (0.61 ng/ml) in all the milk samples, whereas salicylic acid was detected at very low concentrations. The average concentration of salicylic acid observed was 24 ng/ml and the estimated relative infant dose was 0.4%.
Conclusion:
Acetylsalicylic acid transfer into milk is so low that it is undetectable even by highly sophisticated methodology. Salicylic acid does appear in the human milk in comparatively low amounts, which are probably subclinical in infants. Thus, the daily use of an 81-mg dose of aspirin should be considered safe during lactation.
The majority of deaths in ovarian cancer are caused by recurrent metastatic disease which is usually multidrug resistant. This progression has been hypothesised to be due in part to the presence of ...cancer stem cells, a subset of cells which are capable of self-renewal and are able to survive chemotherapy and migrate to distant sites. Side population (SP) cells, identified by the efflux of the DNA-binding dye Hoechst 33342 through ATP-binding cassette (ABC) transporters, are a known adult stem cell group and have been suggested as a cancer stem cell in various cancers. Despite the identification of SP cells in cancer cell lines and patient samples, little attention has been paid to the identification of specific ABC transporters within this cell fraction which efflux Hoechst dye and thus may facilitate drug resistance. In this study, we demonstrate that SP cells can be detected in both ovarian cancer cell lines and ascitic fluid samples, and these SP cells possess stem cell and drug resistance properties. We show that ABCB1 is the functioning ABC transporter in ovarian cancer cell lines, and expression of ABCB1 is associated with a paclitaxel-resistant phenotype. Moreover, silencing of ABCB1 using a specific morpholino oligonucleotide results in an inhibition of the SP phenotype and a sensitising of ovarian cancer cell lines to paclitaxel. ABCB1 should therefore be considered as a therapeutic target in ovarian cancer.
Introduction:
Cyclobenzaprine is a skeletal muscle relaxant primarily used in the treatment of pain. Its use during lactation is a matter of concern as its level of exposure to infants through human ...milk is still unknown.
Main issue:
The aim of this study was to determine cyclobenzaprine concentrations in the milk samples collected from two lactating mothers.
Management:
The present study describes the analysis of cyclobenzaprine in human milk using liquid chromatography mass spectrometry, which determined the drug concentration-time profiles in human milk.
Conclusion:
This study shows low levels of concentrations of cyclobenzaprine in human milk with calculated relative infant dose of 0.5%. However, due to the sedative properties of cyclobenzaprine, regular clinical assessment of the infant is recommended to evaluate for long-term effects.
We present a case of a 27-year-old woman in whom idiopathic hypersomnolence was diagnosed in adolescence with adequate symptomatic control on daily dosage of 250 mg of modafinil. She maintained this ...dosage throughout her pregnancy and during the peripartum period, but did not breastfeed her newborn because of a lack of information on the transmission of modafinil in human breast milk. Samples of her breast milk were obtained at various times over a 24-hour period and analyzed using liquid chromatography mass spectrometry. The relative infant dose was calculated to be 5.3%, below the threshold of concern for drug passage via breast milk. This is the first reported case of modafinil transfer into human breast milk. Given the drug's use in a variety of sleep disorders, the results of this case can be used to advise breastfeeding mothers prescribed modafinil.
PDF
