Zoledronic Acid | Fresenius Kabi Usa, Llc Breastfeeding

Do you know that important immune protective proteins are present in breast milk? Breast milk also contains required vitamins, minerals, saturated and un saturated fats. These things are extremely important for development of healthy brain. If you are taking any medicine for short term or for the chronic reason then that passes in breast milk as well, that is why you should always check the drug with your health care provider. Here at DrLact we try to analyze drugs based on available researches and in this sheet we will present our analysis for Zoledronic Acid | Fresenius Kabi Usa, Llc.

What is Zoledronic Acid | Fresenius Kabi Usa, Llc used for?


Zoledronic acid injection is a bisphosphonate indicated for: •Treatment and prevention of postmenopausal osteoporosis (1.1, 1.2) •Treatment to increase bone mass in men with osteoporosis (1.3) •Treatment and prevention of glucocorticoid-induced osteoporosis (1.4) •Treatment of Paget’s disease of bone in men and women (1.5) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use (1.6) 1.1 Treatment of Osteoporosis in Postmenopausal Women Zoledronic acid injection is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, zoledronic acid injection reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). In patients at high risk of fracture, defined as a recent low-trauma hip fracture, zoledronic acid injection reduces the incidence of new clinical fractures [ see Clinical Studies (14.1)]. 1.2 Prevention of Osteoporosis in Postmenopausal Women Zoledronic acid injection is indicated for prevention of osteoporosis in postmenopausal women [ see Clinical Studies (14.2)]. 1.3 Osteoporosis in Men Zoledronic acid injection is indicated for treatment to increase bone mass in men with osteoporosis [ see Clinical Studies (14.3)]. 1.4 Glucocorticoid-Induced Osteoporosis Zoledronic acid injection is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months [ see Clinical Studies (14.4)]. 1.5 Paget's Disease of Bone Zoledronic acid injection is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [ see Clinical Studies (14.5)]. 1.6 Important Limitations of Use The safety and effectiveness of zoledronic acid injection for the treatment of osteoporosis is based on clinical data of three years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

What are the risk associated with Zoledronic Acid | Fresenius Kabi Usa, Llc usage while breastfeeding? What precautions shall I take while using it in breastfeeding?

Zoledronic Acid | Fresenius Kabi Usa, Llc low risk for breastfeeding
Zoledronic Acid | Fresenius Kabi Usa, Llc contains only one active ingredient that is Zoledronic acid anhydrous. We have analyzed the usage of Zoledronic acid anhydrous in breastfeeding and our analysis suggest that Zoledronic acid anhydrous poses Low risk for infant while breastfeeding and hence Zoledronic Acid | Fresenius Kabi Usa, Llc itself shall be considered Low risk item for breastfeeding.

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers It is not known whether zoledronic acid injection is excreted in human milk. Because many drugs are excreted in human milk, and because zoledronic acid injection binds to bone long-term, zoledronic acid injection should not be administered to a nursing woman.

Zoledronic Acid | Fresenius Kabi Usa, Llc Breastfeeding Analsys


Zoledronic acid anhydrous while Breastfeeding

Low Risk

CAS Number: 118072-93-8

It is composed by bisphosphonates. Most bisphosphonates are acidic compounds that achieve low plasma concentration. Both features make it unlikely excretion into the milk in clinically significant amount. Intestinal absorption of bisphosphonates is very low even during fasting and is considered negligible in the presence of milk due to formation with the calcium of non absorbable compounds. Among bisphosponate preparations, Tiludronate and Zoledronate have the longest half-lives period of elimination and thus they are the less indicated to take while breastfeeding. A latest update no published data were found on excretion in the breast milk. Until more data about this drug regarding breastfeeding is available, safer known alternatives (pamidronate) should be of choice, especially in the neonatal period and in case of prematurity.


Zoledronic Acid | Fresenius Kabi Usa, Llc Breastfeeding Analsys - 2


Zoledronic acid anhydrous while Breastfeeding

CAS Number: 118072-93-8

Because no information is available on the use of zoledronic acid during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. However, absorption of zoledronic acid by a breastfed infant is unlikely.


Is Zoledronic Acid | Fresenius Kabi Usa, Llc safe while breastfeeding

I already used Zoledronic Acid | Fresenius Kabi Usa, Llc and meanwhile I breastfed my baby should I be concerned?

Zoledronic Acid | Fresenius Kabi Usa, Llc is in the category of low risk, if you have already used it then its not a big deal if health and behavior of baby is good. However your health care provider shall be aware of the fact that you have used Zoledronic Acid | Fresenius Kabi Usa, Llc so you should inform him based on your convenience.


My health care provider has asked me to use Zoledronic Acid | Fresenius Kabi Usa, Llc, what to do?

Zoledronic Acid | Fresenius Kabi Usa, Llc comes in category of low risk and if your doctor is aware that you are breastfeeding it should be ok to use without much concerns.


If I am using Zoledronic Acid | Fresenius Kabi Usa, Llc, will my baby need extra monitoring?

Not much monitoring required while using Zoledronic Acid | Fresenius Kabi Usa, Llc


Who can I talk to if I have questions about usage of Zoledronic Acid | Fresenius Kabi Usa, Llc in breastfeeding?

US
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday

UK
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700

Australia
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week

Canada
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week