Pregnancy and Breastfeeding. Note: Pregnancy per se is not considered to be an AE; however, it is discussed here because of the importance of reporting pregnancies that occur during studies and because a medical occurrence observed in the mother or fetus/newborn would be classified as an AE. Female patients of childbearing potential and fertile male patients will be informed as to the potential risk of conception while participating in this study and will be advised that they must use highly effective contraception listed below (i.e., results in a low failure rate when used consistently and correctly) during the dosing period and for a period of at least 3 months after the end of treatment. Highly effective methods include: • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: − Oral − Intravaginal − Transdermal • Progestogen-only hormonal contraception associated with inhibition of ovulation: − Oral − Injectable − Implantable • Intrauterine device • Intrauterine hormone-releasing system • Bilateral tubal occlusion • Vasectomized partner • Sexual abstinence If a patient is confirmed pregnant during the study, study drug administration must be discontinued immediately. The Investigator must immediately notify the Sponsor’s Medical Monitor of the event and record the pregnancy on the Pregnancy Form (provided by Karyopharm). The initial information regarding a pregnancy must be forwarded to Karyopharm’s Pharmacovigilance by email or fax within 24 hours of first knowledge of its occurrence. The pregnancy should be followed up to determine the outcome, including any spontaneous or voluntary termination, details of the birth, and any birth defects, congenital abnormalities, or maternal and/or newborn complications. All pregnancies occurring within 3 months after the patient’s last dose of study drug must be reported to Karyopharm, regardless of whether the patient received selinexor or other study drugs, withdraws from the study, or the study is completed. Patients should be instructed to inform the Investigator regarding any pregnancies. Any SAE that occurs during pregnancy must be recorded on the SAE report form (e.g. maternal serious complications, therapeutic abortion, ectopic pregnancy, stillbirth, neonatal death, congenital anomaly, or birth defect) and reported within 24 hours in accordance with the procedure for reporting SAEs (described in Section 8.2.1.3 ). A pregnancy in a female partner of a male patient must be report...
Pregnancy and Breastfeeding. Denosumab is indicated for the treatment of postmenopausal women. There is no data on the use of denosumab during pregnancy and it is unknown whether it is excreted in breast milk. It is therefore not recommended for use during pregnancy. Latex allergy: The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Denosumab should be used with caution in patients with a known latex allergy.
Pregnancy and Breastfeeding. Denosumab is not recommended for use in pregnant women. It is unknown whether denosumab is excreted in human milk. A decision on whether to abstain from breast-feeding or to abstain from treatment with denosumab should be made, taking into account the benefit of breast-feeding to the new-born /infant and the benefit of denosumab therapy to the woman. No interaction studies have been performed. There are no clinical data on the co- administration of denosumab and hormone replacement therapy (oestrogen), however, the potential for a pharmacodynamic interaction is considered to be low. In postmenopausal women with osteoporosis the pharmacokinetics and pharmacodynamics of denosumab were not altered by previous alendronate therapy, based on data from a transition study (alendronate to denosumab). Patients receiving denosumab may develop skin infections (predominantly cellulitis) leading to hospitalisation. Patients should be advised to seek prompt medical attention if they develop signs or symptoms of cellulitis. Osteonecrosis of the jaw (ONJ) has been reported in patients treated with denosumab. Most cases have been in cancer patients; however some have occurred in patients with osteoporosis. Common side effects include: urinary tract infection, upper respiratory tract infection, sciatica, cataracts, constipation, rash, pain in extremity.
Pregnancy and Breastfeeding. Sleep medicines may cause sedation or other potential effects in the unborn baby when used during the last weeks of pregnancy. Be sure to tell your doctor if you are pregnant, if you are planning to become pregnant, or if you become pregnant while taking LUNESTA. In addition, a very small amount of LUNESTA may be present in breast milk after use of the medication. The effects of very small amounts of LUNESTA on an infant are not known; therefore, as with all other prescription sleep medicines, it is recommended that you not take LUNESTA if you are breastfeeding a baby.
Pregnancy and Breastfeeding. Verso complies with the Pregnancy Discrimination Act (“PDA”), and all applicable state and local laws that provide protections and rights for pregnant and breastfeeding employees, including provision of breaks to breastfeed or pump and provision of a clean and private space to breastfeed. Verso also provides reasonable accommodations for such individuals in accordance with these laws. Pregnant employees are entitled to paid time off for ante-natal medical care.
Pregnancy and Breastfeeding. Patients planning pregnancy or found to be pregnant should have serum calcium and renal function measured at the earliest opportunity as well as being referred to a specialist antenatal clinic. Alfacalcidol is unlikely to be harmful in pregnancy as long as serum calcium in target range (2.0 – 2.2 mmol/l). Risk to the foetus is likely to be greater if the therapy is discontinued through risk of maternal hypocalcaemia. Hypercalcaemia during pregnancy may produce congenital disorders in the offspring. Although it has not been established, it is likely that increased amounts of 1,25-dihydroxyvitamin D will be found in the milk of lactating mothers treated with Alfacalcidol. This may influence calcium metabolism in the infant. Please seek specialist advice. NPSA Safety alert for Alfacalcidol: Highlighting issues with patients developing renal failure due to lack of monitoring of their calcium levels whilst taking Alfacalcidol. It states the necessity for the monitoring of bloods to minimise the chance of associated renal problems.
