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Dyspepsia in Pregnancy

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161. Farydak - panobinostat

in animal studies (see SmPC section 5.3). Given panobinostat’s cytostatic/cytotoxic mode of action, the potential risk to the foetus is high. Farydak should only be used during pregnancy if the expected benefits outweigh the potential risks to the foetus. If it is used during pregnancy or if the patient becomes pregnant while using it, the patient must be informed of the potential risk to the foetus (see SmPC section 4.6 and Risk Management Plan). It is unknown whether panobinostat is excreted in human

2015 European Medicines Agency - EPARs

162. Duavive - oestrogens conjugated / bazedoxifene

Ph.Eur. European Pharmacopoeia PI Product information PKWP Pharmacokinetics working party PMU Pregnant Mare’s Urine PNP Premarin new process PP Per protocol RLX Raloxifene QOL Quality of life QTc corrected QT interval QTcB Bazett's corrected QT interval QTcF Fridericia corrected QT interval QTcN Population corrected QT interval RMC Risk Management Committee RMP Risk management plan RR Relative Risk RVT Retinal vein thrombosis Assessment report EMA/CHMP/383987/2014 Page 8/153 SAE serious adverse event (...) , hydroxyethylcellulose, povidone (E1201), polydextrose (E1200), maltitol liquid, poloxamer 188, isopropyl alcohol and propylene glycol (E1520), as described in section 6.1 of the SmPC. The product is available in PVC/Aclar/PVC/Alu blister, as described in section 6.5 of the SmPC. Assessment report EMA/CHMP/383987/2014 Page 15/153 2.2.2. Active Substance Conjugated Oestrogens General information The “active substance” Conjugated Oestrogens is a mixture of different estrogenic substances isolated from pregnant mare’s

2015 European Medicines Agency - EPARs

163. BindRen (colestilan)

Assessment report Page 20/104 Medicinal product no longer authorisedfor the general condition and reproductive capacity of the F0 generation dams and for the development of their offspring was considered to be 800 mg/kg/day. There is a risk that pregnant patients with malabsorption will experience vitamin K deficiency that could lead to embryotoxicity. This could be prevented by adequate vitamin supplementation. This is adequately reflected in the SmPC, section 4.6. Local Tolerance No specific study (...) incidence. In any case, a warning regarding malabsorption and vitamin deficiencies has been included in the SmPC in section 4.4. There is a risk that pregnant patients with malabsorption will experience vitamin K deficiency that could lead to embryotoxicity. This could be prevented by adequate vitamin supplementation. This is adequately reflected in the SmPC, section 4.6. MCI-196 remains in the gastrointestinal (GI) tract after oral administration until excreted unchanged in the feces along

2015 European Medicines Agency - EPARs

164. Aripiprazole Sandoz

Page 19/30 Pharmacokinetic parameter Geometric Mean Ratio Test/Reference Confidence Intervals CV%* C max (ng/ml) 91.36% 85.12-98.06% 17.30 * estimated from the Residual Mean Squares Safety data There were 26 adverse events reported in the study which were related to the investigational products. AEs that were reported during the study included Body ache, Vomiting, Nausea, Giddiness, Vasovagal Syncope, Dyspepsia, Elevated Creatine Kinase (CK) levels, Giddiness, Fever, Headache, Fatigue and Backache (...) 25/30 Safety concerns Important identified risks Extrapyramidal symptoms (EPS) including tardive dyskinesia Neuroleptic Malignant Syndrome (NMS) Important potential risks Seizures Hyperglycaemia and diabetes mellitus Suicide-related events Orthostatic hypotension Dyslipidaemia Weight gain Somnolence / fatigue Missing information Safety in pregnancy and lactation Safety in paediatrics Pharmacovigilance plan Not applicable. Risk minimisation measures Safety concern Routine risk minimization

2015 European Medicines Agency - EPARs

165. Zykadia - ceritinib

%, 97,2% and 94.6% for the dog, rat, human and monkey, respectively. Ceritinib crosses the placental barrier in animals (rats and rabbits). Maternal ceritinib plasma concentrations were approximately 10- to 20-fold higher than the foetal ceritinib plasma concentration. Ceritinib should not be used during pregnancy. Metabolism Biotransformation of ceritinib has been examined in rats and monkeys, the species used for non-clinical general toxicity testing. In general, metabolism of ceritinib is low (...) only to a limited extent across tested species (rat, monkey and human). In view of this, and with reference to ICH S9, metabolic profiling for ceritinib in rabbit is not considered necessary. No data on excretion in milk are available. Since ceritinib is not intended to be used in pregnant or lactating women, this is considered acceptable. Adequate information and warning has been included in section 4.6 of the SPC. PK interaction Ceritinib at clinically relevant concentration will likely inhibit

2015 European Medicines Agency - EPARs

166. Akynzeo (netupitant / palonosetron)

and this was agreed by the CHMP. Administration of netupitant to rabbits during the period of organogenesis was shown to increase the incidence of some foetal malformations: limb and paw positional anomalies, minimal/partial fusion of sternebrae, and agenesis of accessory lung lobe. The NOAEL for embryo-fetal development is 3 mg/kg/day. Taking into account the teratogen effect of netupitant in rabbit without a safety margin, a contraindication of AKYNZEO during pregnancy with a contraception measure for women (...) of netupitant up to 450 mg were not detected in humans while no significant changes of QT prolongation were seen in the TQT study in healthy volunteers. Appropriate information was included in section 5.3 of the product information. In view of a number of foetoxic findings observed in the rabbit reprotoxicity studies’, a teratogenic risk of the FDC is probable. Alternative treatment options are available in this indication. Therefore Akynzeo has been contraindicated in pregnant women and it is advised

2015 European Medicines Agency - EPARs

167. Aripiprazole Accord (aripiprazole)

such as nausea, dyspepsia, vomiting, constipation, somnolence, accidental injury and akathisia occurred very commonly and led to dose reductions in several patients (Keck PE et al. 2003, Swainston HT et al. 2004). For these reasons, the Applicant requested a biowaiver for the 15 mg and 30 mg tablet strengths. For the reference product Abilify, linear pharmacokinetics (PK) of aripiprazole in the therapeutic dose range of 5-30 mg has been established. Other biowaiver criteria according to the Guideline

2015 European Medicines Agency - EPARs

171. Avibactam sodium / ceftazidime (Avycaz)

-Disease Interactions 145 7.5.5 Drug-Drug Interactions 145 7.6 Additional Safety Evaluations 145 7.6.1 Human Carcinogenicity 145 7.6.2 Human Reproduction and Pregnancy Data 146 7.6.3 Pediatrics and Assessment of Effects on Growth 146 7.6.4 Overdose, Drug Abuse Potential, Withdrawal and Rebound 147 7.7 Additional Submissions / Safety Issues 147 8 POSTMARKET EXPERIENCE 149 9 APPENDICES 151 9.1 Literature Review/References 151 9.2 Labeling Recommendations 151 9.3 Advisory Committee Meeting 153 REFERENCES

2015 FDA - Drug Approval Package

172. Addyi - Flibanserin

in labeling. 4.2 Reproductive Toxicity Data in pregnancy were obtained from pregnant rats and rabbits; the July 16, 2015 pharm/tox review discussed the following data: Data in rats: During organogenesis, pregnant rats administered 400 mg/kg/day dose (the highest dose tested) was associated with “significant maternal toxicity as evidenced by severe clinical signs and marked reductions in weight gain during dosing. Decreased fetal weights, increases in the incidence of decreased ossification (...) of the forelimbs and increased lumbar vertebrae, and two fetuses with anophthalmia were observed in the litters of high dose dams.” The no observed adverse effect level (NOAEL) for maternal and embryofetal toxicity was 80 mg/kg/day (15 times clinical exposure based on area under the curve, AUC). When pregnant rats were given flibanserin during Day 6 to Lactation Day 21 to assess peri- and post-natal development, all doses administered resulted in sedation and decreases in body weight gain during pregnancy

2015 FDA - Drug Approval Package

174. Induction of labour in late intrauterine fetal death: vaginal misoprostol (after oral mifepristone)

completed weeks of pregnancy) and stillbirth advises that the dose of misoprostol should be adjusted according to gestational age (100 micrograms 6-hourly before 26 weeks; 25 to 50 micrograms 4-hourly at 27 weeks or more). An update to the RCOG guideline in July 2011 noted that some hospitals in the UK were using larger doses of misoprostol than recommended in the 2010 guideline, potentially leading to an increased risk of adverse events. This evidence summary focusses particularly on the dose (...) tablets. It received UK marketing authorisation in May 2012 for the termination of intrauterine pregnancy of up to 63 days of amenorrhoea. MisoOne (Exelgyn) contains 400 micrograms of misoprostol for oral administration. In January 2013 it was licensed in the UK for the termination of intrauterine pregnancy, in sequential use with mifepristone, up to 49 days of amenorrhea. The use of any of these products for the induction of labour in late IUFD is off-label. In line with the guidance from the General

2013 National Institute for Health and Clinical Excellence - Advice

175. Autosomal Dominant Polycystic Kidney Disease - Management of Polycystic Liver Disease

kidney disease using abdomi- nal ultrasound (1C). b. We recommend that all female patients with autosomal dominant polycystic kidney disease and livercystsundergocounselingregardingtherisksof pregnancy and exogenous estrogen exposure in worsening liver cyst growth (1C). c. We recommend that females at risk of symptoms fromhepaticcystsavoidestrogensupplements(1D). d. We recommend that a multidisciplinary team (hep- atologist, hepatobiliary surgeon, interventional ra- diologist, and nephrologist) care (...) ,some,mainlythose with severe cystic liver disease, have abdominal pain or swelling, and, less commonly, dyspepsia, early satiety, dyspnea, and back pain. The severity of cystic liver disease can be assessed by magnetic resonance imaging (MRI), based on total cyst number or total liver volume. 5 Complications such as hepatic cyst infection and bleeding cause pain acutely, and are not uncommon, occurring in at least 5% of patients. 7 The treatment is the same as for infected or bleeding kidney cysts

2015 KHA-CARI Guidelines

176. Atrial Fibrillation ? Diagnosis and Management

-threatening pulmonary fibrosis, hepatic dysfunction, and aggravation of arrhythmias Monitor transaminases and thyroid function every 6 months. Reduce dose of concurrently used beta-blockers, procainamide, quinidine, and warfarin by 50%. dronedarone Multaq® (IR tablet: 400 mg) 400 mg PO BID. $139 Limited Coverage Special Authority Diarrhea, dyspepsia, nausea, and hepatic dysfunction (rare) Slight increase in plasma creatinine related to inhibition of secretion Contraindicated in patients with severe heart (...) and strength) Adult dose Cost per 30 days a PharmaCare coverage b Common and/or serious side effects Therapeutic considerations Oral anticoagulants Vitamin K Antagonists warfarin Coumadin®, G (IR tablet: 1, 2, 2.5, 3, 4, 5, 6, 7.5, 10 mg Initial: 2.5-10 mg PO daily, then individualize to maintain an INR of 2-3. $2-10 Regular Coverage Bleeding and skin necrosis Contraindicated in pregnancy. Many potential interactions. Direct Factor Xa Inhibitors dabigatran Pradaxa® (IR capsule: 110, 150 mg) 150 mg PO BID

2015 Clinical Practice Guidelines and Protocols in British Columbia

177. Diabetes - type 2

the right topic? From age 12 months onwards. This CKS topic is largely based on the National Institute for Health and Care Excellence (NICE) guidelines Type 2 diabetes in adults: management [ ] and Diabetes (type 1 and type 2) in children and young people: diagnosis and management [ ]. This CKS topic covers the role of primary care in the diagnosis and management of type 2 diabetes. This CKS topic does not cover the prescribing of insulin or the management of women with type 2 diabetes who are pregnant (...) , planning a pregnancy, or breastfeeding. It also does not cover the diagnosis and management of impaired glucose regulation, or make detailed recommendations on the diagnosis and management of other types of diabetes. There are separate CKS topics on and . The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare. How up-to-date is this topic? How up-to-date is this topic? Changes Changes September 2019 — minor

2019 NICE Clinical Knowledge Summaries

178. Neuropathic pain - drug treatment

on an update to the manufacturer's Summary of Product Characteristics, hyponatraemia has been included as a possible adverse effect of gabapentin [ ]. April 2015 — minor updates: Correction to the prescribing information for tramadol with regards to the legal requirements for hand writing prescriptions. The text regarding the use of tramadol in pregnancy and breastfeeding has been removed and a link to the CKS topic on Analgesia has been provided. June 2014 — minor update. Update to the text to reflect (...) dose, before deciding it is not effective [ ; ; ]. If amitriptyline is not effective or not tolerated, discontinue treatment gradually over a minimum of 4 weeks to prevent discontinuation symptoms (such as dizziness, nausea, paraesthesiae, anxiety, diarrhoea, flu-like symptoms, and headaches) [ ; ]. Pregnancy and breastfeeding Can tricyclic antidepressants be used during pregnancy and breastfeeding? Amitriptyline may be used during pregnancy and breastfeeding for the management of neuropathic pain

2019 NICE Clinical Knowledge Summaries

179. Heart failure - chronic

and pregnancy [ ]. Additionally, some medications used for treatment of heart failure (such as ACE-inhibitors and angiotensin-II receptor antagonists) are contraindicated in pregnancy [ ]. How to assess How should I assess a person with suspected chronic heart failure? If chronic heart failure is : Arrange admission if the person has severe symptoms . If there is uncertainty about the need for admission, seek specialist advice. For pregnant women (or women who have given birth within 6 months (...) on what CKS considers to be good medical practice. Referral of pregnant or postpartum women The recommendation to admit or seek immediate medical advice for pregnant or postpartum women is based on expert opinion that a high index of suspicion is needed to avoid late diagnosis of peripartum cardiomyopathy in the European Society of Cardiology Guideline on the management of cardiovascular disease during pregnancy [ ]. The Royal College of Obstetricians and Gynaecologists guideline Cardiac disease

2019 NICE Clinical Knowledge Summaries

180. Lyme disease

and within 3 days of starting the tetracycline. Adjust the warfarin dose accordingly. [ ; ; ; ] Pregnancy and breastfeeding Pregnancy and breastfeeding Pregnancy Doxycycline is contraindicated in women who are pregnant. Tetracyclines may be considered in the first trimester if required urgently and no suitable alternatives with a better safety profile are available. Breastfeeding Doxycycline is contraindicated in women who are breastfeeding. However, concerns about bone deposition of tetracyclines (...) [ ]. Prescribing information Prescribing information Important aspects of prescribing information relevant to primary healthcare are covered in this section specifically for the drugs recommended in this CKS topic. For further information on contraindications, cautions, drug interactions, and adverse effects, see the (eMC), or the (BNF). Doxycycline Doxycycline Contraindications and cautions Contraindications and cautions Do not prescribe doxycyline to: Pregnant or breastfeeding women and children under 12

2019 NICE Clinical Knowledge Summaries

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