Levemir Approved For Diabetes During Pregnancy, Usa
The U.S. Food and Drug Administration (FDA) has just approved Levemir®, an insulin detemir [rDNA origin] injection, as the first and only basal insulin analog for Pregnancy Category B classification, which indicates that Levemir® does not pose a higher risk of harm for the unborn when used in pregnant women with diabetes. The drug is manufactured by Novo Nordisk. Until now, the standard of care for diabetes in pregnancy has consisted of NPH, i.e. human insulin, however this has now changed, with Novo Nordisk being the only company that is able to provide a complete portfolio of insulin analogs with Pregnancy Category B classification. FDA approval was granted following a review of a large, randomized controlled trial that involved 310 pregnant women with type 1 diabetes, which assessed Levemir's® safety and efficacy compared with NPH insulin. The results demonstrated that women who were administered with Levemir® had a comparable reduction in A1C at gestational week 36 and lower fasting plasma glucose levels at gestational weeks 24 and 36 than women who received NPH. The researchers noted no difference in results regarding Levemir's® overall safety profile during pregnancy, its outcomes or the health of the fetus and newborn. Lois Jovanovič, MD, MACE, Chief Scientific Officer at Sansum Diabetes Research Institute in Santa Barbara, California remarked: "It is exciting that the FDA has granted approval for this new category rating for Levemir®. For women who are pregnant, diabetes can be extremely challenging; they must be even more diligent and careful when monitoring blood sugar levels than before they were pregnant. This approval provides patients with a long-acting insulin analog option that can help them manage their blood sugar." About 1.85 million women of c Continue reading >>
Insulin Glargine Safety In Pregnancy
Go to: Abstract Insulin glargine (Lantus) is an extended-action insulin analog with greater stability and duration of action than regular human insulin. The long duration of action and decreased incidence of hypoglycemia provide potential advantages for its use in pregnancy. However, the placental pharmacokinetics of insulin glargine have not been studied. Therefore, the objective of this study was to determine whether insulin glargine crosses the human placenta using the human perfused placental lobule technique. Placentae were obtained with informed consent after elective cesarean section delivery of noncomplicated term pregnancies. Insulin glargine, at a therapeutic concentration of 150 pmol/l (20 μU/ml) was added to the maternal circulation. Additional experiments were carried out at insulin glargine concentrations 1,000-fold higher than therapeutic levels (150, 225, and 300 nmol/l). A subsequent perfusion for which the maternal circuit remained open and insulin glargine was continuously infused at 150 pmol/l was completed for further confirmation of findings. The appearance of insulin glargine in the fetal circulation was analyzed by a chemiluminescence immunoassay. Results from perfusions carried out at therapeutic concentrations (150 pmol/l) of insulin glargine showed no detectable insulin glargine in the fetal circuit. After perfusion with very high insulin glargine concentrations of 150, 225, and 300 nmol/l, the rate of transfer remained low at 0.079 ± 0.01, 0.14, and 0.064 pmol · min−1 · g tissue−1, respectively. Maternal to fetal transport of insulin glargine Experiment no. Maternal concentration (pmol/l) Lobule weight (g) Fetal concentration (pmol/l) Rate of transfer (pmol · min−1 · g tissue−1) 1 150 15.17 Below LOQ — 2 150 9.8 Below LOQ — Continue reading >>
Which Insulins Cant Be Taken When Pregnant?
Diabetes Forum The Global Diabetes Community Find support, ask questions and share your experiences. Join the community which insulins cant be taken when pregnant? hello, i'm currently planning a pregnancy with my partner. i have been told that some insulins arent safe to take whilst pregnant. i'm on levemir & novorapid. if my insulin has to be changed, will this happen when i'm trying for a baby or once i'm pregnant? i have an appointment in april with diabetic consultant so i'm going to make them aware of my plans. i just want to be prepared & roughly know what to expect Hope you can get specific help and advice from a pre-conception diabetes clinic. Many drugs, not just insulins, have not been tested / approved for use in pregnancy, but that doesn't necessarily mean than they can't be used during pregnancy. Unless things have changed since I was last pregnant (3 years ago) there are no insulins licensed for pregnancy because it would be unethical to test them on pregnant women!! However, we obviously have to carry on taking our insulin so not advised to change. I remember waiting till after one of my pregnancies to change onto a newer insulin analogue as they wouldn't switch me while I was pregnant (think that was the lantus). Good luck! None of them have been specifically tested on pregnant women, however there's absolutely no reason to think that any of them would have any mechanism of harming a foetus. The disruption of blood sugar while you're changing would do harm, so best to leave things as they are. Always discuss it with your nurse / doc though I have a gorgeously healthy 2 yr old girl, throught the entire pregnancy was on Lantus and Novorapid. thanks for the replies ladies. i was told by sum1 else on here that i would have to stop taking my novorapid becau Continue reading >>
Lantus
Lantus is a prescription medication used to treat type 1 and type 2 diabetes. Lantus is a long-acting form of insulin and works by replacing the insulin that is normally produced by the body and by helping the body to use sugar for energy. It also stops the liver from producing more sugar. This medication comes in an injectable form and is usually used once daily. Common side effects include low blood sugar, redness and skin thickening at the injection site, and weight gain. Lantus is a prescription medication used to treat people with type 1 and type 2 diabetes for the control of high blood sugar. Lantus may be used along with fast-acting insulin or oral medications to control blood sugar. This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. Lantus can cause hypoglycemia (low blood sugar), hyperglycemia (high blood sugar), allergy, and skin reactions. Hypoglycemia (low blood sugar): Early warning signs of hypoglycemia may be different, less noticeable or not noticeable at all in some people. That is why it is important to check your blood sugar as you have been advised by your doctor. Symptoms of hypoglycemia may include: anxiety, irritability, restlessness, trouble concentrating, personality changes, mood changes, or other abnormal behavior tingling in your hands, feet, lips, or tongue dizziness, light-headedness, or drowsiness nightmares or trouble sleeping headache blurred vision slurred speech palpitations (fast heart beat) sweating tremor (shaking) unsteady gait (walking). If you have hypoglycemia often or it is hard for you to know if you have the symptoms of hypoglycemia, talk to your doctor. Mild to moderate hypoglycemia is treated by eating or drinking carbohydrates, such as fruit juice, raisins, sugar candies, Continue reading >>
Diabetes Management Guidelines
Endocrine Society Guideline on Diabetes and Pregnancy Source: Blumer I, Hadar E, Hadden DR, et al. Diabetes and pregnancy: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2013;98(11):4227-4249. Available here. Refer to source document for full recommendations, including strength of recommendations and quality of evidence. Jump to a topic or click back/next at the bottom of each page Antihyperglycemic Therapy During Pregnancy Insulin therapy Long-acting insulin detemir Initiate during pregnancy in women who require insulin therapy and for whom appropriate doses of NPH insulin have caused/may cause hypoglycemia* Continue if used successfully prior to pregnancy* Insulin glargine Continue if used successfully prior to pregnancy† Rapid-acting insulin lispro and aspart Use in preference to regular soluble insulin‡ Continuous SC insulin infusion Recommended when treatment has been prior to pregnancy§ Do not initiate during pregnancy unless other insulin strategies – including multiple daily doses of insulin – tried and unsuccessful† Insulin glargine is classified as FDA Pregnancy Category C and should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus *Less strong recommendation, very high quality evidence †Less strong recommendation, low quality evidence ‡Less strong recommendation, moderate quality evidence §Strong recommendation, moderate quality evidence Noninsulin therapy Glyburide May be used as alternative to insulin in women with GDM who do not achieve sufficient glycemic control after 1-week trial of medical nutrition therapy and exercise* Exceptions, in which case insulin is preferred therapy:* Diagnosis of GDM before 25 weeks FPG >110 mg/dL (6.1 mmol/L) Metformin Use only for wo Continue reading >>
Is Lantus Solostar Safe For Pregnant Or Breast-feeding Women?
Is Lantus Solostar safe for pregnant or breast-feeding women? The U.S. Food and Drug Administration classifies Lantus Solostar (insulin glargine) in pregnancy category C because studies do not adequately show whether this drug poses a risk to an unborn child. However, insulin is considered the best treatment for pregnant women who are diabetic. Uncontrolled diabetes can cause high blood sugar (hyperglycemia), which is associated with birth defects. It is unknown whether this drug can be passed in breast milk. Talk to your doctor if you plan on nursing or becoming pregnant while using Lantus Solostar. Is 22 units dosage of Lantus once daily sufficient for a type 1 diabetic? If you are a Type-1 Diabetic and just take Lantus, you will likely die, or at least be very, very ill. T-1 is an autoimmune d... How soon after taking Onglyza will my symptoms improve? Onglyza (saxagliptin) is used together with diet and exercise to control blood sugar levels in people with type 2 diabetes. H... There is no approved generic version of Januvia. The active ingredient in Januvia is sitagliptin phosphate (or sitagliptin), ... Is there a generic version of glyburide-metformin? Glyburide and metformin are the ingredients in a brand name combination drug called Glucovance, which is designed to lower bl... Continue reading >>
Humulin-n And Pregnancy
Registration is fast, simple and absolutely free so please,join our community todayto contribute and support the site. This topic is now archived and is closed to further replies. I'm recently diagnosed T1, 34 and was ttc#2 at time of diagnoses. Baby making is put on hold until given the nod by my endo (which she says shouldn't be too long because my numbers are looking good). I'm currently doing MDI with Humulog at meals and Humulin-N at bedtime. She put me on the Humulin-N because she said it's the best during pregnancy, and doesn't want to have to switch me since I'm planning to be pregnant in the near future. Sorry to haunt you here, but since you were asking in your other post I was intrigued why such a problematic basal insulin was being used. It seems the question may be around whether newer insulins than NPH (Humilin-N) are safe during pregnancy. There may be indications that there have been studies to show they are safe. Here's some previous DF posts for your reading. Those threads probably go into it, but the primary reason Lantus or Levemir might be preferred are that they are flatter and longer lasting, more suited to covering your background needs over 24 hours, than NPH, which also gives a bigger "peak". (I myself found NPH hugely problematic back in the day). As to the status of the safety concerns, I leave to those much more in the know than me. I was determined to go on Levemir during my pregnancy. My endocrinologist was against it, but I went on it anyway (I found a GP to give it to me) I had problems with NPH because it controlled my blood sugars erratic at best. When making the decision to go on Levemir, I considered my blood sugar control which can also damage my baby against the risk of taking a new medication unproven to create problems/improveme Continue reading >>
Taking Insulin During Pregnancy
When your blood glucose levels stay raised despite meal planning and physical activity, insulin must be added to your management plan to keep you and your baby healthy. Pregnancy requires that your body produce extra amounts of insulin. Insulin is a hormone that is made by the pancreas. If your pancreas does not make enough insulin, injections can help you meet the need. Your health care provider and diabetes educator will teach you how to inject insulin safely and comfortably. Determining the right insulin and dosage Tip Keep a record of the type and amount of insulin you take. It is important that you know and remember your insulin type every time you speak with a health care provider. Your health care provider will decide what kind of insulin is right for you, how much to use and when you should take it, based on: your weight (which changes weekly) how far along your pregnancy is your meal plan your most recent blood glucose levels Sometimes, you may need more than one type of insulin. Different types of insulin work at different speeds, and your health care provider may combine insulins to achieve the best results for you. Time-action of different insulins Insulins Starts working Peaks Stops working Rapid acting: Humalog® (lispro) NovoLog® (aspart) Apidra® (glulisine) 5 to 15 minutes 1 to 2 hours 2 to 4 hours Intermediate acting: NPH (N) 2 to 4 hours 4 to 8 hours 10 to 16 hours Basal*: Lantus® (glargine) Levemir® (detemir) 2 hours No peak 24 hours *Lantus® and Levemir® cannot be mixed with any other insulin. How to help insulin work best Take your insulin at the same times each day as directed. Talk with your health care provider if you feel sick. Follow any instructions your health care provider gives you. Don't change your meal plan, physical activity, pres Continue reading >>
What You Should Know About Taking Lantus Solostar U-100 Insulin Subcutaneous When Pregnant, Nursing, Or Administering To Children Or Adults Over 60
No Known Risk: EXCRETION MAY BE EXPECTED SINCE HUMAN INSULIN IS A COMPONENT OF BREASTMILK management or monitoring precaution: Initial dose, incremental increases and maintenance dose should be conservative. Giving Lantus Solostar Insulin Pen to a child under 12 management or monitoring precaution: Safety and efficacy not established age < 6 years. Not studied in type 2 diabetes. Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Continue reading >>
Lantus Insulin During Pregnancy?
Lactic Acidosis is scary so it is probably better that they took you off the Metformin if your blood is showing signs of that happening. Lantus is nice in the sense that it is dosed once daily and will keep your sugar levels a lot more steady. It is safe in pregnancy ( Category C which means caused no harm to animal fetuses in their case studies, but has not been tested on pregnant humans), butif you are not comfortable with the Lantus though, Humalog and Novolin NPH are both suitable replacements, but they will not have the once a day dosing. lantus is perfectly safe, much safer than NOT being on insulin for the baby. When I was pregnant with Ethan, I took Lantus at night and novolog for meals. (Now I have an insulin pump) Some people prefer NPH, but there is a real risk with lows with NPH, it works in waves and that can be scary for someone to get a low. Humalog and novolog are both fast acting, and if your doctor wants you on a long acting, there are 3 choices, really, Lantus, NPH and Levemir. There is little research for levemir during pregnancy, but most endos are fine with it. lantus is the go to drug lantus is perfectly safe, much safer than NOT being on insulin for the baby. When I was pregnant with Ethan, I took Lantus at night and novolog for meals. (Now I have an insulin pump) Some people prefer NPH, but there is a real risk with lows with NPH, it works in waves and that can be scary for someone to get a low. Humalog and novolog are both fast acting, and if your doctor wants you on a long acting, there are 3 choices, really, Lantus, NPH and Levemir. There is little research for levemir during pregnancy, but most endos are fine with it. lantus is the go to drug Continue reading >>
Insulin Glargine Safety In Pregnancy
Abstract OBJECTIVE Insulin glargine (Lantus) is an extended-action insulin analog with greater stability and duration of action than regular human insulin. The long duration of action and decreased incidence of hypoglycemia provide potential advantages for its use in pregnancy. However, the placental pharmacokinetics of insulin glargine have not been studied. Therefore, the objective of this study was to determine whether insulin glargine crosses the human placenta using the human perfused placental lobule technique. RESEARCH DESIGN AND METHODS Placentae were obtained with informed consent after elective cesarean section delivery of noncomplicated term pregnancies. Insulin glargine, at a therapeutic concentration of 150 pmol/l (20 μU/ml) was added to the maternal circulation. Additional experiments were carried out at insulin glargine concentrations 1,000-fold higher than therapeutic levels (150, 225, and 300 nmol/l). A subsequent perfusion for which the maternal circuit remained open and insulin glargine was continuously infused at 150 pmol/l was completed for further confirmation of findings. The appearance of insulin glargine in the fetal circulation was analyzed by a chemiluminescence immunoassay. RESULTS Results from perfusions carried out at therapeutic concentrations (150 pmol/l) of insulin glargine showed no detectable insulin glargine in the fetal circuit. After perfusion with very high insulin glargine concentrations of 150, 225, and 300 nmol/l, the rate of transfer remained low at 0.079 ± 0.01, 0.14, and 0.064 pmol · min−1 · g tissue−1, respectively. CONCLUSIONS Insulin glargine, when used at therapeutic concentrations, is not likely to cross the placenta. Several new long-acting insulin analogs, such as glargine and detemir, are currently available f Continue reading >>
Insulin For Gestational Diabetes - What It Is And How It Works
Where blood sugar levels cannot be lowered and stabilised enough through dietary and lifestyle changes, or through using medication such as Metformin, some ladies will be required to use insulin for gestational diabetes. Insulin is a hormone in the body produced by the pancreas. Your body uses insulin to move the sugar (glucose) obtained from food and drink from the bloodstream into cells throughout the body. The cells are then able to use the sugar for energy. Here are the most commonly asked Q&A on insulin for gestational diabetes from our Facebook support group Why do I need to take insulin for gestational diabetes? If lower blood sugar levels cannot be reached through diet, exercise and medication such as Metformin, then many will be required insulin for gestational diabetes. If blood sugar levels remain high, then the diabetes is not controlled and can cause major complications with the pregnancy and baby. If your levels are rising out of target range, your own insulin production may need to be topped up at the meal time. You may need to take insulin at one or all of your meals. Sometimes the insulin you produce in-between your meals and overnight may also require a top up. This may mean that you require an extra slower-release insulin at bedtime and/or in the morning. Some consultants will prescribe insulin on diagnosis of gestational diabetes on the basis of your GTT results or following other complications relating to gestational diabetes. For the majority, you will be given some time to try diet and exercise changes and then medication such as Metformin before insulin is introduced as a way to help lower and control your levels. NICE guidelines for timing and use of insulin for gestational diabetes 1.2.19 Offer a trial of changes in diet and exercise to women w Continue reading >>
Insulin Glargine During Pregnancy
Insulin Glargine during Pregnancy [bold]Body: [/bold]The long-ac [bold]Body: [/bold]The long-acting analog Glargine is a new insulin with 24-h persistence. This peakless action profile accounts for stable daily plasma glucose profile significant risk reduction for nocturnal hypoglycemia. Only a few reports have described the use of insulin glargine during human pregnancy, so its use is not recommended at present. This observational, multi-centre (three) trial studied the maternal and perinatal outcome of Glargine Insulin and Human long-acting Insulin (Protaphan). Forty-seven consecutive pregnant subjects with type 1 diabetes using Insulin Glargine before conception during 2003-2005 were studied. The control group consisted of 50 pregnant subjects using long-acting insulin (Protaphan) at the same time and who were matched for age, parity, duration of diabetes and diabetes complications. All women injected short-acting insulin analogues before meals. There was no difference for gestational age at delivery, pregnancy complications and perinatal outcome (weight of the new-born, shoulder dystocia, respiratory distress, infections, first plasma glucose after birth). One newborn (Glargine group) had congenital malformation (anencephaly). None of the women experienced significant progression of retino- nor nephropathy. Although mean glycemic control (HbA1c) was similar at first trimester of pregnancy ( 6.9 % in Protaphan group and 7.4% in Glargine group) the decrease from first trimester to third trimester was greater in Glargine Insulin group compared to Protaphan group (P=0.04). There was a tendency towards lower number of hypoglycemic episodes in the Glargine group (11/47) than in the Protaphan group ( 21/50)(P=0.07). In conclusion, treatment with Glargine insulin during pre Continue reading >>
Using Insulin In Pregnancy: Fda Approves Levemir
Novo Nordisk’s Levemir (insulin detemir) has been classified as Category B for pregnant women. “This is the most thrilling news since the discovery of insulin,” says Dr. Lois Jovanovic, CEO and Chief Scientific Officer of the Sansum Diabetes Research Institute and world-renowned expert in diabetes and pregnancy. “I am thrilled.” Given that Dr. Jovanovic is so unequivocally positive, the news deserves a bit more explanation for those of us who aren’t experts and aren’t pregnant. Levemir is the first long-acting insulin other than NPH to be classified as Category B. But what exactly does that mean? And why are we so worried about insulin in pregnancy anyway? The FDA, Dr. Jovanovic explains, needs to make sure drugs taken by women during pregnancy are safe for the baby, and not going to cause any birth defects or abnormalities. The FDA therefore assigns drugs to a category that indicates how they should be used in pregnancy. Category A drugs are things like vitamins—not just okay to use, but actually good for the pregnant woman and the fetus. Category B drugs are not necessarily positive for pregnancy, but all animal and human studies must indicate that the drug is safe for the mother and the baby. Category C drugs are not known to cause birth defects, but have not been sufficiently tested in humans to really be certainly safe. Up until now, untested insulin analogues, and all long-acting insulin analogues other than NPH, fell into Category C—not known to be harmful, but not known to be safe either. Now, normal, non-diabetic women produce their own insulin, and that insulin is obviously safe for fetuses. What, then, makes insulin analogues different and riskier? The answer is that insulin analogues may behave similarly to human insulin in the body, but th Continue reading >>
Safety Of Insulin Glargine Use In Pregnancy
The study was done to compare the safety of using Glargine in place of NPH insulin…. The prevalence of diabetes in women of childbearing age is increasing. As such, the number of pregnancies complicated by diabetes will inevitably increase. New insulin analogues such as the long-acting analogue insulin glargine may represent beneficial treatment options in pregnancy by ensuring that patients achieve excellent glycemic control without risk of maternal hypoglycemia. The study was done to determine the fetal safety of insulin glargine use in the treatment of diabetes in pregnancy compared with NPH insulin therapy. A systematic review and meta-analysis was performed of all original human studies that reported neonatal outcomes among women with pregestational or gestational diabetes who were managed with either insulin glargine or NPH insulin during pregnancy. A systematic literature search was conducted from 1980 to June 1, 2010. Outcomes included large size for gestational age, macrosomia, neonatal hypoglycemia, neonatal intensive care unit admissions, birth trauma, congenital anomalies, preterm delivery, perinatal mortality, respiratory distress, and hyperbilirubinemia. Relative risk ratios and weighted mean differences were computed with 95% confidence intervals. Eight studies reporting on a total of 702 women with pregestational or gestational diabetes in pregnancy treated with either insulin glargine (n = 331) or NPH insulin (n = 371) met the inclusion criteria. There were no statistically significant differences in the occurrence of fetal outcomes studied with the use of insulin glargine compared to NPH insulin. Several new insulin analogues have become available during the past decade, yet data on the fetal safety of insulin glargine are scarce. By avoiding high pe Continue reading >>
