Levemir Side Effects facts and Information
zhion@zhion.com   November 26, 2005
WHAT IS LEVEMIR? Levemir (insulin detemir [recombinant DNA
origin]) is a soluble, long-acting basal insulin analogue that provides
up to a 24-hour duration of action and has been observed in studies
with adults to cause little weight change. Because Levemir is made by
recombinant DNA technology (rDNA) and is chemically different from
the insulin made by the human body, it is called an insulin analog.  
Levemir is indicated for once- or twice-daily subcutaneous
administration for the treatment of adult and pediatric patients with
type 1 diabetes mellitus or adult patients with type 2 diabetes
mellitus who require basal (long acting) insulin for the control of
hyperglycemia, i.e. high blood sugar. [1]

Levemir has already been approved for use in 53 countries
worldwide, including countries throughout Europe. Levemir was
cleared for marketing in adults by the U.S. Food and Drug
Administration in June 2005.  U.S. Food and Drug Administration (FDA)
has approved Levemir® (insulin detemir [rDNA origin] injection) for
use in children on October 20, 2005. Novo Nordisk will launch Levemir
for adults and children within the next eight months. [1]

Levemir® is a registered trademark of Novo Nordisk A/S.
Who Should Not Use Levemir?
People do not take Levemir if their
blood sugar is too low (hypoglycemia) and if they are allergic to insulin
detemir or any of its ingredients. Levemir is contraindicated in
patients hypersensitive to insulin detemir or its excipients. [1]
What Are The Risks, the possible side effects? Hypoglycemia is the
most common adverse effect of insulin therapy, including Levemir. [1]
Hypoglycemia (low blood sugar) can occur with: (1) the wrong insulin
dose. (2) medicines that directly lower glucose or increase sensitivity
to insulin.  (3) medical conditions that limit the bodyÂ’s glucose
reserve, lengthen the time insulin stays in the body, or that increase
sensitivity to insulin. (4) not enough carbohydrate (sugar or starch)
intake. And (5) too much glucose use by the body. Hyperglycemia
(high blood sugar) can occur with: (1) the wrong insulin dose. (2)
medicines that directly increase glucose or decrease sensitivity to
insulin.  (3) medical conditions that increase the bodyÂ’s production of
glucose or decrease sensitivity to insulin and (4) too much
carbohydrate intake.

What are other possible side effects? Serious allergic reaction.  Get
medical help right away if you develop a rash over your whole body,
have trouble breathing, a fast heartbeat, or sweating. Reaction at the
injection site (local allergic reaction). You may get redness, swelling,
and itching at the injection site. If you have serious or continuing
reactions, you may need to stop using Levemir and use another
insulin. Skin thickens or pits at the injection site, especially if the
injection site is not rotated. Vision changes that may require
evaluation by an ophthalmologist (medical doctor specializing in eye
disease) or changes in your eyeglasses or contact lens prescription.
Fluid retention or swelling of your hands and feet. Low potassium in
your blood (hypokalemia).

What Should I Tell My Healthcare Professional? Before starting
Levemir, tell your healthcare professional about all your medical
conditions including if you: [1] have liver or kidney problems. [2] are
pregnant, are trying to become pregnant, or are breast-feeding or
planning to breast-feed. [3] take any other medicines.
Are There Any Interactions With Drugs Or Foods? Tell your healthcare
professional  about all the medicines you are taking including
prescription and nonprescription medicines, vitamins, and herbal
supplements. Alcohol, certain medicines, food, supplements may
increase or decrease glucose or may increase or decrease sensitivity
to insulin.  

RESEARCH REPORT HIGHLIGHTS
Chapman TM and Perry CM Spotlight on insulin detemir in type 1 and 2
diabetes mellitus. BioDrugs. 2005;19(1):67-9.
Insulin detemir has a
more predictable, protracted, and consistent effect on blood glucose
than neutral protamine Hagedorn (NPH) insulin, with less intrapatient
variability in glycemic control than NPH insulin or insulin glargine.
Insulin detemir, administered once or twice daily, is at least as
effective as NPH insulin in maintaining overall glycemic control, with a
similar or lower risk of hypoglycemia, especially nocturnal
hypoglycemia, compared with NPH insulin in patients with type 1 or
type 2 diabetes. Insulin detemir also provides the added clinical
benefit of no appreciable bodyweight gain in patients with type 1
diabetes and less bodyweight gain than NPH insulin in patients with
type 2 diabetes. Insulin detemir is, therefore, a promising new option
for basal insulin therapy in patients with type 1 or 2 diabetes.

De Leeuw I et al, Insulin detemir used in basal-bolus therapy in
people with type 1 diabetes is associated with a lower risk of
nocturnal hypoglycaemia and less weight gain over 12 months in
comparison to NPH insulin. Diabetes Obes Metab. 2005 Jan;7(1):73-
82.
A multicentre, open-label, parallel-group study was conducted
over 12 months and completed by 308 people. Patients were
randomized in a 2:1 ratio to receive insulin detemir or NPH insulin
before breakfast and dinner, with insulin aspart at mealtimes.
RESULTS: Glycaemic control improved in both groups with HbA(1c)
decreasing by 0.64 and 0.56% point in the insulin detemir and NPH
insulin groups. No significant difference was apparent between
treatments. Fewer hypoglycaemic events (major and minor) occurred
in association with insulin detemir compared with NPH insulin, but the
overall hypoglycaemic risk did not differ statistically significantly.
However, the risk of nocturnal hypoglycaemia during the maintenance
phase (month 2-12) was 32% lower in the detemir group. After 12
months, baseline-adjusted mean body weight was significantly lower
in the insulin detemir group than in the NPH insulin group..
CONCLUSIONS: In long-term basal-bolus therapy, insulin detemir with
insulin aspart as mealtime insulin is well tolerated and reduces the
risks of nocturnal hypoglycaemia and weight gain compared to NPH
insulin.

ABOUT DIABETES
The U.S. diabetes epidemic continues to grow at an alarming rate.
Research shows that a male born in 2000 has almost a 1 in 3 chance
of developing diabetes during his lifetime and females fare even
worse with a 2 in 5 chance.. Approximately one in every 400 to 500
children and adolescents has type 1 diabetes. The risk of developing
type 1 diabetes is higher than virtually all other severe chronic
diseases of childhood. Peak incidence occurs during puberty, around
10 to 12 years of age in girls and 12 to 14 years of age in boys. The
symptoms of type 1 diabetes can mimic the flu in children. [1]

DO NOT COPY NOR TRANSFER THIS ARTICLE TO OTHER WEBSITE NOR OTHER
TYPES OF PUBLICATIONS. ALL RIGHT RESERVED 2008 zhion.

REFERENCE
[1] FDA Approves Levemir® (insulin detemir [rDNA origin] injection)
for treatment of diabetes in children, New Treatment Provides Up To
24-Hour Duration of Action For Growing Patient Population Novo
Nordisk Press Release, October 20, 2005. [2] Patient Information
Sheet, Insulin Detemir [rDNA origin] Injection (marketed as Levemir),
FDA Online Publication, November 26, 2005.
Popular Search
Abilify
Accutane
Actonel
Actoplus
Actos
AcuTect
Adderall
Agenerase
Aggrastat
Alamast
Alimta
Alinia
Aloxi
Alrex
Ambien CR
Amerge
Amidarone
Amphadase
Antagon
Apidra
Apokyn
Aptivus
Arava
Arqatroban
Aripiprazole
Avanafil
Arixtra
Aromasin
Arranon
Asmanex
Atacand
Avandia
Avastin
Banzel
Duodote
Erbitux
Gardasil
GDNF
Ghrelin
GRN163
Herceptin
Increlex
Keppra
Kogenate FS
Levemir
Levothyroxine
Liraqlutide
Lithium
Carbonate
Lucentis
Lyrica
Omnitrope
Prezista
PSN010
PX12
Rapaflo
Remicade
Revlimid
Rozerem
Sorafenib
Sutent
Tamsulosin
Tapentadol HCL
Torcetrapib
Toviaz
Tykerb
Tysabri
Vectibix
Xeloda
Zoledronic acid