Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Product Modules > Levemir PI > Flashcards

Levemir PI Flashcards

1
Q

Levemir is indicated to improve glycemic control in adults and ____________ with diabetes mellitus.

A

children

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

How can Levemir be dosed?

A

Either once daily or in divided daily doses.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

When should Levemir be dosed when dosing once daily?

A

Either with the evening meal or at bedtime.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Why should injection sites be rotated within an injection area when taking Levemir?

A

to reduce the risk of lipodystrophy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

May converting from other insulin therapies require adjustment of timing and dose of Levemir?

A

Yes. Blood glucoses should be monitored closely upon converting to Levemir.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

How is Levemir supplied?

A

in either a 3mL Levemir FlexPen or a 10mL vial

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Is it ok to administer Levemir via an insulin pump?

A

No, Levemir should not be administered via an insulin pump.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Is it ok to mix or dilute Levemir with other insulins or solutions?

A

No.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What are the adverse reactions associated with Levemir?

A
  1. hypoglycemia
  2. allergic reactions
  3. injection site reactions
  4. lipodystrophy
  5. rash
  6. pruritus
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

The signs of hypoglycemia may be reduced or absent in patients taking ___________ drugs with Levemir.

A

anti-andrenergic drugs.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What are examples of anti-adrenergic drugs?

A
  • beta blockers
  • clonidine
  • guanethidine
  • reserpine
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Has Levemir been studied in children with type 2 diabetes?

A

No, Levemir has not been studied in children with type 2 diabetes. It has also not been studied in children with type 1 diabetes less than 2 years of age.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What specific populations is Levemir indicated to treat?

A
  • adults with type 1 or type 2 diabetes
  • children with type 1 diabetes who are 2 years of age or older
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

What 3 ways may Levemir be dosed when doing twice daily injections?

A
  1. with the evening meal
  2. at bedtime
  3. 12 hours after the morning dose
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What is the recommended starting dose of Levemir in patients with Type 1 diabetes?

A

approximately 1/3 of their total daily insulin requirements

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What is the recommended starting dose of Levemir in patients with type 2 diabetes who are inadequately controlled on oral antidiabetic medications?

A

10 units (or 0.1-0.2 units/kg) given once daily in the evening or divided into a twice daily regimen

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

When changing from Lantus to Levemir, can the change be done on a unit-to-unit basis?

A

Yes.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

If converting from NPH to Levemir, can the change be done on a unit-for-unit basis?

A

Yes, but some patients may require more Levemir than NPH.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Can Levemir be administered intravenously or intramuscularly?

A

No, the intended duration of activity of Levemir is dependent on SC injection. Severe hypoglycemia could be caused by IM or IV injection.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

What is the most common adverse reaction associated with insulin therapy, Levemir included?

A

Hypoglycemia

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

If a GLP-1 agonist is used in combination with Levemir what considerations should be made?

A

the Levemir dose may need to be lowered or more conservatively titrated to guard against hypoglycemia

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Was any difference observed in the pharmacokinetics of Levemir between non-diabetic individuals with renal impairment and healthy volunteers?

A

No, difference was observed. However, some studies have shown increased circulating insulin concentrations in patients with renal impairment.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

True/False: Non-diabetic individuals with severe hepatic impairment had lower systemic exposures to insulin detemir compared to healthy volunteers.

A

True. Although some studies have shown increased circulating insulin concentrations in patients with liver impairment.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

In the Levemir add-on to liraglutide+met trial, what dose of liraglutide did all patients receive during the 12-week run-in period?

A

1.8 mg

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

During the run-in period of the Levemir add-on to liraglutide+met trial, what percentage of patients withdrew from the trial?

A

17% (or 167 patients)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

Why did most patients in the run-in period of the Levemir add-on to liraglutide+met withdraw from the trial?

A

GI adverse events

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

True/False: only patients who completed the 12-week run-in period of the Levemir add-on to lira+met trial with inadequate control were randomized to 26 weeks of add-on therapy with Levemir, or continued unchanged on lira 1.8 mg+met.

A

True

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

During the 26 week trial looking at Levemir as add-on to lira+met, what was the only adverse reaction reported in >5% of patients and greater than in patients treated with lira 1.8 mg+met alone?

A

Diarrhea

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

In 2 pooled trials, 1155 adults with type ___ diabetes were exposed to individualized doses of Levemir (n=767) or NPH (n=388).

A

type 1 diabetes

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

The mean duration of exposure to Levemir during the Levemir/NPH pooled trial was ___ days, and the total exposure to Levemir was ___ patient years.

A

153 days, 321 patient years.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

In 2 pooled clinical trials of 16 weeks and 24 weeks comparing Levemir to NPH in adults with type 1, excluding hypoglycemia, what was the most common adverse reactions (incidence over 5%) in the Levemir arm?

A
  1. Upper respiratory infection - 26.1%
  2. Headache - 22.6%
  3. Pharyngitis - 9.5%
  4. Flu-like illness - 7.8%
  5. Abdominal pain - 6.0%
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
32
Q

In a 26-week trial comparing Levemir +aspart to Lantus+aspart in adults with Type 1, what were the most common adverse events (over 5%) in the Levemir arm?

A
  1. Upper respiratory infection - 26.7%
  2. Headache - 14.3%
  3. Back pain - 8.1%
  4. Flu-like illness - 6.2%
  5. Gastroenteritis - 5.6%
  6. Bronchitis - 5.0%
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
33
Q

In 2 pooled clinical trials of 22 weeks and 24 weeks in adults with Type 2 diabetes comparing Levemir+aspart to NPH+aspart, what were the most common adverse events (excluding hypoglycemia)?

A
  1. Upper respiratory infection - 12.5%
  2. Headache - 6.5%
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
34
Q

Trial Info:

Levemir+aspart vs. NPH+aspart

26 weeks

Children and Adolescents

Type 1 diabetes

List the adverse events.

A
  1. Upper respiratory infection - 35.8%
  2. Headache - 31.0%
  3. Pharyngitis - 17.2%
  4. Gastroenteritis - 16.8%
  5. Flu-like illness - 13.8%
  6. Abdominal pain - 13.4%
  7. Pyrexia - 10.3%
  8. Cough - 8.2%
  9. Viral infection - 7.3%
  10. Nausea - 6.5%
  11. Rhinitis - 6.5%
  12. Vomiting - 6.5%
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
35
Q

True/False: Intensification or rapid improvement in glucose control has been associated with a transitory, reversible opthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.

A

True.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
36
Q

Can weight gain occur with Levemir use?

A

Yes.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
37
Q

In phase 3 clinical trials of Levemir, antibody development was observed with _______ impact on glycemic control.

A

no apparent

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
38
Q

True/False: the adverse events associated with Levemir were less than those observed with other insulin therapies.

A

False. The adverse events observed with Levemir were comparable to those observed with other insulin therapies.

39
Q

Was the incidence of severe hypoglycemia similar for both Levemir and NPH patients with type 1 or type 2 diabetes?

A

Yes, although the incidence was higher overall in patients with type 1 diabetes.

40
Q

List some of the drugs that may increase the blood-glucose-lowering effect of insulins including Levemir.

A
  • OAD meds
  • pramlintide acetate
  • angiotensin converting enzyme (ACE) inhibitors
  • disopyramide
  • fibrates
  • fluoxetine
  • monoamine oxidase (MAO) inhibitors
  • propoxyphene
  • pentoxifylline
  • salicylates
  • somatostatin analogs
  • sulfonamide antibiotics
41
Q

List some of the drugs that may reduce the blood-glucose-lowering effect insulins including Levemir.

A
  • corticosteroids
  • niacin
  • danazol
  • diuretics
  • sympathomimetic agents (epiniphrine, albuterol, terbutaline)
  • glucagon
  • isoniazid
  • phenothiazine derivatives
  • somatropin
  • thyroid hormones
  • estrogens
  • progestogens (in oral contraceptives)
  • protease inhibitors
  • atypical antipsychotic medications
42
Q

Name some medications that may either increase or decrease the blood-gucose lowering effect of insulin including Levemir.

A
  • beta blockers
  • clonidine
  • lithium salts
  • alcohol
  • Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia
43
Q

Anti-adrenergic drugs like beta blockers, clonidine, guanethidine, and reserpine may do what in patients taking insulin?

A

may reduce or hide the signs of hypoglycemia

44
Q

What pregnancy category is Levemir?

A

Pregnancy Category B

45
Q

True/False: A randomized controlled clinical trial of pregnant women with type 1 diabetes using Levemir during pregnancy did not show an increase in the risk of fetal abnormalities.

A

True.

46
Q

What were the 2 most common adverse reactions in pregnant patients with type 1 diabetes?

A
  1. Nasopharyngitis
  2. Headache
47
Q

True or False: the rates of pre-eclampsia observed in the Levemir study with pregnant patients were within expected rates for pregnancy complicated by diabetes.

A

True.

48
Q

What was the proportion of patients experiencing severe hypoglycemia in Levemir and NPH treated patients?

A
  • Levemir - 16.4%
  • NPH - 20.4%
  • But the rate was 1.1 and 1.2 events per patient year, respectively.
49
Q

In about _____% of infants, Levemir was detected in the infant cord blood at levels above the lower level of quantification (<25pmol/L).

A

25%

50
Q

True or False: No differences in pregnancy outcomes or the health of the fetus and newborn were seen with Levemir use.

A

True.

51
Q

Is it known whether Levemir is excreted in human milk?

A

No, it is not known whether Levemir is excreted in human milk. Therefore, caution should be used when adminstering Levemir to a nursing woman.

52
Q

What population of pediatric patients is acceptable to use Levemir.

A
  • Type 1 patients who are 2 years of age or older
53
Q

Has Levemir been studied in type 2 pediatric patients?

A

No, it has not.

54
Q

Has Levemir been studied in the geriatric population?

A

Yes (3.9% of type 1 patients were over 65 and 28.6% in type 2 study were over 65; a total of 1.9% of patients were over 75 years).

55
Q

What percentage of patients in the type 1 study were over the age of 65?

A

3.9% (64 patients)

56
Q

What percentage of patients in the type 2 Levemir study were over 65?

A

28.6% (309 patients)

57
Q

Was there any overall difference observed in safety or effectiveness between younger and geriatric patients in Levemir trials?

A

No.

58
Q

True or False: Levemir and NPH had similar effects on A1c levels and hypoglycemia in pediatric patients.

A

True.

59
Q

How is insulin detemir (Levemir) different from human insulin?

A
  • amino acid threonine in position B30 has been omitted
  • a C14 fatty acid chain has been atached to the amino acid B29
60
Q

Describe how Levemir’s duration of action is generated?

A
  1. Self-associates to dimers and hexamers to delay absorption
  2. slowed by binding to albumin
61
Q

A pharmacodynamic study of Levemir in type 1 patients showed a range of mean time between injection and the end of pharmacodynamic event to be from _____ to _________.

A

7.6 hours, >24 hours (24 hours was the end of the monitoring period).

62
Q

True or False: In general, Levemir has a gradual GIR (glucose infusion rate) increase and sustained activity for many hours.

A

True.

63
Q

After SC injection of Levemir, serum concentrations had a relatively constant concentration/time profile over _____ hours with the maximum serum concentration reached between ______ hours post-dose.

A

24 hours, 6-8 hours

64
Q

Cmax of Levemir is achieved when?

A

between 6-8 hours post-dose

65
Q

Levemir was more slowly absorbed when injected into the thigh. How much lower was its AUC compared to the upper arm and abdomen?

A

30-40% lower

66
Q

What is the absolute bioavailability of Levemir?

A

approximately 60%

67
Q

More than ____% of insulin detemir in the bloodstream is bound to albumin.

A

98%

68
Q

Levemir has a very small volume of distribution. What is it?

A

0.1 L/kg

69
Q

What is the terminal half-life of Levemir?

A

5-7 hours depending on the dose

70
Q

Injection of Levemir resulted in higher AUC levels in what special populations?

A

children (6-12 years) 10% and elderly patients (>68 years) 35% due to reduced clearance

71
Q

Was there any difference in pharmacokinetics of Levemir in healthy patients and patients with renal impairment?

A

No, the pharmacokinetics were not changed (although some studies of insulin have suggested that renal impairment may increase circulating levels of insulin).

72
Q

True or False: Liver dysfunction was observed to change the pharmacokinetic parameters of Levemir.

A

True.

73
Q

What was the change in pharmacokinetics of Levemir in patients with hepatic (liver) impairment?

A

Levemir exposure DECREASED with increasing degrees of hepatic impairment with a corresponding INCREASE in apparent clearance.

74
Q

Describe the various clinical trials of Levemir.

A
  1. Levemir compared to NPH (either once or twice daily) in adult type 1 patients
  2. Levemir compared to NPH (either once or twice daily) in pediatric type 1 patients
  3. Levemir compared to NPH (either once or twice daily) in adults with type 2
  4. Levemir twice daily compared to Lantus once daily in patients with type 1 diabetes
75
Q

In the Levemir clinical trials, what was used to determine the morning Levemir dosing titration?

A

the pre-dinner blood glucose from the evening before

76
Q

In the Levemir clinical trials, was the reduction in HbA1c similar between Levemir, Lantus, and NPH groups>

A

Yes. There were no clinically relevant differences.

77
Q

Describe Study A (Home study) of the Levemir clinical trials.

A
  • 16 weeks
  • Open label
  • Adults with type 1 diabetes
  • Patients were randomized to either:
  1. Levemir at 12 hour intervals
  2. Levemir in the morning at bedtime
  3. NPH in the morning and bedtime
  • Insulin aspart (Novolog) was given before each meal
  • Results: A1c reductions and FPG were similar in both arms
78
Q

Describe Study B (Pieber study) of the Levemir clinical trials.

A
  • 26 weeks
  • Open label
  • N = 320
  • Adults with type 1 diabetes
  • Randomized to either:
  1. twice daily Levemir (AM and bedtime)
  2. once daily Lantus (bedtime)
  • patients received Novolog pre-meals
  • A1c reductions were similar between the 2 arms
79
Q

Describe Study C (Russell-Jones study) of the Levemir clinical trials.

A
  • 24 weeks
  • Open label
  • N = 749
  • Adults with type 1 diabetes
  • Randomized to either:
  1. once daily Levemir (at bedtime) with regular human insulin at meals
  2. once daily NPH (at bedtime) with regular human insulin at meals
  • Levemir and NPH had similar effects on A1c reduction
80
Q

Studies A, B, and C in the Levemir clinical trials all studied what specific patient?

A

Type 1 adult patients

81
Q

What was the duration of Study A comparing twice daily Levemir to twice daily NPH?

A

16 weeks

82
Q

What was the duration of Study B comparing twice daily Levemir to once daily Lantus?

A

26 weeks

83
Q

What was the duration of Study C comparing once daily Levemir to once daily NPH?

A

24 weeks

84
Q

Describe the pediatric clinical trials for Levemir.

A

Study D - Type 1 (Robertson study)

  • 26 weeks
  • ages 6-17
  • once or twice daily Levemir compared to once or twice daily NPH
  • Novolog before meals

Study I - Type 1 (Thalange study)

  • 52 weeks
  • Ages 2-16
  • once or twice daily Levemir compared to once or twice daily NPH
  • Novolog before meals
85
Q

Describe the Levemir clinical trials for adults with type 2 diabetes.

A

Study E (Hermansen study)

  • 24 weeks
  • open label
  • Levemir twice daily vs. NPH twice daily
  • in combination with 1 or 2 of these orals:
    • metformin
    • SFU
    • AGI
  • all patients were new to insulin
  • A1c reductions were similar in both arms

Study F (Raslova study)

  • 22 weeks
  • open label
  • Levemir vs.NPH both either once or twice daily with Novolog at meals
  • Similar efficacy in both arms
86
Q

What percentage of patients achieved an A1c goal of <7% in the adult type 2 Levemir studies who were not adequately controlled on OADs alone?

A

70% of Levemir patients and 74% of NPH patients

87
Q

Describe the design of the Levemir combination trial with liraglutide.

A
  • 26 week
  • open label
  • 988 patients inadequately controlled on metformin alone or inadequately controlled on metformin + SFU
  • If pt was already on met+SFU, pt discontinued SFU for 12-week run-in period
  • during the run-in period, pts received titrated 1.8mg Victoza
  • 50% of pts after run-in period achieved <7%; these pts continued treatment in nonrandomized, observational arm
  • 17% of pts withdrew due to GI events
  • Remaining pts were randomized to 26 weeks of once daily Levemir (w/ met) or continued unchanged on Lira+met.
  • Starting dose of Levemir was 10u
  • Mean dose at study end was 39 u/day.
88
Q

What percentage of patients discontinued the Levemir-liraglutide+met trial due to ineffective therapy in the lira arm vs the Levemir arm?

A
  1. 2% in the Victoza arm
  2. 2% in the Levemir arm
89
Q

What was the percentage of patients achieving <7% in the Levemir+Lira+Met arm compared to the Lira+Met arm?

A
  • 43% (Levemir+lira+met)
  • 17% (lira+met arm)
90
Q

How should unused Levemir be stored?

A

in the refrigerator between 2-8 degrees C (36-46 degrees F)

91
Q

How long is unopened Levemir good without refrigeration?

A

Unfrigerated Levemir should be discarded 42 days after it is first kept out of the refrigerator.

92
Q

After initial use, where should Levemir vials be kept?

A

in a refrigerator

93
Q

Can an in-use vial of Levemir be stored outside of a refrigerator?

A

The in-use Levemir vial may be kept at room temperature, but it should be discarded 42 days after first being unrefrigerated.

94
Q

After first use, how should a Levemir FlexPen be stored?

A
  • it must NOT be stored in a refrigerator
  • it must NOT be stored with a needle in place
  • it must be kept in a cool place, away from direct sunlight and heat
  • Unrefrigerated Levemir FlexPens should be discarded 42 days after first kept out of refrigerator.

Product Modules (4 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions