Janumet Question

[calicokid]

I was told I can not get Janumet from the VA. This pill is 2 drugs in one--does anyone know if the VA supplies januvia seperately?

[purple]

Your Doc will have to put in a special request for this med. Did your doc try that and get denied??

[carlie]

You should not have a problem getting it if you are

1) SC'd for diabetes.

2) Stabalized on both medications

I think your profile shows 40 % SC.

Hope this helps a vet.

carlie

Here's the VA Formulary:

http://www.visn20.med.va.gov/wwwrx/rxbyname.html

Scroll down almost to the bottom and see:

HS502 SITAGLIPTIN/METFORMIN ORAL TAB JANUMET Sitagliptin/metformin

Sitagliptin/metformin

Sitagliptin/metformin combination product (NF) is available for patients stabilized on both medications.

Sept 2007 VISN 20 P&T

ALSO:

HS502 SITAGLIPTIN ORAL TABLET JANUVIA Sitagliptin

Sitagliptin

MAP/PBM Non-Formulary Criteria for Use of Sitagliptin (JanuviaTM)

Sitagliptin as monotherapy (Must meet both criteria)

1) Patient is a candidate for oral therapy and is intolerant of or has

contraindications to all of the following: metformin, sulfonylureas,

and thiazolidinediones (TZDs)1

AND

2) Target value for HbA1c based onVA/DoD Guidelines

http://www.oqp.med.va.gov/cpg/DM_base.htm

is likely to be attainable based on clinical trial data

In 3 clinical trials, the AVERAGE absolute decrease in HbA1c with

sitagliptin monotherapy ranged from -0.48 to -0.61%.

The AVERAGE placebo-subtracted decrease was greater in those with higher

baseline HbA1c: baseline HbA1c <8.0% (0.44 - 0.57%);

baseline HbA1c 8 - 8.9% (0.6 - 0.8%);

baseline HbA1c > 9% (1.2 -1.5%)

Insulin may be considered at anytime prior to using sitagliptin; however,

it should be considered if patient is symptomatic or a greater reduction

beyond what is achievable by sitagliptin is desired.

Sitagliptin as part of a 2-drug regimen (Must meet both criteria)

1) Inadequate glycemic control with metformin monotherapy and requires

the addition of a second agent AND has contraindications to or is

unable to tolerate both sulfonylureas and TZDs1

OR

Inadequate glycemic control with TZD monotherapy and requires the

addition of a second agent AND has contraindications to or is unable to

tolerate both sulfonylureas and metformin1

OR

Inadequate glycemic control with sulfonylurea monotherapy and requires

addition of a second agent AND has contraindications to or is unable to

tolerate both metformin and TZDs1

AND

2) Target value for HbA1c based onVA/DoD Guidelines

http://www.oqp.med.va.gov/cpg/DM_base.htm

is likely to be attainable based on clinical trial data

Insulin may be considered at anytime prior to using sitagliptin; however,

it should be considered if patient is symptomatic or a greater reduction

beyond what is achievable by sitagliptin is desired.

In clinical trials, the AVERAGE absolute decrease in HbA1c in

patients receiving sitagliptin + metformin was -0.67% [95%CI -0.77 to

-0.57].

The AVERAGE decrease was greater for those with higher baseline HbA1c:

baseline HbA1c < 8.0% (-0.53%)

baseline HbA1c 8 - 8.9% (0.82 - 1.13%)

baseline HbA1c > 9% (0.91-1.68%)

In a clinical trial, the AVERAGE absolute decrease in HbA1c in

patients receiving sitagliptin + pioglitazone was -0.7% [95%CI -0.85 to

-0.54].

The AVERAGE decrease was greater for those with higher baseline HbA1c:

baseline HbA1c < 8.5% (-0.73%)

baseline HbA1c > 8.5% (-1.17%)

In a In a clinical trial, the average absolute decrease in HbA1c when

combining sitagliptin and a sulfonylurea was -0.3 % [95%CI -0.48 to -0.12]

1Intolerance to other oral agents includes but is not limited to the

following: Sulfonylureas (clinically significant hypoglycemia);

metformin (persistent severe GI effects); TZDs (clinically significant

edema, new onset or worsening heart failure)

Sitagliptin as part of an oral 3-drug regimen (must meet all 4 criteria)

1) Inadequate glycemic control on combination therapy with any 2 of the

following drugs: sulfonylurea, metformin, or TZD

2) Patient has contraindications to or is unable to tolerate addition of a

3rd agent from the above mentioned group.

3) Patient is not a good candidate for or refuses addition of insulin

4) Target value for HbA1c based on VA/DoD Guidelines

http://www.oqp.med.va.gov/cpg/DM_base.htm

is likely to be attainable based on clinical trial data

In a subgroup of patients receiving sitagliptin + glimepiride + metformin,

the AVERAGE absolute decrease in HbA1c was -0.59% [95%CI -0.74 to

-0.44].

The AVERAGE placebo-subtracted decrease was greater in those with higher

baseline HbA1c:

baseline HbA1c < 8.0% (-0.55%)

baseline HbA1c 8 to 8.9% (-0.97%)

baseline HbA1c > 9% (-1.34%)

Sitagliptin as part of an oral 4-drug regimen

- The efficacy and safety of such a combination is not known and should

be strongly discouraged. Such a trial might rarely be considered in

patients with inadequate glycemic control on 3 drug therapy and who are

not good candidates for or refuse the addition of insulin.

Dosage

Sitagliptin is administered as 100mg once daily and may be taken with or

without food.

When used with a sulfonylurea, a lower dose of the sulfonylurea may be

required as hypoglycemia was reported more often in those treated with

this combination.

Dosage adjustment is recommended for patients with moderate-severe renal

insufficiency and endstage renal disease (ESRD).

50mg once daily for patients with moderate renal impairment (CrCl

= 30 to <50mL/min or SCr >1.7- = 3.0mg/dl for males >1.5- = 2.5mg/dl

females)

25mg once daily for patients with severe renal impairment (CrCl <

30mL/min or SCr > 3.0mg/dl for males or > 2.5mg/dl for females) and for

ESRD requiring dialysis. Sitagliptin may be administered without regard

to time of dialysis.

Discontinuation criteria

If HbA1c goals are not met after 3-6 months of sitagliptin therapy,

sitagliptin should be discontinued and insulin initiated (no safety and

efficacy data for combined use with insulin at this time).

Combination of sitagliptin with insulin is not recommended until

data on its safety and efficacy are available.

There have been postmarketing reports of serious allergic and

hypersensitivity reactions (e.g. anaphylaxis, angioedema, exfoliative

skin conditions including Stevens-Johnson syndrome). If these reactions

occur, discontinue sitagliptin and initiate alternative treatment for

diabetes.

June 2008 VISN 20 P&T Committee

[calicokid]

I will try a special request. Thank you.