# Criteria for Use Checklist

# Aliskiren (Tekturna^®^)

# VA Pharmacy Benefits Management Service and Medical Advisory Panel

*The following recommendations are based on current medical evidence and
expert opinion from clinicians. The content of the document is dynamic
and will be revised as new clinical data becomes available. The purpose
of this document is to assist practitioners in clinical decision-making,
to standardize and improve the quality of patient care, and to promote
cost-effective drug prescribing. The clinician should utilize this
guidance and interpret it in the clinical context of the individual
patient. The manufacturer's labeling and/or the National PBM-MAP Drug
Monograph at [www.pbm.va.gov](http://www.pbm.va.gov/) or*
[http://vaww.pbm.va.gov](http://vaww.pbm.va.gov/) *should be consulted
for detailed information when prescribing aliskiren.*

Thiazide-type diuretics are the preferred first line agents for patients
with uncomplicated hypertension (HTN). In addition, most patients will

require more than one agent to control their blood pressure. Another
class of medication \[e.g., angiotensin-converting enzyme inhibitor
(ACEI), long-acting CCB, or angiotensin II receptor antagonist (ARB) if
ACEI intolerant\] may be considered in patients who have a
contraindication to or are inadequately controlled on a thiazide-type
diuretic OR in patients who have an indication for an agent in another
antihypertensive class (e.g., beta-blocker in a patient with
prior-myocardial infarction or symptomatic coronary ischemia; ACEI and
beta-blocker in patients with systolic heart failure). Therapy with
other antihypertensive drug classes may be considered in patients who do
not achieve an adequate clinical response despite therapy as recommended
above. Due to the lack of published long-term outcome and safety data,
aliskiren should be reserved for patients with HTN who do not tolerate
or are not controlled on antihypertensive medications within the drug
classes currently recommended as initial or alternative/supplemental
drug therapy, as well as a reasonable trial of other supplemental drug
therapy as per VHA/DoD Clinical Practice Guideline for Management of
Hypertension in Primary Care (refer to www.oqp.med.va.gov), and that are
available on the VA National Formulary
(<http://www.pbm.va.gov/NationalFormulary.aspx>). The long-term efficacy
and safety of combination therapy with aliskiren and an ACEI or ARB in
the treatment of HTN compared to combination with an antihypertensive
agent with a different mechanism of action is unknown; therefore,
combination therapy with aliskiren and an ACEI or ARB is not advised at
this time. In addition, the role of aliskiren as monotherapy or
combination therapy with either an ACEI or ARB in influencing long-term
outcomes for other indications (e.g., chronic kidney disease, heart
failure) has not been determined.

+-----------------------------------------------------------------------+
| ######## INCLUSI                                                      |
| ON CRITERIA FOR ALISKIREN (must fulfill the following to be eligible) |
+-----------------------------------------------------------------------+
| -   Treatment of hypertension in patients who have documented lack of |
|     inadequate response or contraindication to, or inability to       |
|     tolerate at least three antihypertensive agents on the VA         |
|     National Formulary, one from each of the following drug classes:  |
|     thiazide-type diuretic, ACEI (or ARB if an ACEI is indicated and  |
|     the patient is ACEI intolerant\*), long-acting calcium channel    |
|     blocker. Since most patients will require more than one           |
|     antihypertensive agent to control their blood pressure, if the    |
|     patient's blood pressure is not at goal despite therapy as        |
|     recommended above, a trial of at least two additional             |
|     antihypertensive agents listed on the VA National Formulary       |
|     (e.g., reserpine, beta-adrenergic blocker, centrally acting       |
|     agent, vasodilator, aldosterone antagonist, alpha-blocker) as     |
|     supplemental therapy should be attempted prior to considering     |
|     aliskiren                                                         |
|                                                                       |
| \*Unable to tolerate an ACEI due to cough or other non                |
| life-threatening reason. It is unknown if an ARB can be safely used   |
| as an alternative in patients who develop significant kidney          |
| dysfunction, hyperkalemia, or angioedema with an ACEI, as these       |
| adverse events have also occurred with the use of an ARB              |
+-----------------------------------------------------------------------+
| ###                                                                   |
| ##### EXCLUSION CRITERIA (if ONE is checked, patient is not eligible) |
+-----------------------------------------------------------------------+
| -   Pregnancy                                                         |
|                                                                       |
| -   Women of child-bearing potential not using adequate method of     |
|     contraception after discussion of risk vs. benefit of treatment   |
|     (refer to Monitoring)                                             |
|                                                                       |
| -   History of angioedema with an angiotensin-converting enzyme       |
|     inhibitor (ACEI) or angiotensin II receptor antagonist (ARB)      |
|     (while not specifically a contraindication, the risk vs. benefit  |
|     of treatment in these patients should be taken into               |
|     consideration)                                                    |
|                                                                       |
| -   Use for indications other than hypertension                       |
+-----------------------------------------------------------------------+
| **DOSING RECOMMENDATIONS**                                            |
+-----------------------------------------------------------------------+
| -   The initial recommended total daily dose of aliskiren is 150 mg   |
|     administered once daily                                           |
|                                                                       |
| -   The dose may be increased to a maximum of 300 mg once daily after |
|     two weeks if the blood pressure goal is not achieved              |
|                                                                       |
| -   It is recommended that aliskiren be administered at a consistent  |
|     interval in relation to meals as a high fat meal decreased the    |
|     absorption of the drug, the clinical significance of this is      |
|     unknown                                                           |
+-----------------------------------------------------------------------+
| **MONITORING**                                                        |
+-----------------------------------------------------------------------+
| -   Administration of medications that act at the                     |
|     renin-angiotensin-aldosterone system (RAAS) during pregnancy has  |
|     resulted in neonatal morbidity and mortality; therefore,          |
|     aliskiren should be discontinued as soon as possible after a      |
|     patient becomes pregnant                                          |
|                                                                       |
| -   As with other agents that act at the RAAS (e.g., ACEIs, ARBs,     |
|     aldosterone antagonists), it is recommended that kidney function  |
|     be monitored in patients where kidney function depends on the     |
|     RAAS (e.g., renal artery stenosis, volume depletion, severe heart |
|     failure) and in patients with prior kidney dysfunction or         |
|     diabetes mellitus (DM). Serum potassium should be monitored in    |
|     patients receiving potassium-sparing diuretics, potassium         |
|     supplements, or other medications that may increase serum         |
|     potassium, and in patients with kidney impairment, DM, or heart   |
|     failure. The frequency of routine monitoring should take into     |
|     consideration the patient's concomitant therapy and comorbid      |
|     conditions                                                        |
|                                                                       |
| -   Symptomatic hypotension may occur in patients who may be sodium   |
|     or volume depleted (e.g., in patients receiving diuretic therapy) |
|     upon initial therapy with aliskiren; it is recommended to correct |
|     the volume depletion prior to starting aliskiren, otherwise       |
|     therapy should be initiated under close medical supervision       |
|                                                                       |
| ```{=html}                                                            |
| <!-- -->                                                              |
| ```                                                                   |
| -   Aliskiren should be used with caution in the following patients:  |
|     those with greater than moderate kidney dysfunction (defined as   |
|     serum creatinine [\>]{.underline} 1.7 mg/dL for women and         |
|     [\>]{.underline} 2.0 mg/dL for men, or estimated Glomerular       |
|     Filtration Rate \< 30 mL/min), on dialysis, with a history of     |
|     nephrotic syndrome or renovascular HTN; as these patients were    |
|     not included in the clinical trials                               |
|                                                                       |
| -   It has been reported that the blood concentrations of furosemide  |
|     are significantly reduced when given in combination with          |
|     aliskiren; therefore, the clinical effects of furosemide may be   |
|     decreased after initiation of aliskiren                           |
+-----------------------------------------------------------------------+
| **RECOMMENDATIONS FOR DISCONTINUATION**                               |
+-----------------------------------------------------------------------+
| -   Patient does not experience an improvement in blood pressure      |
|     control                                                           |
|                                                                       |
| -   Patient experiences a significant drug related adverse event      |
+-----------------------------------------------------------------------+

Contact person: Elaine M. Furmaga, PharmD, Clinical Pharmacy Specialist,
VACO PBM Service