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U.S. Department of Health and Human Services

Safety

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Tekturna (aliskiren) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

 

November 2013

Summary View

WARNINGS AND PRECAUTIONS

Hypotension
  • Symptomatic hypotension may occur after initiation of treatment with Tekturna in patients with marked volume depletion, patients with salt depletion, or with combined use of aliskiren and other agents acting on the renin-angiotensin-aldosterone system. Thevolume or salt depletion should be corrected prior to administration of Tekturna, or the treatment should start under close medical supervision.

 

 

April 2012

Summary View

 

*Concomitant use with ARBs or ACEIs in diabetes


CONTRAINDICATIONS

  • Do not use aliskiren with ARBs or ACEIs in patients with diabetes
 

WARNINGS AND PRECAUTIONS

Renal Impairment/Hyperkalemia/Hypotention with Tekturna is given in combination with ARBs or ACEI
  • Tekturna is contraindicated in patients with diabetes who are receiving ARBs or ACEI because of the increased risk of renal impairment, hyperkalemia, and hypotension \
  • Avoid use of Tekturna with ARBs or ACEI in patients with moderate renal impairment (GFR <60 ml/min).
Impaired Renal Function
  • Monitor renal function periodically in patients treated with Tekturna. Changes in renal function, including acute renal failure, can be caused by drugs that affect the renin-angiotensin system...
Hyperkalemia
  • Aliskiren
  • Monitor serum potassium periodically in patients receiving Tekturna. Drugs that affect the renin-angiotensin system can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes, combination use with ARBs or ACEI
 

ADVERSE REACTIONS

Clinical Trials Experience
  • These data do not include information from the ALTITUDE study which evaluated the use of aliskiren in combination with ARBs or ACEI
Clinical Laboratory Findings
  • in patients with hypertension not concomitantly treated with ARB or ACEI.
Serum Potassium
  • In patients with hypertension not concomitantly treated with and ARB or ACEI
 

USE IN SPECIFIC POPULATIONS

  • Renal impairment - Safety and effectiveness of Tekturna in patients with severe renal impairment (CrCL <30 ml/min) have not been established as patients with eGFR <30ml/min were excluded in clinical trials
 

PATIENT COUNSELING INFORMATION

Who should not take Tekturna?
  • If you have diabetes and are taking a kind of medicine called an angiotensin-receptor-blocker or angiotensin-converting-enzyme-inhibitor .
Tell your doctor about all medicines you take
  • a kind of medicine called angiotensin receptor blocker or angiotensin converting enzyme inhibitor
What Are Possible Side Effects Of Tekturna?
  • high levels of potassium in the blood (hyperkalemia)

 

November 2009

Summary View

 

BOXED WARNING

WARNING: Avoid Use in Pregnancy
  • When pregnancy is detected, discontinue Tekturna as soon as possible. Drugs that act directly on the reninangiotensin system can cause injury and death to the developing fetus.

WARNINGS AND PRECAUTIONS

Fetal/neonatal mobidity and mortality
  • If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Impaired Renal Function
  • Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances particularly in patients with severe renal impairment.
Head and Neck Angioedema (section revised)
  • Discontinue Tekturna immediately in patients who develop angioedema, and do not readminister.

ADVERSE REACTIONS

Clinical Studies Experience
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.

DRUG INTERACTIONS

Effects of Aliskiren on Other Drugs
  • Patients receiving furosemide could find its effect diminished after starting aliskiren

USE IN SPECIFIC POPULATIONS 

Pregnancy
  • When pregnancy is detected, Tekturna should be discontinued as soon as possible.
PATIENT COUNSELING INFORMATION
Information for Patients (added)
  • Symptomatic Hypotension...
  • Potassium Supplements...
  • Relationship to Meals...

FDA Approved Patient Labeling

  • What Is High Blood Pressure? Drugs that lower blood pressure lower your risk of having a stroke or heart attack.
  • Who Should Not Take Tekturna? Do not take Tekturna if you are allergic to any of its ingredients, See the end of this leaflet for a complete list of the ingredients in Tekturna.
  • What Are Possible Side Effects Of Tekturna? 
    • Angioedema...
    • Common side effects of Tekturna include...
  • How Do I Store Tekturna? Medicines are sometimes prescribed for condition not listed in the patient information leaflet. Do not take Tekturna for a condition for which is was not prescribed. ...If you have more questions about Tekturna talk with your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals.
  • What Should I Tell My Doctor Before Taking Tekturna?  Have ever had a reaction called angioedema, to an ACE inhibitor medicine. Angioedema causes swelling of the face, lips, tongue, throat, arms, and legs, and may cause difficulty breathing.
    • Tell your doctor about all the medicines you take...Atorvastatin (medicine to lower cholesterol in your blood)
  • What Are Possible Side Effects Of Tekturna?  Injury or death to an unborn baby.
  • How Should I Take Tekturna? Tekturna can be taken by itself or safely in combination with other medicines to lower high blood pressure. Your doctor may change your dose if needed.