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U.S. Department of Health and Human Services

Safety

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Tekamlo (aliskiren/amlodipine) 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 Tekamlo 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. The volume or salt depletion should be corrected prior to administration of Tekamlo, 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/Hypotension when Tekamlo is given in
combination with ARBs or ACEI
  • Tekamlo 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 Tekamlo 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 Tekamlo. Changes in renal function, including acute renal failure, can be caused by drugs that affect the reninangiotensin system…
 
Hyperkalemia
  • Aliskiren
  • Monitor serum potassium periodically in patients receiving aliskiren. 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 whichevaluated the use of aliskiren in combination with ARBs or ACEI
 
Clinical Laboratory Test Abnormalities
  • In patients with hypertension not concomitantly treated with an ARB or ACEI,
 
Serum Potassium
  • In patients with hypertension not concomitantly treated with an ARB or ACEI,
 

USE IN SPECIFIC POPULATIONS

Renal impairment
  • Safety and effectiveness of Tekamlo in patients with severe renal impairment (CrC1 ≤ 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 Tekamlo?
  • If you have diabetes and are taking a kind of medicine called an angiotensinreceptor-blocker or angiotensin-converting-enzyme-inhibitor .
 
Especially tell your doctor if you take:
  • a kind of medicine called angiotensin receptor blocker or angiotensin converting enzyme inhibitor
 
The most common side effects of Tekamlo include:
Common side effects of Tekamlo include:
  • diarrhea
  • cough
  • dizziness
  • flu-like symptoms
  • tiredness
  • high levels of potassium in the blood (hyperkalemia)

 

February 2012

Summary View

 

BOXED WARNING

WARNING: FETAL TOXICITY
  • When pregnancy is detected, discontinue Tekamlo as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
 

WARNINGS AND PRECAUTIONS

Fetal toxicity
Pregnancy Category D
  • Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.
  • When pregnancy is detected, discontinue Tekamlo as soon as possible
 

USE IN SPECIFIC POPULATIONS

Pregnancy
Pregnancy Category D
  • Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria…
Pediatric
  • Neonates with a history of in utero exposure to Tekamlo: If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis…
 

PATIENT COUNSELING INFORMATION

  • Female patients of childbearing age should be told about the consequences of exposure to Tekamlo during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
 
Patient Information
What is the most important information I should know about Tekamlo?
  • Tekamlo can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking Tekamlo, tell your doctor right away.

 

November 2011

Summary View

WARNINGS AND PRECAUTIONS

Drug Interactions with Amlodipine
  • Simvastatin: Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.

 

March 2011

Summary View

 

WARNINGS AND PRECAUTIONS

Cyclosporine or Itraconazole
  • Avoid concomitant use of aliskiren with cyclosporine or itraconazole

ADVERSE REACTIONS

Post-Marketing Experience
  • Aliskiren: Blood creatinine increased

DRUG INTERACTIONS

Aliskiren
  • Cyclosporine: Avoid co-administration of cyclosporine with aliskiren.
  • Itraconazole: Avoid co-administration of itraconazole with aliskiren.