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U.S. Department of Health and Human Services

Safety

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Valturna (aliskiren/valsartan) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) - February and May 2011, February and April 2012

 

April 2012

Summary View

 

CONTRAINDICATIONS

  • Do not use in patients with diabetes
 

WARNINGS AND PRECAUTIONS

  • Renal Impairment/Hyperkalemia/Hypotension when Valturna is given in combinationwith ARBs or ACEI.
  • Valturna is contraindicated in patients with diabetes because of the increased risk of renal impairment, hyperkalemia, and hypotension.
  • Avoid use of Valturna in patients with moderate renal impairment (GFR <60 ml/min).
 

ADVERSE REACTIONS

Aliskiren
  • These data do not include information from the ALTITUDE study which evaluated the use of Aliskiren in combination with ARBs or ACEI
 

USE IN SPECIFIC POPULATIONS

  • Renal impairment: Safety and effectiveness of aliskiren 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 INFORMATION

Who should not take Valturna?
  • If you have diabetes
Tell your doctor about all the medicines you take:
  • a kind of medicine called angiotensin receptor blocker or angiotensin converting enzyme inhibitor
The most common side effects of Valturna include:
  • high levels of potassium in the blood (hyperkalemia)

 

 

February 2012

Summary View

 

BOXED WARNING

WARNING: FETAL TOXICITY
  • When pregnancy is detected, discontinue Valturna 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 Valturna 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 Valturna: 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 Valturna 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.

 

 

May 2011

Summary View

 

PRECAUTIONS

Drug Interactions
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)
  • In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving valsartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including valsartan may be attenuated by NSAIDs including selective COX-2 inhibitors.

 

February 2011

Summary View

 

WARNINGS and PRECAUTIONS

  • Aliskiren-... Avoid concomitant use of aliskiren with cyclosporine or itraconazole

Drug Interactions

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

ADVERSE REACTIONS

Postmarketing Experience
  • Blood creatinine increased