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U.S. Department of Health and Human Services

Safety

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Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February, June and October 2011, and February 2012

 

February 2012

Summary View

 

Tekturna and Tekturna HCT

*Fetal Toxicity

 

BOXED WARNING

WARNING: FETAL TOXICITY
  • When pregnancy is detected, discontinue Tekturna HCT 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 Tekturna 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, hypotension, renal failure, and death. When pregnancy is detected, discontinue Tekturna as soon as possible. These…
Pediatric Use

Neonates with a history of in utero exposure to Tekturna:

  • If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.
 

PATIENT INFORMATION

What is the most important information I should know about Tekturna?
  • Tekturna 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 Tekturna, tell your doctor right away.

 

Tekturna HCT 

 

WARNINGS AND PRECAUTIONS

Impaired Renal Function
  • Changes in renal fuction including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on Tekturna HCT. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on Tekturna HCT.
 
Serum Electrolyte Abnormalities
  • Hydrochlorothiazide can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Monitor serum electrolytes periodically.
 
Metabolic Disturbances
Hydrochlorothiazide
  • Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.
  • Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.
  • Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving Tekturna HCT.
 

ADVERSE REACTIONS

Post Marketing Experience
Aliskiren
  • Hypersensitivity: angioedema requiring airway management and hospitalizationPeripheral edema
  • Blood creatinine increased
  • Severe cutaneous adverse reactions, including Stevens Johnson syndrome and toxicepidermal necrolysis
Hydrochlorothiazide
  • Acute renal failure, renal disorder, aplastic anemia, erythema mutliforme, pyrexia, muscle spasm, asthenia, acute angle-closure glaucoma, bone marrow failure, worsening of diabetes control, hypokalemia, blood lipids increased, hyponatremia, hypomagnesemia, hypercalcemia, hyperchloremic alkalosis, impotence, visual impairment Pathological changes in the parathyroid gland of patients with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy. If hypercalcemia occurs, further diagnostic evaluation is necessary.
 

DRUG INTERACTIONS

  • Non-Steroidal Anti-Inflammatory Agents (NSAIDS) including Selective Cyclooxygenase 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 COX-2 inhibitors with agents acting on the renin-angiotensin system, including aliskiren, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving aliskiren and NSAID therapy.
  • The antihypertensive effect of agents acting on the renin-angiotensin system, including aliskiren, may be attenuated by NSAIDs.
Hydrochlorothiazide
  • Lithium: Diuretic agents increase the risk of lithium toxicity. Refer to the package insert for lithium before use of such preparation with Tekturna HCT. Monitoring of serum lithium concentrations is recommended during concurrent use.
  • Ion exchange resins:Staggering the dosage of hydrochlorothiazide and ion exchange resins (e.g., cholestyramine, colestipol) such that hydrochlorothiazide is administered at least 4 hours before or 4-6 hours after the administration of resins would potentially minimize the interaction.
 

USE IN SPECIFIC POPULATIONS

Hydrochlorothiazide
  • Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma. Hydrochlorothiazide, like other diuretics, can cause placental hypoperfusion. It accumulates in the amniotic fluid, with reported concentrations up to 19 times higher than in umbilical vein plasma. Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia. Since they do not prevent or alter the course of EPH (Edema, Proteinuria, Hypertension) gestosis (pre eclampsia), these drugs should not be used to treat hypertension in pregnant women. The use of hydrochlorothiazide for other indications (e.g. heart disease) in pregnancy should be avoided.
Renal Impairment
  • Safety and effectiveness of Tekturna HCT in patients with severe renal impairment (CrCl ≤ 30 mL/min) have not been established. No dose adjustment is required in patients with mild (CrCl 60-90 mL/min) or moderate (CrCl 30-60) renal impairment.
Hepatic Impairment
  • Aliskiren: No dose adjustment is necessary for patients with mild-to-severe liver disease.
  • Hydrochlorothiazide: Minor alterations of fluid and electrolyte balance may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease.
 

Patient Information sheet

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you are taking:
  • potassium-containing medicines, potassium supplements, or salt substitutes containing potassium

 

October 2011 

Summary View

 

USE IN SPECIAL POPULATIONS

Geriatric Use
  • Of the total number of patients receiving aliskiren in clinical studies, 1,275 (19%)..... Blood pressure response and adverse effects were generally similar to those in younger patients.

 

June 2011

Summary View

 

*eye problems

WARNINGS AND PRECAUTIONS

Acute Myopia and Secondary Angle-Closure Glaucoma
  • Hydrochlorothiazide, a sulfonamide, can cause an idosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
 
Cyclosporine or Itraconazole
  • Aliskiren: When aliskiren was given with cyclosporine or itraconazole, the blood concentrations of aliskiren were significantly increased. Avoid concomitant use of aliskiren with cyclosporine or intraconazole

 

ADVERSE REACTIONS

Post-Marketing Experience
  • Blood creatinine increased

 

DRUG INTERACTIONS

Aliskiren
  • Cyclosporine: Avoid co-administration of cyclosporine with aliskiren.
  • Itraconazole: Avoid co-administration of itraconazole with aliskiren.
 
Patient Labeling
What are the possible side effects of Tekturna HCT?
  • Eye problems. One of the medicines in Tekturna HCT can cause eye problems that may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting Tekturna HCT. Tell your doctor right away if you have:
    • Decrease in vision
    • Eye pain

 

February2011

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