TEKTURNA and TEKTURNA HCT are indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.
Use TEKTURNA HCT as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. Switch a patient whose blood pressure is not adequately controlled with aliskiren or hydrochlorothiazide (HCTZ) monotherapy to TEKTURNA HCT.
TEKTURNA HCT may be substituted for its titrated components.
Safety and efficacy of aliskiren in pediatric patients have not been established.
Base the choice of TEKTURNA HCT as initial therapy on an assessment of potential benefits and risks. Individualize the decision to use a combination as initial therapy by weighing factors such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy.
IMPORTANT SAFETY INFORMATION
WARNING: FETAL TOXICITY
- When pregnancy is detected, discontinue TEKTURNA or TEKTURNA HCT as soon as possible. (5.1).
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1).
Contraindications: Do not use aliskiren with angiotensin receptor blockers (ARBs) or ACE angiotensin-converting enzyme inhibitors (ACEIs) in patients with diabetes because of increased risk of renal impairment, hyperkalemia, and hypotension.
Because of the HCTZ component, TEKTURNA HCT is contraindicated in patients with anuria or hypersensitivity to sulfonamide-derived drugs like HCTZ. Hypersensitivity reactions may range from urticaria to anaphylaxis.
Anaphylactic Reactions and Angioedema: Hypersensitivity reactions such as anaphylactic reactions and angioedema of the face, extremities, lips, tongue, glottis and/or larynx have been reported in patients treated with aliskiren and have necessitated hospitalization and intubation. This may occur at any time during treatment and has occurred in patients with and without a history of angioedema with ACEIs or angiotensin receptor antagonists. Discontinue TEKTURNA or TEKTURNA HCT immediately in patients who develop anaphylactic reactions or angioedema, and do not readminister.
Hypotension: In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur in patients receiving RAAS blockers. Correct these conditions before administering TEKTURNA or TEKTURNA HCT, or start the treatment under close medical supervision.
Impaired Renal Function: Avoid use of TEKTURNA or TEKTURNA HCT with ARBs or ACEIs in patients with moderate renal impairment (GFR <60 mL/min). Monitor renal function periodically in patients receiving aliskiren, as changes in renal function, including acute renal failure, can be caused by drugs that affect the RAAS. Patients whose renal function may depend in part on the activity of the RAAS (eg, patients with renal artery stenosis, severe heart failure, post-MI, or volume depletion) or patients receiving ARB, ACEI, or NSAID therapy may be at particular risk for developing acute renal failure on aliskiren. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function.
Hyperkalemia: Monitor serum potassium periodically in patients receiving aliskiren. Drugs that affect the RAAS can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes, and combination use of aliskiren with ARBs or ACEIs, NSAIDs, potassium supplements, or potassium-sparing diuretics.
Cyclosporine, Itraconazole, or Lithium: Avoid use of TEKTURNA or TEKTURNA HCT with cyclosporine or itraconazole. Additionally, avoid use of TEKTURNA HCT with lithium.
Important Considerations Due to the HCTZ Component: Hypersensitivity reactions to HCTZ may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in those with such a history. Thiazides have been reported to cause exacerbation or activation of systemic lupus erythematosus.
HCTZ can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia, which appears difficult to treat despite potassium repletion. HCTZ may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. HCTZ may raise serum uric acid level and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients. Monitor calcium levels in patients with hypercalcemia receiving TEKTURNA HCT, as HCTZ may cause elevations of serum calcium.
HCTZ, a sulfonamide, can cause an idiosyncratic reaction resulting in transient myopia and angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Discontinue HCTZ as rapidly as possible in these patients. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
Common AEs: Adverse events (AEs) with increased rates for TEKTURNA compared with placebo included: diarrhea (2.3% vs 1.2%), cough (1.1% vs 0.6%), rash (1.0% vs 0.3%), elevated uric acid (0.4% vs 0.1%), gout (0.2% vs 0.1%), and renal stones (0.2% vs 0%).
Adverse events with increased rates for TEKTURNA HCT compared with placebo included: dizziness (2.3% vs 1.0%), influenza (2.3% vs 1.6%), diarrhea (1.6% vs 0.5%), cough (1.3% vs 0.5%), vertigo (1.2% vs 0.5%), asthenia (1.2% vs 0%), and arthralgia (1.0% vs 0.5%).