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Noden Pharma DAC
D’Olier Chambers
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Dublin 2, Ireland

IMPORTANT SAFETY INFORMATION

When pregnancy is detected, discontinue TEKTURNA or TEKTURNA HCT as soon as possible. (5.1, 8.1)
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1, 8.1)

INDICATIONS and USAGE

TEKTURNA (aliskiren) is indicated for the treatment of hypertension in adults and in pediatric patients weighing 50kg or greater who are at least 6 years of age, to lower blood pressure.

The safety and effectiveness of aliskiren have been established in pediatric patients 6 years of age and older weighing 20 kg or more, but Tekturna is not approved in patients 6 years of age and older weighing 20 kg to less than 50 kg because of the lack of an appropriate dosage form. The safety and effectiveness of TEKTURNA have not been established in pediatric patients younger than 6 years of age and patients less than 20 kg. Avoid use in patients 2 years to less than 6 years and patients weighing less than 20 kg.

TEKTURNA HCT (aliskiren and hydrochlorothiazide) is 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating risk reduction with either TEKTURNA or TEKTURNA HCT. 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.

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 targetgoal, and the incremental likelihood of achieving goal with a combination compared to monotherapy.

TEKTURNA or TEKTURNA HCT should be administered as instructed in the Prescribing Information.

IMPORTANT SAFETY INFORMATION

When pregnancy is detected, discontinue TEKTURNA or TEKTURNA HCT as soon as possible. (5.1, 8.1)
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1, 8.1)

Contraindications: Do not use TEKTURNA or TEKTURNA HCT with angiotensin receptor blockers (ARBs) or angiotensin-converting enzyme inhibitors (ACEIs) in patients with diabetes because of increased risk of renal impairment, hyperkalemia, and hypotension. TEKTURNA and TEKTURNA HCT are contraindicated in patients with hypersensitivity to any of the components. 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. TEKTURNA is contraindicated in pediatric patients less than 2 years of age.

Anaphylactic Reactions and Head and Neck 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 combined use of aliskiren-containing products with ARBs or ACEIs in patients with renal impairment (creatinine clearance less than 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 and by diuretics. Patients whose renal function may depend in part on the activity of the RAAS (e.g. patients with renal artery stenosis, severe heart failure, post-MI, or volume depletion) or patients receiving ARBs, ACEIs, or nonsteroidal anti-inflammatory drugs (NSAIDs), including selective Cyclooxygenase-2 inhibitors (COX-2 inhibitors), 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. Safety and effectiveness of aliskiren in patients with severe renal impairment (creatinine clearance less than 30 mL/min) have not been established.

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 (hydrochlorothiazide) Component in TEKTURNA HCT: 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.

Non-melanoma Skin Cancer: Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.

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%), hyperkalemia (0.9% vs 0.6%), 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%).

Lactation: Breastfeeding is not recommended during treatment with TEKTURNA or TEKTURNA HCT.

Relationship to meals: Advise patients to establish a routine pattern for taking TEKTURNA or TEKTURNA HCT tablets. High-fat meals decrease absorption substantially.

Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.

Overdosage: Limited data are available and the most likely manifestation of overdosage would be hypotension. If symptomatic hypotension occurs, supportive treatment should be initiated. As aliskiren is poorly dialyzed, hemodialysis is not adequate to treat overexposure.

To report SUSPECTED ADVERSE REACTIONS, contact Noden Pharma USA Inc. at Safety@nodenpharma.com or 1-844-800-8007 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Patient Information, including IMPORTANT WARNING, for TEKTURNA.

Please see full Prescribing Information and Patient Information, including IMPORTANT WARNING, for TEKTURNA HCT.

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