Tekturna Side Effects

Generic Name: aliskiren

Please note - some side effects for Tekturna may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Tekturna - for the Consumer

Tekturna

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tekturna:

Mild diarrhea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the hands, eyes, mouth, face, lips, or tongue; hoarseness); symptoms of low blood pressure (eg, fainting, severe dizziness, lightheadedness); trouble swallowing.

Tekturna HCT

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tekturna HCT:

Cough; dizziness; flu-like symptoms (eg, headache, muscle or joint aches, tiredness); mild diarrhea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased urination; fainting; fever, chills, or persistent sore throat; increased thirst; irregular heartbeat; muscle pain or cramps; red, swollen, blistered, or peeling skin; severe or persistent dizziness; severe or persistent nausea or stomach pain; shortness of breath; unusual bruising or bleeding; unusual tiredness or weakness; unusually dry mouth; yellowing of the eyes or skin.

Tekturna Side Effects - for the Professional

Tekturna

Tekturna® (aliskiren) has been evaluated for safety in more than 6,460 patients, including over 1,740 treated for longer than 6 months, and more than 1,250 for longer than 1 year. In placebo-controlled clinical trials, discontinuation of therapy due to a clinical adverse event, including uncontrolled hypertension occurred in 2.2% of patients treated with Tekturna, vs. 3.5% of patients given placebo.

Two cases of angioedema with respiratory symptoms were reported with aliskiren use in the clinical studies. Two other cases of periorbital edema without respiratory symptoms were reported as possible angioedema and resulted in discontinuation. The rate of these angioedema cases in the completed studies was 0.06%.

In addition, 26 other cases of edema involving the face, hands, or whole body were reported with aliskiren use, including 4 leading to discontinuation.

In the placebo controlled studies, however, the incidence of edema involving the face, hands or whole body was 0.4% with aliskiren compared with 0.5% with placebo. In a long term active control study with aliskiren and HCTZ arms, the incidence of edema involving the face, hand or whole body was 0.4% in both treatment arms.

Aliskiren produces dose-related gastrointestinal (GI) adverse effects. Diarrhea was reported by 2.3% of patients at 300 mg, compared to 1.2% in placebo patients. In women and the elderly (age ≥65) increases in diarrhea rates were evident starting at a dose of 150 mg daily, with rates for these subgroups at 150 mg comparable to those seen at 300 mg for men or younger patients (all rates about 2.0%-2.3%). Other GI symptoms included abdominal pain, dyspepsia, and gastroesophageal reflux, although increased rates for abdominal pain and dyspepsia were distinguished from placebo only at 600 mg daily. Diarrhea and other GI symptoms were typically mild and rarely led to discontinuation.

Aliskiren was associated with a slight increase in cough in the placebo-controlled studies (1.1% for any aliskiren use vs. 0.6% for placebo). In active-controlled trials with ACE inhibitor (ramipril, lisinopril) arms, the rates of cough for the aliskiren arms were about one-third to one-half the rates in the ACE inhibitor arms.

Other adverse effects with increased rates for aliskiren compared to placebo included rash (1% vs. 0.3%), elevated uric acid (0.4% vs. 0.1%), gout (0.2% vs. 0.1%), and renal stones (0.2% vs. 0%).

Single episodes of tonic-clonic seizures with loss of consciousness were reported in two patients treated with aliskiren in the clinical trials. One of these patients did have predisposing causes for seizures and had a negative electroencephalogram (EEG) and cerebral imaging following the seizures (for the other patient EEG and imaging results were not reported). Aliskiren was discontinued and there was no rechallenge.

The following adverse events occurred in placebo-controlled clinical trials at an incidence of more than 1% of patients treated with aliskiren, but also occurred at about the same or greater incidence in patients receiving placebo: headache, nasopharyngitis, dizziness, fatigue, upper respiratory tract infection, back pain, and cough.

Clinical Laboratory Findings

In controlled clinical trials, clinically relevant changes in standard laboratory parameters were rarely associated with the administration of Tekturna. In multiple-dose studies in hypertensive patients Tekturna had no clinically important effects on total cholesterol, HDL, fasting triglycerides, fasting glucose, or uric acid.

Minor increases in blood urea nitrogen (BUN) or serum creatinine were observed in less than 7% of patients with essential hypertension treated with Tekturna alone vs. 6% on placebo.

Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.08 g/dL and 0.16 volume percent, respectively, for all aliskiren monotherapy) were observed. The decreases were dose-related and were 0.24 g/dL and 0.79 volume percent for 600 mg daily. This effect is also seen with other agents acting on the renin angiotensin system, such as angiotensin inhibitors and angiotensin receptor blockers, and may be mediated by reduction of angiotensin II which stimulates erythropoietin production via the AT1 receptor. These decreases led to slight increases in rates of anemia with aliskiren compared to placebo were observed (0.1% for any aliskiren use, 0.3% for aliskiren 600 mg daily, vs. 0% for placebo). No patients discontinued therapy due to anemia.

Increases in serum potassium >5.5 meq/L were infrequent in patients with essential hypertension treated with Tekturna alone (0.9% compared to 0.6% with placebo). However, when used in combination with an angiotensin-converting enzyme inhibitor (ACEI) in a diabetic population increases in serum potassium were more frequent (5.5%) and routine monitoring of electrolytes and renal function is indicated in this population.

Aliskiren monotherapy produced small median increases in serum uric acid levels (about 6 µmol/L) while HCTZ produced larger increases (about 30 µmol/L). The combination of aliskiren with HCTZ appears to be additive (about a 40 µmol/L increase). The increases in uric acid appear to lead to slight increases in uric acid-related AEs: elevated uric acid (0.4% vs. 0.1%), gout (0.2% vs. 0.1%), and renal stones (0.2% vs. 0%).

Increases in creatine kinase of >300% were recorded in about 1% of aliskiren monotherapy patients vs. 0.5% of placebo patients. Five cases of creatine kinase rises, three leading to discontinuation and one diagnosed as subclinical rhabdomyolysis and another as myositis, were reported as adverse events with aliskiren use in the clinical trials. No cases were associated with renal dysfunction.

Side Effects by Body System

Hypersensitivity

Two cases of angioedema with respiratory symptoms were reported with aliskiren use in clinical studies, and two other cases of periorbital edema without respiratory symptoms were reported as possible angioedema and resulted in discontinuation. The rate of angioedema cases in completed studies was 0.06%. Twenty-six other cases of edema involving the face, hands, or whole body were reported with aliskiren use, including four which led to discontinuation. In the placebo controlled studies, the incidence of edema involving the face, hands or whole body was 0.4% with aliskiren compared with 0.5% with placebo.

Hypersensitivity side effects have included cases of angioedema involving the face, hands, and body with or without respiratory symptoms. Periorbital edema without respiratory symptoms were also reported as possible angioedema and resulted in discontinuation.

Gastrointestinal

Gastrointestinal side effects have been reported and appear to be dose related. These have included diarrhea (2.3%), abdominal pain, dyspepsia, and gastroesophageal reflux.

In women and the elderly (65 years of age or older), increases in diarrhea rates were evident starting at a dose of 150 mg daily. Diarrhea and other GI symptoms were typically mild and rarely led to discontinuation.

Dermatologic

Dermatologic side effects have included rash (1%).

Metabolic

Metabolic side effects have included elevated uric acid (0.4%), gout (0.2%), and renal stones (0.2%).

Nervous system

Episodes of tonic-clonic seizures were reported in two patients treated with aliskiren in the clinical trials. One patient had predisposing causes for seizures and a negative electroencephalogram (EEG) and cerebral imaging following the seizures (the other patient's EEG and imaging results were not reported). Aliskiren was discontinued and there was no re-challenge.

Nervous system side effects have included headache, dizziness, fatigue, and single episodes of tonic-clonic seizures with loss of consciousness.

Respiratory

Respiratory side effects have included nasopharyngitis, upper respiratory tract infection, and cough.

Other

Other side effects have included back pain.

Cardiovascular

Cardiovascular side effects have included extremely rare cases of hypotension (0.1%) and angioedema (0.06%).

General

In general, aliskiren is well tolerated with an adverse event profile similar to placebo. Most adverse effects reported were mild to moderate in severity.

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