From the Guidelines
Aliskiren is still available on the market in the United States, sold under the brand name Tekturna, in oral tablets of 150 mg and 300 mg strengths. Aliskiren is a direct renin inhibitor used to treat hypertension, either alone or in combination with other antihypertensive medications 1, 2, 3. The typical starting dose is 150 mg once daily, which may be increased to 300 mg daily if blood pressure is not adequately controlled. Patients should take aliskiren at approximately the same time each day, with or without food, though high-fat meals can reduce absorption. Some key points to consider when prescribing aliskiren include:
- It should not be used during pregnancy as it can cause injury or death to the developing fetus.
- It should not be combined with ACE inhibitors or ARBs in patients with diabetes or moderate to severe kidney impairment due to increased risk of kidney problems, hypotension, and hyperkalemia 4, 5, 6, 7.
- Common side effects include diarrhea, cough, dizziness, headache, and elevated potassium levels. It's essential to monitor serum creatinine/estimated glomerular filtration rate and serum potassium levels at least annually in patients treated with aliskiren, especially when combined with other antihypertensive medications 1, 2, 3.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Availability of Aliskiren in the United States
- The studies provided do not directly address whether aliskiren is currently on the market in the United States 8, 9, 10, 11, 12.
- However, it is mentioned that aliskiren was approved by the Food and Drug Administration in 2007 for the treatment of hypertension 9, 10.
- There is no information in the provided studies about aliskiren being withdrawn from the market or its current availability in the United States.
- The studies focus on the efficacy, safety, and clinical development of aliskiren as a treatment for hypertension, rather than its market status 8, 9, 10, 11, 12.
Regulatory Approval and Clinical Use
- Aliskiren is described as the first orally active direct renin inhibitor approved for the treatment of hypertension 9, 10, 12.
- It has been shown to be effective in reducing blood pressure, both as monotherapy and in combination with other antihypertensive agents 8, 9, 10, 11.
- The studies suggest that aliskiren is well tolerated, with a safety profile similar to that of placebo 9, 11.