Aliskiren warnings and precautions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Warnings and Precautions
5.1 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 oligohydramnioscan 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 [see Use in Specific Populations (8.1)].
5.2 Renal Impairment/Hyperkalemia/Hypotension when Tekturna is given in combination with ARBs or ACEIs
Tekturna is contraindicated in patients with diabetes who are receiving ARBs or ACEIs because of the increased risk of renal impairment, hyperkalemia, and hypotension[see Contraindications (4) and Clinical Studies (14.3)].
Avoid use of Tekturna with ARBs or ACEIs in patients with moderate renal impairment (GFR <60 ml/min).
5.3 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 Tekturna and has 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 ACE inhibitors or angiotensin receptor antagonists. Anaphylactic reactions have been reported from post-marketing experience with unknown frequency. If angioedema involves the throat, tongue, glottis or larynx, or if the patient has a history of upper respiratory surgery, airway obstruction may occur and be fatal. Patients who experience these effects, even without respiratory distress, require prolonged observation and appropriate monitoring measures since treatment with antihistamines and corticosteroids may not be sufficient to prevent respiratory involvement. Prompt administration of subcutaneous epinephrine solution 1:1000 (0.3 to 0.5 ml) and measures to ensure a patent airway may be necessary.
Discontinue Tekturna immediately in patients who develop anaphylactic reactions or angioedema, and do not readminister.
5.4 Hypotension
Symptomatic hypotension may occur after initiation of treatment with Tekturna in patients with marked volume depletion, patients with salt depletion, or with combined use of aliskiren and other agents acting on the renin-angiotensin-aldosterone system. The volume or salt depletion should be corrected prior to administration of Tekturna, or the treatment should start under close medical supervision.
A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
5.5 Impaired Renal Function
Monitor renal function periodically in patients treated with Tekturna. Changes in renal function, including acute renal failure, can be caused by drugs that affect the renin-angiotensin-aldosterone system. Patients whose renal function may depend in part on the activity of the renin-angiotensin-aldosterone system (e.g., patients with renal artery stenosis, severe heart failure, post-myocardial infarction or volume depletion) or patients receiving ARB, ACEI or non-steroidal anti-inflammatory (NSAID) therapy may be at particular risk for developing acute renal failure on Tekturna [see Contraindications (4), Warnings and Precautions (5.2), Clinical Studies (14.3)]. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function.
5.6 Hyperkalemia
Monitor serum potassium periodically in patients receiving Tekturna. Drugs that affect the renin-angiotensin-aldosterone system can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes, combination use with ARBs or ACEIs [see Contraindications (4), Warnings and Precautions (5.2), and Clinical Studies (14.3)], NSAIDs, or potassium supplements or potassium sparing diuretics.
5.7 Cyclosporine or Itraconazole
When aliskiren was given with cyclosporine or itraconazole, the blood concentrations of aliskiren were significantly increased. Avoid concomitant use of aliskiren with cyclosporine or itraconazole [see Drug Interactions (7)].[1]
References
- ↑ "TEKTURNA (ALISKIREN HEMIFUMARATE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]". Retrieved 25 February 2014.
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