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ALISKIREN- aliskiren hemifumarate tablet, film coated


Patient Information

Advise the patient to read the FDA-approved patient labeling (Patient Information) and Instructions for Use.

Information for Patients

Pregnancy: Advise female patients of child-bearing age about the consequences of exposure to Aliskiren during pregnancy. Discuss treatment options with women planning to become pregnant. Advise patients to report pregnancies to their physicians as soon as possible.

Lactation

Advise nursing women that breastfeeding is not recommended during treatment with Aliskiren[see Use in Specific Populations (8.2)].

Anaphylactic Reactions and Angioedema: Advise patients to immediately report any signs or symptoms suggesting a severe allergic reaction (difficulty breathing or swallowing, tightness of the chest, hives, general rash, swelling, itching, dizziness, vomiting, or abdominal pain) or angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to take no more drug until they have consulted with the prescribing physicians.

Angioedema, including laryngeal edema, may occur at any time during treatment with Aliskiren.

Symptomatic Hypotension: Advise patients that lightheadedness can occur, especially during the first days of Aliskiren therapy, and that it should be reported to the prescribing physician. Advise patients that if syncope occurs, Aliskiren should be discontinued until the physician has been consulted.

Caution patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

Potassium Supplements: Advise patients receiving Aliskiren not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician.

Relationship to Meals: Advise patients to establish a routine pattern for taking Aliskiren with regard to meals. High-fat meals decrease absorption substantially.

Administration of Oral Pellets: Advise the patient or caregiver not to swallow capsules containing Aliskiren oral pellets. Review administration instructions for Oral Pellets with the patient or caregiver.

PCR-750-12217
January 2019



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