Aliskiren

Aliskiren is an anti-hypertensive (blood pressure lowering) medicine. It works by decreasing substances in the body that narrow blood vessels and raise blood pressure.

Aliskiren is used to treat high blood pressure (hypertension).

Aliskiren may also be used for purposes not listed in this medication guide.

Do not use if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant.

If you have diabetes, you should not use aliskiren together with certain heart or blood pressure medicines (such as Accupril, Benicar, Capoten, Cozaar, Diovan, Lotensin, Mavik, Prinivil, Vasotec, and many others).

You should not take aliskiren if you are allergic to it.

If you have diabetes, you should not use aliskiren together with certain heart or blood pressure medicines, such as:

• azilsartan (Edarbi, Edarbyclor), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), olmesartan (Azar, Benicar), valsartan (Diovan, Exforge, Tribenzor), telmisartan (Micardis); or
• benazepril (Lotensin), captopril (Capoten, Capozide), enalapril (Vasotec, Vasoretic), fosinopril (Monopril), lisinopril (Prinivil, Zestoretic, Zestril), moexipril (Uniretic, Univasc), perindopril (Aceon), quinapril (Accupril, Accuretic), ramipril (Altace), or trandolapril (Mavik, Tarka).

You may also need to avoid taking these medicines with aliskiren if you have kidney disease.

To make sure you can safely take aliskiren, tell your doctor if you have any of these other conditions:

• kidney disease (or if you are on dialysis);
• heart disease;
• if you are on a low-salt diet; or
• if you have ever had an allergic reaction to an ACE inhibitor heart or blood pressure medicine (benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, quinapril, ramipril, trandolapril).

FDA pregnancy category D. Do not use aliskiren if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Aliskiren can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.

It is not known whether aliskiren passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medicine to anyone under 18 years old without medical advice.

Avoid taking this medicine with a high-fat meal, which can make it harder for your body to absorb aliskiren.

Do not use salt substitutes or potassium supplements while taking aliskiren, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of aliskiren.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with aliskiren, especially:

• atorvastatin (Lipitor);
• antifungal medicine;
• any heart or blood pressure medicines;
• cyclosporine;
• a diuretic or "water pill";
• a potassium supplement such as K-Dur, Klor-Con;
• salt substitutes that contain potassium; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with aliskiren, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

1-10%

Diarrhea (2.3%)

Cough (1.1%)

Rash (1%)

Increase in serum creatinine (<7%)

Hyperkalemia (<1%)

<1%

Angioedema

Headache

Gout

Renal stones

Seizure

Severe hypotension

Rhabomyolysis

Toxic epidermal necrolysis

Increase in uric acid

Angina

Postmarketing Reports

Peripheral edema

Increased serum creatinine

Nausea/vomiting

Hyponatremia

Aliskiren may be found in some form under the following brand names:

• Amturnide

• Tekamlo

• Tekturna

• Tekturna HCT

• Valturna

Do not take aliskiren:

• If you get pregnant. Stop taking aliskiren and call your doctor right away. If you plan to become pregnant, talk to your doctor about other treatment options for your high blood pressure. 
• If you have diabetes and are taking a kind of medicine called an angiotensin-receptor-blocker or angiotensin-converting-enzyme-inhibitor.
• If you are allergic to any of its ingredients.

Aliskiren has not been studied in children under 18 years of age.

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

If you have diabetes, do not use aliskiren together with certain heart or blood pressure medicines (such as Accupril, Benicar, Capoten, Cozaar, Diovan, Lotensin, Mavik, Prinivil, Vasotec, and many others).

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Usual Adult Dose for Hypertension:

Initial: 150 mg orally once a day
Maintenance: the dosage may be increased to 300 mg daily if blood pressure is not adequately controlled.

Comments:
-The antihypertensive effect is substantially attained by 2 weeks.
-Tablets should be taken the same way each day, either with or without a meal. (High-fat meals decrease absorption of aliskiren substantially).
Aliskiren may be used alone or in combination with other antihypertensive agents.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For aliskiren, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to aliskiren or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of aliskiren in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aliskiren in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking aliskiren, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using aliskiren with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Candesartan
• Captopril
• Enalapril
• Enalaprilat
• Eprosartan
• Fosinopril
• Irbesartan
• Lisinopril
• Losartan
• Moexipril
• Olmesartan Medoxomil
• Perindopril
• Quinapril
• Ramipril
• Telmisartan
• Trandolapril
• Valsartan

Using aliskiren with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine
• Eliglustat
• Itraconazole
• Simeprevir

Using aliskiren with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Furosemide
• Rifampin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using aliskiren with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use aliskiren, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of aliskiren. Make sure you tell your doctor if you have any other medical problems, especially:

• Airway surgery, history of—At risk for severe complications from angioedema (swelling of the face, lips, tongue, throat, arms, or legs).

• Angioedema, history of—May increase the risk of this condition occurring again.

• Congestive heart failure, severe
• Heart attack, history—Use may lead to kidney problems.

• Diabetes or
• Kidney problems—May increase risk of having high potassium in the blood.

• Diabetes patients who are also taking certain blood pressure medicines such as angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs)—Should not be used in patients with this condition.

• Electrolyte imbalances (e.g., high potassium or low sodium in the body) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea)—Use with caution. May make these conditions worse.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Body aches or pain
• chills
• cough
• diarrhea
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Ankle, knee, or great toe joint pain
• blood in the urine
• joint pain
• joint stiffness or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of bladder control
• loss of consciousness
• lower back or side pain
• nausea and vomiting
• pain in the groin or genitals
• sharp back pain just below the ribs
• swelling of the feet or lower legs

• Blistering, peeling, or loosening of the skin
• bloating or swelling of the face, arms, hands, lower legs, or feet
• itching
• joint or muscle pain
• rapid weight gain
• red skin lesions, often with a purple center
• red, irritated eyes
• sores, ulcers, or white spots in the mouth or on the lips
• tingling of the hands or feet
• unusual weight gain or loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• back pain
• belching
• dizziness
• heartburn
• indigestion
• muscle aches
• rash
• stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take aliskiren or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to aliskiren. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

May lead to false-positive or false-negative aldosterone/renin ratio (ARR) (Funder 2016)

Applies to aliskiren: oral tablet

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.[Ref]

Frequency not reported: Angioedema (face, hands, and body) with or without respiratory symptoms
Postmarketing reports: Angioedema[Ref]

Gastrointestinal

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.[Ref]

Common (1% to 10%): Diarrhea, abdominal pain, dyspepsia, gastroesophageal reflux (these side effects appear to be dose related)
Postmarketing reports: Nausea, vomiting[Ref]

Dermatologic

Common (1% to 10%): Rash
Rare (less than 0.1%): Angioedema (involving the face, hands, or whole body)
Postmarketing reports: Severe cutaneous adverse reactions (including Stevens Johnson syndrome and toxic epidermal necrolysis)[Ref]

Metabolic

Uncommon (0.1% to 1%): Elevated uric acid, gout, renal stones
Postmarketing reports: Peripheral edema, hyponatremia[Ref]

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 rechallenge.[Ref]

Frequency not reported: Headache, dizziness, fatigue, episodes of tonic-clonic seizures with loss of consciousness.[Ref]

Respiratory

Frequency not reported: Nasopharyngitis, upper respiratory tract infection, cough[Ref]

Cardiovascular

Rare (less than 0.1%): Hypotension[Ref]

Hematologic

Uncommon (0.1% to 1%): Small decreases in hemoglobin and hematocrit
Postmarketing reports: Increased blood creatinine[Ref]

Musculoskeletal

Common (1% to 10%): Back pain

Other

Rare (less than 0.1%): Parosmia
Frequency not reported: Tinnitus[Ref]

Some side effects of aliskiren may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Breastfeeding is not recommended during use of this drug. Excreted into human milk: Unknown Excreted into animal milk: Yes