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Drug overview for ALISKIREN (aliskiren hemifumarate):
Generic name: aliskiren hemifumarate (AL-is-KYE-ren)
Drug class: Angiotensin Inhibiting Agents
Therapeutic class: Cardiovascular Therapy Agents
Aliskiren is a nonpeptide renin inhibitor.
No enhanced Uses information available for this drug.
Generic name: aliskiren hemifumarate (AL-is-KYE-ren)
Drug class: Angiotensin Inhibiting Agents
Therapeutic class: Cardiovascular Therapy Agents
Aliskiren is a nonpeptide renin inhibitor.
No enhanced Uses information available for this drug.
DRUG IMAGES
ALISKIREN 150 MG TABLET
ALISKIREN 300 MG TABLET
The following indications for ALISKIREN (aliskiren hemifumarate) have been approved by the FDA:
Indications:
Hypertension
Professional Synonyms:
Elevated blood pressure
Essential hypertension
Hyperpiesia
Hyperpiesis
Hypertensive disorder
Systemic arterial hypertension
Indications:
Hypertension
Professional Synonyms:
Elevated blood pressure
Essential hypertension
Hyperpiesia
Hyperpiesis
Hypertensive disorder
Systemic arterial hypertension
The following dosing information is available for ALISKIREN (aliskiren hemifumarate):
Dosage of aliskiren hemifumarate is expressed in terms of aliskiren.
Aliskiren is administered orally. The manufacturer recommends that patients establish a routine pattern for taking aliskiren with regard to meals; administration with a high-fat meal substantially decreases absorption of the drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ALISKIREN 150 MG TABLET | Maintenance | Adults take 1 tablet (150 mg) by oral route once daily |
| ALISKIREN 300 MG TABLET | Maintenance | Adults take 1 tablet (300 mg) by oral route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ALISKIREN 150 MG TABLET | Maintenance | Adults take 1 tablet (150 mg) by oral route once daily |
| ALISKIREN 300 MG TABLET | Maintenance | Adults take 1 tablet (300 mg) by oral route once daily |
The following drug interaction information is available for ALISKIREN (aliskiren hemifumarate):
There are 3 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Aliskiren/Cyclosporine SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Aliskiren is a substrate for the P-glycoprotein (P-gp) system. Cyclosporine is a potent inhibitor of P-gp.(1) CLINICAL EFFECTS: The concurrent use of aliskiren and cyclosporine may result in elevated levels of aliskiren. This may result in increased effect and toxicity of aliskiren such as hypotension.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of aliskiren states that concurrent use of cyclosporine should be avoided.(1) The UK manufacturer of aliskiren states that the concurrent use of potent P-gp inhibitors such as cyclosporine is contraindicated.(2) DISCUSSION: In a study in healthy subjects, concurrent cyclosporine (200 mg and 600 mg) increased the maximum concentration (Cmax) and area-under-curve (AUC) of aliskiren (75 mg) by 2.5-fold and 5-fold, respectively.(1,2) |
CYCLOSPORINE, CYCLOSPORINE MODIFIED, GENGRAF, NEORAL, SANDIMMUNE |
| Aliskiren/Quinidine SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Aliskiren is a substrate for the P-glycoprotein (P-gp) system. Quinidine is a potent inhibitor of P-gp.(1) CLINICAL EFFECTS: The concurrent use of aliskiren and quinidine may result in elevated levels of aliskiren. This may result in increased effect and toxicity of aliskiren including hypotension.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The UK manufacturer states the use of aliskiren and potent P-glycoprotein inhibitors are contraindicated.(1) DISCUSSION: In a study in healthy subjects, concurrent cyclosporine (200 mg and 600 mg), another potent inhibitor of P-glycoprotein, increased the maximum concentration (Cmax) and area-under-curve (AUC) of aliskiren (75 mg) by 2.5-fold and 5-fold, respectively.(1) |
NUEDEXTA, QUINIDINE GLUCONATE, QUINIDINE SULFATE |
| Sparsentan/Angiotensin II Receptor Blockers; Endothelin Receptor Antagonists; Aliskiren SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Sparsentan is an antagonist of the endothelin type A receptor and the angiotensin II type 1 receptor which are thought to contribute to the pathogenesis of IgA nephropathy.(1) Coadministration with angiotensin II receptor blockers (ARBs), endothelin receptor antagonists (ERAs), or aliskiren may result in additive inhibition of angiotensin. CLINICAL EFFECTS: Concurrent use of sparsentan with ARBs, ERAs, or aliskiren may result in hypotension, syncope, hyperkalemia, and changes in renal function (including renal failure).(1) PREDISPOSING FACTORS: Patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion may be at risk of developing acute kidney injury on sparsentan.(1) Patients with advanced kidney disease or taking concomitant potassium-increasing drugs (e.g., potassium supplements, potassium-sparing diuretics), or using potassium-containing salt substitutes are at increased risk for developing hyperkalemia.(1) PATIENT MANAGEMENT: Do not coadminister sparsentan with ARBs, ERAs, or aliskiren. Prior to initiating treatment with sparsentan, discontinue use of ARBs, ERAs, and aliskiren.(1) DISCUSSION: The US manufacturer of sparsentan states that concomitant use of sparsentan with ARBs, ERAs, or aliskiren is contraindicated.(1) |
FILSPARI |
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Aliskiren/Selected P-glycoprotein (P-gp) Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Aliskiren is a substrate for the P-glycoprotein (P-gp) system. Inhibitors of P-gp may increase the absorption of aliskiren.(1-3) CLINICAL EFFECTS: The concurrent use of aliskiren and P-gp inhibitors may result in elevated levels of aliskiren. This may result in increased effect and toxicity of aliskiren including hypotension.(1-3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of aliskiren states that concurrent use of itraconazole should be avoided.(1) The UK manufacturer of aliskiren states that the concurrent use of P-gp inhibitors such as itraconazole is contraindicated.(2) The US manufacturer of itraconazole states that concurrent administration of aliskiren is not recommended during and two weeks after itraconazole treatment.(4) DISCUSSION: In a study in healthy subjects, concurrent itraconazole (100 mg) increased the maximum concentration (Cmax) and area-under-curve (AUC) of aliskiren (150 mg) by 5.8-fold and 6.5-fold, respectively.(2,3) Selected P-gp inhibitors linked to this monograph include: azithromycin, belumosudil, clarithromycin, danicopan, daridorexant, fostamatinib, indinavir, itraconazole, lopinavir/ritonavir, mavorixafor, nirmatrelvir/ritonavir, pirtobrutinib, rifampin and vimseltinib.(4,5) |
AZITHROMYCIN, CLARITHROMYCIN, CLARITHROMYCIN ER, ITRACONAZOLE, ITRACONAZOLE MICRONIZED, JAYPIRCA, KALETRA, LANSOPRAZOL-AMOXICIL-CLARITHRO, LOPINAVIR-RITONAVIR, OMECLAMOX-PAK, PAXLOVID, QUVIVIQ, REZUROCK, RIFADIN, RIFAMPIN, ROMVIMZA, SPORANOX, TAVALISSE, TOLSURA, VOQUEZNA TRIPLE PAK, VOYDEYA, XOLREMDI, ZITHROMAX, ZITHROMAX TRI-PAK |
| Aliskiren/ACE Inhibitors; ARBs SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The exact mechanism is unknown. CLINICAL EFFECTS: In the ALTITUDE study, concurrent use of aliskiren for 18-24 months in patients maintained on either an ACE inhibitor or an ARB resulted in an increase in non-fatal stroke, renal complications, hyperkalemia, and hypotension.(1,2) PREDISPOSING FACTORS: Patients with Type II diabetes and/or renal impairment may be at a higher risk from this combination.(1) PATIENT MANAGEMENT: Novartis no longer recommends the concurrent use of aliskiren with either an ACE inhibitor or an ARB.(1,3) Hypertension regimens of patients receiving concurrent therapy should be re-evaluated.(1) Concurrent use of aliskiren in diabetic patients receiving either an ACE inhibitor or an ARB is contraindicated.(2,4) Avoid the combination in patients with CrCl less than 60 ml/min.(5) DISCUSSION: ALTITUDE was a multinational study designed to evaluate the use of aliskiren for more than 1 year in patients with Type II diabetes and renal impairment, who are known to have a high risk for cardiovascular and renal events. Aliskiren was given with optimal cardiovascular treatment, including an ACE inhibitor or ARB. After 18-24 months of concurrent therapy with aliskiren and either an ACE inhibitor or an ARB, there was an increase in non-fatal stroke, renal complications, hyperkalemia, and hypotension.(1,2) |
ACCUPRIL, ACCURETIC, ALTACE, AMLODIPINE BESYLATE-BENAZEPRIL, AMLODIPINE-OLMESARTAN, AMLODIPINE-VALSARTAN, AMLODIPINE-VALSARTAN-HCTZ, ARBLI, ATACAND, ATACAND HCT, AVALIDE, AVAPRO, AZOR, BENAZEPRIL HCL, BENAZEPRIL-HYDROCHLOROTHIAZIDE, BENICAR, BENICAR HCT, CANDESARTAN CILEXETIL, CANDESARTAN-HYDROCHLOROTHIAZID, CAPTOPRIL, CAPTOPRIL-HYDROCHLOROTHIAZIDE, COZAAR, DIOVAN, DIOVAN HCT, EDARBI, EDARBYCLOR, ENALAPRIL MALEATE, ENALAPRIL-HYDROCHLOROTHIAZIDE, ENALAPRILAT, ENTRESTO, ENTRESTO SPRINKLE, EPANED, EPROSARTAN MESYLATE, EXFORGE, EXFORGE HCT, FOSINOPRIL SODIUM, FOSINOPRIL-HYDROCHLOROTHIAZIDE, HYZAAR, IRBESARTAN, IRBESARTAN-HYDROCHLOROTHIAZIDE, LISINOPRIL, LISINOPRIL-HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM, LOSARTAN-HYDROCHLOROTHIAZIDE, LOTENSIN, LOTENSIN HCT, LOTREL, MICARDIS, MICARDIS HCT, MOEXIPRIL HCL, OLMESARTAN MEDOXOMIL, OLMESARTAN-AMLODIPINE-HCTZ, OLMESARTAN-HYDROCHLOROTHIAZIDE, PERINDOPRIL ERBUMINE, PRESTALIA, QBRELIS, QUINAPRIL HCL, QUINAPRIL-HYDROCHLOROTHIAZIDE, RAMIPRIL, TELMISARTAN, TELMISARTAN-AMLODIPINE, TELMISARTAN-HYDROCHLOROTHIAZID, TRANDOLAPRIL, TRANDOLAPRIL-VERAPAMIL ER, TRIBENZOR, VALSARTAN, VALSARTAN-HYDROCHLOROTHIAZIDE, VASERETIC, VASOTEC, ZESTORETIC, ZESTRIL |
There are 6 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Furosemide/Aliskiren SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The exact mechanism is unknown. CLINICAL EFFECTS: Concurrent use of aliskiren may decrease levels and effectiveness of furosemide.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Monitor patients receiving concurrent aliskiren and furosemide for decreased furosemide effects. The dose of furosemide may need to be adjusted if aliskiren is initiated or discontinued, or furosemide may need to be replaced with an alternative diuretic agent. DISCUSSION: Concurrent aliskiren decreased furosemide maximum concentration (Cmax) and area-under-curve (AUC) by 50% and 30%, respectively. There were no significant effects on aliskiren levels.(1) Concurrent aliskiren decreased furosemide Cmax and AUC by 27% and 17%, respectively and 24-hour urinary furosemide excretion was reduced by 29%. There were no significant effects on aliskiren levels.(2) |
FUROSCIX, FUROSEMIDE, FUROSEMIDE-0.9% NACL, LASIX |
| Tizanidine/Selected Antihypertensives SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Tizanidine is an alpha-2 agonist. Concurrent use with antihypertensive agents may result in additive effects on blood pressure.(1) CLINICAL EFFECTS: Concurrent use of antihypertensives and tizanidine may result in hypotension.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for hypotension. The risk of hypotension may be decreased by careful titration of tizanidine dosages and monitoring for hypotension prior to dose advancement. Counsel patients about the risk of orthostatic hypotension.(1) DISCUSSION: Severe hypotension has been reported following the addition of tizanidine to existing lisinopril therapy.(2-4) |
TIZANIDINE HCL, ZANAFLEX |
| Aliskiren/NSAIDs; Salicylates SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The exact mechanism is unknown. It is believed to be related to inhibition of prostaglandin synthesis by the NSAIDs. Use of an NSAID in combination with aliskiren, whose hypotensive effects may be related to the increase in hypotensive prostaglandins, may negate any decrease in blood pressure. CLINICAL EFFECTS: Concurrent use of aliskiren with NSAIDs may result in decreased antihypertensive effects. In patients with existing renal impairment, the use of these agents together may also result in further deterioration of renal clearance caused by renal hypoperfusion. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients maintained on aliskiren should be monitored for a loss of blood pressure control and a change in renal function if an NSAID is added to their regimen. Patients receiving concurrent therapy may require higher doses of aliskiren. If blood pressure control cannot be achieved or if the patient's renal function deteriorates, the NSAID may need to be discontinued. Patients should be monitored for hypotension if NSAIDs are withdrawn from concurrent aliskiren therapy. DISCUSSION: Indomethacin has been shown to inhibit the antihypertensive effect of captopril, cilazapril, enalapril, losartan, perindopril, and valsartan. Ibuprofen has been shown to decrease the antihypertensive effects of captopril. Two separate case reports describe individuals suspected of ACEI-associated angioedema precipitated by NSAIDs. Both cases reported symptom resolution after cessation of the NSAID. Studies have shown that sulindac does not affect the antihypertensive effects of captopril and enalapril. |
ACETYL SALICYLIC ACID, ANAPROX DS, ANJESO, ARTHROTEC 50, ARTHROTEC 75, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, ASPIRIN, ASPIRIN-DIPYRIDAMOLE ER, BISMUTH SUBSALICYLATE, BROMFENAC SODIUM, BUPIVACAINE-KETOROLAC-KETAMINE, BUTALBITAL-ASPIRIN-CAFFEINE, CALDOLOR, CAMBIA, CARISOPRODOL-ASPIRIN, CARISOPRODOL-ASPIRIN-CODEINE, CELEBREX, CELECOXIB, CHOLINE MAGNESIUM TRISALICYLAT, COMBOGESIC, COMBOGESIC IV, CONSENSI, COXANTO, DAYPRO, DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM ER, DICLOFENAC SODIUM MICRONIZED, DICLOFENAC SODIUM-MISOPROSTOL, DIFLUNISAL, DISALCID, DOLOBID, DURLAZA, EC-NAPROSYN, ELYXYB, ETODOLAC, ETODOLAC ER, FELDENE, FENOPROFEN CALCIUM, FENOPRON, FLURBIPROFEN, HYDROCODONE-IBUPROFEN, IBU, IBUPAK, IBUPROFEN, IBUPROFEN LYSINE, IBUPROFEN-FAMOTIDINE, INDOCIN, INDOMETHACIN, INDOMETHACIN ER, INFLAMMACIN, INFLATHERM(DICLOFENAC-MENTHOL), KETOPROFEN, KETOPROFEN MICRONIZED, KETOROLAC TROMETHAMINE, KIPROFEN, LODINE, LOFENA, LURBIPR, MB CAPS, MECLOFENAMATE SODIUM, MEFENAMIC ACID, MELOXICAM, NABUMETONE, NABUMETONE MICRONIZED, NALFON, NAPRELAN, NAPROSYN, NAPROTIN, NAPROXEN, NAPROXEN SODIUM, NAPROXEN SODIUM CR, NAPROXEN SODIUM ER, NAPROXEN-ESOMEPRAZOLE MAG, NEOPROFEN, NORGESIC, NORGESIC FORTE, ORPHENADRINE-ASPIRIN-CAFFEINE, ORPHENGESIC FORTE, OXAPROZIN, PHENYL SALICYLATE, PHENYLBUTAZONE, PIROXICAM, R.E.C.K.(ROPIV-EPI-CLON-KETOR), RELAFEN DS, ROPIVACAINE-CLONIDINE-KETOROLC, ROPIVACAINE-KETOROLAC-KETAMINE, SALSALATE, SODIUM SALICYLATE, SPRIX, SULINDAC, SUMATRIPTAN SUCC-NAPROXEN SOD, SYMBRAVO, TOLECTIN 600, TOLMETIN SODIUM, TORONOVA II SUIK, TORONOVA SUIK, TOXICOLOGY SALIVA COLLECTION, TRESNI, TREXIMET, URELLE, URETRON D-S, URIBEL TABS, URIMAR-T, URNEVA, URO-MP, URO-SP, VIMOVO, VIVLODEX, YOSPRALA, ZIPSOR, ZORVOLEX, ZYNRELEF |
| Aliskiren/Potassium Sparing Diuretics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Aliskiren may decrease the renal excretion of potassium. CLINICAL EFFECTS: Concurrent use of potassium sparing diuretics with aliskiren may result in hyperkalemia. PREDISPOSING FACTORS: Impaired renal function; diabetes mellitus. PATIENT MANAGEMENT: Monitor serum potassium and adjust the dosage accordingly in patients receiving concurrent therapy with a potassium sparing diuretic and aliskiren. In all patients taking eplerenone who start taking aliskiren, check serum potassium and creatinine levels after 3-7 days of concurrent therapy. DISCUSSION: Several studies have indicated that serum potassium levels increase when ACE inhibitors and ARB therapy is initiated and decrease when the drug is lowered. There are case reports of hyperkalemia during concurrent therapy with ARBs and spironolactone and with aliskiren and spironolactone. Based on this data, serum potassium levels should be monitored in patients receiving concomitant aliskiren with potassium sparing diuretics. |
ALDACTONE, AMILORIDE HCL, AMILORIDE-HYDROCHLOROTHIAZIDE, CAROSPIR, DYRENIUM, EPLERENONE, INSPRA, KERENDIA, SPIRONOLACTONE, SPIRONOLACTONE-HCTZ, TRIAMTERENE, TRIAMTERENE-HYDROCHLOROTHIAZID |
| Aliskiren/Potassium Supplements SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Aliskiren may decrease the renal excretion of potassium. CLINICAL EFFECTS: Concurrent use of potassium supplements with aliskiren may result in hyperkalemia. PREDISPOSING FACTORS: Impaired renal function; diabetes mellitus. PATIENT MANAGEMENT: Monitor serum potassium and adjust the dosage accordingly in patients receiving concurrent therapy with potassium supplements and aliskiren. DISCUSSION: Several studies have indicated that serum potassium levels increase when ACE inhibitors and ARB therapy is initiated and decrease when the drug is lowered. Increased potassium levels have also been seen with aliskiren. Based on this data, serum potassium levels should be monitored in patients receiving potassium supplements with aliskiren. |
CLINIMIX E, DEXTROSE 5%-ELECTROLYTE #48, EFFER-K, K-PHOS NO.2, K-PHOS ORIGINAL, KABIVEN, KCL-D5W-0.2% NACL, KCL-D5W-0.225% NACL, KCL-D5W-0.45% NACL, KCL-D5W-0.9% NACL, KLOR-CON, KLOR-CON 10, KLOR-CON 8, KLOR-CON M10, KLOR-CON M15, KLOR-CON M20, KLOR-CON-EF, NUTRILYTE, PERIKABIVEN, POKONZA, POTASSIUM ACETATE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE IN D5LR, POTASSIUM CHLORIDE-0.45% NACL, POTASSIUM CHLORIDE-0.9% NACL, POTASSIUM CHLORIDE-DEXTROSE 5%, POTASSIUM CHLORIDE-WATER, POTASSIUM CITRATE, POTASSIUM CITRATE ER, POTASSIUM CL-LIDOCAINE-NS, POTASSIUM GLUCONATE, POTASSIUM PHOSPHATE, POTASSIUM PHOSPHATE-0.9% NACL, POTASSIUM PHOSPHATES, TPN ELECTROLYTES, UROCIT-K |
| Apomorphine/Selected Antihypertensives and Vasodilators SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Apomorphine causes dose-dependent decreases in blood pressure. Concurrent use with antihypertensive agents may result in additive effects on blood pressure.(1) CLINICAL EFFECTS: Concurrent use of antihypertensives and apomorphine may result in orthostatic hypotension with or without dizziness, nausea, or syncope.(1) PREDISPOSING FACTORS: The risk of orthostatic hypotension may be increased during dose escalation of apomorphine and in patients with renal or hepatic impairment.(1) PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for hypotension. Counsel patients about the risk of orthostatic hypotension.(1) DISCUSSION: Healthy volunteers who took sublingual nitroglycerin (0.4 mg) concomitantly with apomorphine experienced a mean largest decrease in supine systolic blood pressure (SBP) of 9.7 mm Hg and in supine diastolic blood pressure (DBP) of 9.3 mm Hg, and a mean largest decrease in standing SBP and DBP of 14.3 mm Hg and 13.5 mm Hg, respectively. The maximum decrease in SBP and DBP was 65 mm Hg and 43 mm Hg, respectively. When apomorphine was taken alone, the mean largest decrease in supine SBP and DBP was 6.1 mm Hg and 7.3 mm Hg, respectively, and in standing SBP and DBP was 6.7 mm Hg and 8.4 mm Hg, respectively.(1) |
APOKYN, APOMORPHINE HCL, ONAPGO |
The following contraindication information is available for ALISKIREN (aliskiren hemifumarate):
Drug contraindication overview.
Concomitant use of aliskiren and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor antagonist in patients with diabetes mellitus. (See Use in Combination with Angiotensin-converting Enzyme Inhibitors or Angiotensin II Receptor Antagonists under Warnings/Precautions: Other Warnings/Precautions, in Cautions.) Known hypersensitivity to aliskiren or any ingredient in the formulation. Use in pediatric patients younger than 2 years of age. (See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.)
Concomitant use of aliskiren and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor antagonist in patients with diabetes mellitus. (See Use in Combination with Angiotensin-converting Enzyme Inhibitors or Angiotensin II Receptor Antagonists under Warnings/Precautions: Other Warnings/Precautions, in Cautions.) Known hypersensitivity to aliskiren or any ingredient in the formulation. Use in pediatric patients younger than 2 years of age. (See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.)
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Pregnancy |
There are 4 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Hyperkalemia |
| Hyponatremia |
| Hypotension |
| Hypovolemia |
There are 4 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
The following adverse reaction information is available for ALISKIREN (aliskiren hemifumarate):
Adverse reaction overview.
Common adverse effects reported in hypertensive patients receiving aliskiren include diarrhea, headache, dizziness, fatigue, cough, back pain, flu-like symptoms, rash, hyperkalemia, small increases in BUN or serum creatinine concentration, and increased serum creatine kinase (CK, creatine phosphokinase, CPK) concentrations.
Common adverse effects reported in hypertensive patients receiving aliskiren include diarrhea, headache, dizziness, fatigue, cough, back pain, flu-like symptoms, rash, hyperkalemia, small increases in BUN or serum creatinine concentration, and increased serum creatine kinase (CK, creatine phosphokinase, CPK) concentrations.
There are 14 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Anaphylaxis Anemia Angioedema Hyperkalemia Hyperuricemia Hyponatremia Hypotension Kidney stone Periorbital edema Peripheral edema Seizure disorder Stevens-johnson syndrome Toxic epidermal necrolysis |
There are 13 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea |
Cough Skin rash |
| Rare/Very Rare |
|---|
|
Acute abdominal pain Dizziness Dyspepsia Erythema Gastroesophageal reflux disease Kidney disease with reduction in glomerular filtration rate (GFr) Nausea Pruritus of skin Urticaria Vomiting |
The following precautions are available for ALISKIREN (aliskiren hemifumarate):
Safety of aliskiren therapy has been evaluated in pediatric patients 6-17 years of age receiving the drug for up to 52 weeks. (See Uses: Hypertension in Pediatric Patients.) In these studies, no unanticipated adverse effects were observed; adverse effects in pediatric patients 6 years of age or older are expected to be similar to those observed in adults. Preclinical studies in rats indicate a potential for a substantial increase in exposure to aliskiren in pediatric patients.
The manufacturer states that aliskiren is contraindicated in children younger than 2 years of age and should not be used in children 2 to younger than 6 years of age or in children who weigh less than 20 kg. If oliguria or hypotension occurs in neonates with a history of in utero exposure to aliskiren, blood pressure and renal function should be supported; exchange transfusions or dialysis may be required. (See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)
Contraindicated
Severe Precaution
Management or Monitoring Precaution
The manufacturer states that aliskiren is contraindicated in children younger than 2 years of age and should not be used in children 2 to younger than 6 years of age or in children who weigh less than 20 kg. If oliguria or hypotension occurs in neonates with a history of in utero exposure to aliskiren, blood pressure and renal function should be supported; exchange transfusions or dialysis may be required. (See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Aliskiren can cause fetal harm when administered to a pregnant woman. (See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)
Aliskiren is distributed into milk in rats; it is not known whether the drug is distributed into human milk. Breast-feeding is not recommended during treatment with aliskiren.
When the total number of patients studied in clinical trials of aliskiren is considered, 19% were 65 years of age or older, while 3.4% were 75 years of age or older. In clinical trials of aliskiren in fixed combination with hydrochlorothiazide, 19.6%
of patients were 65 years of age or older and 3.2% were 75 years of age and older. Although no overall differences in efficacy or safety were observed between geriatric and younger patients and other clinical experience revealed no evidence of age-related differences, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.
of patients were 65 years of age or older and 3.2% were 75 years of age and older. Although no overall differences in efficacy or safety were observed between geriatric and younger patients and other clinical experience revealed no evidence of age-related differences, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.
The following prioritized warning is available for ALISKIREN (aliskiren hemifumarate):
WARNING: This drug can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. It is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication. If you are planning pregnancy, become pregnant, or think you may be pregnant, tell your doctor right away.
WARNING: This drug can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. It is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication. If you are planning pregnancy, become pregnant, or think you may be pregnant, tell your doctor right away.
The following icd codes are available for ALISKIREN (aliskiren hemifumarate)'s list of indications:
| Hypertension | |
| I10 | Essential (primary) hypertension |
| I11 | Hypertensive heart disease |
| I11.0 | Hypertensive heart disease with heart failure |
| I11.9 | Hypertensive heart disease without heart failure |
| I12 | Hypertensive chronic kidney disease |
| I12.0 | Hypertensive chronic kidney disease with stage 5 chronic kidney disease or end stage renal disease |
| I12.9 | Hypertensive chronic kidney disease with stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease |
| I13 | Hypertensive heart and chronic kidney disease |
| I13.0 | Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease |
| I13.1 | Hypertensive heart and chronic kidney disease without heart failure |
| I13.10 | Hypertensive heart and chronic kidney disease without heart failure, with stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease |
| I13.11 | Hypertensive heart and chronic kidney disease without heart failure, with stage 5 chronic kidney disease, or end stage renal disease |
| I13.2 | Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease |
| I15.1 | Hypertension secondary to other renal disorders |
Formulary Reference Tool