veltassa

For adults, the recommended starting dose of Veltassa is 8.4 grams administered orally once daily. ( 2.2 ) For adults, adjust dose by 8.4 grams daily as needed at one-week intervals to obtain desired serum potassium target range. ( 2.2 ) For pediatric patients 12 to 17 years of age, the recommended starting dose of Veltassa is 4 grams administered orally once daily. ( 2.2 ) For pediatric patients 12 to 17 years of age, adjust dose by 4 grams daily as needed at one-week intervals to obtain desired serum potassium target range. ( 2.2 ) The maximum recommended dosage in adults and pediatric patients older than 12 years is 25.2 grams once daily. ( 2.2 ) 2.1 General Information Administer Veltassa at least 3 hours before or 3 hours after other oral medications except those shown to not have a clinically important interaction [see Drug Interactions (7) and Clinical Pharmacology (12.3) ]. Do not heat Veltassa (e.g., microwave) or add to heated foods or liquids. Do not take Veltassa in its dry form. 2.2 Recommended Dosing and Titration The recommended starting dose of Veltassa varies with age and is shown below. Multiple packets may be used to achieve the prescribed dose. Monitor serum potassium and adjust the dose of Veltassa based on the serum potassium level and the desired target range. The dose may be increased or decreased, as necessary, to reach the desired serum potassium…

The following adverse reaction is discussed in greater detail elsewhere in the label: Hypomagnesemia [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥ 2%) are constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vifor Pharma, Inc. at 1-844-VELTASSA (1-844-835-8277) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adult Patients Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Veltassa cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. In the safety and efficacy clinical trials, 666 adult patients received at least one dose of Veltassa, including 219 exposed for at least 6 months and 149 exposed for at least one year. Table 1 provides a summary of the most common adverse reactions (occurring in ≥ 2% of patients) in adult patients treated with Veltassa in these clinical trials. Most adverse reactions were mild to moderate. Constipation generally resolved during the course of treatment. Table 1: Adverse Reactions Reported in ≥ 2% of Patients Adverse Reactions Adult Patients treated with Veltassa (N=666) Note: Diarrhea is an aggregate term for Diarrhea and frequent bowel…

Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components [see Adverse Reactions (6.1) ]. Known hypersensitivity to Veltassa or any of its components. ( 4 )

Doses of Veltassa in excess of 50.4 grams per day have not been tested. Excessive doses of Veltassa may result in hypokalemia. Restore serum potassium if hypokalemia occurs.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

Veltassa has the potential to bind some oral co-administered medications, which could decrease their gastrointestinal absorption. Binding of Veltassa to other oral medications not listed in Table 3 below could cause decreased gastrointestinal absorption and loss of efficacy when taken close to the time Veltassa is administered. Administer other oral medications at least 3 hours before or 3 hours after Veltassa [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) ] . Take other orally administered drugs at least 3 hours before or 3 hours after Veltassa except those shown to not have a clinically important interaction. ( 2.1 , 7 ) 7.1 Clinically Important Interaction of Veltassa with Other Drugs The in-vitro binding of the following drugs to patiromer was evaluated and potentially clinically significant binding was observed. Some drugs were subsequently tested in-vivo and significant reduction in systemic exposure was observed [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) ] . Binding by Veltassa may reduce the systemic exposure and decrease the clinical efficacy of the co-administered drugs shown in Table 2. The administration of these drugs (and any drugs not listed in Table 3) should be separated by at least 3 hours from Veltassa. Table 2: Clinically important drug interactions of Veltassa Angiotensin II receptor blockers (ARB) Telmisartan β-adrenoceptor blockers (β-blocker) Bisoprolol, carvedilol, nebivolol Antibiotics Ciprofloxacin Anti-Parathyroid Agents and Thyroid Preparations Levothyroxine Blood Glucose Lowering Drugs Metformin Immunosuppressants Mycophenolate mofetil Others Quinidine, thiamine 7.2 No Observed Clinically Important Interaction of Veltassa with Other Drugs The binding of the following drugs to patiromer was evaluated [see Clinical Pharmacology (12.3) ] and no clinically significant binding was observed. No separation of dosing is required for these drugs. Table 3: No observed clinically important drug interactions of Veltassa Angiotensin-converting enzyme (ACE) inhibitors Benazepril, captopril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, trandolapril Angiotensin II receptor blockers (ARB) Azilsartan, candesartan, irbesartan, losartan, olmesartan, valsartan β-adrenoceptor blockers (β-blocker) Metoprolol Loop diuretics Furosemide, bumetanide, torasemide Mineralocorticoid receptor antagonists (MRA) Eplerenone, finerenone, spironolactone Neprilysin inhibitors Sacubitril Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Canagliflozin, dapagliflozin, empagliflozin Antibiotics Trimethoprim, amoxicillin, cephalexin Anticoagulants Warfarin, apixaban, rivaroxaban Anti-parathyroid agents and Thyroid preparations Cinacalcet Antithrombotic agents Clopidogrel, acetylsalicylic acid Blood glucose lowering drugs Glipizide Calcium channel blockers Amlodipine, verapamil Immunosuppressants Tacrolimus Others Lithium, allopurinol, atorvastatin, digoxin, phenytoin, riboflavin, sevelamer