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VELTASSA (patiromer) for oral suspension

2015-11-09 11:08:33 来源: 作者: 【大中小】浏览:508次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use VELTASSA™ safely and effectively. See full prescribing information for VELTASSA.

VELTASSA (patiromer) for oral suspension
Initial U.S. Approval: 2015
WARNING: BINDING TO OTHER ORAL MEDICATIONS
Veltassa binds to many orally administered medications, which could decrease their absorption and reduce their effectiveness. Administer other oral medications at least 6 hours before or 6 hours after Veltassa. Choose Veltassa or the other oral medication if adequate dosing separation is not possible. (2.1, 5.1, 7)

INDICATIONS AND USAGE

Veltassa is a potassium binder indicated for the treatment of hyperkalemia. (1)

Limitation of Use

Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action. (1)
DOSAGE AND ADMINISTRATION

The recommended starting dose of Veltassa is 8.4 grams administered orally once daily with food. (2.2)
Adjust dose by 8.4 grams daily as needed at one week intervals to obtain desired serum potassium target range. (2.2)

DOSAGE FORMS AND STRENGTHS

Powder: 8.4, 16.8 and 25.2 grams patiromer packets. (3)

CONTRAINDICATIONS

Known hypersensitivity to Veltassa or any of its components. (4)

WARNINGS AND PRECAUTIONS

Worsening of Gastrointestinal Motility (5.2)
Hypomagnesemia (5.3)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥ 2%) are constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Relypsa at 1-844-VELTASSA (1-844-835-8277) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Take other orally administered drugs at least 6 hours before or 6 hours after Veltassa. (2.1, 5.1, 7)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 10/2015

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: BINDING TO OTHER ORAL MEDICATIONS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 General Information

2.2 Recommended Dosing and Titration

2.3 Preparation of Veltassa

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Binding to Other Orally Administered Medications

5.2 Worsening of Gastrointestinal Motility

5.3 Hypomagnesemia

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Two-Part, Randomized Withdrawal Study

14.2 One-Year Study

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Stability and Storage

17 PATIENT COUNSELING INFORMATION

*: Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS AND USAGE

Veltassa is indicated for the treatment of hyperkalemia.

Limitation of Use: Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Pharmacodynamics (12.2)].

2 DOSAGE AND ADMINISTRATION

2.1 General Information

Administer Veltassa at least 6 hours before or 6 hours after other oral medications [see Warnings and Precautions (5.1) and Drug Interactions (7)].

Administer Veltassa with food. 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 is 8.4 grams patiromer once daily. 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 concentration, up to a maximum dose of 25.2 grams once daily. The dose can be up-titrated based on serum potassium level at 1-week or longer intervals, in increments of 8.4 grams.

2.3 Preparation of Veltassa

Prepare each dose immediately prior to administration following the steps below:

Step 1:	Add about 1 ounce (30 milliliters) of water to an empty glass or cup.
Step 2:	Empty the entire contents of the packet(s) into the glass or cup.
Step 3:	Stir the mixture thoroughly.
Step 4:	Add an additional 2 ounces (60 milliliters) of water to the glass or cup containing the mixture.
Step 5:	Stir the mixture thoroughly; the powder will not dissolve and the mixture will look cloudy.
Step 6:	Drink the mixture immediately. If some powder remains in the glass after drinking, add more water, stir and drink immediately. Repeat as needed to ensure the entire dose is administered.

3 DOSAGE FORMS AND STRENGTHS

Veltassa is an off-white to light-brown powder for oral suspension packaged in single-use packets containing 8.4 grams, 16.8 grams or 25.2 grams patiromer.

4 CONTRAINDICATIONS

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

5 WARNINGS AND PRECAUTIONS

5.1 Binding to Other Orally Administered Medications

Veltassa binds many orally administered medications, which could decrease their gastrointestinal absorption and lead to reduced efficacy. Administer other oral medications at least 6 hours before or 6 hours after Veltassa. Choose Veltassa or the other oral medication if adequate dosing separation is not possible [see Dosage and Administration (2.1) and Drug Interactions (7)].