Patiromer for Oral Suspension- Veltassa -@-(Oct 2015) - For Hyperkalemia
Drug Name:Patiromer for Oral Suspension- Veltassa -@-(Oct 2015) - For Hyperkalemia
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Take other orally administered drugs at least 6 hours before or 6 hours
after Veltassa.
Indication:
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)
NEW MOLECULAR ENTITY AND NEW THERAPEUTIC BIOLOGICAL
PRODUCTS APPROVED FOR 2015
Certain drugs are classified as New molecular Emtities- NME- for FDA review
Many of these products contain active moieties that have not been approved
by FDA previously, either as a single ingredient or as part of a combination
products; these products frequently provide important new therapies for the
patients.
Some drugs are characterized as NMEs for administrative purposes ,but
nonetheless contain certain active moieties in products that have been
previously approved by FDA. For example, CDER classifies biological
products submitted in an application under section 351(a) of the Public
Service Act as NME for purposes of FDA review, regardless of whether
the agency previously approved a related active moiety in a different
product.
FDAs classification of a drug as an -NME- for review purposes is distinct
from FDAs determination of whether a drug is a - New Chemical Entity or - NCE-
within the meaning of the Federal Food,Drug, and Cosmetic Act
No.30
Drug Name - Patriomer for oral Suspension
Active Ingredient- Veltassa
Date of approval - 10/21/2015
FDA-approved use - To treat Hyperkalemia, a serious condition in
which the amount of Potassium in the blood
is too high
Approved by US FDA on 10/21/2015- (Ref- FDA approved List- 2015)
INDICATIONS AND USAGE
Veltassa is a potassium binder 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.
Adverse Reaction:
Most common adverse reactions (incidence . 2%) are constipation,
hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence.
Contra-Indications:
CONTRAINDICATIONS
Known hypersensitivity to Veltassa or any of its components.
WARNINGS AND PRECAUTIONS
Worsening of Gastrointestinal Motility
Hypomagnesemia
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
Veltassa is a potassium binder 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.
DOSAGE AND ADMINISTRATION
The recommended starting dose of Veltassa is 8.4 grams administered orally
once daily with food.
Adjust dose by 8.4 grams daily as needed at one week intervals to obtain
desired serum potassium target range.
DOSAGE FORMS AND STRENGTHS
Powder: 8.4, 16.8 and 25.2 grams patiromer packets.
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Drug Interactions
Advise patients who are taking other oral medication to separate the dosing of
Veltassa by at least 6 hours (before or after)
Dosing Recommendations
Inform patients to take Veltassa as directed with food and adhere to their prescribed
diets. Instruct patients to prepare each dose separately using the preparation
instructions provided in the FDA-approved patient labeling (Medication Guide).
Inform patients that Veltassa should not be heated (e.g., microwaved) or added
to heated foods or liquids and should not be taken in its dry form.
Manufactured for:
Relypsa, Inc.
Redwood City, CA 94063
Version 01; October 2015
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Veltassa is a non-absorbed, cation exchange polymer that contains a
calcium-sorbitol counterion.Veltassa increases fecal potassium excretion through
binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium
reduces the concentration of free potassium in the gastrointestinal lumen, resulting
in a reduction of serum potassium levels.
2. Pharmacokinetics
In radiolabeled ADME studies in rats and dogs, patiromer was not systemically
absorbed and was excreted in the feces. Quantitative whole-body autoradiography
analysis in rats demonstrated that radioactivity was limited to the gastrointestinal tract,
with no detectable level of radioactivity in any other tissues or organs.
Drug Interactions
Veltassa binds many other orally administered medications in the gastrointestinal tract,
which could lead to a decrease in absorption of other medications.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1 Pregnancy
Risk Summary
Veltassa is not absorbed systemically following oral administration and maternal
use is not expected to result in fetal risk.
2 Lactation
Risk Summary
Veltassa is not absorbed systemically by the mother, so breastfeeding is not
expected to result in risk to the infant.
3. Pediatric Use
Safety and efficacy in pediatric patients have not been established.
4. Geriatric Use
Of the 666 patients treated with Veltassa in clinical studies, 59.8% were age 65
and over, and 19.8% were age 75 and over. No overall differences in
effectiveness were observed between these patients and younger patients.
Patients age 65 and older reported more gastrointestinal adverse reactions
than younger patients.
