A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Renagel Side Effects, and Drug Interactions - Sevelamer Hcl
Renagel Side Effects, and Drug Interactions - Sevelamer Hcl
SIDE EFFECTS
In a placebo-controlled study with a treatment duration of two weeks, the adverse events reported for Renagel Capsules (N=24) were similar to those reported for placebo (N=12). In a cross-over study with treatment durations of eight weeks each, the adverse events reported for Renagel Capsules (N=82) were similar to those reported for calcium acetate (N=82) and included headache, infection, pain, hypertension, hypotension, thrombosis, diarrhea, dyspepsia, vomiting, and cough increased. In a parallel design study with treatment duration of 52 weeks, adverse events reported for Renagel Tablets (N=99) were similar to those reported for calcium (calcium acetate and calcium carbonate) (N=101). (Table 3).
Table 3. Treatment-Emergent Adverse Events ³10 % from a Parallel Design Trial of Renagel Tablets versus Calcium for 52 Weeks of Treatment |
Adverse Event |
Renagel (N=99) |
Calcium (N=101) |
Patients % |
Patients % |
Gastrointestinal Disorders
|
Vomiting
|
22.2
|
21.8
|
Nausea
|
20.2
|
19.8
|
Diarrhea
|
19.2
|
22.8
|
Dyspepsia
|
16.2
|
6.9
|
Constipation
|
8.1
|
11.9
|
Infections and Infestations
|
Nasopharyngitis
|
14.1
|
7.9
|
Bronchitis
|
11.1
|
12.9
|
Upper Respiratory
|
|
|
Tract Infection
|
5.1
|
10.9
|
Musculoskeletal, Connective Tissue and Bone Disorders
|
Pain in Limb
|
13.1
|
14.9
|
Arthralgia
|
12.1
|
17.8
|
Back Pain
|
4.0
|
17.8
|
Skin Disorders
|
|
|
Pruritus
|
13.1
|
9.9
|
Respiratory, Thoracic and Mediastinal Disorders
|
Dyspnea
|
10.1
|
16.8
|
Cough
|
7.1
|
12.9
|
Vascular Disorders
|
|
|
Hypertension
|
10.1
|
5.9
|
Nervous System Disorders
|
|
|
Headache
|
9.1
|
15.8
|
General Disorders and Site Administration Disorders
|
Mechanical Complication of Implant
|
6.1
|
10.9
|
Pyrexia
|
5.1
|
10.9
|
In the parallel design study, the major reason for drop out in the Renagel group was gastrointestinal adverse events. In a long-term, open-label extension trial, adverse events possibly related to Renagel Capsules and which were not dose-related, included nausea (7%), constipation (2%), diarrhea (4%), flatulence (4%), and dyspepsia (5%). During post-marketing experience, the following adverse events have been reported in patients receiving Renagel although no direct relationship to Renagel could be established: pruritis, rash, and abdominal pain.
DRUG INTERACTIONS
Renagel Capsules were studied in human drug-drug interaction studies with digoxin, warfarin, enalapril metoprolol and iron.
Digoxin: In 19 healthy subjects receiving 6 Renagel capsules three times a day with meals for 2days, Renagel did not alter the pharmaco-kinetics of a single dose of digoxin.
Warfarin: In 14 healthy subjects receiving 6 Renagel capsules three times a day with meals for 2days, Renagel did not alter the pharmaco-kinetics of a single dose of warfarin.
Enalapril: In 28 healthy subjects a single dose of 6 Renagel capsules did not alter the pharmacokinetics of a single dose of enalapril.
Metoprolol: In 31 healthy subjects a single dose of 6 Renagel capsules did not alter the pharmacokinetics of a single dose of metoprolol.
Iron: In 23 healthy subjects, a single dose of 7 Renagel capsules did not alter the absorption of a single oral dose of iron as 200 mg exsiccated ferrous sulfate tablet.
However, when administering any other oral medication where a reduction in the bioavailability ofthat medication would have a clinically significant effect on safety or efficacy, the drug should beadministered at least one hour before or three hours after Renagel, or the physician should consider monitoring blood levels of the drug. Patients taking anti-arrhythmic and anti-seizure medications were excluded from the clinical trials. Special precautions should be taken when prescribing Renagel to patients also taking these medications.
top
