Renagel

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Uses

RENAGEL®1 (sevelamer hydrochloride) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of Renagel in CKD patients who are not on dialysis have not been studied.

1: Renagel is a Registered Trademark of Genzyme Corporation.

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Other Information

The active ingredient in Renagel Tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is poly(allylamine hydrochloride) crosslinked with epichlorohydrin in which forty percent of the amines are protonated. It is known chemically as poly(allylamine-co-N,N’-diallyl-1,3-diamino-2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is hydrophilic, but insoluble in water. The structure is represented in Figure 1.

Figure 1. Chemical Structure of Sevelamer Hydrochloride

a, b = number of primary amine groups a + b = 9

c = number of crosslinking groups c = 1

n = fraction of protonated amines n = 0.4

m = large number to indicate extended polymer network

The primary amine groups shown in the structure are derived directly from poly(allylamine hydrochloride). The crosslinking groups consist of two secondary amine groups derived from poly(allylamine hydrochloride) and one molecule of epichlorohydrin.

Renagel® Tablets: Each film-coated tablet of Renagel contains either 800 mg or 400 mg of sevelamer hydrochloride on an anhydrous basis. The inactive ingredients are hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. The tablet imprint contains iron oxide black ink.

Sources

Renagel Manufacturers

State Of Florida Doh Central Pharmacy

Renagel | State Of Florida Doh Central Pharmacy

Patients Not Taking a Phosphate Binder. The recommended starting dose of Renagel is 800 to 1600 mg, which can be administered as one or two 800 mg Renagel® Tablets or two to four 400 mg Renagel® Tablets, with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renagel for patients not taking a phosphate binder.
Table 1. Starting Dose for Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Renagel® 800 mg Renagel® 400 mg
> 5.5 and < 7.5 mg/dL

1 tablet three times daily with meals

2 tablets three times daily with meals

≥ 7.5 and < 9.0 mg/dL

2 tablets three times daily with meals

3 tablets three times daily with meals

≥ 9.0 mg/dL

2 tablets three times daily with meals

4 tablets three times daily with meals

Patients Switching From Calcium Acetate. In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of Renagel and calcium acetate. Table 2 gives recommended starting doses of Renagel based on a patient’s current calcium acetate dose.
Table 2. Starting Dose for Dialysis Patients Switching From Calcium Acetate to Renagel Calcium Acetate 667 mg
(Tablets per meal) Renagel® 800 mg
(Tablets per meal) Renagel® 400 mg
(Tablets per meal)
1 tablet

1 tablet

2 tablets

2 tablets

2 tablets

3 tablets

3 tablets

3 tablets

5 tablets

Dose Titration for All Patients Taking Renagel. Dosage should be adjusted based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5 mg/dL or less. The dose may be increased or decreased by one tablet per meal at two week intervals as necessary. Table 3 gives a dose titration guideline. The average dose in a Phase 3 trial designed to lower serum phosphorus to 5.0 mg/dL or less was approximately three Renagel 800 mg tablets per meal. The maximum average daily Renagel dose studied was 13 grams.
Table 3. Dose Titration Guideline Serum Phosphorus
Renagel® Dose

>5.5 mg/dL

Increase 1 tablet per meal at 2 week intervals

3.5 - 5.5 mg/dL

Maintain current dose

<3.5 mg/dL

Decrease 1 tablet per meal

No Recall
Remedyrepack Inc.

Renagel | Remedyrepack Inc.

Patients Not Taking a Phosphate Binder. The recommended starting dose of Renagel is 800 to 1600 mg, which can be administered as one or two 800 mg Renagel® Tablets or two to four 400 mg Renagel® Tablets, with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renagel for patients not taking a phosphate binder.
Table 1. Starting Dose for Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Renagel® 800 mg Renagel® 400 mg
> 5.5 and < 7.5 mg/dL

1 tablet three times daily with meals

2 tablets three times daily with meals

≥ 7.5 and < 9.0 mg/dL

2 tablets three times daily with meals

3 tablets three times daily with meals

≥ 9.0 mg/dL

2 tablets three times daily with meals

4 tablets three times daily with meals

Patients Switching From Calcium Acetate. In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of Renagel and calcium acetate. Table 2 gives recommended starting doses of Renagel based on a patient’s current calcium acetate dose.
Table 2. Starting Dose for Dialysis Patients Switching From Calcium Acetate to Renagel Calcium Acetate 667 mg
(Tablets per meal) Renagel® 800 mg
(Tablets per meal) Renagel® 400 mg
(Tablets per meal)
1 tablet

1 tablet

2 tablets

2 tablets

2 tablets

3 tablets

3 tablets

3 tablets

5 tablets

Dose Titration for All Patients Taking Renagel. Dosage should be adjusted based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5 mg/dL or less. The dose may be increased or decreased by one tablet per meal at two week intervals as necessary. Table 3 gives a dose titration guideline. The average dose in a Phase 3 trial designed to lower serum phosphorus to 5.0 mg/dL or less was approximately three Renagel 800 mg tablets per meal. The maximum average daily Renagel dose studied was 13 grams.
Table 3. Dose Titration Guideline Serum Phosphorus
Renagel® Dose

>5.5 mg/dL

Increase 1 tablet per meal at 2 week intervals

3.5 - 5.5 mg/dL

Maintain current dose

<3.5 mg/dL

Decrease 1 tablet per meal

No Recall
Aphena Pharma Solutions – Tennessee, Llc

Renagel | Aphena Pharma Solutions - Tennessee, Llc

Patients Not Taking a Phosphate Binder. The recommended starting dose of Renagel is 800 to 1600 mg, which can be administered as one or two 800 mg Renagel® Tablets or two to four 400 mg Renagel® Tablets, with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renagel for patients not taking a phosphate binder.
Table 1. Starting Dose for Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Renagel® 800 mg Renagel® 400 mg
> 5.5 and < 7.5 mg/dL

1 tablet three times daily with meals

2 tablets three times daily with meals

≥ 7.5 and < 9.0 mg/dL

2 tablets three times daily with meals

3 tablets three times daily with meals

≥ 9.0 mg/dL

2 tablets three times daily with meals

4 tablets three times daily with meals

Patients Switching From Calcium Acetate. In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of Renagel and calcium acetate. Table 2 gives recommended starting doses of Renagel based on a patient’s current calcium acetate dose.
Table 2. Starting Dose for Dialysis Patients Switching From Calcium Acetate to Renagel Calcium Acetate 667 mg
(Tablets per meal) Renagel® 800 mg
(Tablets per meal) Renagel® 400 mg
(Tablets per meal)
1 tablet

1 tablet

2 tablets

2 tablets

2 tablets

3 tablets

3 tablets

3 tablets

5 tablets

Dose Titration for All Patients Taking Renagel. Dosage should be adjusted based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5 mg/dL or less. The dose may be increased or decreased by one tablet per meal at two week intervals as necessary. Table 3 gives a dose titration guideline. The average dose in a Phase 3 trial designed to lower serum phosphorus to 5.0 mg/dL or less was approximately three Renagel 800 mg tablets per meal. The maximum average daily Renagel dose studied was 13 grams.
Table 3. Dose Titration Guideline Serum Phosphorus
Renagel® Dose

>5.5 mg/dL

Increase 1 tablet per meal at 2 week intervals

3.5 - 5.5 mg/dL

Maintain current dose

<3.5 mg/dL

Decrease 1 tablet per meal

No Recall
Atlantic Biologicals Corps

Renagel | Atlantic Biologicals Corps

. The recommended starting dose of Renagel is 800 to 1600 mg, which can be administered as one or two 800 mg Renagel Tablets or two to four 400 mg Renagel Tablets, with meals based on serum phosphorus level. provides recommended starting doses of Renagel for patients not taking a phosphate binder. Patients Not Taking a Phosphate Binder®®Table 1
Table 1. Starting Dose for Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Renagel®800 mg Renagel®400 mg
> 5.5 and < 7.5 mg/dL

1 tablet three times daily with meals

2 tablets three times daily with meals

≥ 7.5 and < 9.0 mg/dL

2 tablets three times daily with meals

3 tablets three times daily with meals

≥ 9.0 mg/dL

2 tablets three times daily with meals

4 tablets three times daily with meals

. In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of Renagel and calcium acetate. gives recommended starting doses of Renagel based on a patient’s current calcium acetate dose. Patients Switching From Calcium AcetateTable 2
Table 2. Starting Dose for Dialysis Patients Switching From Calcium Acetate to Renagel Calcium Acetate 667 mg (Tablets per meal)
Renagel 800 ®mg (Tablets per meal)
Renagel®400mg(Tablets per meal)

1 tablet

1 tablet

2 tablets

2 tablets

2 tablets

3 tablets

3 tablets

3 tablets

5 tablets

. Dosage should be adjusted based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5 mg/dL or less. The dose may be increased or decreased by one tablet per meal at two week intervals as necessary. gives a dose titration guideline. The average dose in a Phase 3 trial designed to lower serum phosphorus to 5.0 mg/dL or less was approximately three Renagel 800 mg tablets per meal. The maximum average daily Renagel dose studied was 13 grams. Dose Titration for All Patients Taking RenagelTable 3
Table 3. Dose Titration Guideline Serum Phosphorus
Renagel Dose ®

>5.5 mg/dL

Increase 1 tablet per meal at 2 week intervals

3.5 - 5.5 mg/dL

Maintain current dose

<3.5 mg/dL

Decrease 1 tablet per meal

No Recall
Cardinal Health

Renagel | Teva Pharmaceuticals Usa Inc

2.1 Recommended Dosing and Dose Modification Guidelines
Dosage of temozolomide must be adjusted according to nadir neutrophil and platelet counts in the previous cycle and the neutrophil and platelet counts at the time of initiating the next cycle. For temozolomide dosage calculations based on body surface area (BSA) see Table 5. For suggested capsule combinations on a daily dose see Table 6.

Patients with Newly Diagnosed High Grade Glioma

Concomitant Phase

Temozolomide is administered at 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions) followed by maintenance temozolomide for 6 cycles. Focal RT includes the tumor bed or resection site with a 2- to 3- cm margin. No dose reductions are recommended during the concomitant phase; however, dose interruptions or discontinuation may occur based on toxicity. The temozolomide dose should be continued throughout the 42-day concomitant period up to 49 days if all of the following conditions are met: absolute neutrophil count greater than or equal to 1.5 x 109/L, platelet count greater than or equal to 100 x 109/L, common toxicity criteria (CTC) nonhematological toxicity less than or equal to Grade 1 (except for alopecia, nausea, and vomiting). During treatment a complete blood count should be obtained weekly. Temozolomide dosing should be interrupted or discontinued during concomitant phase according to the hematological and nonhematological toxicity criteria as noted in Table 1. Pneumocystis pneumonia (PCP) prophylaxis is required during the concomitant administration of temozolomide and radiotherapy, and should be continued in patients who develop lymphocytopenia until recovery from lymphocytopenia (CTC Grade less than or equal to 1).
TABLE 1: Temozolomide Dosing Interruption or Discontinuation During Concomitant Radiotherapy and Temozolomide * Treatment with concomitant TMZ could be continued when all of the following conditions were met: absolute neutrophil count greater than or equal to 1.5 x 10 9/L; platelet count greater than or equal to 100 x 10 9/L; CTC nonhematological toxicity less than or equal to Grade 1 (except for alopecia, nausea, vomiting).
Toxicity

TMZ Interruption*

TMZ Discontinuation

Absolute Neutrophil Count

greater than or equal to 0.5
and less than 1.5 x 109/L

less than 0.5 x 109/L

Platelet Count

greater than or equal to 10
and less than 100 x 109/L

less than 10 x 109/L

CTC Nonhematological Toxicity
(except for alopecia, nausea, vomiting)

CTC Grade 2

CTC Grade 3 or 4

Maintenance Phase

Cycle 1

Four weeks after completing the temozolomide + RT phase, temozolomide is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.

Cycles 2 to 6

At the start of Cycle 2, the dose can be escalated to 200 mg/m2, if the CTC nonhematologic toxicity for Cycle 1 is Grade less than or equal to 2 (except for alopecia, nausea, and vomiting), absolute neutrophil count (ANC) is greater than or equal to 1.5 x 109/L, and the platelet count is greater than or equal to 100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.

Dose Reduction or Discontinuation During Maintenance

Dose reductions during the maintenance phase should be applied according to Tables 2and 3.

During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose of temozolomide) or within 48 hours of that day, and weekly until the ANC is above 1.5 x 109/L (1500/microL) and the platelet count exceeds 100 x 109/L (100,000/microL). The next cycle of temozolomide should not be started until the ANC and platelet count exceed these levels. Dose reductions during the next cycle should be based on the lowest blood counts and worst nonhematologic toxicity during the previous cycle. Dose reductions or discontinuations during the maintenance phase should be applied according to Tables 2 and 3.
TABLE 2: Temozolomide Dose Levels for Maintenance Treatment
Dose Level

Dose (mg/m2/day)

Remarks

-1

100

Reduction for prior toxicity

0

150

Dose during Cycle 1

1

200

Dose during Cycles 2 to 6 in absence of toxicity
TABLE 3: Temozolomide Dose Reduction or Discontinuation During Maintenance Treatment * TMZ dose levels are listed in Table 2. † TMZ is to be discontinued if dose reduction to less than 100 mg/m 2 is required or if the same Grade 3 nonhematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Toxicity

Reduce TMZ by 1 Dose Level*

Discontinue TMZ

Absolute Neutrophil Count

less than 1 x 109/L

See footnote†

Platelet Count

less than 50 x 109/L

See footnote†

CTC Nonhematological Toxicity
(except for alopecia, nausea, vomiting)

CTC Grade 3

CTC Grade 4†

Patients with Refractory Anaplastic Astrocytoma

For adults the initial dose is 150 mg/m2 once daily for 5 consecutive days per 28-day treatment cycle. For adult patients, if both the nadir and day of dosing (Day 29, Day 1 of next cycle) ANC are greater than or equal to 1.5 x 109/L (1500/microL) and both the nadir and Day 29, Day 1 of next cycle platelet counts are greater than or equal to 100 x 109/L (100,000/microL), the temozolomide dose may be increased to 200 mg/m2/day for 5 consecutive days per 28-day treatment cycle. During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until the ANC is above 1.5 x 109/L (1500/microL) and the platelet count exceeds 100 x 109/L (100,000/microL). The next cycle of temozolomide should not be started until the ANC and platelet count exceed these levels. If the ANC falls to less than 1 x 109/L (1000/microL) or the platelet count is less than 50 x 109/L (50,000/microL) during any cycle, the next cycle should be reduced by 50 mg/m2, but not below 100 mg/m2, the lowest recommended dose (see Table 4). Temozolomide therapy can be continued until disease progression. In the clinical trial, treatment could be continued for a maximum of 2 years, but the optimum duration of therapy is not known.

TABLE 4: Dosing Modification Table

TABLE 5: Daily Dose Calculations by Body Surface Area (BSA)
TABLE 5: Daily Dose Calculations by Body Surface Area (BSA)
Total BSA
(m2)

75 mg/m2

(mg daily)

150 mg/m2

(mg daily)

200 mg/m2

(mg daily)

1

75

150

200

1.1

82.5

165

220

1.2

90

180

240

1.3

97.5

195

260

1.4

105

210

280

1.5

112.5

225

300

1.6

120

240

320

1.7

127.5

255

340

1.8

135

270

360

1.9

142.5

285

380

2

150

300

400

2.1

157.5

315

420

2.2

165

330

440

2.3

172.5

345

460

2.4

180

360

480

2.5

187.5

375

500
TABLE 6: Suggested Capsule Combinations Based on Daily Dose in Adults
Number of Daily Capsules by Strength (mg)

Total Daily Dose (mg)

250 mg

180 mg

140 mg

100 mg

20 mg

5 mg

75

0

0

0

0

3

3

82.5

0

0

0

0

4

0

90

0

0

0

0

4

2

97.5

0

0

0

1

0

0

105

0

0

0

1

0

1

112.5

0

0

0

1

0

2

120

0

0

0

1

1

0

127.5

0

0

0

1

1

1

135

0

0

0

1

1

3

142.5

0

0

1

0

0

0

150

0

0

1

0

0

2

157.5

0

0

1

0

1

0

165

0

0

1

0

1

1

172.5

0

0

1

0

1

2

180

0

1

0

0

0

0

187.5

0

1

0

0

0

1

195

0

1

0

0

0

3

200

0

1

0

0

1

0

210

0

0

0

2

0

2

220

0

0

0

2

1

0

225

0

0

0

2

1

1

240

0

0

1

1

0

0

255

1

0

0

0

0

1

260

1

0

0

0

0

2

270

1

0

0

0

1

0

280

0

0

2

0

0

0

285

0

0

2

0

0

1

300

0

0

0

3

0

0

315

0

0

0

3

0

3

320

0

1

1

0

0

0

330

0

1

1

0

0

2

340

0

1

1

0

1

0

345

0

1

1

0

1

1

360

0

2

0

0

0

0

375

0

2

0

0

0

3

380

0

1

0

2

0

0

400

0

0

0

4

0

0

420

0

0

3

0

0

0

440

0

0

3

0

1

0

460

0

2

0

1

0

0

480

0

1

0

3

0

0

500

2

0

0

0

0

0
2.2 Preparation and Administration
Temozolomide Capsules

In clinical trials, temozolomide was administered under both fasting and nonfasting conditions; however, absorption is affected by food [see Clinical Pharmacology (12.3)], and consistency of administration with respect to food is recommended. There are no dietary restrictions with temozolomide. To reduce nausea and vomiting, temozolomide should be taken on an empty stomach. Bedtime administration may be advised. Antiemetic therapy may be administered prior to and/or following administration of temozolomide.

Temozolomide Capsules should not be opened or chewed. They should be swallowed whole with a glass of water. If capsules are accidentally opened or damaged, precautions should be taken to avoid inhalation or contact with the skin or mucous membranes [see How Supplied/Storage and Handling (16.1)].

No Recall
Genzyme Corporation

Renagel | Janssen Biotech, Inc.

2.1 Recommended Dosage
The recommended dose of ZYTIGA is 1,000 mg (four 250 mg tablets) administered orally once daily in combination with prednisone 5 mg administered orally twice daily. ZYTIGA must be taken on an empty stomach. No food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken [see Clinical Pharmacology (12.3)]. The tablets should be swallowed whole with water. Do not crush or chew tablets.
2.2 Dose Modification Guidelines in Hepatic Impairment and Hepatotoxicity
Hepatic Impairment

In patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the recommended dose of ZYTIGA to 250 mg once daily. A once daily dose of 250 mg in patients with moderate hepatic impairment is predicted to result in an area under the concentration curve (AUC) similar to the AUC seen in patients with normal hepatic function receiving 1,000 mg once daily. However, there are no clinical data at the dose of 250 mg once daily in patients with moderate hepatic impairment and caution is advised. In patients with moderate hepatic impairment monitor ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. If elevations in ALT and/or AST greater than 5× upper limit of normal (ULN) or total bilirubin greater than 3× ULN occur in patients with baseline moderate hepatic impairment, discontinue ZYTIGA and do not re-treat patients with ZYTIGA [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Do not use ZYTIGA in patients with baseline severe hepatic impairment (Child-Pugh Class C).

Hepatotoxicity

For patients who develop hepatotoxicity during treatment with ZYTIGA (ALT and/or AST greater than 5× ULN or total bilirubin greater than 3× ULN), interrupt treatment with ZYTIGA [see Warnings and Precautions (5.3)]. Treatment may be restarted at a reduced dose of 750 mg once daily following return of liver function tests to the patient's baseline or to AST and ALT less than or equal to 2.5× ULN and total bilirubin less than or equal to 1.5× ULN. For patients who resume treatment, monitor serum transaminases and bilirubin at a minimum of every two weeks for three months and monthly thereafter.

If hepatotoxicity recurs at the dose of 750 mg once daily, re-treatment may be restarted at a reduced dose of 500 mg once daily following return of liver function tests to the patient's baseline or to AST and ALT less than or equal to 2.5× ULN and total bilirubin less than or equal to 1.5× ULN.

If hepatotoxicity recurs at the reduced dose of 500 mg once daily, discontinue treatment with ZYTIGA. The safety of ZYTIGA re-treatment of patients who develop AST or ALT greater than or equal to 20× ULN and/or bilirubin greater than or equal to 10× ULN is unknown.
2.3 Dose Modification Guidelines for Strong CYP3A4 Inducers
Avoid concomitant strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) during ZYTIGA treatment. Although there are no clinical data with this dose adjustment in patients receiving strong CYP3A4 inducers, because of the potential for an interaction, if a strong CYP3A4 inducer must be co-administered, increase the ZYTIGA dosing frequency to twice a day only during the co-administration period (e.g., from 1,000 mg once daily to 1,000 mg twice a day). Reduce the dose back to the previous dose and frequency, if the concomitant strong CYP3A4 inducer is discontinued [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall