Prescription Drug Information: Azasan (Page 3 of 3)

DOSAGE AND ADMINISTRATION

Patients with TPMT and/or NUDT Deficiency: Consider testing for TPMT and NUDT15 deficiency in patients who experience severe bone marrow toxicities. Early drug discontinutation may be considered in patients with abnormal CBC results that do ot respond to dose reduction (see CLINICAL PHARMACOLOGY, WARNINGS:Cytopenias, and PRECAUTIONS:Laboratory Tests).

Homozygous deficiency in either TPMT or NUDT15: Because of the risk of increased toxicity, consider alternative therapies for patients who are known to have TPMT or NUDT15 deficiency (see CLINICAL PHARMACOLOGY, WARNINGS:Cytopenias, and PRECAUTIONS:Laboratory Tests).

Heterozygous deficiency in TPMT and/or NUDT15: Because of the risk of increased toxicity, dosage reduction is recommended in patients known to have heterozygous deficiency of TPMT or NUDT15. Patients who are heterozygous for both TPMT and NUDT15 deficiency may require more substandial dosage reductions (see CLINICAL PHARMACOLOGY, WARNINGS:Cytopenias, and PRECAUTIONS:Laboratory Tests).

Renal Homotransplantation: The dose of AZASAN required to prevent rejection and minimize toxicity will vary with individual patients; this necessitates careful management. The initial dose is usually 3 to 5 mg/kg daily, beginning at the time of transplant. AZASAN is usually given as a single daily dose on the day of, and in a minority of cases 1 to 3 days before, transplantation. Dose reduction to maintenance levels of 1 to 3 mg/kg daily is usually possible. The dose of AZASAN should not be increased to toxic levels because of threatened rejection. Discontinuation may be necessary for severe hematologic or other toxicity, even if rejection of the homograft may be a consequence of drug withdrawal.

Rheumatoid Arthritis: AZASAN is usually given on a daily basis. The initial dose should be approximately 1.0 mg/kg (50 to 100 mg) given as a single dose or on a twice-daily schedule. The dose may be increased, beginning at 6 to 8 weeks and thereafter by steps at 4-week intervals, if there are no serious toxicities and if initial response is unsatisfactory. Dose increments should be 0.5 mg/kg daily, up to a maximum dose of 2.5 mg/kg/day. Therapeutic response occurs after several weeks of treatment, usually 6 to 8; an adequate trial should be a minimum of 12 weeks. Patients not improved after 12 weeks can be considered refractory. AZASAN may be continued long-term in patients with clinical response, but patients should be monitored carefully, and gradual dosage reduction should be attempted to reduce risk of toxicities.

Maintenance therapy should be at the lowest effective dose, and the dose given can be lowered decrementally with changes of 0.5 mg/kg or approximately 25 mg daily every 4 weeks while other therapy is kept constant. The optimum duration of maintenance AZASAN has not been determined. AZASAN can be discontinued abruptly, but delayed effects are possible.

Use in Renal Dysfunction: Relatively oliguric patients, especially those with tubular necrosis in the immediate postcadaveric transplant period, may have delayed clearance of AZASAN or its metabolites, may be particularly sensitive to this drug, and are usually given lower doses.

Procedures for proper handling and disposal of this immunosuppressive antimetabolite drug should be considered. Several guidelines on this subject have been published 15-21.There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

HOW SUPPLIED

AZASAN Tablets, USP are available in:

75 mg, triangle-shaped, yellow, scored tablets,
100 count bottles (NDC 65649-231-41)

100 mg, diamond-shaped, yellow, scored tablets,
100 count bottles (NDC 65649-241-41)

Store at 20° to 25°C (68° to 77° F) [See USP Controlled Room Temperature]

Store in a dry place and protect from light.

Dispense in a tight, light-resistant container as defined in the USP.

REFERENCES

1.Clark JM. The mutagenicity of azathioprine in mice, Drosophila melanogaster, and Neurospora crassa. Mutat Res. 1975; 28:87-99.
2.Data on file, Prometheus Laboratories Inc.
3.Tagatz GE, Simmons RL. Pregnancy after renal transplantation. Ann Intern Med. 1975; 82:113-114. Editorial Notes.
4.Cote’ CJ, Meuwissen HJ, Pickering RJ. Effects on the neonate of prednisone and azathioprine administered to the mother during pregnancy. J Pediatr. 1974; 85:324-328.
5.DeWitte DB, Buick MK, Cyran SE, et al. Neonatal pancytopenia and severe combined immunodeficiency associated with antenatal administration of azathioprine and prednisone. J Pediatr. 1984; 105:625-628.
6.Williamson RA, Karp LE. Azathioprine teratogenicity: review of the literature and case report. Obstet Gynecol. 1981; 58:247-250.
7.Tallent MB, Simmons RL, Najarian JS. Birth defects in child of male recipient of kidney transplant. JAMA. 1970; 211:1854-1855.
8.Data on file, Prometheus Laboratories Inc.
9.Saarikoski S, Seppälä M. Immunosuppression during pregnancy: transmission of azathioprine and its metabolites from the mother to the fetus. Am J Obstet Gynecol. 1973; 115:1100-1106.
10.Coulam CB, Moyer TP, Jiang NS, et al. Breast-feeding after renal transplantation. Transplant Proc. 1982; 14: 605-609.
11.Read AE, Wiesner RH, LaBrecque DR, et al. Hepatic veno-occlusive disease associated with renal transplantation and azathioprine therapy. Ann Intern Med. 1986; 104:651-655.
12.Katzka DA, Saul SH, Jorkasky D, et al. Azathioprine and hepatic veno-occlusive disease in renal transplant patients. Gastroenterology. 1986; 90:446-454.
13.Weitz H, Gokel JM, Loeshke K, et al. Veno-occlusive disease of the liver in patients receiving immunosuppressive therapy. Virchows Arch A Pathol Anat Histol. 1982; 395:245-256.
14.Schusziarra V, Ziekursch V, Schlamp R, et al. Pharmacokinetics of azathioprine under haemodialysis. Int J Clin Pharmacol Biopharm. 1976; 14:298-302.
15.Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety; Clinical Center Pharmacy Department and Cancer Nursing Services, National Institute of Health; 1992. US Dept of Health and Human Services. Public Health Service Publication NIH 92-2621.
16.AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985; 253:1590-1592.
17.National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.
18.Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Aust. 1983; 1:426-428.
19.Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from The Mount Sinai Medical Center. CA Cancer J for Clinicians. 1983; 33:258-263.
20.American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990; 47:1033-1049. 21.Yodaiken RE, Bennett D. OSHA Work-Practice guidelines for personnel dealing with cytotoxic (antineoplastic) drugs. Am J Hosp Pharm, 1996; 43:1193-1204.

Manufactured for:

AZASAN ® is a registered trademark of ALcami Corporation

http://rxdruglabels.com/lib/images-rx/azasan-2/aza02-0000-03.jpg

Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA

Manufactured by:

Alcami Corporation

Wilmington, NC 28405 USA

REV. 05/2019

PACKAGE LABEL — PRINICPAL DISPLAY PANEL — Azasan 75 mg Tablets

100 Tablets

NDC 65649-231-41

(azathioprine)

75 mg

Rx Only

Manufactured by: Alcami Corporation

Wilmington, NC 28405

Manufactured for: Salix Pharmaceuticals

a division of Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

AZASAN® is a registered trademark of Alcami Corporation

aza75mg tablets
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — Azasan 100mg Tablets

100 Tablets

NDC 65649-241-41

(azathioprine)

100 mg

Rx Only

Manufactured by: Alcami Corporation

Wilmington, NC 28405 USA

Manufactured for: Salix Pharmaceuticals

a division of Valeant Pharmacueticals North America LLS

Bridgewater, NJ 08007 USA

AZASAN® is a registered trademark of Alcami Corporation

aza02-0000-05
(click image for full-size original)
AZASAN azathioprine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65649-231
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZATHIOPRINE (AZATHIOPRINE) AZATHIOPRINE 75 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
STEARIC ACID
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
Product Characteristics
Color yellow Score 2 pieces
Shape TRIANGLE Size 14mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65649-231-41 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075252 04/01/2003
AZASAN azathioprine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65649-241
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZATHIOPRINE (AZATHIOPRINE) AZATHIOPRINE 100 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
STEARIC ACID
STARCH, CORN
LACTOSE MONOHYDRATE
POVIDONE, UNSPECIFIED
Product Characteristics
Color yellow Score 2 pieces
Shape DIAMOND Size 14mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65649-241-41 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075252 04/01/2003
Labeler — Salix Pharmaceuticals Inc. (793108036)
Registrant — Alcami Carolinas Corporation (832395235)
Establishment
Name Address ID/FEI Operations
Alcami Carolinas Corporation 079646861 PACK (65649-231), PACK (65649-241)
Establishment
Name Address ID/FEI Operations
Alcami Carolinas Corporation 831351445 ANALYSIS (65649-231), ANALYSIS (65649-241)
Establishment
Name Address ID/FEI Operations
Alcami Carolinas Corporation 832395235 MANUFACTURE (65649-231), MANUFACTURE (65649-241)

Revised: 06/2019 Salix Pharmaceuticals Inc.

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