Allopurinol (Page 4 of 4)

12.5 Pharmacogenomics

The HLA-B*58:01 allele is a genetic marker for severe skin reactions indicative of hypersensitivity to allopurinol [see Warnings and Precautions (5.1)]. The frequency of the HLA-B*58:01 allele ranges from 8 to 10% in Han Chinese populations, about 8% in Thai populations, and about 6% in Korean populations based upon published literature and available databases. The frequency of the HLA-B*58:01 allele is about 4% in Blacks, about 1 to 2 % in indigenous peoples of the Americas and Hispanic populations, and <1% in people from European descent and Japanese.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Allopurinol was administered at doses up to 20 mg/kg/day to mice and rats for the majority of their life span. No evidence of carcinogenicity was seen in either mice or rats (at doses about 1/6 or 1/3 the recommended human dose on a mg/m2 basis, respectively).
Allopurinol administered intravenously to rats (50 mg/kg) was not incorporated into rapidly replicating intestinal DNA. No evidence of clastogenicity was observed in an in vivo micronucleus test in rats, or in lymphocytes taken from patients treated with allopurinol (mean duration of treatment 40 months), or in an in vitro assay with human lymphocytes. Allopurinol oral doses of 20 mg/kg/day had no effect on male or female fertility in rats or rabbits (about 1/3 or 1/2 the human dose on a mg/m2 basis, respectively).

14 CLINICAL STUDIES

A compassionate use trial of allopurinol conducted in the United States from 1977 through 1989 included 718 evaluable patients with malignancies requiring treatment with cytotoxic chemotherapy who were unable to ingest or retain oral medication. Of these patients, 411 had established hyperuricemia and 307 had normal serum urate levels at the time that treatment was initiated. Normal serum uric acid levels were achieved in 68% of the former (reduction of serum uric acid was documented in 93%), and were maintained throughout chemotherapy in 97% of the latter. Because of the study design, it was not possible to assess the impact of the treatment with allopurinol on the clinical outcome of the patient groups.

16 HOW SUPPLIED/STORAGE AND HANDLING

Allopurinol for Injection is supplied in 30 mL flint glass single-dose vials. Each vial contains 500 mg of allopurinol as a sterile, white, lyophilized powder or cake for reconstitution.
NDC 68083-380-01
One vial per carton
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Discard unused portion.

17 PATIENT COUNSELING INFORMATION


Skin Rash and Hypersensitivity
Inform patients that allopurinol may increase the risk of serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and drug reaction with eosinophilia and systemic symptoms (DRESS). Instruct the patient to be alert for skin rash, blisters, fever or other signs and symptoms of these hypersensitivity reactions. Advise patients to stop the allopurinol immediately if they develop any type of rash and seek medical attention [see Warnings and Precautions (5.1)].
Renal Function Impairment
Advise patients to stay well hydrated (e.g., 2 liters of liquid per day) while taking allopurinol [see Warnings and Precautions (5.2)].
Hepatotoxicity
Advise patients of the risk of hepatotoxicity and to report any signs and symptoms of liver failure, including jaundice, pruritus, bleeding, bruising, or anorexia to their healthcare provider [see Warnings and Precautions (5.3)].
Myelosuppression
Advise patients of the risk of myelosuppression and to report any signs and symptoms of infection, fever, bleeding, shortness of breath, or significant fatigue to their healthcare provider [see Warnings and Precautions (5.4)].
Drowsiness
Inform patients that drowsiness has been reported in patients taking allopurinol and to be cautious when engaging in activities where alertness is mandatory [see Warnings and Precautions (5.5)].
Pregnancy
Advise pregnant women of the potential risk to a fetus. Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with allopurinol [see Use in Specific Populations (8.1)].
Lactation
Advise women not to breastfeed during treatment with allopurinol for one week after the last dose [see Use in Specific Populations (8.2)].
Manufactured by:
Gland Pharma Limited
D.P.Pally, Dundigal Post,
Hyderabad — 500043, INDIA
Revised: March 2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label:

NDC 68083-380-01

Allopurinol

for Injection

500 mg/vial
For Intravenous Infusion

Discard Unused Portion

Single-Dose Vial

Rx only Sterile

allopurinol-carton
(click image for full-size original)

Vial Label:

NDC 68083-380-01

Allopurinol

for Injection

500 mg/vial For Intravenous Infusion

Single-Dose Vial

Rx only Sterile

allopurinol-vial
(click image for full-size original)
ALLOPURINOL allopurinol injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-380
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALLOPURINOL SODIUM (ALLOPURINOL) ALLOPURINOL 500 mg in 25 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68083-380-01 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 25 mL in 1 VIAL, GLASS This package is contained within the CARTON (68083-380-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212363 01/26/2022
Labeler — Gland Pharma Limited (918601238)
Establishment
Name Address ID/FEI Operations
GLAND PHARMA LIMITED 918601238 ANALYSIS (68083-380), MANUFACTURE (68083-380), PACK (68083-380)

Revised: 03/2022 Gland Pharma Limited

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