HIGHLIGHTS OF PRESCRIBING INFORMATION

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

methotrexate (UNII: YL5FZ2Y5U1) (methotrexate - UNII:YL5FZ2Y5U1)

Available from:

Cumberland Pharmaceuticals Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

RediTrex is indicated in the management of selected adults with severe, active rheumatoid arthritis (RA) (ACR criteria), or children with active polyarticular juvenile idiopathic arthritis (pJIA), who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs). RediTrex is indicated in adults for the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis "flare" is not due to an undiagnosed concomitant disease affecting immune responses. RediTrex is not indicated for the treatment of neoplastic diseases. RediTrex is contraindicated in the following: - Pregnancy RediTrex can cause embryo-fetal toxicity and fetal death when administered during pregnancy. [see Warnings and Precaut

Product summary:

RediTrex contains methotrexate in a preservative-free sterile solution for a single subcutaneous injection. RediTrex is available in the following strengths and configurations. RediTrex 7.5 mg/0.3 mL RediTrex 10 mg/0.4 mL RediTrex 12.5/0.5 mL RediTrex 15 mg/0.6 mL RediTrex 17.5 mg/0.7 mL RediTrex 20 mg/0.8 mL RediTrex 22.5 mg/0.9 mL RediTrex 25 mg/mL Store between 20˚C to 25˚C (68˚F to 77˚F); excursions permitted to 15˚C to 30˚C (59˚F to 86˚F). PROTECT FROM LIGHT (keep in carton until the time of use). Handling and Disposal Handle and dispose of RediTrex consistent with recommendations for handling and disposal of cytotoxic drugs.1

Authorization status:

New Drug Application

Summary of Product characteristics

REDITREX- METHOTREXATE INJECTION, SOLUTION
CUMBERLAND PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REDITREX® SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR REDITREX.
REDITREX (METHOTREXATE) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1953
WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY AND
DEATH
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SERIOUS TOXIC REACTIONS AND DEATH HAVE BEEN REPORTED WITH THE USE OF
METHOTREXATE.
PATIENTS SHOULD BE CLOSELY MONITORED FOR BONE MARROW, LIVER, LUNG,
SKIN, AND KIDNEY
TOXICITIES (5.1).
METHOTREXATE CAN CAUSE EMBRYO-FETAL TOXICITY, INCLUDING FETAL DEATH.
USE IS
CONTRAINDICATED DURING PREGNANCY (4). ADVISE MALES AND FEMALES OF
REPRODUCTIVE
POTENTIAL TO USE EFFECTIVE CONTRACEPTION DURING AND AFTER TREATMENT
WITH
METHOTREXATE (5.2, 8.1, 8.3).
UNEXPECTEDLY SEVERE (SOMETIMES FATAL) BONE MARROW SUPPRESSION,
APLASTIC ANEMIA,
AND GASTROINTESTINAL TOXICITY HAVE BEEN REPORTED WITH CONCOMITANT
ADMINISTRATION OF
METHOTREXATE (USUALLY IN HIGH DOSAGE) ALONG WITH SOME NONSTEROIDAL
ANTI-
INFLAMMATORY DRUGS (NSAIDS) (5.1).
HEPATOTOXICITY, FIBROSIS, AND CIRRHOSIS MAY OCCUR AFTER PROLONGED USE
(5.1).
METHOTREXATE MAY CAUSE INTERSTITIAL PNEUMONITIS AT ANY TIME DURING
THERAPY AND HAS
BEEN REPORTED AT LOW DOSES. PULMONARY SYMPTOMS (ESPECIALLY A DRY,
NONPRODUCTIVE
COUGH) MAY REQUIRE INTERRUPTION OF TREATMENT AND CAREFUL INVESTIGATION
(5.1).
DIARRHEA, ULCERATIVE STOMATITIS, HEMORRHAGIC ENTERITIS, AND DEATH FROM
INTESTINAL
PERFORATION MAY OCCUR (5.1).
SEVERE, OCCASIONALLY FATAL, SKIN REACTIONS HAVE BEEN REPORTED (5.1).
POTENTIALLY FATAL OPPORTUNISTIC INFECTIONS MAY OCCUR (5.1).
INDICATIONS AND USAGE
RediTrex is a folate analog metabolic inhibitor indicated for the:
Management of patients with severe, active rheumatoid arthritis (RA)
and polyarticular juvenile
idiopathic arthritis (pJIA), who are intolerant of or had an
inadequate response to first-line t