CYCLOSPORINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)

Available from:

Padagis US LLC

INN (International Name):

CYCLOSPORINE

Composition:

CYCLOSPORINE 50 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclosporine is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents. Because of the risk of anaphylaxis, cyclosporine injection should be reserved for patients who are unable to take the soft gelatin capsules or oral solution. Cyclosporine injection is contraindicated in patients with a hypersensitivity to cyclosporine and/or Cremophor® EL (polyoxyethylated castor oil).

Product summary:

Cyclosporine Injection USP, 50 mg/mL FOR INTRAVENOUS INFUSION Supplied as a 5 mL sterile ampule containing 50 mg of cyclosporine per mL, in boxes of 10 ampules. (NDC 0574-0866 -10) Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. Discard unused portion. FOR INFUSION ONLY *Cremophor® is the registered trademark of BASF Aktiengesellschaft. Made in Canada Manufactured by: Jubilant HollisterStier General Partnership Kirkland, Quebec H9H 4J4 Canada Manufactured For Padagis Minneapolis, MN 55427 USA Rev 10-23

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOSPORINE- CYCLOSPORINE INJECTION, SOLUTION
PADAGIS US LLC
----------
CYCLOSPORINE INJECTION, USP
_FOR INFUSION ONLY_
RX ONLY
PRESCRIBING INFORMATION
WARNING
ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND
MANAGEMENT OF ORGAN TRANSPLANT PATIENTS SHOULD PRESCRIBE CYCLOSPORINE.
PATIENTS RECEIVING THE DRUG SHOULD BE MANAGED IN FACILITIES EQUIPPED
AND
STAFFED WITH ADEQUATE LABORATORY AND SUPPORTIVE MEDICAL RESOURCES. THE
PHYSICIAN RESPONSIBLE FOR MAINTENANCE THERAPY SHOULD HAVE COMPLETE
INFORMATION REQUISITE FOR THE FOLLOW-UP OF THE PATIENT.
CYCLOSPORINE SHOULD BE ADMINISTERED WITH ADRENAL CORTICOSTEROIDS BUT
NOT WITH OTHER IMMUNOSUPPRESSIVE AGENTS. INCREASED SUSCEPTIBILITY TO
INFECTION AND THE POSSIBLE DEVELOPMENT OF LYMPHOMA MAY RESULT FROM
IMMUNOSUPPRESSION.
DESCRIPTION
Cyclosporine, the active principle in cyclosporine injection, USP is a
cyclic polypeptide
immunosuppressant agent consisting of 11 amino acids. It is produced
as a metabolite
by the fungus species _Beauveria nivea_.
Chemically, cyclosporine is designated as
[_R_-[_R_*,_R_*-(_E_)]]-cyclic(L-alanyl-D-alanyl-_N_-
methyl-L-leucyl-_N-_methyl-L-leucyl-_N_-methyl-L-valyl-3-hydroxy-_N_,4-dimethyl-L-2-amino-6-
octenoyl-L-α-amino-butyryl-_N-_methylglycyl-_N_-methyl-L-leucyl-L-valyl-_N_-methyl-L-leucyl).
Cyclosporine injection, USP is available in a 5 mL sterile ampule for
intravenous (IV)
administration.
Each mL contains Cyclosporine USP, 50 mg; *Cremophor
EL (polyoxyethylated castor
oil), 650 mg; Absolute Alcohol, 32.9% (v/v). Cyclosporine injection,
USP must be diluted
further with 0.9% Sodium Chloride Injection or 5% Dextrose Injection
before use.
The chemical structure of cyclosporine (also known as cyclosporin A)
is
CLINICAL PHARMACOLOGY
Cyclosporine is a potent immunosuppressive agent, which in animals
prolongs survival
of allogeneic transplants involving skin, heart, kidney, pancreas,
bone marrow, small
intestine, and lung. Cyclosporine has been demonstrated to suppress
some humoral
immunity and to a greater extent, cell-mediated reac