PLATINOL-AQ- cisplatin injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

cisplatin (UNII: Q20Q21Q62J) (cisplatin - UNII:Q20Q21Q62J)

Available from:

Corden Pharma Latina S.p.A.

INN (International Name):

cisplatin

Composition:

cisplatin 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PLATINOL-AQ (cisplatin injection) is indicated as therapy to be employed as follows: In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of PLATINOL-AQ and cyclophosphamide. PLATINOL-AQ, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received PLATINOL-AQ therapy. PLATINOL-AQ is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy. PLATINOL-AQ is contraindicated in patients with preexisting renal impairme

Product summary:

PLATINOL® -AQ (cisplatin injection) NDC 61126-004-01—Each multidose vial contains 50 mg of cisplatin NDC 61126-004-02—Each multidose vial contains 100 mg of cisplatin

Authorization status:

New Drug Application

Summary of Product characteristics

PLATINOL-AQ- CISPLATIN INJECTION, SOLUTION
CORDEN PHARMA LATINA S.P.A.
----------
PLATINOL -AQ
(CISPLATIN INJECTION)
RX ONLY
WARNING
PLATINOL-AQ (cisplatin injection) should be administered under the
supervision of a qualified
physician experienced in the use of cancer chemotherapeutic agents.
Appropriate management of
therapy and complications is possible only when adequate diagnostic
and treatment facilities are
readily available.
Cumulative renal toxicity associated with PLATINOL-AQ is severe. Other
major dose-related
toxicities are myelosuppression, nausea, and vomiting.
Ototoxicity, which may be more pronounced in children, and is
manifested by tinnitus, and/or loss
of high frequency hearing and occasionally deafness, is significant.
_Anaphylactic-like_ reactions to PLATINOL-AQ have been reported.
Facial edema,
bronchoconstriction, tachycardia, and hypotension may occur within
minutes of PLATINOL-AQ
administration. Epinephrine, corticosteroids, and antihistamines have
been effectively employed to
alleviate symptoms (see WARNINGS and ADVERSE REACTIONS sections).
EXERCISE CAUTION TO PREVENT INADVERTENT PLATINOL-AQ OVERDOSE. Doses
greater than 100
mg/m /cycle once every 3 to 4 weeks are rarely used. Care must be
taken to avoid inadvertent
PLATINOL-AQ overdose due to confusion with PARAPLATIN (carboplatin) or
prescribing
practices that fail to differentiate daily doses from total dose per
cycle.
DESCRIPTION
PLATINOL -AQ (cisplatin injection) infusion concentrate is a clear,
colorless, sterile aqueous
solution available in amber vials. Each 50 mL or 100 mL amber vial of
infusion concentrate contains: 1
mg/mL cisplatin, 9 mg/mL sodium chloride, hydrochloric acid and sodium
hydroxide to approximate pH
of 4.0, and water for injection to a final volume of 50 mL or 100 mL,
respectively.
PLATINOL -AQ (cisplatin injection) infusion concentrate must be
further diluted prior to
administration (see DOSAGE AND ADMINISTRATION: ALL PATIENTS).
The active ingredient, cisplatin, is a yellow to orange crystalline
powder with the