APOMORPHINE HYDROCLORIDE- apomorphine hydrochloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

APOMORPHINE HYDROCHLORIDE (UNII: F39049Y068) (APOMORPHINE - UNII:N21FAR7B4S)

Available from:

TruPharma, LLC

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Apomorphine hydrochloride injection is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) in patients with advanced Parkinson's disease. Apomorphine hydrocloride inejction has been studied as an adjunct to other medications [see Clinical Studies (14)] . Apomorphine hydrocloride is contraindicated in patients: - Using concomitant drugs of the 5HT3 antagonist class including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron [see Drug Interactions (7.1)] . There have been reports of profound hypotension and loss of consciousness when apomorphine hydrocloride was administered with ondansetron. - With hypersensitivity/allergic reaction to apomorphine or to any of the excipients of apomorphine hydrocloride, including a sulfite (i.e., sodium metabisulfite). Angioedema or anaphylaxis may occur [see Warnings and Precautions (5.12)]. Risk Summary There are no adequate data on the developmenta

Product summary:

Apomorphine hydrocloride injection is supplied as a clear, colorless, sterile solution in cartridges, 30 mg/3 mL (10 mg/mL), for single-patient-use with a pen injector (APOKYN® Pen). The APOKYN® Pen is supplied separately by a different manufacturer. NDC 52817-720-05  Cartons of five 3 mL cartridges Store at 25°C (77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

APOMORPHINE HYDROCLORIDE- APOMORPHINE HYDROCHLORIDE INJECTION
TRUPHARMA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
APOMORPHINE
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
APOMORPHINE HYDROCHLORIDE INJECTION.
APOMORPHINE HYDROCHLORIDE INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Warnings and Precautions, Hypotension/Orthostatic Hypotension (5.4)
05/2019
Warnings and Precautions, QTc Prolongation and Potential for
Proarrhythymic Effects (5.10)
04/2020
Warnings and Precautions, Hypersensitivity (5.12)
05/2019
Warnings and Precautions, Melanoma removal (5.13)
05/2019
INDICATIONS AND USAGE
Apomorphine hydrocloride injection is a non-ergoline dopamine agonist
indicated for the acute,
intermittent treatment of hypomobility, "off" episodes ("end-of-dose
wearing off" and unpredictable "on/off"
episodes) associated with advanced Parkinson's disease (1)
DOSAGE AND ADMINISTRATION
For subcutaneous use only (2.1)
Always express apomorphine hydrocloride dose in mL to minimize dosing
errors (2.1)
The starting dose of apomorphine hydrocloride is 0.2 mL (2 mg); give
the first dose under medical
supervision; titrate the dose to effect and tolerance; the maximum
recommended dose is 0.6 mL (2.3)
Treatment with a concomitant antiemetic, e.g., trimethobenzamide, is
recommended, starting 3 days
prior to the first dose of apomorphine hydrocloride. Treatment with
trimethobenzamide should only be
continued as long as necessary to control nausea and vomiting, and
generally no longer than two
months (2.2, 5.2, 6.1, 17)
Apomorphine hydrocloride doses must be separated by at least 2 hours
(2.5)
Renal impairment: reduce test dose, and reduce starting dose to 0.1 mL
(1 mg) (2.4, 8.6, 12.3)
DOSAGE FORMS AND STRENGTHS
Injection; 30 mg/3 mL (10 mg/mL) as a clear, colorless, sterile
solution available in single-patient-use
cartridges (3, 16)
CONTRAINDICATIONS
Concomitant use of apomorphine hydroclo