TRETINOIN capsule, liquid filled

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)

Dostupné z:

Bryant Ranch Prepack

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Tretinoin Capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the PML/RARα gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline based chemotherapy is contraindicated. Tretinoin is for the induction of remission only. The optimal consolidation or maintenance regimens have not been defined, but all patients should receive an accepted form of remission consolidation and/or maintenance therapy for APL after completion of induction therapy with tretinoin. Tretinoin is contraindicated in patients with a known hypersensitivity to tretinoin, any of its components, or other retinoids.

Prehľad produktov:

Tretinoin Capsules are available as: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. PROTECT FROM LIGHT

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

TRETINOIN- TRETINOIN CAPSULE, LIQUID FILLED
BRYANT RANCH PREPACK
----------
TRETINOIN CAPSULES
RX ONLY
WARNINGS
1. EXPERIENCED PHYSICIAN AND INSTITUTION
Patients with acute promyelocytic leukemia (APL) are at high risk in
general and can
have severe adverse reactions to tretinoin. Tretinoin should therefore
be
administered only to patients with APL under the strict supervision of
a physician
who is experienced in the management of patients with acute leukemia
and in a
facility with laboratory and supportive services sufficient to monitor
drug tolerance
and protect and maintain a patient compromised by drug toxicity,
including
respiratory compromise. Use of tretinoin requires that the physician
concludes that
the possible benefit to the patient outweighs the following known
adverse effects
of the therapy.
2. RETINOIC ACID-APL SYNDROME
About 25% of patients with APL treated with tretinoin have experienced
a
syndrome called the retinoic-acid-APL (RA-APL) syndrome characterized
by fever,
dyspnea, acute respiratory distress, weight gain, radiographic
pulmonary infiltrates,
pleural and pericardial effusions, edema, and hepatic, renal, and
multi-organ failure.
This syndrome has occasionally been accompanied by impaired myocardial
contractility and episodic hypotension. It has been observed with or
without
concomitant leukocytosis. Endotracheal intubation and mechanical
ventilation have
been required in some cases due to progressive hypoxemia, and several
patients
have expired with multi-organ failure. The syndrome generally occurs
during the
first month of treatment, with some cases reported following the first
dose of
tretinoin.
The management of the syndrome has not been defined rigorously, but
high dose
steroids given at the first suspicion of the RA-APL syndrome appear to
reduce
morbidity and mortality. At the first signs suggestive of the syndrome
(unexplained
fever, dyspnea and/or weight gain, abnormal chest auscultatory
findings or
radiographic abnormalities), high dose steroids (dexamethasone 10 mg
intravenously